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MVA-BN® RSV Vaccine 2023

Bavarian Nordic A/S's MVA-BN® RSV vaccine incorporates five different respiratory syncytial viruses (RSV) antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural reaction to an RSV infection. The RSV vaccine candidate is based on Bavarian Nordic's proprietary MVA-BN® platform technology, also used in the Company's approved vaccines for smallpox and Ebola. 

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for MVA-BN® RSV targeting seniors 60 years and older. It has also been granted access by the European Medicines Agency (EMA) to its priority medicines (PRIME) scheme for MVA-BN® RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years of age.

The peer-review Journal of Infectious Diseases published a Major Article on April 20, 2023, results from a phase 2a randomized double-blind, placebo-controlled clinical trial with adults that concluded MVA-BN-RSV vaccination resulted in lower viral load and symptom scores, fewer confirmed infections, and induced humoral and cellular responses.

On July 22, 2023, Bavarian Nordic announced that its Phase 3 clinical trial of MVA-BN® RSV did not meet all the primary endpoints of preventing LRTD from RSV. The final study results showed that the vaccine candidate had a 59% efficacy in preventing at least two pre-defined LRTD symptoms meeting one of the efficacy criteria of the study. However, when measuring more severe LRTD based on at least three pre-defined symptoms, the vaccine candidate only demonstrated a 42.9% efficacy and missed the study's co-primary endpoint. Based on this outcome, Bavarian Nordic will discontinue its RSV program, including its partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets.

Denmark-based Bavarian Nordic A/S (OMX: BAVA) is a fully integrated vaccines company focused on developing, manufacturing, and commercializing life-saving vaccines.

Nuance Pharma Agreement in China

In 2021, Nuance Pharma agreed with Bavarian Nordic, granting the Company exclusive rights to develop and commercialize MVA-BN RSV in the Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea, and Southeast Asia addition on On November 13, 2022, the Company announced the Center for Drug Evaluation approved its Investigational New Drug application supporting its pivotal phase III clinical trial of the MVA-BN RSV vaccine against RSV in adults in mainland China. Founded by Mark Lotter in 2014, Nuance has built a late clinical-stage innovative portfolio.

MVA-BN RSV Indication

The MVA-BN-RSV Vaccine is indicated to prevent RSV, a highly infectious and the most common cause of lower respiratory tract infection in infants and children worldwide, resulting in many hospitalizations. RSV infections are also a serious health concern in the elderly and adults with cardiopulmonary disease. RSV is a common virus that usually causes mild, cold-like symptoms but, in serious cases, can cause severe lung infections, including bronchiolitis and pneumonia.

According to the U.S. CDC, those at risk are typically young infants, the elderly, and people with weakened immune systems.

MVA-BN RSV Side Effects

No vaccine-related serious adverse events were observed in a recent phase 2 study. In addition, the vaccine was well-tolerated, consistent with the safety profile previously reported in phase 1 and phase 2 clinical studies announced by the Company.

MVA-BN RSV Vaccine News 2023

July 22, 2023 - "We are disappointed that our RSV vaccine candidate was unsuccessful in this pivotal trial," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "While this outcome was unexpected and will impact our short-term growth expectations, we continue to have a unique commercial business, and given the recent strong brand and market growth, this provides a solid foundation for profitable growth in the years to come." 

April 20, 2023 - A peer-review study concluded: The MVA-BN-RSV vaccine appears to represent a mode of action broader than other vaccine candidates focused on the production of neutralizing antibodies to the preF protein. Dependence of RSV vaccines on the activity of neutralizing antibodies against a specific epitope of one protein conformation may be risky, as such reliance may provide selective pressure for the development of mutant viruses capable of neutralizing antibody escape.

April 11, 2023 - Bavarian Nordic A/S announced that the Phase 3 clinical trial of MVA-BN® RSV has accrued the number of cases required to complete the primary efficacy analysis, which is expected around mid-2023. Adjudicated data have confirmed enough patients with both 2+ symptoms and 3+ symptoms as required in the trial.

December 22, 2022 - Bavarian Nordic A/S announced 20,000 adults aged 60 years and older had been enrolled in a phase 3 study. Topline results are anticipated in mid-2023.

November 13, 2022 - "The MVA-BN RSV vaccine holds the potential to become the first to market adult RSV vaccine in China," in a press release, commented Mark G. Lotter, CEO and Co-Founder of Nuance Pharma.

