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Respiratory Syncytial Virus (RSV) Vaccines 2025

The World Health Organization (WHO) continues to prioritize the development of safe and effective vaccines against the respiratory syncytial virus. Since the 1960s, researchers have studied RSV vaccine candidates. Over many years, various strategies have been pursued to develop an effective and safe RSV vaccine, including inactivated virus preparations, live attenuated or ated/genetically engineered viruses, purified RSV protein subunit vaccine preparations, vector-based vaccine candidates, and DNA-based vaccines.

As of August 2025, the U.S. Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), Canada, Japan, the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Germany, and the European Commission (EC) recommend certain adults and pregnant women receive a single dose of an approved RSV vaccine based on specific conditions. On June 25, 2025, the CDC's Advisory Committee on Immunization Practices met and reviewed Maternal/Pediatric RSV immunization options.

On December 12, 2024, the FDA's Vaccines and Related Biological Products Advisory Committee reviewed various presentations on the effectiveness of RSV in pediatrics. On June 26, 2024, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended that most adults aged 60 and older receive an RSV vaccination. For the 2024-2025 respiratory virus season, the CDC recommends that everyone ages 75 and older receive the RSV vaccine an,d people ages 60–74 who are at increased risk of severe RSV, meaning they have certain chronic medical conditions, such as lung or heart disease, or they live in nursing homes, receive the RSV vaccine. As of September 2024, approximately 34% of seniors (aged 75 and above) had received an RSV vaccination.

RSV Vaccines Approved in the U.S.

AREXVY™ RSV vaccine is approved for adults. AREXVY became available in U.S. pharmacies on August 17, 2023. 

ABRYSVO™ RSVpreF, an RSV bivalent vaccine from Pfizer Inc., received approval from the US FDA and European Commission for older adults and pregnant women in 2023.

mRESVIA® mRNA-1345 is a vaccine against RSV developed by ModernaTX, Inc. It is approved for use in the United States and is recommended in Europe.

RSV Vaccination Risk of Guillain-Barré Syndrome

On January 7, 2025, the FDA required and approved safety labeling changes to the Prescribing Information for Abrysvo and Arexvy. Each manufacturer must now include a new warning about the risk of Guillain-Barré syndrome (GBS), a rare neurological disorder in which the immune system mistakenly attacks part of the peripheral nervous system. The FDA noted that the benefits of vaccination with Abrysvo and Arexvy still outweigh the risk. A U.S. CDC MMWR confirmed on May 30, 2024, that GBS was identified as a potential safety concern (Abrysvo 4.4 per million) in clinical trials. On February 29, 2024, the ACIP meeting reviewed the efficacy of the RSV vaccine and discussed GBS Risk Analysis, benefits and risks, as well as ACIP Work Group interpretations and debate.

RSV Vaccination Rate USA

According to the US CDC's RSVVaxView, the overall RSV vaccination rate among pregnant women was about 17.8% as of 2024. As of May 22, 2024, 24.4% of adults 60 years and older were estimated to have received an RSV vaccine. Across the U.S., receipt of an RSV vaccine was lowest in Mississippi, 14.2%, and highest in Colorado, 32.2%.

RSV Vaccine Effectiveness

The JAMA Network published a Research Letter on September 4, 2024, concluding VE against RSV-associated hospitalization was 75% (95% confidence interval: 67% to 87%).

RSV Vaccine Candidates 2025

In early 2025, the RSV immunization development landscape remained active. Thirty candidates were in clinical development using protein-based, live-attenuated, chimeric vectors and mRNA approaches. Various pharmaceutical companies are conducting phase 3 clinical trials on RSV vaccine candidates.

Clover Biopharmaceuticals, Ltd. announced on March 24, 2025, IND clearance by the U.S. FDA and that enrollment of the first participants has been completed in a Phase I revaccination clinical trial evaluating SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate based on Clover's Trimer-Tag vaccine technology platform. 

Vaxxas utilizes a next-generation vaccine antigen (DS2) developed by NIH scientists to elicit a more robust and durable immune response against RSV compared to the antigen used in globally approved vaccines (DS-Cav1). Vaxxas' proprietary HD-MAP offers the potential for needle-free vaccination.

CSPC Pharmaceutical Group Limited's mRNA RSV vaccine candidate, SYS6016, is currently conducting clinical trials in China.

Icosavax/AstraZeneca's IVX-121, a vaccine candidate for RSV and hMPV, incorporates a stabilized prefusion F antigen licensed from the NIAID/NIH (DS-CAV1). VLP technology further enhances the response's magnitude, quality, and durability against the prefusion RSV F. Currently, there are no treatments or preventive therapies for hMPV, and no combination vaccines are available for RSV. In a Phase 1 trial, IVX-A12 induced robust immune responses against RSV and hMPV at Day 28 in older adults across various dosage levels, both with and without adjuvant. The ongoing Phase 2 clinical trial of IVX-A12 results include IVX-A12-induced geometric mean titers (GMTs) in RSV-A neutralizing antibody titers (nAbs) of approximately 12,200 IU/mL, compared to approximately 2,000 IU/mL for the placebo at Day 28. IVX-A12 induced GMTs in RSV-B nAbs of approximately 5,500 IU/mL compared to approximately 1,300 IU/mL for placebo at Day 28; IVX-A12 induced GMTs in hMPV-A nAbs of approximately 1,600 assay units/mL compared to approximately 400 assay units/mL for placebo at Day 28. IVX-A12 induced GMTs in hMPV-B nAbs of approximately 15,300 assay units/mL compared to approximately 6,700 assay units/mL for placebo at Day 28. No standardized international units exist in the field for hMPV.

Clover Biopharmaceuticals, Ltd. SCB-1019 is a bivalent RSV-A/RSV-B vaccine candidate based on the prefusion-stabilized F (PreF) protein. It leverages the validated Trimer-Tag platform and proprietary stabilizing PreF mutations. On June 18, 2024, Clover announced positive preliminary immunogenicity and safety data from its Phase 1 clinical trial evaluating SCB-1019 in the older adult and elderly cohort.

Codagenix Inc.'s CodaVax™-RSV is an intranasal, live-attenuated vaccine candidate for preventing RSV infection, which has received the US FDA Fast Track designation and has launched two Phase 1 studies. A pediatric Phase 1 study evaluating CodaVax has an age-de-escalation, dose-escalation design designed to assess safety and immunogenicity in the 6-month-to-5-year-old population.

Meissa Vaccines MV-012-968 is an investigational, live-attenuated vaccine that protects against RSV. Meissa's intranasal live attenuated MV-012-968 vaccine candidate elicits a systemic and solid mucosal IgA antibody response in RSV-naïve children. As of August 8, 2023, 100% of RSV-naïve infants and toddlers responded to two doses of 107 PFU of MV-012-968. Safety data indicate that MV-012-968 is well-tolerated and highly attenuated, with no serious adverse events related to the vaccine reported, no Grade 2 or 3 fever, and low levels of transient vaccine virus shedding detected at the highest doses.

ResVax is a vaccine candidate from Novavax composed of recombinant RSV F nanoparticles adsorbed to aluminum phosphate. The F protein is essential to RSV infectivity and is the target of palivizumab.

DS-Cav1 was developed by VRC, NIAID, and is composed of the RSV fusion glycoprotein ectodomain assembled as a trimer stabilized in its prefusion native conformation with a foldon trimerization domain at the C-terminus and four internal mutations designated DS-Cav1 (4.1DHFR_RSVAF).

Ad26.RSV preF vaccine is a protein-based RSV vaccine candidate tested in adults produced by Pfizer, Inc.

EDP-938, Enanta's lead N-protein inhibitor, is being developed to treat RSV infection and was granted Fast Track Designation by the US FDA.

Icosavax Inc. IVX-A12 is a bivalent (RSV/hMPV) formulation, incorporating single and multiple hMPV dosage levels in older adults 60 and above. The FDA granted Fast Track designation for IVX-A12 on February 21, 2023.

Artificial Cell Technologies, Inc. developed a fully synthetic microparticle RSV vaccine candidate. 

Calder Biosciences will evaluate DT-preF, its lead RSV vaccine candidate.

RSV/6120/ΔNS2/1030s is a live-attenuated intranasal RSV vaccine candidate containing a deletion of the interferon antagonist NS2 gene and a genetically stabilized temperature-sensitivity mutation in the polymerase gene. It was infectious and induced primary neutralizing serum antibody responses and potent memory antibody responses, n6-- to 24-month-old RSV-seronegative children, but it may be associated with rhinorrhea.

Immorna Biotherapeutics Inc. JCXH-108 is a monovalent RSV vaccine developed using the company's proprietary mRNA and RTU-LNP technologies.

Vicebio Ltd. initiated a Phase I clinical trial with VXB-241, its bivalent vaccine targeting RSV and hMPV. Initial clinical readouts from the Phase 1 study are expected to be released in mid-2025.

AIM Vaccine Co., Ltd. developed an mRNA RSV vaccine.

RSV Vaccines in China

RSV therapeutic candidates are in mainland China, Hong Kong, Macau, and Singapore. Sisunatovir is being evaluated for potentially treating RSV infection in pediatric and adult patients. Pfizer Inc. and LianBio announced on December 19, 2022, that Pfizer opted to develop and commercialize sisunatovir  (RV521). The US FDA granted Sisunatovir Fast Track Designation. Additionally, it is being evaluated in a Phase 2 clinical study in children. On November 14, 2022, Nuance Pharma announced that China's Center for Drug Evaluation had approved its application, supporting the pivotal Phase III MVA-BN RSV vaccine clinical trial.

