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JYNNEOS® Mpox Smallpox Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage

Bavarian Nordic A/S JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®), third-generation, live, attenuated vaccinia virus, Modified Vaccinia Ankara (MVA) vaccine. The MVA is cultured in chicken embryo fibroblast cells and maintained in a serum-free medium. It cannot replicate in the human body but can elicit a potent immune response. It is purified and filtered from the cells using various methods, including benzonase digestion.

Since 2003, Bavarian Nordic (BN) has co-developed JYNNEOS with the U.S. Government's Biomedical Advanced Research and Development Authority (BARDA) to ensure that adult populations can be protected from smallpox, including individuals with weakened immune systems or at high risk of adverse reactions to traditional smallpox vaccines based on replicating vaccinia virus strains. Approved by the U.S. Food and Drug Administration (FDA) in 2019, JYNNEOS was the first smallpox vaccine successfully developed under the Project BioShield initiative. BARDA has supported the development of a freeze-dried formulation of the vaccine to replenish the stockpile, and in 2017, it awarded BN a ten-year contract. BN has supplied a liquid-frozen formulation of JYNNEOS to the U.S. government for stockpiling since 2010 and in response to the mpox outbreak in 2022-2023. The U.S. government recommends two doses to provide robust protection, and routine immunization against mpox is not recommended for the general public. Booster doses (third) are recommended for specific individuals. On February 14, 2025, Interim Clinical Considerations for Use of Vaccine for Mpox Prevention in the United States stated, 'That while two vaccines can be used to prevent mpox (JYNNEOS®, ACAM2000®), only JYNNEOS has been used in the ongoing mpox outbreak.'

A meta-analysis of 16 studies published on April 26, 2024, revealed that the vaccine efficacy (VE) for one preexposure prophylactic JYNNEOS vaccination ranged from 35% to 86%, and the VE for two doses ranged from 66% to 90%. On June 6, 2025, a preprint study reported that MVA-BN vaccination induced sustained immunological memory after two-dose primary vaccination, as evidenced by a rapid anamnestic response up to five years post-vaccination. These results suggest that immunity does not wane for at least five years.

Since September 13, 2024, JYNNEOS has been commercially available in the U.S. and added to the World Health Organization (WHO) prequalification (PQ) list. The WHO PQ and Emergency Use Listing are mechanisms for evaluating the quality, safety, and efficacy of medical products, including vaccines. According to estimates from the U.S. Centers for Disease Control and Prevention (CDC), approximately two million U.S. individuals are eligible for mpox vaccination. Recent data shows that 15% of eligible people have received only one dose of the JYNNEOS vaccine. 

On June 5, 2025, the WHO Director-General, Dr Tedros Adhanom Ghebreyesus, announced that the mpox upsurge continues to meet the criteria of a public health emergency of international concern. On June 5, 2025, the WHO released new recommendations for clinical management and infection prevention and control (IPC) for mpox. This living guideline from WHO incorporates new evidence to dynamically update recommendations for clinical management and IPC for mpox infection. As of November 2025 (WHO reported #59), approximately 1 million vaccine doses (JYNNEOS®) have been administered to people across 12 African countries, and it remains available in the United States.

Bavarian Nordic A/S, headquartered in Kvistgaard, Denmark (OTCMKTS: BVNRY) (OMX: BAVA), focuses on developing, manufacturing, and commercializing life-saving vaccines. The MVA-BN® vaccine is marketed under the brand names IMVANEX® in the European Union, IMVAMUNE® in Canada, and JYNNEOS® in the U.S. JYNNEOS® is the only mpox vaccine that the WHO has prequalified. In 2025, JYNNEOS vaccine revenues increased by 51%, primarily driven by the phasing of supply and also positively impacted by supplemental payments for the freeze-dried vaccines delivered to the U.S. government, triggered under options exercised in May 2025.

JYNNEOS Vaccine Availability

As of 2025, healthcare providers in the United States can order JYNNEOS through their preferred wholesalers and distribution partners to make it available to at-risk individuals at pharmacies, physician offices, and public health clinics. This HHS operational planning guide is provided to aid state, tribal, local, and territorial health officials in their planning and response efforts. JYNNEOS  became commercially available at pharmacies in the U.S. in 2024.

IMVAMUNE® (MVA-BN) Vaccine Availability

The European Commission issued marketing authorization for smallpox prevention for MVA-BN (Imvanex) in 2013. It was extended to include mpox for adults in 2022, based on efficacy data in non-human primates and immunogenicity data from numerous studies involving more than 4,000 healthy and immunocompromised individuals. On September 19, 2024, the European Medicines Agency (EMA) recommended extending the indication of the smallpox and monkeypox vaccine Imvanex to adolescents aged 12 to 17. It is inferred that the vaccine will provide similar protection in adolescents as in adults. On November 11, 2024, the WHO confirmed that the Mpox Vaccines Access and Allocation Mechanism endorsed an independent Technical Review Committee to allocate 899,000 MVA-BN vaccine doses to nine countries across the African region. As of June 27, 2025, more than 731,000 doses of the MVA-BN vaccine have been administered in Africa. On October 31, 2025, BN announced an order for 750,000 MVA-BN vaccines to be delivered in Europe in 2026.

JYNNEOS (IMVANEX®) and 4CMenB Vaccination Program in the United Kingdom

Effective August 1, 2025, a new routine mpox and gonorrhoea vaccination (4CMenB) program, primarily for men who have sex with men at higher risk of acquiring these infections, will be delivered by local authority-commissioned sexual health services in the United Kingdom.

Bavarian Nordic JYNNEOS Production

Since 2022, Bavarian Nordic has built a vaccine inventory to provide surge capacity in the event of potential outbreaks. Bavarian Nordic has identified 50 million doses that could be supplied during the next 12-18 months, pending regulatory approvals and demand. The Company has informed the African CDC that it can manufacture an additional 10 million doses by the end of 2025, which aligns with current orders.

On December 16, 2024, Bavarian Nordic announced a license and manufacturing agreement for its MVA-BN® mpox vaccine with Serum Institute of India Pvt. Ltd. Adar Poonawalla, CEO of Serum Institute of India, said, "Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."