March 21, 2022 - Bavarian Nordic A/S announced an exclusive license and supply agreement with Nuance Pharma on the development and commercialization of MVA-BN® RSV against RSV in adults in the Chinese Mainland-Hong Kong, Macau, Taiwan, South Korea, and certain Southeast Asian countries.

February 14, 2022 - The Company announced that the U.S. FDA had granted Breakthrough Therapy Designation for MVA-BN RSV for active immunization to prevent lower respiratory tract disease caused by RSV in adults aged 60 years or older. 

September 1, 2021 - Bavarian Nordic A/S announced results from a human challenge trial of MVA-BN® RSV. The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint of this pivotal study. At the same time, the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. As a result, the MVA-BN RSV vaccine demonstrated an efficacy of up to 79% in preventing symptomatic RSV infections.

August 8, 2018: Bavarian Nordic announced positive data from the extension study of its Phase 2 study investigating the safety and immune responses of its universal RSV vaccine, MVA-BN® RSV, in an older adult population. 

September 29, 2016: Bavarian Nordic announced the presentation of data from a Phase 1 study of its novel, broad-spectrum RSV (respiratory syncytial virus) vaccine candidate, MVA-BN RSV®.

MVA-BN RSV Clinical Trials

The Company developed a Phase 3 program. The global, randomized, placebo-controlled, double-blind Phase 3 VANIR clinical trial has enrolled more than 20,000 participants across more than 100 centers in the U.S. and Germany. The study's primary objective will assess the vaccine candidate's efficacy against LTRD caused by RSV. The trial is designed to run through the RSV season 2022/2023, with topline results expected mid-2023 if the pre-defined number of lower-respiratory tract disease events has occurred.

A Phase 2a Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN® RSV Vaccine Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants. Clinical Trial NCT02873286:  After receiving MVA-BN-RSV or placebo, 31 and 32 participants, respectively, were challenged. Viral load areas under the curve from nasal washes were lower (p = 0.017) for MVA-BN-RSV (median = 0.00) than placebo (median = 49.05). Total symptom scores also were lower (median = 2.50 and 27.00, respectively; p = 0.004). Vaccine efficacy against symptomatic, laboratory-confirmed, or culture-confirmed infection was 79.3% to 88.5% (p = 0.022 and 0.013). Serum immunoglobulin A and G titers increased ∼4-fold after MVA-BN-RSV vaccination. Interferon-γ-producing cells increased 4- to 6-fold after MVA-BN-RSV in response to stimulation with the encoded RSV internal antigens. Injection site pain occurred more frequently with MVA-BN-RSV. No serious adverse events were attributed to vaccination.

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.

Ebola Vaccine Zabdeno® and Mvabea® Clinical Trials, Dosage, Indication, News

The J&J Innovative Medicine Ebola vaccine consists of two components, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo). Zabdeno is given first, and Mvabea is administered approximately eight weeks later as a vaccine booster. This prime-boost vaccination method is an established approach for preventing infectious diseases during Ebola outbreaks for individuals at risk of exposure and preventively before episodes, says J&J.

J&J developed Zabdeno, a monovalent vaccine designed to provide active, specific, acquired immunity to the Ebola virus. The vaccine is based on an adenovirus type 26 (Ad26) vector expressing the glycoprotein of the Ebola virus Mayinga variant. Bavarian Nordic's Mvabea (MVA-BN-Filo) is a multivalent vaccine preparation designed to provide active acquired immunity to Sudan, Ebola, Marburg, and Tai Forest (formerly Côte d'Ivoire ebolavirus). The Zabdeno and Mvabea combination was evaluated under the European Medicines Agency (EMA) (EMEA/H/C/005337) accelerated assessment. However, as a precautionary measure, a Zabdeno booster vaccination should be considered for individuals at imminent risk of exposure to the Ebola virus, for example, healthcare professionals and those living in or visiting areas with an ongoing Ebola virus outbreak who completed the Zabdeno, Mvabea 2-dose primary vaccination regimen.

On June 4, 2021, J&J welcomed a new recommendation by the WHO's Strategic Advisory Group of Experts on Immunization (SAGE) that supports the use of the Ebola vaccine regimen both during outbreaks for individuals at risk of Ebola exposure and preventively in the absence of an outbreak, as protection against Ebola virus disease (EVD) is considered a significant public health interest. Accordingly, African countries began evaluating a single dose of Bavarian Nordic's Mvabea (MVA-BN-Filo) to treat the Marburg virus disease in August 2021. 