RSV Vaccine Coadministration With Influenza Vaccine

According to the US CDC, the available data on the immunogenicity of coadministering RSV and other vaccines is currently limited. The US CDC presented the following coadministration information on September 19, 2023: There is currently limited data on the immunogenicity of coadministration of RSV and other vaccines. In general, the coadministration of RSV and seasonal influenza vaccines met noninferiority criteria for immunogenicity. However, RSV and influenza antibody titers were generally somewhat lower with coadministration; the clinical significance of this is unknown. Additional studies on the immunogenicity of coadministration of RSV with other adult vaccines are being conducted. A draft, revised vaccine schedule addendum was presented on September 22, 2023.

RSV Vaccination Timing

The CDC confirmed in January 2024 that most of the continental United States could administer the maternal RSV vaccine from September through January 31. However, in jurisdictions where seasonality differs from that of most of the continental United States, such as Alaska, southern Florida, Guam, Hawaii, Puerto Rico, the US-affiliated Pacific Islands, and the U.S. Virgin Islands, healthcare providers should follow state, local, or territorial guidance on the timing of administering the RSV vaccine (Pfizer Abrysvo) for pregnant women.

RSV Vaccine Price

The global RSV Therapeutics Market Size is estimated to reach approximately $836 million by 2028, exhibiting a compound annual growth rate (CAGR) of 5.76%. Additional RSV vaccine and treatment price information is posted at InstantRx™.

RSV Vaccine Market Size USA

Data provider Airfinity indicates the U.S. market for RSV vaccines in elderly adults in 2023 totaled about $2.4 billion. Affinity expects 2024 revenues to decline slightly to $2.2 billion and forecasts RSV vaccine sales to be about $1.7 million annually by 2030.

RSV Monoclonal Antibody

As of January 2025, the US FDA approved RSV monoclonal antibody therapies for children. The WHO SAGE recommends that all countries introduce passive immunization to prevent severe RSV disease in young infants.

RSV Vaccination Pre-Term Births

WHO's SAGE reported in September 2024 that there were no serious adverse events in the vaccinated women. However, an excess in pre-term births was observed in the vaccine group. This non-statistically significant imbalance was observed in trial sites in two upper-middle-income countries but not in other settings. To mitigate the potential risk of pre-term births, SAGE considered narrowing the gestational age for maternal RSV vaccination. For countries deciding to use the maternal vaccine to prevent severe RSV disease in infants, SAGE recommends a single dose of vaccine in the third trimester of pregnancy.

Avigan (Favipiravir) Antiviral Description For 2022

Avigan (Favipiravir) (T-705) (Reeqonus) Tablet is a pyrazinecarboxamide derivative with activity against RNA viruses. Host enzymes convert Favipiravir to the ribofuranosyltriphosphate derivative and selectively inhibit the influenza viral RNA-dependent RNA polymerase.

Avigan (Favipiravir) was approved for manufacture and sale in Japan in 2014 as an influenza antiviral. However, Avigan is considered for use only when there is an outbreak of novel or re-emerging influenza virus infections.

Favipiravir-based drugs are sold worldwide, such as Avigan, FabiFlu, Avifavir, Favijaj, Ciplenza, FluGuard, Avifavir, Coronavir, and Reeqonus in Canada.

Avigan undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate) is recognized as a substrate RdRp and inhibits the RNA polymerase activity, and is a pyrazinecarboxamide derivative. Favipiravir-RTP is a nucleoside analogue. It mimics both guanosine and adenosine for the viral RdRP.

Since the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action underpins a broader spectrum of antiviral activities of favipiravir.

The active favipiravir-RTP selectively inhibits RNA polymerase and prevents replication of the viral genome. In addition, studies have shown that favipiravir-RTP is incorporated into a nascent RNA strand prevents RNA strand elongation and viral proliferation. Studies have also found that the presence of purine analogs can reduce favipiravir's antiviral activity, suggesting competition between favipiravir-RTP and purine nucleosides for RdRp binding.

Toyama Chemical Co., Ltd. discovered Avigan (favipiravir), which selectively inhibits RNA polymerase necessary for influenza virus replication. Due to this mechanism of action, it is expected that Avigan may potentially have an antiviral effect on the new coronavirus, SARS-CoV-2, because, like influenza viruses, coronaviruses are single-stranded RNA viruses that also depend on viral RNA polymerase.

Glenmark Pharmaceuticals confirmed on September 15, 2021, a prospective, open-label, multicentre, single-arm phase 4 study of Favipiravir showed that fever resolution was four days, while the time for a clinical cure was seven days. And, no new safety signals or concerns with the use of Favipiravir, and already-known side effects were found to be mild.

Appili Therapeutics Inc. announced that the Phase 3 PRESECO clinical trial evaluating oral antiviral Avigan (Reeqonus) (favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery.

Favipiravir Accession Number: DB12466; Chemical Formula: C5H4FN3O2; ATC code: J05AX27 

Avigan (Favipiravir) Antiviral History

On September 23, 2020, Fujifilm Toyama Chemical Co. announced a small phase III trial in Japan, which began in March 2020, was now complete. It intends to apply the medication to be approved for treating coronavirus patients after trials showed it could shorten recovery time. In this study, the median value of primary endpoints, using 156 individuals as analysis targets, was 11.9 days for the Avigan group and 14.7 days for the placebo group. FUJIFILM Toyama Chemical confirmed, with a statistically significant difference (p-value = 0.0136), that the administration of Avigan to COVID-19 patients with non-serious pneumonia demonstrates a shorter time to resolution. The adjusted hazard ratio*2 showed 1.593 (95% confidence interval of 1.024 – 2.479). No new safety concerns were noted in this trial.

Previously, Fujifilm signed a patent license agreement on its anti-influenza medication Avigan (favipiravir) Tablet with China's significant pharmaceutical Company Zhejiang Hisun Pharmaceutical in June 2016.

On June 1, 2020, Avifavir (Favipiravir) received a temporary registration certificate from the Ministry of Health of the Russian Federation, which has included Avifavir in its latest 7th edition of the prevention guidelines diagnosis, and treatment of new coronavirus infection COVID-19. Starting June 10, 2020, Avifavir was delivered to more than 50 Russian regions and Belarus and Kazakhstan.

Favipiravir-based drugs, such as Coronavir, have demonstrated efficacy in clinical trials held in the leading medical centers across Russia, involving patients with confirmed cases of COVID-19. The drugs disrupt the coronavirus's reproduction mechanisms, relieve symptoms, and halve the treatment period compared to standard therapy.

On July 13, 2020, Glenmark Pharmaceuticals announced that it would lower the price of its generic version of favipiravir, FabiFlu, to 75 rupees ($0.9983) per tablet. This indicates a treatment course with FabiFlu would require a patient to take 122 tablets over 14 days and will now cost 8,475 rupees ($112.80) per patient at the new price.

Glenmark reported results from a phase 3 trial on July 22, 2020, that showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding virus in the Favipiravir treatment arm. In addition, Glenmark's Favipiravir was well tolerated with no serious adverse events or fatalities in the Favipiravir-treated arm.

Avigan is not approved for distribution in the USA by the U.S. FDA.

FUJIFILM Toyama Chemical Co., Ltd. is located at 14-1, Kobayashi 2-Chome, Chuo-Ku, Tokyo 104-0031 Japan. The Drugbank Accession Number is DB12466.

Avigan (Favipiravir) Antiviral Indication

Avigan (favipiravir) (REEQONUS) is effective against a wide range of types and subtypes of influenza viruses, including strains resistant to existing anti-influenza drugs, says a study published by the U.S. NIH.

Of note is that favipiravir shows antiviral activities against other RNA viruses such as arenaviruses, bunyaviruses, and filoviruses, all known to cause fatal hemorrhagic fever. These unique antiviral profiles will make Avigan a potentially promising drug for specifically untreatable RNA viral infections. The main advantages of favipiravir are that it is administered orally. Thus, it can be given in patients who are symptomatic but not ill enough to be hospitalized, stated a study published in September 2020. Favipiravir has been investigated to treat life-threatening pathogens such as the Ebola virus and Lassa virus.

Avigan (Favipiravir) Antiviral Indication For COVID-19

Appili Therapeutics Inc. announced on November 12, 2021, that the Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial evaluating oral antiviral  Avigan / Reeqonus(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery.

eBioMedicine published a study on September 23, 2021, The combined treatment of Molnupiravir and Favipiravir results in a potentiation of antiviral efficacy in a SARS-CoV-2 hamster infection model. When animals were treated with a combination of suboptimal doses of Molnupiravir and Favipiravir at the time of infection, a marked combined potency at the endpoint is observed. 

On September 15, 2021: Glenmark Pharmaceuticals announced the successful completion of its Post Marketing Surveillance study on Favipiravir (FabiFlu®) in India. The time for fever resolution was 4 days, while the time for a clinical cure was 7 days.

On June 19, 2020, Glenmark Pharmaceutical became the first Company in India to receive restricted emergency use approval from India's drug regulator for FabiFlu®, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The mortality rate in the Favipiravir study group was approximately 30% less than the control group when used early in the treatment of a SARS-CoV-2 virus infection, reported the journal Nature on May 26, 2021.

Avigan (Favipiravir) Antiviral Availability For 2022

Cellvera holds directly, or through its affiliates worldwide (excluding Japan), exclusive rights to Avigan® and all strengths and formulations of Favipiravir, as of January 24, 2022. Regulators authorized Avigan® in several markets to treat COVID-19 and/or influenza, including Japan, Malaysia, Thailand, United Arab Emirates, Indonesia, Mexico, and India. Several other countries purchase it on a compassionate patient basis, including the United Kingdom, Greece, Hungary, and Saudi Arabia. The governments of those countries have ordered a total of 80m tablets in the past 12 months.