Bavarian Nordic - Biomedical Advanced Research and Development Authority Agreements 

Bavarian Nordic has collaborated with the U.S. government on the development, manufacturing, and supply of the mpox (smallpox) vaccine. On May 6, 2025, Bavarian Nordic announced that BARDA had exercised additional options, valued at $143.6 million, under the existing contract to supply a freeze-dried formulation of JYNNEOS smallpox vaccine. On September 24, 2024, Bavarian Nordic announced that it had received an additional order valued at $63 million from BARDA to manufacture additional bulk products and final freeze-dried doses of the JYNNEOS® smallpox/mpox vaccine. On August 8, 2024, Bavarian Nordic announced a new order valued at $156.8 million from the BARDA to manufacture additional bulk products for JYNNEOS®. On August 3, 2023, Bavarian Nordic announced it would manufacture and supply additional liquid-frozen doses of JYNNEOS to the U.S. government in 2023, valued at $3 million. Additionally, on August 3, 2023, Bavarian Nordic announced that BARDA had placed a new $120 million order, primarily for manufacturing a new bulk product for the JYNNEOS smallpox/mpox vaccine.

JYNNEOS Vaccine U.S. FDA

The U.S. Food and Drug Administration (FDA ) initially approved JYNNEOS for smallpox prevention in September 2019, based on a comprehensive development program comprising 22 clinical trials, including two Phase 3 studies. The FDA granted Bavarian Nordic a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure program, thereby accelerating the FDA's review of the application. The FDA's emergency use authorization (EUA) for JYNNEOS for mpox was issued by Peter Marks, MD, Ph.D., in Application Number 28801 on August 9, 2022. JYNNEOS' or mpox use was based on survival data from lethal mpox virus challenge studies (FDA's Rule) on human primates. The FDA granted an Emergency Use Authorization for use in adolescents in 2022. On March 15, 2023, the U.S. FDA updated JYNNEOS - STN: BL 125678/20. As of June 2025, JYNNEOS is the only FDA-approved smallpox and mpox vaccine for military and non-military use. On March 31, 2025, the FDA approved the freeze-dried formulation of JYNNEOS.

JYNNEOS Vaccine U.S. CDC

As of June 2025, the U.S. Centers for Disease Control and Prevention (CDC) recommends the JYNNEOS vaccine for specific populations, including those affected by the clade II mpox outbreak. In November 2021, the CDC Advisory Committee on Immunization Practices (ACIP) vaccine committee unanimously recommended JYNNEOS as an alternative to ACAM2000 for primary and booster doses of smallpox vaccine. The ACIP group leader, Pablo Sanchez, MD, led the presentations on the mpox vaccine on October 20, 2022, and February 22, 2023. The CDC announced Interim Clinical Considerations on February 22, 2023: Mpox vaccination should continue to be offered to people with the highest potential for exposure to mpox. An updated U.S. National Mpox Vaccination Strategy was published on February 6, 2023. 

On June 23, 2023, Agam Rao, MD, CAPT, U.S. Public Health Service, presented: Considerations for Long-term Protection against Mpox - No CDC Recommendation for a Third JYNNEOS Dose, Including Persons with Advanced HIV or Other Severe Immunocompromised Immune Systems. On August 18, 2023, the CDC stated that all adults at risk for mpox should receive the JYNNEOS vaccine, regardless of childhood smallpox vaccination status. On October 25, 2023, the CDC recommended the routine use of JYNNEOS for individuals at risk of smallpox or mpox infection. Survey results published in the U.S. CDC's Volume 30, Number 5, May 2024, showed that among vaccine-eligible GBMSM, uptake was 69% (95% CI 65%–72%; 601/875) and 92% (95% CI 89%–94%; 601/655) among those offered the JYNNEOS vaccine.

MVA-BN® Vaccine

As of October 2025, the European Commission currently approves MVA-BN for individuals aged 12 years and older. As of May 2025, the Democratic Republic of the Congo (DRC) had administered more than half a million mpox vaccine doses since October 2024, having received over 950,000 doses from various sources. The European Commission delivered 10,000 doses of the MVA-BN® vaccine to Uganda in January 2025. On September 26, 2024, Bavarian Nordic announced an agreement with UNICEF to supply 1 million doses of the MVA-BN® mpox vaccine for African countries. Under the agreement, UNICEF has negotiated a price of up to $65 per vaccine dose, the lowest on the market. On August 20, 2024, USAID confirmed that it would donate 50,000 Jynneos vaccines to the DRC. On August 13, 2024, Bavarian Nordic announced a new order from the European Health Emergency Preparedness and Response Authority (HERA) for the MVA-BN® vaccine. HERA will procure 175,420 vaccine doses for donation to the Africa Centers for Disease Control and Prevention.

Additionally, Bavarian Nordic will donate 40,000 doses to HERA. This more significant donation follows a recent pledge from the Company for 15,000 doses as part of a coordinated response in the African region by Gavi, WHO, and UNICEF. Bavarian Nordic was awarded a contract on September 13, 2023, to supply its MVA-BN smallpox vaccine to rescEU, a strategic reserve within the European Union.

MVA-BN® Vaccine For Adolescents

On October 7, 2025, BN announced topline results from a phase 2 clinical study of its MVA-BN® mpox/smallpox vaccine in children aged 2 to 11. Pending final results from the survey, the Company plans to submit the data to the European Medicines Agency in 2026 to support an extension of the vaccine's approval to include children aged 2 years and older.

As of 2025, the CDC has published updated Clinical Considerations for Mpox in Children and Adolescents in the United States.

On April 15, 2025, Dr. Buddy Creech presented the immunogenicity and safety of JYNNEOS in 12- to 17-year-olds to the U.S. CDC's Advisory Committee on Immunization Practices (ACIP). The Evidence-to-Recommendations Framework: Vaccination with Jynneos for Adolescents at Risk of Mpox During Outbreaks was presented by Faisal Syed Minhaj, PharmD, MPH. Additionally, Routine Vaccination with Jynneos for Adolescents at Risk of Mpox was discussed.

A National Institutes of Health-funded Phase 2 clinical trial of JYNNEOS in 229 adolescents found it to be. It generated an antibody response equivalent to that seen in adults—a peer-reviewed study funded by the U.K. The Health Security Agency, in a June 15, 2023, publication, concluded that a single dose of MVA–BN for post-exposure prophylaxis was well tolerated in children and induced robust antibody and cellular responses up to 15 weeks after vaccination. On September 15, 2022, the U.S. CDC confirmed that children and adolescents exposed to people with suspected or confirmed mpox infections might be eligible for post-exposure prophylaxis with vaccination. In addition, the CDC published interim Clinical guidance for Healthcare Providers in September 2022.