The Lancet published a study on September 13, 2021, concluding, 'The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimens were well tolerated in a clinical trial (NCT02509494), with no safety concerns in children. The vaccine induced robust humoral immune responses. Data from two papers published in The Lancet Infectious Diseases demonstrated that Zabdno and Mvabea generated robust humoral immune responses in adults and children, with the immune responses persisting in adults for at least two years. The data also showed that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial immunization, induced a robust anamnestic response within seven days. On December 14, 2022, a study published by the New England Journal of Medicine concurred with The Lancet's findings. In addition, the JAMA Network published Ebola Vaccines Safe and Immunogenic in Clinical Trials on January 24, 2023. On March 26, 2024, The Lancet Infectious Diseases published results from a study that found the J&J vaccine regimen and booster dose were well tolerated. A similar and robust humoral immune response was observed for participants boosted one year and two years after the first dose, supporting the use of the regimen and flexibility of booster dose administration for prophylactic vaccination in at-risk populations. 

Janssen is now Johnson & Johnson Innovative Medicine.

Zabdeno and Mvabea Vaccine History

The U.S. National Institutes of Health sponsored the initial development of the Mvabea (MVA-BN-Filo) vaccine. The U.S. NIAID, BARDA, and other funding partners supported the development, preclinical, and clinical testing of this investigational vaccine regimen designed to protect against the virus responsible for the 2014-2016 Ebola outbreak in West Africa. On May 29, 2020, the EMA human medicines committee recommended granting Zabdeno and Mvabea a positive opinion for marketing authorizations under exceptional circumstances because the applicant was able to demonstrate that it is not possible to conduct a randomized controlled study that might generate comprehensive clinical data on the efficacy of the latest Ebola vaccine even after authorization. The EMA has approved its use in individuals aged one year or older.

Zabdeno and Mvabea Indication

The Ad26.ZEBOV / MVA-BN-Filo combination is indicated to provide an active acquired immunity to the Ebola virus. Clinical results suggest that Ad26.ZEBOV prime immunization readily induces an immune response enhanced by MVA-BN-Filo boosting. Heterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filowere were used against the Ebola virus and were well tolerated and immunogenic in healthy volunteers. The vaccine is administered as an intramuscular injection. A study published in 2020 found that the two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo were safe, well-tolerated, and immunogenic, with humoral and cellular immune responses persisting for one year after vaccination.

Zabdeno and Mvabea Side Effects

The most common side effects found in participants in the clinical trials were injection-site reactions (pain, warmth, and swelling), fatigue, headache, myalgia, arthralgia, and chills reported by the EMA. In a phase 1 study, the reporting of A.E.s was identical to that described for the VAC52150EBL1003 trial. Briefly, solicited A.E.s were recorded in a diary by participants for seven days following each vaccination, and unsolicited A.E.s were collected at all visits until 21 days after dose 2. 

Zabdeno and Mvabea Safety

In November 2023, The Lancet Global Health published: Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomized, double-blind, active-controlled trial in Guinea and Sierra Leone. This analysis that included Ad26.ZEBOV and MVA-BN-Filo were well tolerated and induced strong humoral responses in infants younger than one-year-old. There were no safety concerns related to vaccination.

Zabdeno and Mvabea News

March 26, 2024 - The Innovative Medicines Initiative 2 Joint Undertaking and Coalition for Epidemic Preparedness Innovations funded a study: Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccine regimen plus Ad26.ZEBOV booster at one year versus two years in healthcare and front-line workers in the Democratic Republic of the Congo: secondary and exploratory outcomes of an open-label, randomized, phase 2 trial.

January 31, 2023 - The JAMA Network published a review of three vaccine regimens against Zaire Ebola virus disease that safely produced immune responses for up to 12 months, according to two clinical trials of adults and children reported in the New England Journal of Medicine.

December 9, 2021 - The peer-reviewed journal PLOS Pathogens published: Current state of Ebola virus vaccines: A snapshot.

October 4, 2021 - The journal PLOS Medicine published a RESEARCH ARTICLE: Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomized, placebo-controlled Phase II clinical trial in Africa. Conclusions - Ad26.ZEBOV, MVA-BN-Filo vaccination was well tolerated and immunogenic in healthy and HIV-infected African adults.