On July 12, 2021, FDC Limited announced the launch of India's first oral suspension of Favipiravir – Favenza Oral Suspension, used to treat mild to moderate cases of COVID-19. This prescription-only solution is currently available at all retail, medical outlets, and hospital pharmacies across the country.

Avigan (Favipiravir) Antiviral Dosage

As an influenza antiviral drug approved for manufacture and sale in Japan, Avigan (Favipiravir) selectively inhibits RNA polymerase necessary for influenza virus replication. The dosage of Avigan to treat COVID-19 disease patients is currently being evaluated in various clinical studies. For example, in a phase 2 study in Boston, Massachusetts, Aviagn tablets are being evaluated: on the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of ten days for oral administration of the drug.

However, reports indicate Avigan cannot be administered to expecting mothers or those who may become pregnant. On September 2, 2020, a study from India found that the drug's side-effect profile also seems acceptable, with asymptomatic hyperuricemia and mild, reversible elevation in transaminases being the most frequently reported adverse effects. In the Indian trial, no special safety signal was elicited. However, it is teratogenic and must never be used in pregnant women.

The main disadvantage is a high pill burden, which works out to a loading dose of 18-tablets on the first day and then 8-tablets a day for the rest of the course.

Avigan (Favipiravir) Antiviral Side Effects

A CLINICAL COMMENTARY was published on January 21, 2022: Angioedema after favipiravir treatment: Two cases. Clinicians should be careful about the side effects and possible skin manifestations, especially including angioedema, related to the use of favipiravir.

Dove Press published a study on July 30, 2021, that included, 'Favipiravir is a prodrug converted to favipiravir-RTP, an active form of ribofuranosyl-5-triphosphate that competes for polymerase active binding sites. Favipiravir is capable of inhibiting the RdRp enzyme of RNA viruses like influenza.'

Avigan (Favipiravir) Antiviral News For 2015 - 2022

March 11, 2022 - Fujifilm Holdings Corp announced it was halting enrolment in the phase 3 clinical trial of Avigan. With the recent spread of the Omicron variant that has lower symptom severity rates than conventional strains, and the assumption that a vast majority of patients who had recently been enrolled in the trial having infected by the Omicron strain, Fujifilm decided that, even if trials were continued under the current clinical trial protocol, it would be difficult to verify Avigan’s efficacy to suppress the symptoms from becoming severe, and that continuation of the placebo control trial would not lead to the subjects’ benefits. 

January 24, 2022 - Cellvera announced a supply of millions of its COVID-19 oral antiviral Avigan to Malaysia in the coming weeks. Favipiravir works by inhibiting a viral enzyme called RNA polymerase, preventing viral replication within human cells. This viral enzyme is common to several viruses, including SARS-CoV-2, which causes COVID-19.

November 12, 2021 - “While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19,” said Dr. Armand Balboni, CEO, Appili Therapeutics.

November 5, 2021 - National Geographic published an article: How the rise of antivirals may change the course of the pandemic.

November 3, 2021 - The journal Nature published an article - In a bid to stave off looming disaster, scientists are trying to repurpose drugs used for malaria and other diseases, but infrastructure and recruitment challenges stymie progress.

October 28, 2021 - AiPharma owned Global Response Aid and Pharmax announced they have partnered to supply Avigan (Favipiravir) in the UAE. Favipiravir was added to the list of approved therapeutics in the Dubai Health Authority's National Guidelines for Clinical Management and Treatment of COVID-19 in June 2020.

October 14, 2021 - Appili Therapeutics (TSX: APLI) announced the closing of a Public Offering of $7,000,220. Dr. Armand Balboni, CEO, Appili Therapeutics, commented, "With the COVID-19 pandemic continuing to evolve, the need for at-home oral antivirals remains urgent. As Appili rapidly approaches the top-line readout from our Phase 3 PRESECO trial, which is evaluating the oral antiviral Avigan®/Reeqonus™ (favipiravir) for the treatment of mild-to-moderate COVID-19, this funding will support us as we move aggressively to deliver this critically needed medicine and hopefully change the trajectory of this pandemic."

September 29, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) and AiPharma Global Holdings LLC announced a strategic alliance to advance the global development of Avigan® / Reeqonus™ (favipiravir).

September 20, 2021 - Appili Therapeutics Inc. announced it entered into an agreement with FUJIFILM Toyama Chemical Co., Ltd., that will provide funding support for its Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial. The new funding of $1,000,000 USD was secured from FFTC, one of the Company's partners in a global consortium focused on the worldwide development, commercialization, and distribution of Avigan®/Reeqonus™ (favipiravir) tablets for the potential treatment and prevention of COVID-19.

September 17, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) announced it has completed patient enrollment in the viral shedding sub-study portion of its Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral antiviral COVID-19 treatment in the USA. The viral shedding sub-study is designed to identify COVID-19 variants in study patients and evaluate the direct antiviral effect of favipiravir against the SARS-CoV-2 virus, including recent and emerging variants. 

September 15, 2021 - Glenmark Pharmaceuticals announced the successful completion of its Post Marketing Surveillance phase 4 study on Favipiravir (FabiFlu®) in India. The study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1,083 patients were enrolled in the prospective, open-label, multicentre, single-arm study. Results showed no new safety signals or concerns with the use of Favipiravir.

August 8, 2021 - Thailand's Department of Medical Services Public Health Ministry decided to administer Favipiravir to more groups of Covid-19 patients and is planning to stockpile 420 million tablets of the drug, reported local media.

July 7, 2021 - The Indonesian Food and Drug Supervisory Agency granted an emergency permit to use Avigan to treat COVID-19 patients.

June 24, 2021 - Appili Therapeutics Inc. announced in a press statement: "We are encouraged that an independent Data and Safety Monitoring Board has recommended continuation without modification of Appili's ongoing Phase 3 PRESECO trial evaluating Avigan® / Reeqonus™ (favipiravir). We look forward to the completion of the PRESECO trial and are hopeful that Avigan/Reeqonus will emerge as one of the first prescription oral medicine for newly diagnosed patients with COVID-19," commented Dr. Balboni. 

June 17, 2021 - Appili Therapeutics Inc. has added several clinical research sites in Mexico and Brazil to its Phase 3 clinical trial evaluating Avigan® / Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. The expansion into Mexico and Brazil will ensure timely completion of this pivotal trial and reaffirm favipiravir as one of the most advanced oral COVID-19 antiviral candidates in development, with top-line data expected in Q3 2021.

June 14, 2021 - Ireland-based AiPharma announced a production and distribution deal for China and the Russian Federation with FUJIFILM for its influenza antiviral drug Avigan® for COVID-19.

June 8, 2021 - Glenmark Pharmaceuticals announced interim data of 503 patients from its Post Marketing Surveillance study on Favipiravir (FabiFlu) in India. The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day 7. The study commenced in July 2020 aimed to evaluate the safety and efficacy of Favipiravir in mild to moderate Covid-19 patients. A total of 1,083 patients have been enrolled in the prospective, open-label, multicenter, single-arm study. A total of 13 sites – both Government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum took part. Glenmark's interim data to the regulator reveals no new safety signals or concerns using Favipiravir and already-known side effects such as weakness, gastritis, diarrhea, vomiting, etc., which were found to be mild in nature. The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day 7.

June 7, 2021 - India's Union health and family welfare ministry revised the Covid-19 treatment guidelines and removed the use of the antiviral drug favipiravir from its list of advised treatment.

May 27, 2021 - BMC published: Favipiravir for treating patients with COVID-19: a systematic review and meta-analysis. Conclusions - Favipiravir induces viral clearance by 7 days and contributes to clinical improvement within 14 days. The results indicated that favipiravir is strongly capable of treating COVID-19, especially in patients with the mild-to-moderate illness. However, additional well-designed studies, including examinations of the dose and duration of treatment, are crucial for reaching definitive conclusions.

May 26, 2021 - The journal Nature published a study: The efficacy and safety of Favipiravir in treatment of COVID-19: a systematic review and meta-analysis of clinical trials. Finding: The mortality rate in the Favipiravir group was approximately 30% less than the control group, but this finding was not statistically significant. Favipiravir possibly exerted no significant beneficial effect in the term of mortality in the general group of patients with mild to moderate COVID-19. We should consider that perhaps the use of antiviral once the patient has symptoms is too late, which would explain their low efficacy in the clinical setting.

May 22, 2021 - India-based Bharat Parenterals confirmed it received approval from the Drugs Controller General of India for favipiravir l00mg/ml oral suspension for treating COVID-19.

May 17, 2021 - Appili Therapeutics Inc. announced that an independent Data and Safety Monitoring Board had recommended continuation without modifying the ongoing Phase 3 PRESECO trial evaluating Avigan® / Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19.

May 10, 2021 - Vivimed Labs received India's approval to manufacture and market Favipiravir Tablet 200 mg and 400 mg for the Indian market.

May 4, 2021 -  PTI reported India-based Bajaj Healthcare announced the launch of its antiviral Favipiravir tablets under the brand name 'Favijaj' to treat mild to moderate COVID-19 infections in India said in a BSE filing. The Company successfully developed the active pharmaceutical ingredient and formulated favipiravir through its own in-house R&D team.

April 21, 2021 - FUJIFILM Toyama Chemical Co., Ltd. announced a new phase III clinical trial in Japan concerning its anti-influenza drug Avigan® Tablet (Avigan; favipiravir), targeting patients infected with COVID-19. The trial is a double-blind, placebo-controlled clinical trial investigating the drug's efficacy and safety in patients with early-onset COVID-19 with risk factors for progression to severe symptoms.