Bavarian Nordic announced on October 29, 2024, the initiation of a Phase 2 clinical study (NCT06549530) of the MVA-BN mpox/smallpox vaccine in children aged 2 to 11 years in the Democratic Republic of the Congo (DRC), with plans also to include sites in Uganda. The study is partially funded by the Coalition for Epidemic Preparedness Innovations, which announced on May 30, 2024, that it awarded BN $6.5 million to support phase 2 clinical trials.

MVA-BN® Vaccine For Pediatrics

On June 26, 2025, Bavarian Nordic announced the initiation of a Phase 2 clinical trial designed to support approval and use of the MVA-BN® vaccine in infants under 2 years of age. The first participants have been vaccinated in a study (NCT06844487) in Africa, evaluating the safety and immunogenicity of MVA-BN in 344 infants aged 4-24 months. Bavarian Nordic is also sponsoring a trial of MVA-BN in children aged 2-11 years. Topline results from this Phase 2 trial (NCT06549530) are anticipated in the third quarter of 2025. Both studies are part of the PregInPoxVac research project, led by the University of Antwerp and the University of Kinshasa.

JYNNEOS For Pregnant Women

Bavarian Nordic announced on June 26, 2025, the initiation of a Phase 2 clinical trial recruiting for a Phase 2 study (NCT06844500), which is planned to enroll 359 women (pregnant or breastfeeding), also to be evaluated for the safety and immunogenicity of MVA-BN, conducted in the Democratic Republic of Congo. This study is part of the PregInPoxVac research project.

The U.S. FDA says available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Four developmental toxicity studies conducted in female rats and rabbits evaluated the effect of JYNNEOS on embryo-fetal and postnatal development.

JYNNEOS Vaccine HIV

The European AIDS Clinical Society recommends the vaccine for adults infected with HIV or on preexposure prophylaxis treatment, and it may support additional national recommendations for the vaccine in the future. On August 5, 2022, the early release of the CDC Report - Interim Guidance - confirmed the JYNNEOS vaccine can be safely given to people who are living with HIV infection and those who are taking preexposure prophylaxis (PrEP). HIV immunocompromised persons may have a diminished immune response to JYNNEOS.

JYNNEOS Vaccine Efficacy

On July 26, 2024, BN announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) had recommended approval of a Type II variation for the IMVANEX smallpox and mpox vaccine. BN confirmed that in real-world studies, vaccine effectiveness (VE) against mpox (clade 2) disease was demonstrated at least 14 days after vaccination, with adjusted VE estimates ranging from 35% (95% CI, -2-59) to 89% (95% CI, 76-95) after one MVA-BN dose and from 66% (95% CI, 47-78) to 90% (95% CI, 86-92) after two MVA-BN doses.

The JAMA Network published results from a study on October 3, 2024, which concluded that two doses provided 66% effectiveness and one dose provided 36% effectiveness in achieving peak immunity during the 2022 mpox outbreak. The findings of a study conducted in the context of a targeted vaccination program in Canada, published on September 11, 2024, suggested that a single dose of MVA-BN is moderately effective (58% [95% CI 31% to 75%]) at preventing clade 2 mpox infection. The study showed that the MVA-BN vaccine generated mpox serum antibody responses that largely waned after 6 to 12 months. High titers of mpox NAbs (median titer 965) were detected at three months. MVA-BN provided 66% efficacy as a 2-dose regimen and 36% as a 1-dose regimen at peak immunity during the 2022 mpox outbreak in the U.S.

U.S. CDC research, published in the journal Emerging Infectious Diseases, Volume 30, Number 10—October 2024, concluded that the estimated effectiveness of the 2-dose JYNNEOS vaccine was approximately 80%. Results from a study announced in March 2024 showed mpox antibodies waned within a year of JYNNEOS vaccination. Among individuals who received childhood smallpox vaccination, most had detectable IgG antibodies one year after vaccination. The GMT reduction between 4 weeks after the last vaccine dose in 2022 and the one-year follow-up visit was 2.5-fold for those vaccinated with two doses of JYNNEOS and 1.9-fold for those vaccinated with one dose of JYNNEOS.

On March 14, 2024, the U.S. CDC staff stated, 'JYNNEOS vaccination is expected to be effective regardless of mpox clade. The Mpox virus is divided into two clades: Clade I, further divided into lineages 1–5, and Clade II, divided into subclades IIa and IIb. Clade IIb is responsible for the global mpox outbreak that began in May 2022. On December 7, 2023, the CDC published a Health Alert Network Health Advisory stating that mpox vaccines are expected to be effective for both Clade I and Clade II MPXV infections. However, the ECDC reported in 2023 that real-world data regarding JYNNEOS' effectiveness against clade 1 is lacking.

The Lancet Infectious Diseases reported on December 7, 2023, that 12% of vaccinated individuals were non-antibody responders, whereas all people with mpox infection developed a neutralizing antibody response. A case series (67) study published in The Lancet Infectious Diseases on September 4, 2023, confirmed that natural and vaccine-induced immunity are not fully protective against mpox infection. Demographic subgroup information is available in Section 1.1 of the Clinical Review Memo, which details participation in the clinical trials and notable analyses of demographic subgroup outcomes. And Section 6.2 (Postmarketing Experience) to the Package Insert.

The CDC reported in October 2023 that the JYNNEOS Vaccine's Effectiveness (VE) against mpox ranges from 36% to 75% for a single dose and 66% to 89% for a two-dose regimen. VE trended higher among immunocompetent participants than among those who self-reported as immunocompromised. The Lancet Infectious Diseases reported that the JYNNEOS vaccine showed effectiveness of 66–78%, and second mpox episodes and breakthrough infections among fully vaccinated individuals have been reported. On June 29, 2023, Original Research estimated adjusted vaccine effectiveness was 66% (95% confidence interval [CI], 47.4 to 78.1), and 146 case patients and 1000 control patients received one dose, among whom the estimated adjusted vaccine effectiveness was 35.8% (95% CI, 22.1 to 47.1).