September 13, 2021 - A study published by the journal The Lancet assessed the Safety and immunogenicity of a two-dose heterologous vaccine regimen comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a pediatric population in Sierra Leone, Africa. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine were observed in about 97% of the children. And there were no treatment-related deaths.

August 17, 2021 - The World Health Organization Africa confirmed it helped the vaccine deployment from Guinea to Cote d'Ivoire of about 3,000 vaccine doses manufactured by Johnson & Johnson, which will be used to boost the vaccination in areas not experiencing active Ebola transmission.

June 4, 2021 - Johnson & Johnson announced it 'welcomes the Strategic Advisory Group of Experts on Immunization recommendation for the WHO.

November 17, 2020 - Study published by The Lancet: Vaccine - Study Interpretation - The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo were safe, well-tolerated, and immunogenic, with humoral and cellular immune responses one year after vaccination. Together, these data support the intended prophylactic indication for the vaccine regimen.

July 1, 2020 - The European Commission adopted the decision granting marketing authorizations to Janssen, a Johnson & Johnson company, for a vaccine against Ebola.

June 12, 2020 - Bavarian Nordic A/S announced that the Company has entered into a new supply contract with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson valued at USD 13.9 million. Under the agreement, Bavarian Nordic will manufacture and deliver bulk drug substances of its MVA-BN® Filo vaccine, which Janssen has licensed as part of its Ebola vaccine regimen.

April 19, 2019 - A phase 1 study of healthy volunteers, immunization with Ad26.ZEBOV or MVA-BN-Filo did not result in any vaccine-related serious adverse events.

March 14, 2017 - Immune Responses to Novel Adenovirus Type 26 and Modified Vaccinia Virus Ankara–Vectored Ebola Vaccines at 1 Year.

September 12, 2016 – Bavarian Nordic A/S announced that Janssen Vaccines & Prevention B.V. (Janssen) had completed a submission to the WHO for Emergency Use Assessment and Listing for its Ebola prime-boost vaccine regimen, which includes the MVA-BN® Filo vaccine.

October 22, 2014 – Bavarian Nordic A/S announced a global license and supply agreement for its MVA-BN Filovirus (Ebola and Marburg) vaccine candidate with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. 

Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) Ebola Vaccine Clinical Trials

As a result of these collaborations, more than 6,500 individuals have now participated in clinical studies for the Ebola vaccine across the U.S., Europe, and Africa. So far, the data from these studies suggest that the vaccine stimulates a robust immune response and has a favorable safety profile.

ClinicalTrials.gov: NCT0—9494—Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo (EBOVAC-SaThe lone). It was last posted on June 29, 2020.

Ervebo® (rVSVΔG-ZEBOV-GP) Ebola Vaccine Clinical Trials, Dosage, Efficacy, Indication, Side Effects

Merck Ervebo® Ebola Vaccine (rVSV-ZEBOV-GP, rVSV-ZEBOV, v920) is a live, recombinant, replication-competent Ebola virus zairense vaccine. Ervebo's active ingredient is Vesicular Stomatitis Virus (VSV), whose surface protein has been replaced with that of Ebola virus disease (EBOV). In addition, the Ervebo vaccine was genetically engineered to express the main glycoprotein from the Zaire ebolavirus, thereby provoking a neutralizing immune response. In November 2019, the World Health Organization (WHO) prequalified Ervebo. The U.S. Food and Drug Administration (FDA) issued STN: BL 125690/0 on December 19, 2019, and STN: BL 125690/55 on July 27, 2023. On August 3, 2023, the FDA approved (STN: 125690) an expanded indication for Ervebo for individuals 12 months and older. In Canada, Ervebo was approved in November 2022. 

Ervebo was granted Conditional Approval by the European Medicines Agency (EMA) for the European Union on November 11, 2019 (EMEA/H/C/004554). On July 20, 2023, the EMA's Committee for Medicinal Products for Human Use recommended the expanded approval of Ervebo for active immunization of individuals one year or older. As of September 7, 2023, Ervebo is indicated by the EMA (EMA/344888/2023) for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older living in Europe.