April 19, 2021 - Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) announced that Dr. Armand Balboni would present at the fully virtual Bloom Burton & Co. Healthcare Investor Conference taking place on April 20 and 21, 2021.

April 12, 2021 - Philippines-based My Med Rx Plus Corporation announced it had placed orders for 1 million Favipiravir (Avigan) and 3 million tablets of Umifenovir (Arbidol) tablets to secure supplies for hospitals and patients.

March 31, 2021 - The journal Nature published a study: Safety and efficacy of favipiravir versus hydroxychloroquine in management of COVID-19: A randomized controlled trial. Finding: Favipiravir is a safe, effective alternative for hydroxychloroquine in mild or moderate COVID-19 infected patients.

March 24, 2021 - The Russian Direct Investment Fund and the ChemRar group of companies announce that they have received a registration certificate from the Indonesian Medicines and Foods Control Agency for the Avifavir antiviral (favipiravir). Registration of Avifavir in Indonesia was carried out according to an accelerated procedure based on data from an extended phase II-III clinical trial, which took place from April to September 2020, at 30 specialized centers throughout Russia with the participation of 460 patients.

March 17, 2021 – Appili Therapeutics Inc. announced that it would present at the fully virtual Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC taking place on March 17th through 19th. In addition, Appili CEO Dr. Armand Balboni, M.D., Ph.D., will participate in a Fireside Chat on Friday, March 19th at 4:30 PM ET. Appili is developing a version of Avigan (Favipiravir) for use in Canada and the USA. "While we are encouraged by the early signals that favipiravir may be active against COVID-19, we realize that there is a duty to provide robust clinical data evaluating favipiravir as an early treatment option and prophylactic agent. Appili is honored to be a part of this world-class clinical program as we race to find options for the greatest public health threat of our lifetime."

March 9, 2021 - According to IQVIA data, Favipiravir posted total sales of Rs 424 crore from June to December 2020 in India.

February 21, 2021 - Kyodo News reported that Fujifilm Holdings Corp is considering restoring a clinical trial for its drug Avigan in treating COVID-19 patients. Details, including when the trial would start in Japan, have yet to be determined.

February 12, 2021 - Appili Therapeutics Inc. announced recent operational highlights including: Signing a collaboration, development, and supply agreement to create a global consortium with Dr. Reddy's Laboratories Ltd. and Global Response Aid for oral COVID-19 antiviral candidate favipiravir (REEQONUS); Working with partner DRL to support the filing of an application under Health Canada's interim order for favipiravir oral tablets (REEQONUS in Canada) on behalf of the global consortium; Dosing the first participant and activating over 50% of the planned sites in the U.S. for its Phase 3 PRESECO study evaluating favipiravir for the early treatment of mild-to-moderate COVID-19 infections; Receiving a 'No Objection Letter' from Health Canada to initiate the Phase 3 PEPCO study evaluating favipiravir for the prevention of COVID-19 in exposed individuals in the community setting.

January 28, 2021 - Appili Therapeutics Inc. announced that its Phase 3 PRESECO (PReventing SEvere COvid-19) clinical trial actively recruited participants in 12 out of 20 sites in the USA. Based on current forecasts, Appili believes it will reach the enrollment threshold required to provide an interim data readout by late March 2021. PRESECO evaluates favipiravir, an oral antiviral, in the early treatment of COVID-19 in the outpatient setting. The Company is also pursuing regulatory approvals to expand PRESECO into Mexico, Brazil, and Colombia.

January 27, 2021 - India-based Dr. Reddy's Laboratories Ltd. and Global Response Aid FZCO announced the termination of the Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID-19 patients in a hospital setting.

January 6, 2021 - The Lancet published a commentary: Understanding the pharmacokinetics of Favipiravir: Implications for treating influenza and COVID-19. Results from this study, as well as others, demonstrate a highly complex pharmacokinetic profile.

January 1, 2021 - Study: Role of favipiravir in the treatment of COVID-19. Conclusion: Considering the approved status, evidence on the safety, and key indicators of efficacy of favipiravir in COVID-19 from trials/registries in Russia, Japan, China, and Thailand, it appears to be useful management of COVID-19, particularly mild to moderate disease.

December 22, 2020 - Dr. Reddy's Laboratories Ltd., Appili Therapeutic, and Global Response Aid FZCO announced that Dr. Reddy's Canada had filed an application on behalf of the consortium for REEQONUS™ (favipiravir) Tablets for the acute treatment of mild to moderate COVID-19 adult patients under Health Canada's Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use concerning COVID-19. REEQONUS is also known as Avigan® (favipiravir) Tablets, developed by FUJIFILM Toyama Chemical Co., Ltd.

December 19, 2020 - According to the National Institute of Pharmacy and Food Health (OGYÉI), a new coronavirus drug-containing favipiravir, manufactured by the Hungarian pharmaceutical company Egis, has been approved, so it is expected to be used in the treatment of coronavirus patients from mid-January. The preparation is managed by the state health reserve and delivered to health care providers, writes MTI.

December 17, 2020 - Japanese authorities have found it difficult to conclude the effectiveness of antiviral drug Avigan in treating COVID-19 patients based on clinical testing results by its developer, FUJIFILM Toyama Chemical Co., Ltd. However, according to local media, the Pharmaceuticals and Medical Devices Agency's latest assessment will likely decide whether to approve the use of Avigan to treat COVID-19 in Japan.

December 14, 2020 - The Philippines Department of Health announced it had to tweak the Avigan clinical trial protocol against COVID-19 to get more participants. The anti-flu drug Avigan is among the off-label drugs being studied as a possible treatment for the new coronavirus disease. As of December 7, the study had a total of 16 participants.

December 11, 2020 - Professor Fehmi Tabak of Istanbul University's Cerrahpaşa Faculty of Medicine says favipiravir is one of the strongest currently available medicines against COVID-19. Still, people stopping intake based on rumors see their situation worsen. "The drug might have minor side effects on people with liver problems, but it does not have any side effect for COVID-19 patients without any underlying disease," he said.

December 10, 2020 - Nepal Health Research Council has decided to test antiviral medicine favipiravir on Covid-19 patients admitted to Kathmandu and Pokhara hospitals. The drug, administered under a phase-III trial, will be given to 600 patients with mild or moderate contagious disease symptoms. Favipiravir is being manufactured by Deurali-Janta Pharmaceuticals Pvt. Ltd in Nepal.

December 2, 2020 - Appili Therapeutics Inc. announced that investigators had dosed the first participant in its Phase 3 trial (referred to as the "PRESECO" clinical trial) evaluating oral Avigan® tablets (favipiravir) for the treatment of COVID-19. Appili expects to report early data from the PRESECO study in the first half of 2021. Appili is initially focusing the trial in the United States but may expand it to other areas of the world affected by COVID-19.

November 30, 2020 - The sovereign wealth fund of the Russian Federation and the ChemRar group of companies announce an increase in production of the first Russian drug against the new coronavirus infection, Avifavir. The production level is now 200,000 packs per month. Avifavir (favipiravir) is the first drug globally with the active ingredient favipiravir, registered to treat new coronavirus infections.

November 24, 2020 - Appili Therapeutics Inc. announced the initiation of its Phase 3 Post Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan® tablets (favipiravir) in the prevention of COVID-19. And Health Canada has provided a 'No Objection Letter (NOL)' for Appili's proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in the USA. This is the second Phase 3 study that Appili has announced to evaluate Avigan tablets' utility against COVID-19 in the community setting. The other study, also known as the PRESECO study, evaluates Avigan for treating adults with mild-to-moderate symptoms of COVID-19.

November 20, 2020 - The Ministry of Healthcare of the Russian Federation confirmed the 'permanent registration of Avifavir, which enables the drug to be used both in outpatient and inpatient settings. 

November 16, 2020 - Phase III study published in the International Journal of Infectious Diseases showed that early treatment with favipiravir might be associated with more rapid viral clearance of COVID-19.

November 6, 2020 - The Russian Direct Investment Fund and the ChemRar group of companies announced a permit for the outpatient use of the first Russian anti-coronavirus drug, Avifavir (Favipiravir), provided to COVID-19 patients free of charge. The drug is already provided free of charge under the compulsory medical insurance program to patients undergoing treatment for coronavirus in medical institutions.

October 30, 2020 - Appili Therapeutics Inc. announced that it had signed a collaboration, development, and supply agreement with Dr. Reddy's Laboratories Ltd. Global Response Aid. The agreements work together to coordinate and accelerate the worldwide development, commercialization, and distribution of Avigan® tablets (favipiravir) for the potential treatment and prevention of COVID-19.

October 30, 2020 - FDC Limited announced the launch of new strength variants of its Favipiravir brands– PiFLU and Favenza- to treat mild to moderate cases of COVID-19 in India. These prescription-only drugs will be available at all retail, medical outlets, and hospital pharmacies across the country from the 1st of November, 2020. The 800mg version of the drugs will help reduce the number of tablets taken by any patient by 75%. Patients must take 18 pills on the first day, followed by 8 tablets every day for the next 13 days.

October 29, 2020 - A review provides insights into the evidence-based evolving role of favipiravir in the management of COVID-19 infection with emphasis on the benefits of initiating an early antiviral therapy with a special focus on favipiravir, its pharmacodynamic, pharmacokinetic, in vitro, clinical data, and inclusion in the treatment protocols of COVID-19.

October 22, 2020 - Fujifilm Holdings Corp. announced it has partnered with Shanghai-based Carelink Pharmaceutical Co. to seek approval in China for Avigan to treat COVID-19 and influenza.

October 20, 2020 - Appili Therapeutics Inc. announced that investigators enrolled and dosed the first cluster of participants in Appili's CONTROL COVID-19 clinical trial. 