On May 18, 2023, the New England Journal of Medicine (NEJM) published data from Cosmos, a nationwide Epic Electronic Health Record (EHR) database, to assess the effectiveness of JYNNEOS vaccination in preventing mpox disease among adults who received two doses of the vaccine. The estimated adjusted vaccine effectiveness was 66% (95% confidence interval [CI], 47.4 to 78.1), and among those who received one dose, the estimated adjusted VE was 35.8% (95% CI, 22.1 to 47.1). 

JYNNEOS Vaccine Coadministration

As of 2025, the CDC says limited clinical trial data have been presented on administering the JYNNEOS vaccine simultaneously with other vaccines. 

JYNNEOS Vaccine Dosage

In the U.S., the FDA-approved regimen for JYNNEOS involves subcutaneous administration of 2 injections of 0.5 mL, 4 weeks apart. 

JYNNEOS Vaccine Booster

In June 2025, results from a preprint study confirmed durable disease protection for 5 years after three doses of JYNNEOS. On October 3, 2024, JAMA published a Research Letter concluding that data suggest protective immunity may be waning in individuals vaccinated with MVA-BN in 2022 and that booster doses may be required to maintain robust protective immunity. The U.S. CDC wrote 'Based on currently available data from the unpublished CDC study, protection after the two-dose JYNNEOS vaccine series does not wane for at least five years. Thus, booster doses are not recommended for the general population.' However, France recommends a booster dose for people vaccinated more than 2 years ago.

JYNNEOS Pre- and Post-Exposure Vaccination

The mpox vaccine can be administered as post-exposure prophylaxis (PEP) to individuals with known or presumed exposure to the Monkeypox virus (MPXV). The mpox vaccine can also be given to individuals with certain risk factors and recent experiences that may increase their likelihood of exposure to mpox. As PEP, the vaccine should be administered as soon as possible, ideally within four days of exposure; administration between 4 and 14 days after exposure may still provide some protection against mpox.

On July 29, 2024, a Phase 4 clinical study was launched to assess whether an mpox vaccine can protect people against the disease after exposure to the potentially deadly infection. A study published in January 2024 concluded that the time to PEP and the observed incubation period resulted in overestimating PEP effectiveness using a conventional method. On October 10, 2022, the WHO confirmed that post-exposure vaccination (PEPV) is recommended for close contacts with MPX cases, ideally within four days of first exposure and up to 14 days after exposure without symptoms.

JYNNEOS Cell Line

JYNNEOS (MVA-BN) vaccine utilizes Chicken Embryo Fibroblast cells to produce the vaccine. Replication-competent poxvirus strains can cause clinical infections in humans and contain infectious viruses that can be transmitted to others. However, replication-deficient poxvirus strains, including MVA, do not produce contagious viruses in humans and therefore do not cause infection. As such, replication-deficient poxvirus strains pose a substantially lower risk of adverse events than replication-competent strains. 

JYNNEOS Vaccine Myocarditis Risk

According to the U.S. CDC, myocarditis and pericarditis have occurred following either primary vaccination or revaccination with live vaccinia virus smallpox vaccines, and are a known health risk for military forces (2003). The CDC reported on October 25, 2023, that VAERS and VSD data suggest an increased risk for myocarditis or pericarditis following JYNNEOS. As with smallpox vaccination, the possibility of negligible risk cannot be excluded.

JYNNEOS Side Effects

A study funded by the European Medicines Agency (EMA) concluded in March 2025 that the MVA-BN vaccination was safe and well-tolerated. The risk of a severe allergic reaction should be weighed against the risk of smallpox or mpox. A Research Letter published on May 5, 2023, reviewed a Phase 4 clinical study of adverse events following Jynneos vaccination and found that local adverse event rates were highest following intradermal administration. The adverse event rate was highest following dose 1 of intradermal vaccination (53%) and low immunization dose 2 of subcutaneous vaccination (31%). The adverse effects of immunization included local redness, itching, and swelling following intradermal vaccination, as well as local pain, swelling, and redness following subcutaneous immunization.

Jonathan Dufimmunization, Immunization Safety Office, CDC Advisory Committee on Immunization Practices, presented JYNNEOS Vaccine Safety Monitoring During the 2022 Mpox Outbreak on February 22, 2023. According to VAERS, the number of serious adverse events reported after JYNNEOS was 26. The CDC announced on December 8, 2022, that the vaccine's safety profile was consistent with the results of pre-licensure studies. The most common adverse health events reported were nonserious, including injection site reactions. Serious adverse events were rare among adults.

Severe adverse reactions, such as those associated with replicating vaccinia virus strains, including myocarditis, encephalitis, generalized vaccinia, or eczema vaccinatum, were not observed during the Jynneos development program. The U.S. FDA reports in smallpox vaccine-naïve healthy adults, the most common (> 10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%).

JYNNEOS Contraindication 

According to the CDC, JYNNEOS is contraindicated in persons with allergies to any vaccine component.

JYNNEOS Immunocompromised

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS.

JYNNEOS Storage Requirement

 JYNNEOS must be safely stored at 20 degrees Celsius (20°C). 

Bavarian Nordic JYNNEOS Revenues 2025

Revenue from sales of JYNNEOS/IMVANEX/IMVAMUNE in the first quarter of 2025 was DKK 629 million (DKK 344 million), which includes revenue from ongoing contracts with the U.S. government, other governments, and organizations, as well as private markets (the U.S. and Germany). For 2025, DKK 3,000-4,000 million in revenue from JYNNEOS/IMVANEX/IMVAMUNE is still expected, of which contracts have secured DKK 2,650 million as of May 2025. The ongoing, global mpox clade 1 and 2 outbreak continues to drive a surge in demand, resulting in the guided annual revenue exceeding the communicated base level of DKK 1,500-2,000 million.

In the United States, JYNNEOS (50632-0001-03) is commercially available at clinics and pharmacies, with insurance coverage for most individuals.

JYNNEOS MVA-BN® Vaccine News

October 7, 2025 - Nina Wressnigg, Head of Clinical Development Science at CEPI, said: "Although MVA-BN has been licensed for emergency use in children in the Democratic Republic of the Congo - the worst affected country - many other countries lack this access causing children to continue to bear the brunt of the suffering, marked by severe illness and possible loss of life. These new topline data provide additional positive findings that could expand licensure to children in more countries to control the ongoing outbreak."