The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM-CBRN) helped provide a test that enabled Merck Sharp & Dohme B.V. to test human and non-human primate samples. The Ervebo vaccine protects people from Zaire but not against other Ebolavirus (Sudan) or Marburgvirus species. Additionally, it is unlikely that people could become infected with EBOV from the Ervebo vaccine, as it only contains one gene from the Ebola virus, not the entire virus. Specifically, it includes a gene for the EBOV glycoprotein that replaces the gene for the native VSV glycoprotein, says the U.S. Centers for Disease Control and Prevention (CDC). Merck and the U.S. government initially partnered in December 2014 through a third party, BioProtection Systems. In 2017, utilizing Project BioShield Act authority, U.S. BARDA funded work with Merck to continue late-stage development activities and began collaborating to expand ERVEBO's indication to include pediatrics. 

As of May 2024, the U.S. CDC reported that most doses (139,120; 95%) shipped from the ICG stockpile since 2021 have been repurposed for preventive vaccination of high-risk groups, compared with 6,570 (5%) used for outbreak response. The WHO's Annexes to the recommendations for using the Ebola vaccines, providing evidence to support the decision, were published in June 2024. As of April 2025, about 500,000 doses are stored in Switzerland. 

Drugbank's Accession Number: DB15595. ATC code: J07BX02. STN: 125690. Clinical Reviewer: Rebecca Reindel.

New Jersey-based Merck Sharp & Dohme LLC licensed the global R&D and manufacturing rights from Newlink Genetics Corp.'s phase I Ebola vaccine in 2014. The Public Health Agency of Canada, which initially developed the vaccine, retained noncommercial rights in the agreement.

Ervebo Vaccine Efficacy 

The Lancet Infectious Diseases, Volume 24, Issue 12, pp. 1357-1365, December 2024, confirms that rVSV-ZEBOV is highly protective against Zaire Ebolavirus disease and supports its use during outbreaks, even in challenging contexts, such as the eastern Democratic Republic of the Congo. A real-world study published on August 20, 2024, found that rVSV-ZEBOV was 84% effective against infection. On May 9, 2024, a preprint study published by The Lancet concluded that new data add further evidence of rVSV-ZEBOV safety and immunogenicity, including in people with pre-existing antibodies from suspected natural ZEBOV infection, which do not blunt the rVSV-ZEBOV immune response. On February 7, 2024, the Lancet Infectious Diseases published an analysis of all 2,279 patients with confirmed Ebola virus disease. rVSVΔG-ZEBOV-GP vaccination significantly lowered case fatality risk (vaccinated: 25% [106/423] vs not vaccinated: 56% [570/1015]; p<0·0001). A related commentary stated that this study shows that VSV-EBOV's protection extends beyond infection. The CDC evaluated vaccine efficacy in a two-part phase 3, open-label, cluster-randomized, controlled ring vaccination trial in Guinea during the 2014–2016 Ebola outbreak in West Africa. Based on cluster-level data, vaccine efficacy in the follow-up study was estimated at 100% (95% CI: 79.3%–100%).

Ervebo Vaccine Booster Dose

The Lancet Microbe published results from a study on October 4, 2024, which, in marked contrast to earlier trials evaluating short-term boosting, concluded. Delaying a rVSVΔG-ZEBOV-GP booster until month 18 resulted in an increase in GMT that remained several-fold above the GMT of the no-booster group for at least 18 months. These findings could have implications for defining the optimal timing of booster doses as preexposure prevention in populations at ongoing risk for Ebola virus exposure.

Ervebo Vaccine Availability

As of December 2024, the Ervebo vaccine was licensed in the U.S., U.K., European Union, Canada, Switzerland, Burundi, Central African Republic, the Democratic Republic of the Congo, Ghana, Guinea, Rwanda, Uganda, and Zambia. The Ervebo vaccine is not planned for commercial marketing in the U.S. but is maintained in the U.S. Strategic National Stockpile (SNS), with access facilitated by the U.S. government.

Ervebo Ingredients 

The inactive ingredients of this Ebola vaccine include recombinant human serum albumin and tromethamine (Tris) buffer, which contain a trace amount of rice protein.

Ervebo Indication

The Ervebo vaccine is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. However, the duration of protection conferred by Ervebo is unknown. Additionally, the effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusions is unknown. The WHO published the revised Ebola Vaccine FAQ, and the U.S. CDC published Ebola Vaccine: Information for U.S. Healthcare Providers. Merck advises against administering Ervebo to individuals with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including rice protein.