October 16, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced that the Company filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan® Tablet the Ministry of Health, Labour and Welfare in Japan. The filing seeks to add an indication and other items relating to novel coronavirus infections (COVID-19).

October 9, 2020 - Pre-clinical study: The potent antiviral efficacy of high favipiravir doses is in line with a recent study in which thrice-daily dosing of ∼1,400 mg⋅kg−1⋅d−1 of favipiravir resulted in significant reductions in virus infection in hamsters. Favipiravir plasma exposures were consistent in both studies, although the doses used were not completely the same.

October 3, 2020 - Moscow's Mayor Sobyanin said 'COVID-19 outpatients in Moscow will receive the antiviral drugs "Areplivir" and "Coronavir," which are versions of Avigan, for free.'

September 24, 2020 - The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, and ChemRar Group have agreed to supply Avifavir, the world's first registered favipiravir-based drug against coronavirus and Russia's first drug approved for the treatment of COVID-19, to 17 countries. The drug has already been delivered to Belarus, Bolivia, Kazakhstan, Kyrgyzstan, Turkmenistan, and Uzbekistan.

September 23, 2020 - FUJIFILM Toyama Chemical Co., Ltd. announced that the primary endpoint had been met in phase III clinical trial of "Avigan Tablet" (generic name: favipiravir, "Avigan") conducted in Japan for patients with novel coronavirus infections. As an influenza antiviral drug approved for manufacture and sale in Japan, Avigan selectively inhibits RNA polymerase necessary for influenza virus replication.

September 18, 2020 - Russia-based R-Pharm announced the approval of Coronavir for outpatient treatment of mild to moderate COVID-19 coronavirus infection. Coronavir is manufactured at R-Pharm's facility in Yaroslavl, will be available in Russian pharmacies.

September 17, 2020 - Article: Rapid incorporation of Favipiravir by the fast and permissive viral RNA polymerase complex results in SARS-CoV-2 lethal mutagenesis. 

September 11, 2020 - Appili Therapeutics Inc. announced that it had submitted a new protocol to its open investigational new drug application with the U.S. FDA to conduct a Phase 3 clinical study evaluating favipiravir, the early treatment outpatient setting for adult COVID-19 infections. Favipiravir is a broad-spectrum antiviral administered in oral tablet form.

September 3, 2020 - The start of clinical trials for the Japanese flu drug, Avigan, in the Philippines has been delayed anew because the ethics board of the Department of Health has not given its approval for the participation of three of four local hospitals in the trials, Health Undersecretary Maria Rosario Vergeire said. Japan turned over the Avigan (favipiravir) tablets to the Philippines, used by 100 patients with coronavirus disease (COVID-19).

September 2, 2020 - India review article 'Favipiravir: A new and emerging antiviral option in COVID-19. The main advantages of favipiravir are that it is administered orally and that it can be given to patients who are symptomatic but not ill enough to be hospitalized. '

August 19, 2020 - Dr. Reddy's Laboratories Ltd. announced the launch of AVIGAN® (Favipiravir) 200 mg Tablets in India. The launch is part of the global licensing agreement with FUJIFILM Toyama Chemical Co. Ltd. It grants Dr. Reddy's exclusive rights to manufacture, sell, and distribute AVIGAN (Favipiravir) 200 mg Tablets in India.

August 17, 2020 - The Philippines started 9-month clinical trials for Avigan to study the anti-flu drug's efficacy against the COVID-19 disease. Health Undersecretary Maria Rosario Vergeire said the clinical trials would include just four hospitals in Metro Manila.

August 14, 2020 - Fujifilm Holdings Corp. announced it expects to complete clinical tests in Japan of the antiviral drug Avigan, a potential candidate treatment for COVID-19, after a delay caused by difficulty in September securing enough patient data.

August 10, 2020 - Appili Therapeutics announced the U.S. FDA had granted the Company clearance to proceed after Appili filed an investigational new drug application for broad-spectrum antiviral favipiravir known as Avigan. Appili's Phase 2 clinical trial is leveraging the versatility of favipiravir as an oral tablet suitable for administration across a wide variety of care settings, including long-term care. Appili intends to enroll up to 760 participants in this Phase 2 clinical trial across the U.S. and Canada. In addition, health Canada provided regulatory clearance on May 21, 2020, for Appili's Phase 2 study evaluating FUJIFILM Toyama Chemical's (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks.

August 4, 2020 - Sun Pharmaceutical Industries Ltd., the world's 4th largest generic pharmaceutical company, announced on Twitter that it would launch favipiravir (Avigan) under the brand 'FluGuard' ₹35 per pill, making it the cheapest brand of the antiviral drug in India. Favipiravir is used to treat mild to moderate Covid-19 disease through an emergency use authorization from India's Drug Controller General. 'FluGuard' is the sixth generic of favipiravir to be launched in India, with Glenmark Pharmaceuticals Ltd being the first to launch it in June after conducting a 150-patient clinical trial.

August 4, 2020 - The Philippine government announced that it had begun clinical trials for Japanese anti-flu drug Avigan to see whether it would effectively treat COVID-19, the disease caused by the new coronavirus.

August 3, 2020 – Chromis, a joint venture established by the Russian Direct Investment Fund and ChemRar Group, announced the signing of a distribution agreement with South Africa's 3Sixty Biopharmaceuticals, a subsidiary of 3Sixty Global Solutions Group, to deliver Avifavir, the first Russian anti-COVID drug, to South Africa.

July 30, 2020 - The Philippine government said Thursday it would stockpile Japanese anti-flu drug Avigan to treat severe cases of the new coronavirus, as planned clinical trials for the drug draw closer.

July 28, 2020 - Fujifilm has not yet submitted the drug for approval to Japanese authorities as a treatment for COVID-19 and has said it will take that step as soon as possible. Health ministry official Yasuyuki Sahara said the government stands ready to review Avigan once Fujifilm submits it for approval. And Stanford University is soon to start a phase II trial of 120 patients with mild symptoms and could move to a phase III around September, said Stanford professor Yvonne Maldonado.

July 24, 2020 - Hyderabad: Optimus Pharma Pvt. Ltd Director P. Prashanth Reddy announced that their Company had received approval from the Drugs Controller General of India (DCGI) to manufacture the active pharmaceutical ingredient, Favipiravir, through its subsidiary, Optrix Laboratories, and manufacture and market its antiviral drug, Favipiravir tablets. The drug was jointly developed by Cipla and the Council of Scientific and Industrial Research's Indian Institute of Chemical Technology.

July 22, 2020 - Glenmark Pharmaceuticals Ltd. announced top-line results from a Phase 3 clinical trial in mild to moderate COVID-19 patients conducted across seven clinical sites in India.

July 18, 2020 - Fujifilm Holdings Corp. announced it would start a clinical study of the antiviral drug Avigan in Kuwait in collaboration with India's Dr. Reddy's Laboratories Ltd, up to 1,000 people to assess the flu drug's effectiveness as a COVID-19 preventive therapy.

July 17, 2020 - The Kingdom of Saudi Arabia is set to play a key role in developing a Russian COVID-19 vaccine that produced promising results in the first phase of human trials. Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said the Kingdom could be part of Phase III, involving thousands of people, expected to begin in August 2020.

July 13, 2020 - Glenmark Pharmaceuticals Ltd said it would lower its generic version of favipiravir, FabiFlu, to 75 rupees ($0.9983) per tablet for restricted emergency use for patients with mild-to-moderate COVID-19 symptoms in India. Due to better yield and scale, Glenmark benefits patients by reducing the price of oral antiviral FabiFlu® by 27 % in India. 

July 1, 2020 - FUJIFILM Corporation announced a partnership with Dr. Reddy's Laboratories Ltd. and Global Response Aid concerning the development, manufacture, and sales of Avigan® Tablets (favipiravir), a potential drug for the treatment of COVID-19 disease. Because it has a mechanism of action that selectively inhibits viral RNA polymerase, thereby preventing viral proliferation, Avigan may have an antiviral effect on the novel SARS-CoV-2 coronavirus, classified into the same type of RNA virus as influenza viruses. 

June 30, 2020 - Stanford Medicine researchers are launching a clinical trial to test whether an oral drug can reduce symptoms and viral shedding in people with COVID-19. The researchers aim to enroll 120 participants, beginning July 6, who was recently diagnosed with the disease but were not hospitalized.

June 15, 2020 - Istanbul Medipol University Faculty Member Assoc. Prof. Dr. Mustafa Guzel and his team managed to create the local synthesis of Favipiravir, used to treat COVID-19.

June 11, 2020 - Russian Direct Investment Fund and ChemRar Group have delivered the 1st batch of Avifavir drugs against the coronavirus to Russian hospitals. As many as 60,000 courses of Avifavir will be delivered to Russian hospitals in June. If necessary, production of Avifavir could be increased to 2m courses per year. Clinics and pharmaceutical organizations in Moscow, Leningrad, Novgorod, Kirov, and Nizhny Novgorod regions and the Republic of Tatarstan and Ekaterinburg have already received the first deliveries drug.

June 8, 2020 - Fujifilm Holdings said it would continue clinical tests of its anti-influenza drug Avigan, a potential treatment for people infected with SARS-CoV-2 coronavirus, beyond the initially scheduled end in June 2020 due to a lack of sufficient data.

June 2, 2020 - Dr. Monika Tandon, VP & Head, Clinical Development Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals, told Telangana Today, "Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to an overall improvement in clinical parameters." Simultaneously Glenmark is also conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients enrolled from 9 leading government and private hospitals across India.