June 26, 2025 - Paul Chaplin, President & CEO of Bavarian Nordic, stated in a press release, "These new studies will fill the gap by providing essential data about the use of MVA-BN in infants and pregnant women

May 19, 2025 - A study reported that genomics reveals zoonotic and sustained human Mpox spread in West Africa. It was noted that hMPXV-1 emerged in humans in August 2014 in southern Rivers State and circulated undetected for three years.

May 15, 2025 - The WHO published the 52nd situation report on the multi-country mpox outbreak, with data as of May 2025. The African Region has administered more than 668,000 doses of MVA-BN vaccines across seven countries.

May 9, 2025 – Bavarian Nordic A/S announced that Public Preparedness (mpox, smallpox) revenue increased by 83% to DKK 629 million compared to the first quarter of 2024.

May 6, 2025 - Paul Chaplin, President & CEO of Bavarian Nordic, stated, "Following the recent FDA approval of the freeze-dried formulation of our smallpox/mpox vaccine, we applaud the U.S. government's steadfast commitment to improving national health security through the exercise of these options. The freeze-dried vaccine, with its improved shelf life, significantly contributes to securing the long-term availability of countermeasures to protect U.S citizens against life-threatening diseases."

March 19, 2025 - Prof. Leif Erik Sander, Director of the Department of Infectious Diseases and Critical Care Medicine at Charité and a research group leader at the Berlin Institute of Health at Charité, commented, "Our results confirm that a single dose of the vaccine provides good protection against Mpox, at least for a short time. Unfortunately, we found that people with HIV – even those taking adequate medication – are not sufficiently protected by a single dose."

December 20, 2024 - Gavi CEO Dr. Sania Nishtar: "We thank the U.S. for these donations, which substantially strengthen the global mpox response. In addition to the 500,000 doses that Gavi procured directly in September through our First Response Fund, working with our donors, we now have legal frameworks in place to facilitate a substantial volume of additional pledged doses, which we will work with our partners to ensure are rolled out as quickly as possible."

November 22, 2024 - The WHO Director-General, in agreement with the advice of the IHR Emergency Committee, has determined that the mpox upsurge continues to constitute a public health emergency of international concern.

November 15, 2024 - Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: "We have had a busy but highly purposeful and rewarding third quarter, during which we have worked intensively to support efforts to curb the ongoing mpox outbreak in Africa."

October 23, 2024 - A study reported a distinct clade I sequence from Sudan, suggesting local circulation of Monkeypox virus (MPXV) in Eastern Africa over the past four decades.

October 14, 2024 - The WHO approved JYNNEOS for people aged 12 to 17.

September 26, 2024 - Bavarian Nordic A/S announced an agreement with UNICEF to supply 1 million doses of the MVA-BN® mpox vaccine for African countries.

August 27, 2024 - Germany intends to donate 100,000 mpox vaccine doses to African countries.

August 16, 2024 - "Children and adolescents are disproportionately affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden access to vaccines and therapies for this vulnerable population. We applaud the NIH for their work on this study and are pleased to report data that support the use of our vaccine in adolescents, adding to the growing pool of evidence that MVA-BN is well tolerated and able to generate a relevant immune response in adolescents and adult populations," said Paul Chapel, President and Chief Executive Officer of Bavarian Nordic.

April 2, 2024 - Brian Hujdich, Executive Director of the National Coalition for LGBTQ Health, commented: "JYNNEOS is a vital step toward ensuring equitable access to healthcare for the LGBTQ+ community and marks a significant stride in preventing the spread of mpox."

JYNNEOS Vaccine Clinical Trial

The results of a Phase 2 study, posted as a preprint on September 9, 2022, concluded that priming with either 1 or 2 doses of MVA-BN induced durable immune memory, similar to the generated by replicating smallpox vaccines. When the MVA-BN vaccine was administered as a booster to individuals who had been primed 2 years earlier with MVA-BN or an older-generation replicating smallpox vaccine, it elicited a similarly rapid and durable immune response, generally well-tolerated. One-dose priming with MVA induced a long-term B-cell memory, resulting in robust anamnestic responses following an MVA booster two years later. This suggests that a single dose may offer protection against future exposure.

The FDA approval of JYNNEOS for smallpox is based on a development program comprising 22 clinical trials, including two Phase III trials. The program enrolled 7,871 individuals aged 18 to 80 who received at least one dose of the vaccine. Approval for the monkeypox indication is based on survival data from studies conducted in non-human primates. The survival rate ranged from 80% to 100% in animals vaccinated with JYNNEOS, compared to 0% to 40% in the control group.

Upon successful completion of the current study, expected in 2021, the Company plans to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN, anticipated in 2022.

BBV87 Chikungunya Vaccine Description

Bharat Biotech International Ltd's (BBIL) Chikungunya vaccine candidate (BBV87) is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype. Based on the ECSA strain, BBIL developed a pure, inactivated CHIKV immunogenic formulation. BBV87 vaccine completed standard pre-clinical studies, and the adjuvanted vaccine elicited an optimum immune response in phase 1 clinical trials in India.

On August 24, 2023, the International Vaccine Institute (IVI) announced the first participant received BBV87 in a Phase II/III clinical trial in Costa Rica, marking the start of a multi-country study funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology, India. In addition to the trial at Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 2021 and in Thailand and Guatemala soon after.

On June 15, 2023, MDPI published: An Overview of Indian Biomedical Research on the Chikungunya Virus with Particular Reference to Its Vaccine. This review gives an overview of the outbreak history and CHIKV-related research in India to favor novel; high-quality research works that promote effective treatment and preventive strategies, including vaccine development, against CHIKV infection.

Inactivated virion technology has a safety profile that potentially makes this vaccine accessible to special populations, such as immunocompromised and pregnant women, that some other technologies cannot reach.

The first report on CHIKV was from Tanzania, an eastern African country, in 1952. The first CHIKV outbreak in India was recorded in the city of Kolkata in 1963. Chikungunya is an emerging arthritogenic arboviral illness caused by the chikungunya virus (CHIKV), a member of the genus Alphavirus in the  Togaviridae family. The pathologic mechanism of this virus leads to acute infection of several weeks, which can persist for months with an incubation period of 2–12 days. The hallmark characteristics of CHIKV infection are saddle-back fever, polyarthralgia (mainly in small joints – ankles, toes, wrists, and phalanges), and a petechial or maculopapular rash (mainly on the face, limbs, and trunk). CHIKV affects all age groups with dengue-like symptoms characterized by nausea, fever, chills/rigors, headache, polyarthralgia, myalgia, photophobia, and skin rash.