Ervebo Dosage

The Ervebo vaccine is administered as a single-dose intramuscular injection in the top of your arm. Pre-vaccination serological screening is not required.

Ervebo Booster Dose

The U.S. FDA approves initial doses of ERVEBO for the prevention of EVD. Since an Ervebo vaccine booster dose is not an EMA or FDA-approved indication, the U.S. CDC sponsored an expanded access Investigational New Drug program in April 2022. This program allowed booster doses of preexposure prophylaxis for adults who were vaccinated at least 6 months prior and had a potential risk of occupational exposure to EBOV.

Ervebo Side Effects

On December 14, 2022, the NEJM published an Original Article confirming the safety and effectiveness of the ERVEDO vaccine. Do not administer ERVEBO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including rice protein. Among 18,616 participants vaccinated with at least one dose of ERVEBO in clinical trials, 2 reported anaphylaxis. Injection-site side events include injection-site pain and redness.

The most common injection-site adverse events were injection-site pain (70%), swelling (17%), and redness(12%). The most common systemic adverse events reported following vaccination with ERVEBO were headache (37%), feverishness (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and abnormal sweating (3%). 

The safety and effectiveness of ERVEBO, a live virus vaccine, have not been assessed in immunocompromised individuals, and its effectiveness may be diminished in this population. The risk of vaccination with ERVEBO in immunocompromised individuals should be weighed against the risk of disease due to the Zaire ebolavirus.

Inform your healthcare provider promptly about any unusual or severe symptoms that occur after receiving this vaccine. You may also report any side effects to Merck Sharp & Dohme Corp, a Merck & Co., Inc. subsidiary, at 1-877-888-4231 or the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967, or you can report online at www.vaers.hhs.gov.

Ervebo Pregnant Women

Among immediately vaccinated pregnant women, 14 of 31 (45%) experienced pregnancy loss compared with 11 of 33 (33%) unvaccinated pregnant women (unadjusted RR: 1.35; 95% CI: 0.73–2.52). Overall, the pregnancy loss rate among pregnant women who received immediate vaccination was not statistically significantly higher than that among unvaccinated pregnant women. In addition, no external congenital anomalies were detected among live-born infants in either group (n = 44).

Ervebo U.S. CDC - FDA Presentations

The U.S. CDC published an update to the VIS sheet on June 30, 2022. On November 3, 2021, Jason Malenfant, MD, MPH, Epidemic Intelligence Service Officer, Viral Special Pathogens Branch, CDC, presented 'Evidence for Expansion of Recommendations for PreExposure Vaccination with rVSVΔG-ZEBOV-GP Ebola Vaccine for Special Pathogens Treatment Centers and Laboratory Response Network Facilities.' In addition, Wilbur Chen, MD, Chair of the Ebola Vaccine Working Group at the University of Maryland School of Medicine, presented an Overview. Caitlin Cossaboom, DVM, Ph.D., MPH, presented policy questions.

The U.S. FDA granted a Priority Review and a Tropical Disease Priority Review Voucher on September 17, 2019. The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine. On December 19, 2019, the FDA announced the licensing of the Ervebo (rVSVΔG-ZEBOV-GP) Ebola Vaccine. On February 15, 2020, Merck announced that African countries, including the Democratic Republic of the Congo, Burundi, Ghana, and Zambia, had approved the use of Ervebo. On January 8, 2021, the U.S. CDC's Advisory Committee on Immvaccine Practices (ACIP) recommended the use of the rVSVΔG-ZEBOV-GP Ebola vaccine (Ervebo) in the U.S. for preexposure vaccination for adults aged ≥18 years who are at the highest risk for potential occupational exposure to Ebola virus species Zaire ebolavirus because they are responding to an outbreak of EVD, work as health care personnel at fedCDC'sy designated Ebola treatment centers in the USA, or work as laboratorians or other staff at biosafety level 4 facilities in the USA.

INO-4201 Booster Dose

A Phase 1b clinical trial evaluated the DNA vaccine candidate INO-4201 as a booster in healthy adult participants who had previously received a single injection of Ervebo. The prosecution was well tolerated and boosted humoral responses in all 36 participants (100%).