June 1, 2020 - The Russian Direct Investment Fund, Russia's sovereign wealth fund, and the ChemRar Group announced that Avifavir, a Favipiravir-based drug, has received a temporary registration certificate from the Ministry of Health of the Russian Federation. Avifavir is Russia's first COVID-19 drug and has shown high efficacy in treating patients with coronavirus during clinical trials.

May 22, 2020 - Fujifilm Holdings Corp. said it is on course to supply the anti-influenza drug Avigan for 2 million COVID-19 patients by next March 2021, meeting a target set by the Japanese government to ramp up production of the potential treatment for the new coronavirus.

May 20, 2020 - Avigan, a candidate drug for treating COVID-19, has not shown apparent efficacy in treating respiratory disease in clinical trials so far, raising doubts about its approval by the end of this month as sought by the government sources familiar with the matter. "There is currently no data showing that Avigan has high efficacy," said Daisuke Tamura, an associate professor at Jichi Medical University specializing in pediatric infectious disease.

May 15, 2020 - Favipiravir Observational Study Group (principal investigator: Dr. Yohei Doi, Fujita Health University) released a preliminary report of the Favipiravir Observational Study in Japan on the Japanese Association for Infectious Diseases website. Given that over 80% of COVID-19 patients have a mild disease that often improves by supportive therapy, caution is required to interpret the efficacy of favipiravir based on the data presented here.

May 13, 2020: The ChemRar Group and Russia's sovereign wealth fund announced interim results of the multi-center, randomized, open comparative clinical trial of the drug Favipiravir (Avigan) tablets hospitalized with COVID-19 disease.

May 13, 2020: Japan's health ministry decided to allow pharmaceutical companies to bypass standard clinical trial procedures to facilitate the fast-track approval of the anti-flu medicine Avigan as an early-stage treatment for COVID-19 disease.

May 12, 2020: Glenmark Pharmaceuticals has initiated Phase 3 clinical trials in India on the antiviral tablet Favipiravir, for which it received approval from India's drug regulator DCGI in late April. Clinical trials have commenced, and over 10 leading government & private hospitals in India are enrolled for the study. Glenmark estimates study completion by July/August 2020.

May 4, 2020:  Japanese Prime Minister Shinzo Abe said Monday he wants Avigan (favipiravir) approved for COVID-19 treatment in May, as Japan moves to fast-track approval remdesivir as well.

May 1, 2020: Japan will provide anti-flu drug Avigan free of charge to 43 countries for clinical studies on its efficacy as a coronavirus treatment, Foreign Minister Toshimitsu Motegi said to local media.

April 30, 2020:  FUJIFILM Diosynth Biotechnologies teams with COVID-19 Therapeutics Accelerator to reserve manufacturing capacity and provide technical expertise to deliver future COVID-19 therapies.

April 30, 2020: Glenmark Pharmaceuticals announced that it had received approval from the Drug Controller General of India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 disease patients. The product is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a Fujifilm Corporation subsidiary.

April 15, 2020: Fujifilm accelerates the production of its influenza antiviral drug "Avigan® Tablet" for COVID-19.

April 9, 2020:  Fujifilm announces phase II clinical study of its influenza antiviral drug "Avigan® Tablet" (favipiravir) for patients with COVID-19 collaboration Brigham and Women's Hospital, Massachusetts General Hospital, and UMass Medical School.

March 17, 2020: China's health leadership announced they found the Japanese-developed anti-influenza drug Avigan to treat COVID-19 disease patients effectively.

February 17, 2020:  The Taizhou government of Zhejiang province China announced Avigan (favipiravir) was approved for marketing.

June 22, 2016: Fujifilm signs a patent license agreement on its anti-influenza drug Avigan Tablet* with China's major pharmaceutical Company Zhejiang Hisun Pharmaceutical.

November 11, 2015:  Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults.

Avigan (Favipiravir) Clinical Trials

FujiFilm announces a new Phase III Clinical Trial of Anti-influenza Drug Avigan Tablet in Japan, Targeting COVID-19 Patients. Avigan (Favipiravir) continues to be tested in clinical trials.

ClinicalTrials.gov Identifier: NCT04600895 - The Phase 3 PRESECO (PREventing SEvere COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in the United States, Brazil, and Mexico. Participants are outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring patients remotely. Last updated on August 13, 2021.

Stanford University is conducting a phase II trial of 120 patients with mild coronavirus symptoms in the USA. This study was last updated on July 27, 2020. And a separate phase II study in Massachusetts was last updated on September 9, 2020.

Lyme Disease Vaccine (VLA15) Clinical Trials, Dosage, Side Effects, Usage

Lyme disease candidate VLA15 is a multivalent recombinant protein vaccine targeting Borrelia's outer surface protein A (OspA). It is designed for prophylactic and active immunization against Lyme disease, protecting people against most human-pathogenic Borrelia species. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick bite. The VLA15 vaccine protects humans by raising antibodies that prevent Borrelia from migrating from ticks after a bite. VLA15 is designed to cover about 97% of Borrelia in North America and Europe. VLA15 is being tested as an alum-adjuvanted formulation and administered intramuscularly. As of December 2025, VLA15 is the only Lyme disease vaccine candidate in advanced phase 3 clinical development. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to the VLA15 vaccine development program in July 2017.

On November 26, 2025, Valneva announced positive final immunogenicity and safety data from the Phase 2 study, VLA15-221. VLA15 showed a strong anamnestic immune response and a favorable safety profile six months after a third booster dose (month 48) in all age groups, confirming compatibility with the anticipated benefits of a yearly vaccination before each Lyme season. On September 3, 2025, Valneva announced a strong immune response following the third annual booster dose in children and adults, as well as a significant anamnestic antibody response across all six serotypes. The independent Data Monitoring Committee observed no safety concerns across age groups, consistent with previous booster results from the ongoing Phase 2 study. On November 7, 2025. the Lancet Infectious Disease published an article confirming the immunogenicity and safety of an 18-month booster dose of the VLA15 in a phase 2 trial, which revealed the safety and robust anamnestic immune responses associated with VLA15 boosting, supporting its use as a strategy to increase anti-OspA antibody levels before tick season among children, adolescents, and adults.

On April 25, 2025, The Lancet Infectious Diseases published a Pfizer and Valneva-funded phase 2 study confirming previously observed safety and immunogenicity profiles of VLA15 in adults and extending them to children aged 5 years and older and adolescents. The greater immunogenicity of VLA15 in children and adolescents might translate into greater flexibility in the real-world clinical setting. On March 20, 2025, Valneva confirmed that its Lyme disease program is progressing according to plan, including the completion of the primary vaccination series (three doses) in the ongoing Phase 3 study VALOR, the reporting of further positive Phase 2 booster results, and the publication of Phase 2 data in The Lancet. Valneva confirmed on February 18, 2025, and May 7, 2025, that the first data readout of the Lyme disease Phase 3 clinical trial is expected by the end of 2025.

On September 3, 2024, Valenva announced that the VLA15-221 Phase 2 study had posted strong immune responses one month after a second booster dose (month 2) in pediatric and adult populations. A significant anamnestic antibody response was observed across all six serotypes, consistent with previous results, and a favorable safety profile of VLA15 was observed in all age groups and for all vaccinations. On May 31, 2024, The Lancet published an article titled "Optimization of Dose Level and Vaccination Schedule for the VLA15 Lyme Borreliosis Vaccine Candidate Among Healthy Adults: Two Randomized, Phase 2 Studies" provides a detailed analysis of the VLA15-201 and VLA15-202 trial results, which investigated different dose levels and vaccination schedules of VLA15, a hexavalent Lyme disease vaccine candidate targeting most prevalent  Borrelia species (serotype 1-6) in North America and Europe. On November 26, 2025, Valneva announced positive final immunogenicity and safety data from the Phase 2 study, VLA15-221, which confirmed the benefits of a yearly vaccination before each Lyme season.

Valneva SE and Pfizer, Inc., a New York-based company,  announced a development and commercialization collaboration for VLA15 in April 2020. Pfizer leads the vaccine's late-stage development and commercialization. Pfizer presented its Lyme disease strategy on slide #18, indicating it could submit a Biologics License Application to the FDA and a Marketing Authorization Application to the European Medicines Agency (EMA) in 2026, subject to positive phase 3 study data. 

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company based in Saint-Herblain, France, that develops vaccines to prevent diseases with significant unmet medical needs. On June 25, 2025, Valneva announced that all the resolutions recommended by the Board of Directors were approved by the shareholders at its Annual General Meeting. On February 18, 2025, Valneva announced that it had met its 2024 growth targets for sales revenue (+13% compared to 2023) and total revenues (+10% compared to 2023).

U.S. CDC Advisory Committee on Immunization Practices Workgroup - Lyme Disease Vaccine VLA15

Grace E. Marx, MD, MPH, presented an Introduction to the Advisory Committee on Immunization Practices (ACIP) Lyme Disease Vaccines Work Group on April 15, 2025. The first work group meeting will be held in May 2025, followed by an ACIP presentation on the epidemiology, burden, and clinical manifestations of Lyme disease in June 2025.

Lyme Disease Vaccine VLA15 Indication

VLA15 is a vaccine designed to prevent Lyme disease in people. According to the U.S. Centers for Disease Control and Prevention (CDC), Lyme disease is a systemic infection caused by the Borrelia bacteria, which are transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere and Europe. Nearly all human infections are caused by three B burgdorferi sensu lato genospecies: Borrelia garinii, Borrelia afzelii, and B burgdorferi sensu stricto. All three species cause Lyme borreliosis in Europe, whereas only Borrelia burgdorferi sensu stricto causes Lyme borreliosis in the United States.