Bharat Biotech creates innovative vaccines and bio-therapeutics trusted by physicians around the world. USFDA, KFDA, and WHO approve BBIL's manufacturing facilities.

BBV87 Chikungunya Vaccine Indication

Chikungunya virus was first identified in Tanzania in 1952, with sporadic disease outbreaks reported across Africa and Asia. In 2004, the disease began to spread quickly, causing large-scale outbreaks worldwide. Since the re-emergence of the virus, the total number of cases has been estimated at over 3.4 million in 43 countries. Outbreaks during the last decade worldwide have prompted the National Institute of Allergy and Infectious Diseases (NIAID) to add CHIKV to the category C priority pathogen biodefense list.

BBV87 Chikungunya Vaccine Dosage

A 2-dose live-inactivated vaccine (BBV87) against Chikungunya is being tested.

BBV87 Chikungunya Vaccine News

June 3, 2020 - The Coalition for Epidemic Preparedness Innovations (CEPI) announced a new partnering agreement to advance the development of a Chikungunya vaccine. The CEPI will provide the consortium up to US $14.1 million for vaccine manufacturing and clinical development of a 2-dose live-inactivated vaccine (BBV87) against Chikungunya. The European Union's Horizon 2020 program supports the funding through an existing framework partnership agreement with CEPI. The consortium was also supported with a grant of up to US $2.0 million from the Indian Government's Ind-CEPI initiative to fund the set-up of GMP manufacturing facilities for the vaccine in India and subsequent manufacture of clinical trial materials.

June 2, 2020 - Oslo, Norway; Seoul, South Korea; Telangana, India—CEPI, in collaboration with Ind-CEPI, has announced a new partnering agreement with a consortium comprising Bharat Biotech (BBIL) and the International Vaccine Institute (IVI) to advance the development of a Chikungunya vaccine.

BBV87 Chikungunya Vaccine Clinical Trial

The BBV87 vaccine candidate completed pre-clinical studies, and an optimum immune response was elicited by the adjuvanted vaccine in phase 1 clinical trials in India.

A Phase II/III Adaptive Seamless Design, Randomized, Controlled Trial To Evaluate Safety And Immunogenicity of 2 Dose-Regimen of BBV87 Chikungunya Vaccine In Healthy Subjects Aged 12 to 65 Years in Latin America and Asia.

Novavax COVID-19 Vaccine (Nuvaxovid) Clinical Trials, Dosage, Indication, Side Effects

Novavax Inc. COVID-19 vaccine (Nuvaxovid™(XBB.1.5 dispersion for injection) (NVX-CoV2373) (NVX-CoV2601) (NVX-CoV2705) is a protein-based vaccine engineered from the genetic sequence of the SARS-CoV-2 beta coronavirus. The vaccine was developed using Novavax's proprietary nanoparticle technology, Matrix-M, an adjuvant that enhances immune responses and stimulates high levels of neutralizing antibodies. Matrix-M has demonstrated a potent, well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, thereby boosting the immune response and facilitating the production of antibodies against the coronavirus in immunized individuals. Novavax's vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. The baculovirus infects a culture of Sf9 moth cells, which generate and display the spike protein on their cell membranes. Next, the spike proteins are harvested and assembled onto a synthetic lipid nanoparticle of about 50 nanometers, each displaying up to 14 spike proteins. 

On December 17, 2021, the World Health Organization (WHO) granted Emergency Use Listing (EUL) for Novavax's NVX‑CoV2373 (Covovax) vaccine, manufactured and marketed by Serum Institute of India Pvt. Ltd. (SII). On November 29, 2022, the WHO issued an updated Emergency Use Listing (EUL) for the Nuvaxovid vaccine, recommending it as a two-dose primary series for adolescents aged 12 through 17 and as a booster for adults. On November 28, 2023, the WHO authorized Nuvaxovid, enabling its 194 member states to expedite regulatory approvals for importing and administering the vaccine. As of 2025, Novavax's COVID-19 vaccine was one of the vaccines listed by the WHO. On May 15, 2025, the WHO's Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) advised manufacturers that monovalent JN.1 or KP.2 vaccines remain appropriate vaccine antigens. That monovalent LP.8.1 is a suitable alternative vaccine antigen.

On June 27, 2024, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of a universal recommendation for the use of 2024-2025 COVID-19 vaccines authorized under Emergency Use Authorization (EUA) or approved by Biologics License Application in individuals aged six months and older. On June 24, 2024, Novavax confirmed the JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3.

As of May 18, 2025, Novavax's vaccine is the only non-mRNA COVID-19 vaccine available in the United States, following the U.S. Food and Drug Administration's (FDA) granting of emergency use authorization (EUA) for the updated 2024-2025 Formula COVID-19 Vaccine version (NVX-CoV2705). On May 17, 2025, the U.S. FDA approved Nuvaxovid (STN: 125817) for specific individuals aged 12 and older.

Novavax COVID-19 vaccine brands include Nuvaxovid, Covovax, NVX-CoV2373, and TAK-019 (outside the USA)—trademark filing #90813423. A global listing of NVX‑CoV2373 studies is available at this link—NNVX-CoV2373's Drugbank Accession Number: DB15810; UNII: UK9AK2IN1P. Additionally, global information about the Novavax COVID-19 Vaccine varies by country and is available on this webpage. And at NovavaxMedInfo.com. See the Summary of Product Characteristics with Package Leaflet, Prescribing Information, Important Safety Information, and adverse event reporting instructions, or request additional information by visiting www.NovavaxCovidVaccine.com. 

Maryland-based Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company located at 21 Firstfield Road, Gaithersburg, MD 20878. It promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. SK bioscience announced on August 9 that it had also made an equity investment in Novavax, following a similar move by Sanofi in May 2024.

Novavax JN.1 Vaccine

Novavax's updated COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3. NVX-CoV2705 is an updated version of Novavax's NVX-CoV2373, formulated to target the JN.1 variant. The JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating its potential to protect against forward-drift variants.