Thermostable Second-Generation Zaire Ebolavirus Vaccine

In November 2022, Hilleman Laboratories announced a collaboration with MSD to develop a thermostable second-generation Zaire ebolavirus vaccine candidate, building on MSD's approved ERVEBO®. In November 2023, SK Bioscience forged a development licensing agreement with Hilleman Laboratories for this second-generation Zaire Ebola virus vaccine candidate.

Ervebo Vaccine Price

This vaccine is not commercially available in the U.S. This UNICEF table shows the awarded price per dose, product, supplier, and calendar year based on a multi-year supply. Additional Ebola vaccine price information is available at InstantRx™.

Ervebo Vaccine News

September 14, 2025 - An initial 400 doses of the Ervebo Ebola vaccine—from the DRC's stockpile of 2000 doses prepositioned in the capital Kinshasa—have been delivered to Bulape.

September 4, 2025 - Health authorities in the Democratic Republic of the Congo announced that 2000 doses of Ervebo are already prepositioned in Kinshasa and will be quickly moved to Kasai to vaccinate contacts and frontline health workers.   

December 4, 2024 - Sierra Leone became the first country to launch a preventive Ebola vaccination campaign targeting 20,000 frontline workers in all 16 districts nationwide.

November 28, 2023, 9News reported that the staff at the Denver Health Regional Emerging Special Pathogen Treatment Center received the Ervebo vaccine as a preventive measure.

September 7, 2023 - "The European Commission's expanded approval of ERVEBO for children one year of age and older is an important milestone for the prevention of disease caused by Zaire ebolavirus," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

April 27, 2022 - The DRC launched an Ebola vaccination in Mbandaka to halt the spread of the virus following an outbreak that has claimed two lives since April 21. Around 200 doses of the rVSV-ZEBOV Ebola vaccine will be deployed.

February 8, 2022 - A study published by PNAS examined the antibody response at 21 days and six months postvaccination after a single dose of rVSVΔG-ZEBOV-GP among EVD-exposed and potentially exposed populations in the DRC. At 21 days of follow-up, 87.2% had an antibody response. Additionally, 95.6% demonstrated antibody persistence at the six-month follow-up. These findings prove that antibody response and persistence after Ebola vaccination are robust in outbreak settings in the DRC.

November 3, 2021: The U.S. CDC's vaccine advisory committee voted to support vaccines as PrEP for certain healthcare personnel and/or lab support staff at facilities that handle Ebola virus specimens.

October 13, 2021—The WHO confirmed that a vaccination program related to the new Ebola outbreak had been launched in the DRC.

October 11, 2021 - The CEO of GAVI Tweeted,' About 1,000 doses of the rVSV-ZEBOV vaccine are still available in the country (DRC), so vaccination can start immediately to contain this outbreak. And 248,500 supported doses are available in the global stockpile and ready to ship in case of. Need' @GaviSeth.

January 27, 2021—The journal Nature published a new study titled "Ebola virus antibody decay: stimulation in a high proportion of survivors." The study observed the highest antibody reactivity around 200 days after recovery. The model suggests that EBOV antibody reactivity declines over 0.5–2 years after recovery. In a high proportion of healthy survivors, antibody responses undergo rapid restimulation.

February 14, 2020 - Merck confirmed that four African countries approved the ERVEBO vaccine. ERVEBO has now been registered in the following African countries: DRC, Burundi, Ghana, and Zambia.

December 1920—The U.S. FDA announced the approval of Ervebo, the first FDA-approved vaccine for preventing the Ebola virus disease caused by the Zaire ebolavirus.

May 23, 2019 - The School of Public Health Ethics Committee of the University of Kinshasa approved the compassionate belt vaccination protocol amendment for the rVSV-ZEBOV vaccine to expand its targets to pregnant women after the first trimester and lactating women identified as contacts. It is maintained that children can be vaccinated from 6 years old. Between November 26, 2018, and May 26, 2019, 319 pregnant women and 603 lactating women who were registered as contacts were unable to receive vaccination.

July 25, 2016 - Merck announced two regulatory milestones for its investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to the vaccine candidate, and the European Medicines Agency has granted PRIME status.

December 23, 2015: Merck announced the Emergency Use Assessment and Listing application for its investigational Ebola Zaire vaccine, V920 (rVSV∆G-ZEBOV-GP, live attenuated), which the World Health Organization accepted for review.

Ervebo Clinical Trials

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live). Clinical trial information is available on the Merck Vaccines website.