On June 13, 2022, the journal BMJ Global Health reported that approximately 14% of the world's population likely has or has had Tickborne Lyme disease, as indicated by antibodies in the blood, based on a pooled data analysis of available evidence. In addition, the reported global estimate of Bb seropositivity is relatively high, with the top three regions being Central Europe, Western Europe, and Eastern Asia. 

A report from FAIR Health indicates that, from 2007 to 2021, Lyme disease diagnoses rose by 357% in rural areas and 65% in urban areas. In June and July, insurance claim lines with Lyme disease diagnoses were more common in rural than urban areas. But from November to April, claim lines with Lyme disease diagnoses occurred more often in urban than rural areas. Additionally, the CDC published "Comparison of Lyme Disease in the United States and Europe" on July 18, 2021. Patients with erythema migrans more often have concomitant systemic symptoms in the United States than in Europe.

Lyme Disease Vaccine VLA15 Mechanism of Action

Valneva has developed an innovative mechanism of action for VLA15: Upon feeding, the tick ingests antibodies from the host's blood. In the tick gut, OspA antibodies bind to B. burgdorferi's OspA. OspA-bound antibodies inhibit the dissemination of bacteria in the tick, thereby blocking transmission to the host (i.e., humans). A 2017 study found that immunological memory could be confirmed by a three-prime immunization followed by a booster dose administered five months later. Additionally, the half-lives of anti-OspA serotype-specific antibody titers following booster immunization were longer than those after primary vaccination. In addition, the clinical data showed that VLA15 induced protection in mice against challenges with four clinically relevant Borrelia species (B. burgdorferi, B. afzelii, B. garinii, and B. bavariensis), which express five of the six OspA serotypes included in the vaccine.

Lyme Disease Vaccine VLA15 Dosage

The randomized, placebo-controlled, Phase 3 VALOR study participants received a three-dose (Months 0, 2, and 6) or a two-dose (Months 0 and 6) vaccination schedule. Higher antibody levels were observed in the three-dose vaccination schedule. A fourth "booster" dose is being evaluated for 2024/2025. ValnevOner 10, 2024, that VValneva clarified LA15 the dosage could include annual booster doses.

Lyme Disease Vaccine VLA15 Side Effects

In the VLA15-202 Phase 2 study, VLA15 was found to be safe and well-tolerated across all doses and age groups. No serious adverse events related to the treatment were observed in any treatment group or during the one-month post-booster period. VLA15-221's leading safety and immunogenicity readouts in adults were performed at month seven. The clinical trial is ongoing to assess the safety and immunogenicity of VLA15 in children aged 5 years and older.

Disease Tests

The U.S. CDC currently recommends a 2-step testing process for Lyme disease. Both steps are required and can be done using the same blood sample. The peer-reviewed journal Cell Reports published a study on November 15, 2022, titled "Gene set predictor for post-treatment Lyme disease." By distilling gene sets from this study with those from other sources, the researchers identified a subset of genes highly expressed in the cohorts that were not previously established as biomarkers for inflammatory responses or other viral or bacterial infections. They further reduce this gene set by highlighting the importance of developing an mRNA biomarker set capable of distinguishing healthy individuals from those with acute L.D. or PTLD as a candidate for translation into an L.D. diagnostic.

Lyme Disease Vaccine VLA15 News

November 7, 2025 - The Lancet Infectious Diseases published: Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial.

September 3, 2025 - Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, "These latest data further reinforce the potential benefits of booster doses across all evaluated age groups."

August 12, 2025 - Valneva confirmed Pfizer aims to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to EMA in 2026, subject to positive Phase 3 data.

June 4, 2025 - The Company stated: Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development.

April 25, 2025 - The Lancet published: Immunogenicity and safety of different immunization schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomized, observer-blind, placebo-controlled, phase 2 trial. 

March 20, 2025 - Valneva confirmed that its 2025 outlook reflects solid revenue growth and positive commercial cash flows, supporting strategic R&D investments with lower operating cash burn. It met its 2024 growth targets for product sales (+13% comp vs) and total revenues (+10% comp vs).

February 18, 202: Peter Bühler, Valneva's Chief Financial Officer, commented, "Once again, we successfully delivered double-digit sales growth.. We made significant clinical and regulatory progress last year, setting the stage for several vital catalysts to drive value in 2025, most notably the first Phase 3 study results for our lead Lyme disease vaccine candidate, VLA15.

November 22, 2024 - Parasites & Vectors published a study that finds that 50% of adult blacklegged ticks carry the bacteria that cause Lyme disease.

October 10, 2024 - Vlaneva SE presented an investor update.

August 16, 2024 - Do We Need a Lyme Disease Vaccine? Plotkin, Stanley A., MD. The Pediatric Infectious Disease Journal.

September 19, 2024 - U.S. CDC - New Clinical Tools and Resources to Support Patients with Prolonged Symptoms and Concerns about Lyme Disease.

September 3, 2024—Annaliesa Anderson, Ph. D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, commented in a press release, "Together with our partner Valneva, we look forward to progressing our vaccine candidate in the ongoing Phase 3 clinical trials."

December 4, 2023 - Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a press release. "The completion of enrollment is an important milestone in developing a potential vaccine for Lyme disease."

August 11, 2022—Valneva announced excellent progress on the late-stage Lyme Disease Vaccine Candidate VLA15. The Phase 3 study was initiated in August 2022, and other positive Phase 2 results, including the first pediatric data, were reported.

August 8, 2022 - Pfizer Inc. and Valneva SE announced the initiation of the Phase 3 clinical study, "Vaccine Against Lyme for Outdoor Recreationists," to investigate the efficacy, safety, and immunogenicity of the Lyme disease vaccine candidate VLA15.

April 26, 2022 - Valneva SE and Pfizer Inc. reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15, in pediatric participants aged 5-17 years.

July 28, 202: Pfizer, Inc. published its Lyme disease vaccine strategy on slide #18 of its final results presentation. This assay demonstrated Phase 2 efficacy, with more than 90% of subjects seroconverting to all six serotypes commonly found in the United States and the European Union following a three-dose vaccination schedule.

November 3, 2020—Valneva reported a serum bactericidal assay assessing the functional immune response against Lyme disease after vaccination with VLA15. This assay was conducted for the first time in VLA15-202 and demonstrated the functionality of antibodies against all OspA serotypes.

July 22, 202: Valneva SE announced positive initial results for its first Phase 2 study (VLA15-201) of the Lyme disease vaccine candidate VLA15. The vaccine was found efficacious across all dose groups tested.

April 30, 202: Valneva SE and Pfizer announced a collaboration to develop and commercialize Valneva's Lyme disease vaccine candidate, VLA15. The candidate is currently in Phase 2 clinical studies.

July 1, 2019 - A second Phase 2 clinical trial for developing Lyme disease vaccine candidate VLA15 has been announced. Following the Run-In phase for one's first Phase 2 study, VLA15-201, the two dosage levels (135 µg and 180 µg) have been selected for further development, subject to approval from the Data and Safety Monitoring Board. 

VLA15 Clinical Trials

VLA15 continues to undergo clinical trials to assess immunogenicity, safety, and dosing as of 2025.

A Pfizer- and Valneva-funded Phase 2 study, announced on December 25, 2025, confirmed the previously observed safety and immunogenicity profiles of VLA15 in adults and extended them to children aged 5 years and older. The greater immunogenicity of VLA15 in children and adolescents might translate into greater flexibility in the real-world clinical setting.

On July 4, 2023, The Lancet Infectious Diseases wrote. Between January 23, 2017, and January 16, 2019, of 254 participants screened for eligibility, 179 were randomly assigned into six groups: alum-adjuvanted 12 μg (n=29), 48 μg (n=31), or 90 μg (n=31) and non-adjuvanted 12 μg (n=29 participants), 48 μg (n=29), or 90 μg (n=30). VLA15 was well-tolerated and safe; most adverse events were mild to moderate in severity. Overall, adverse events were more frequent in the 48 μg and 90 μg groups (range 28−30 participants [94−97%]) when compared with the 12 μg group (25 [86%] participants, 95% CI 69·4–94·5) for adjuvanted and non-adjuvanted groups. Common local reactions were tenderness (151 [84%] participants; 356 events, 95% CI 78·3−89·4) and injection site pain (120 [67%]; 224 events, 59·9–73·5); most frequent systemic reactions were headache (80 [45%]; 112 events, 37·6–52·0), excessive fatigue (45 [25%]; 56 events, 19·4–32·0), and myalgia (45 [25%]; 57 events, 19·4–32·0). A similar safety and tolerability profile was observed between adjuvanted and non-adjuvanted formulations. The majority of solicited adverse events were mild or moderate. VLA15 was immunogenic across all OspA serotypes, with higher immune responses induced in the adjuvanted higher-dose groups (geometric mean titer range: 90 μg with alum, 61.3 U/mL–321.7 U/mL vs. 23.8 U/mL–111.5 U/mL at 90 μg without alum).

On February 17, 2023, Pfizer and Valnea announced that Pfizer, as the sponsor of the VALOR Phase 3 clinical study, had decided to discontinue the study for a significant number of participants enrolled in the U.S. These study participants, representing approximately half of the total number of participants recruited for the trial, were discontinued following violations of Good Clinical Practice at specific clinical trial sites operated by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event. The companies confirmed on March 23, 2023, that they intend to work with regulatory authorities and, as previously announced, aim for Pfizer to potentially maintain the original submission timelines, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

Clinical Study VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. The first clinical study with VLA15 enrolls pediatric patients aged 5 years and older. 294 healthy adult participants received VLA15 at two different immunization schedules (month 0-2-6 [N=97] or month 0-6 [N=90]) or three doses of placebo (month 0-2-6 [N=107]). Vaccine recipients received VLA15 at a dose of 180 µg, selected based on data from the two previous Phase 2 studies. The primary safety and immunogenicity readouts in adults were performed at month 7. A subset of participants will receive a booster dose of VLA15 or placebo at month 18 (booster phase) and will be followed for three additional years to monitor antibody persistence. The VLA15-221 trial is ongoing to assess the safety and immunogenicity of VLA15 in pediatric patients aged 5 years and older.