On April 15, 2025, Novavax announced preliminary results from the SHIELD-Utah study, showing that Novavax's COVID-19 Vaccine, Adjuvanted (2024-2025 Formula), targeting the JN.1 strain, resulted in fewer and less severe reactogenicity symptoms than the Pfizer-BioNTech mRNA vaccine (2024-2025 Formula). This real-world study also showed that the impact of symptoms on daily activities, including work and family responsibilities, was lower in recipients of Novavax's vaccine.

As discussed at the June 2024 FDA Vaccines and Related Biological Products Advisory Committee meeting, targeting JN.1, the parent strain of the most common currently circulating variants, has a public health benefit. Nonclinical data have demonstrated that Novavax's JN.1 vaccine induces broad neutralization responses against JN.1 lineage viruses, including those carrying the F456L and R346T mutations, as well as against "FLiRT" and "FLuQE" variants. Novavax's vaccine also elicits conserved, polyfunctional, Th1-biased CD4+ T cell responses across a range of JN.1 lineage variants. 

Novavax and Sanofi Pasteur Inc. Agreement

Novavax and Sanofi Pasteur Inc. announced on May 10, 2024, that they entered into a co-exclusive licensing agreement that includes a co-exclusive license to co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan and South Korea where Novavax has existing partnership agreements) effective January 2025; a sole license to Novavax's adjuvanted COVID-19 vaccine for use in combination with Sanofi's flu vaccines, while Novavax retains the right to and is developing its own COVID-19-Influenza Combination vaccine candidate; a non-exclusive license to use Novavax's adjuvanted COVID-19 vaccine for use in combination with non-flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) $70 million equity investment in Novavax, issue a $500 million upfront payment, Up to $700 million in COVID-19, and combination product near-term milestones, plus ongoing tiered royalties on product sales; Up to $210 million in milestones plus royalties for each new vaccine developed utilizing Novavax's Matrix-M adjuvant.

On December 13, 2024, Novavax confirmed it had achieved a milestone in its Phase 2/3 clinical trial of its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

NVX-CoV2373 Vaccine U.S. FDA Authorizations

The U.S. FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024, meeting Presentation was led by Robert Walker, MD, and included Novavax Data in Support of the 2024-2025 Vaccine. On October 3, 2023, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 and older, to include the 2023-2024 formula. Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose, and unvaccinated individuals receive two doses. On September 12, 2023, Dr. Filip Dubovsky, President of Research & Development, presented Data supporting the Novavax XBB.1.5 Vaccine.

On June 15, 2023, Novavax, Inc. participated in the VRBPAC meeting and presented updated data. The meeting resulted in a unanimous vote recommending updating the current COVID-19 vaccine composition to a monovalent XBB lineage. On June 6, 2023, the FDA confirmed that the Novavax COVID-19 Vaccine, Adjuvanted, is available under Emergency Use Authorization (EUA) in the United States to prevent COVID-19 in individuals 12 years of age and older and for booster doses for specific individuals.

On February 13, 2023, Novavax announced a modification to its agreement with the U.S. Department of Health and Human Services (HHS) to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine. The U.S. FDA publishes Fact Sheets for Healthcare Providers, RECIPIENTS, and CAREGIVERS. Novavax, Inc., Filip Dubovsky, MD, MPH, Executive Vice President & Chief Medical Officer, presented to the VRBPAC on January 26, 2023 - Novavax Vaccine Regimens Addressing COVID-19. Where authorized under state law in the U.S., standing orders enable eligible nurses and other healthcare professionals (e.g., pharmacists) to assess and vaccinate persons who meet the criteria in the "Procedure" section without the need for clinician examination or direct order from the attending provider at the time of the interaction.

On October 19, 2022, Novavax announced that the Novavax COVID-19 Vaccine had received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The FDA confirmed on August 19, 2022, that the Novavax COVID-19 Vaccine was available under Emergency Use Authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. The CDC approved this EUA on August 22, 2022. Previously, on August 15, 2022, Novavax, Inc. announced that it had submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine as a homologous and heterologous booster in adults aged 18 and older. As of August 8, 2022, Novavax received U.S. FDA Emergency Use Authorization (EUA) and CDC recommendations for NVX-CoV2373, marking the first protein-based, non-mRNA COVID-19 vaccine authorized in the U.S. for adults. On June 7, 2022, the VRBPAC's 22 members voted 21 -1, with one abstention, to endorse the authorization of the protein-based Novavax COVID-19 vaccine. The VRBPAC digital meeting reviewed various authorization presentations.

Nuvaxovid™ XBB.1.5 Dispersion for Injection NVX-CoV2601 COVID-19 Vaccine Authorizations

On March 11, 2024, Canada's National Advisory Committee on Immunization announced it had published updated guidance on the use of Nuvaxovid™ XBB.1.5, a recombinant protein subunit COVID-19 vaccine. The recommendations state that Nuvaxovid XBB.1.5 can be used in individuals aged 12 years and older, regardless of vaccination status. On February 7, 2024, the U.K.'s Joint Committee on Vaccination and Immunisation advised that Nuvaxovid may be used as a booster dose for individuals aged 12 years and older when alternative vaccines are not considered clinically suitable. In January 2024, Novavax's updated protein-based non-mRNA COVID-19 vaccine became available in the United Kingdom and Taiwan. As of December 19, 2023, Novavax's updated vaccine is available in France, Italy, Poland, Sweden, and Singapore, and is the only COVID-19 vaccine option available in Poland. Health Canada granted expanded authorization on December 5, 2023. On October 31, 2023, the European Commission (EC) approved Nuvaxovid XBB.1.5 dispersion for injection as the COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV 2601) for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals aged 12 and older. The EC decision follows a positive opinion for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

On July 6, 2023, Nuvaxovid received Full Marketing Authorization from the EU for use as a primary series in individuals aged 12 and older and as a booster in adults. On June 16, 2022, the European Medicines Agency (EMA) published clinical data EMEA/H/C/005808/0000. The EMA's human medicines committee (CHMP) recommended granting an indication extension for the COVID-19 vaccine Nuvaxovid, developed by Novavax CZ, a.s., to include adolescents aged 12 to 17 years. The EMA and European Commission authorized Nuvaxovid for adults on December 20, EU study number: EudraCT number 2020-004123-16.