On August 8, 2022, the companies announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to investigate the efficacy, safety, and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15. The Estimated Primary Completion Date is December 31, 2024.

On July 22, 2020, the Phase 2 Lyme disease study, VLA15-201, announced that it had met its endpoints. Compared to Phase 1, the higher doses used in this trial elicited higher antibody responses across all serotypes. An encouraging immunogenicity profile was confirmed, including in older adults.

Ebanga™ Ebola Monoclonal Antibody Clinical Trials, Dosage, Indication, Side Effects

Ebanga™ (mAb114, Ansuvimab-zykl) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody (mAb) indicated for the treatment of infection in adults and children. Ebanga (mAb114) is available in a lyophilized form and is a single monoclonal antibody (mAb) that binds to the core receptor binding domain of the Zaire ebolavirus surface protein, preventing the virus from infecting human cells. It was isolated from the blood of a survivor of the 1995 Ebola virus disease (EVD) outbreak in the Democratic Republic of Congo (DRC). mAbs are proteins produced in a lab or other manufacturing facility that act like natural antibodies to stop a germ, such as a virus, from replicating after it has infected a person. These particular mAb binds to a portion of the Ebola virus's surface called the glycoprotein, which prevents the virus from entering a person's cells. This area of the Ebola glycoprotein, the receptor binding domain (RBD), was previously thought to be unreachable by antibodies because it is well-hidden by other parts of the virus and only becomes exposed after it enters the cell.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) and researchers at Dartmouth College studied how Ebang neutralizes the EBOV and determined that it binds to the core of the Ebola glycoprotein, blocking its interaction with a receptor on human cells. The U.S. Vaccine Research Center developed Ebanga (mAb114) with support from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA). Ebanga was granted an FDA Orphan Drug and Breakthrough Therapy designation. The U.S. Food and Drug Administration (FDA) authorized Ebanga for intravenous injections on December 21, 2020.

On August 19, 2022, the World Health Organization (WHO) Guideline Development Group (GDG) made a Strong Recommendation for treatment with mAb114 for patients with real-time polymerase chain reaction (RT-PCR) confirmed EVD and for neonates of unconfirmed EVD status, seven days or younger, born to mothers with confirmed EVD. This new WHO living guideline is written to accompany the optimized supportive care (oSoC) for EVD standard operating procedures.

As of September 14, 2025, treatment courses of Mab114 have been dispatched to treatment centers in Bulape, DRC.

Emergent BioSolutions agreed with Ridgeback Biotherapeutics to expand the availability of Ebanga on July 7, 2022. Emergent is responsible for the manufacturing, sale, and distribution of Ebanga in the USA and Canada, and Ridgeback Bio serves as the global access partner for Ebanga. Ridgeback Biotherapeutics L.P. is located in Miami, FL. Ridgeback obtained a license for mAb114 from the U.S. NIH in 2018. DrugBank: DB16385; UNII: TG8IQ19NG2.

Ebanga Indication

Ebanga is indicated for treating infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Zaire ebolavirus is one of four Ebolavirus species that can cause a potentially fatal human disease. It is transmitted through blood, body fluids, tissues of infected people or wild animals, and surfaces and materials, such as bedding and clothing, contaminated with these fluids. The efficacy of Ebanga has not been established for other species of the Ebolavirus and Marburgvirus genera. Zaire ebolavirus can change over time, and factors such as the emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use Ebanga.

Ebanga Dosage

Ebanga is administered by IV infusion at doses of 5, 25, and 50 mg. Ebanga is available in a lyophilized form. For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution.

Ebanga Side Effects and Interactions

Hypersensitivity reactions, including infusion-associated events, have been reported with Ebanga. These may include acute, life-threatening responses during and after the infusion. Discontinue the administration of EBANGA immediately and administer appropriate emergency care. No studies have been conducted on vaccine interactions. Ebanga may reduce the efficacy of the live vaccine. The interval between the administration of Ebanga therapy and live vaccination should be in accordance with current vaccination guidelines.

BARADA Agreements

BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). On September 12, 2024, Emergent announced that it had been awarded a contract modification valued at $41.9 million for drug substance engineering and scale-up process validation, as well as long-term stability and commercial readiness, to support its ongoing scale-up program for Ebanga. On July 31, 2023, Emergent announced that BARDA had awarded it a 10-year contract, valued at up to a maximum of $704 million, under contract number 75A50123C00037, for the advanced development, manufacturing scale-up, and procurement of Ebanga™. On January 13, 2025, the company executed a contract modification for the second option period, valued at approximately $16.7 million, for drug product process and analytical testing validation, as well as long-term stability, for Ebanga™.

Ebanga (mAb114) News

September 14, 2025 - The WHO reported that treatment courses of the monoclonal antibody therapy (Mab114) drug have also been sent to treatment centers in Bulape, an area in the DRC, for clinical care during the 17th Ebola outbreak.

January 13, 2025 - Simon Lowry, M.D., chief medical officer, head of research and development, Emergent, commented, "Ebola is a devastating infectious illness with limited treatment options. This important work reinforces Emergent's leadership in developing solutions to address priority public health threats."

September 12, 2024 - Paul Williams, senior vice president of products business, Emergent, stated, "We look forward to progressing the program to supply treatment courses to enable preparedness against the Ebola virus. This important work demonstrates our leadership position in providing critical medical countermeasures."

July 31, 2023: Dr. Kelly Warfield, senior vice president of science and development at Emergent, stated in a press release, "The Ebola virus can emerge unexpectedly, posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, underscoring the importance of preparedness efforts against this public health threat."

March 8, 2023: The journal Frontiers published an article titled "Ebanga™: The most recent FDA-approved drug for treating Ebola."

September 30, 2022 - AllAfrica published Ebola - What Are the Symptoms, How Does It Spread, and Where Did It Come From?

August 19, 2022: The WHO published its first guideline for Ebola virus disease therapeutics, with strong new recommendations for monoclonal antibodies. The WHO calls on the global community to increase access to these medicines.

July 7, 2022 - Emergent BioSolutions Inc. confirmed an agreement with Ridgeback Biotherapeutics to expand the availability of Ebanga. 

April 1, 2021 - The NEJM Journal reported that during the 2018–2020 Ebola virus disease (EVD) outbreak in North Kivu province in the Democratic Republic of Congo, EVD was diagnosed in a patient who had received the recombinant vesicular stomatitis virus-based vaccine expressing a ZEBOV glycoprotein (rVSV-ZEBOV) (Merck). His treatment included an Ebola virus (EBOV) -specific monoclonal antibody (mAb114), and he recovered within 14 days. However, six months later, he presented again with severe EVD-like illness and EBOV viremia and died. Epidemiologic and genomic investigations showed that the patient relapsed into acute EVD, leading to a transmission chain resulting in 91 cases across six health zones over four months.

February 2, 2021—The antibody mAb114, or ansuvimab, is marketed as Ebanga by Ridgeback Therapeutics L.P. of Miami. The company licensed the antibody and manufacturing processes from NIAIOverhan. In 2018, the Frederick National Laboratory's Vaccine Clinical Materials Program manufactured 10,000 drug product vials for use in clinical trials in the Democratic Republic of the Congo.

December 22, 2020 - Ridgeback Biotherapeutics L.P. announced today that the U.S. Food and Drug Administration approved Ebanga to treat Ebola. Ebanga is now approved to treat infections caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to mothers who are RT-PCR positive for Zaire ebolavirus infection. The efforts of the Pamoja Tulinde Maisha (PALM ["Together Save Lives" in the Kiswahili language]) study team conclusively demonstrated Ebanga's safety and efficacy in a randomized controlled trial conducted during the 2nd largest and longest outbreak in DRC history. The PALM study team's efforts represent a landmark achievement in developing medical countermeasures for emerging infectious diseases.

December 21, 2020 - The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment of Ebolavirus infection in adults and children. Ebanga blocks the binding of the virus to the cell receptor, preventing its entry into the cell.

August 28, 2020—Ridgeback Biotherapeutics LP. announced the implementation of an expanded access protocol to ensure rapid access to its promising Ebola treatment, ansuvimab, in the Democratic Republic of the Congo (DRC). The Institut National de Recherche Biomédicale of the DRC is conducting an open-label, expanded-access clinical trial, initiated earlier this month. Ridgeback is providing study drug and operational support for this trial.

September 6, 2019: Ridgeback Biotherapeutics L.P. announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation. 

August 13, 2019: The first-ever multi-drug randomized controlled trial to evaluate the safety and efficacy of Ebola Zaire therapeutic medications reported two experimental products that would continue to be studied. The investigational agents in the Pamoja Tulinde Maisha study were ZMapp, remdesivir, mAb114, and REGN-EB3. Additionally, this DSMD said, 'all future study participants should be randomized to receive either the REGN-EB3 or mAb114 medications.'

December 13, 2018 - Ridgeback Biotherapeutics L.P. announced that it has entered into a patent license agreement with the NIH for intellectual property related to the mAbs mAb114, an experimental treatment for Ebola.

Ebanga (mAb114) Antibody Clinical Trials

The Pamoja Tulinde Maisha (PALM [together save lives]) study was a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114, and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018, in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces. EBANGA lowered the risk of dying from the infection.