As of April 2024, the Novavax XBB.1.5 vaccine is under evaluation by the Australian Therapeutic Goods Administration (TGA). The Novavax XBB.1.5 vaccine will be introduced into the program as soon as possible following approval by the Therapeutic Goods Administration (TGA).

Novavax COVID-19 Vaccine Production

Nuvaxovid has manufacturing sites in the Czech Republic, Australia, Canada, Japan, and South Korea. In 2021, Novavax licensed and transferred its manufacturing technologies, providing the Matrix-M adjuvant, to enable Takeda to manufacture the vaccine at its Hikari facility in Japan.

CovoVax™ Authorizations

Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) confirmed the CovoVax™ vaccine was authorized in Indonesia on December 1, 2021. India's Drugs Controller General of India (DCGI) issued its authorization on December 28, 2021. The DCGI authorized the Novavax co-branded vaccine for adolescents aged 12 to 17 years in India. On May 2, 2022, the Standing Technical Sub-Committee of the NTAGI authorized Covovax for individuals aged 12 years and above. On June 28, 2022, the DCGI of India approved Covovax for restricted use in children aged 11 and below. On September 13, 2022, the companies confirmed that CovoVax was authorized in South Africa. 

Novavax COVID-19 Vaccine Availability

Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine was authorized for use in individuals aged 12 and older in the European Union and Japan to prevent COVID-19. In the U.S., the Novavax COVID‑19 Vaccine, Adjuvanted (2024-2025 Formula), is available at certain pharmacies, including, but not limited to, Costco, CVS Pharmacy, Giant, Publix, Rite Aid, and Stop & Shop. Pharmacies in the U.K. offer Novavax to patients. Novavax vaccines have been delivered in about 40 global markets. Global information about the Novavax COVID-19 Vaccine is found on this weblink. The Company has announced regulatory filings for its vaccine in the U.K., Austria,   Australia,   Canada, Cyprus, Estonia, European Commission,   Indonesia, The Philippines, Croatia, New Zealand, Singapore, South Korea, UAE, Japan, Finland, South Africa, France, Germany, Israel, India, Ireland,   Germany, Switzerland, the Netherlands, Taiwan, Thailand, Switzerland, Portugal, and Singapore.

NVX-CoV2373 Side Effects

The CDC published a Morbidity and Mortality Weekly Report on August 4, 2023 - During July 13, 2022–March 13, 2023, a total of 69,227 Novavax doses were administered to persons aged ≥12 years in the U.S., and 230 reports of adverse events after the Vaccine Adverse Event Reporting System received 230 reports of adverse events after vaccinationVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted. Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, and lymphadenopathy-related reactions. Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following the Novavax COVID-19 Vaccine, Adjuvanted outside clinical trials. Do not administer the Novavax COVID-19 Vaccine Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine Adjuvanted.

Filip Dubovsky, M.D., MPH, with Novavax, Inc., presented heart health (Post-Authorization Myocarditis / Pericarditis) information - 1,072,074 doses administered worldwide as of June 30, 2022; a Broad search safety database yielded 68 potential reports; Reports often had limited information; Brighton Collaborative Case definition used to evaluate reports: 1 met the definitive case definition of myocarditis, 6 met the probable case definition of myocarditis, 10 met the likely case definition of pericarditis.

On July 14, 2022, the European Medicines Agency (EMA) updated the Novavax COVID-19 vaccine (NVX-CoV2373) label to include the risk of severe allergic reactions. The EMA reported that 964 cases of suspected side effects spontaneously reported from EU/EEA countries had been treated with Nuvaxovid; none of these cases were fatal as of May 15, 2022. The WHO states that Nuvaxovid is contraindicated in individuals with a history of hypersensitivity to the active substance or excipients. Appropriate medical treatment and supervision should be readily available for anaphylaxis reactions.

To the extent feasible, report adverse events to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829). Also, read more about the side effects on the FDA's Fact Sheet for Recipients and Caregivers.

Novavax COVID-19 Vaccine Pregnancy and Breastfeeding

Available data on the Novavax COVID-19 Vaccine, Adjuvanted, administered to pregnant women, are insufficient to inform vaccine-associated risks in pregnancy. The Company says if you are pregnant or breastfeeding, discuss the options with your healthcare provider. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine during pregnancy. 

Novavax COVID-19 Vaccine Immunocompromise

For immunocompromised individuals, an additional dose of the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), may be administered at least 2 months after the last dose of a COVID-19 vaccine (2023-2024 Formula). Additional doses of the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) may be administered at the healthcare provider's discretion, based on the individual's clinical circumstances. The timing of the additional doses may be based on the individual's clinical circumstances.

Novavax COVID-19 Vaccine Coadministration

The U.S. CDC publishes Interim Clinical Considerations for Use of COVID-19 Vaccines. In Nov. 2023, 2023–24 Formula Vaccine Presentation. In 2022, a systematic review of clinical studies on the coadministration of influenza and COVID-19 vaccines was published. Novavax's COVID-19 Influenza combination Vaccine (CIC), COVID-NanoFlu, is a combination vaccine candidate that integrates NanoFlu and NVX-CoV2373. 

Novavax COVID-19 Vaccine Price

As of 2025, the Novavax COVID-19 vaccine is offered to the Vaccine for Children program.

NVX-CoV2373 Vaccine Cell Lines

"No human fetal-derived cell lines or tissue, including HEK293 cells, are used to develop, manufacture, or produce NVX-CoV2373," a Novavax spokesperson told Religion News Service on February 8, 2022.

Novavax and Pharmacists

As of November 2024, Nuvaxovid™ is available in prefilled syringe presentation in over 30,000 locations across major pharmacy retailers and regional grocers in the U.S. Silvia Taylor, Executive Vice President, Chief Corporate Affairs, and Advocacy Officer of Novavax, Inc., stated on January 12, 2024, that Novavax is proud to celebrate the invaluable contributions of pharmacists. Perhaps pharmacists have never been more essential to our health and well-being than they have been over the past three years, working tirelessly to ensure access to vaccines in communities everywhere. We recognize the vital role pharmacists and their teams play in communities worldwide in promoting public health and wellness, and we want to Thank You for your commitment. 

Novavax Vaccine News

May 5, 2025 - "Our ongoing partnership with Takeda is important for Novavax and our strengthened agreement enhances our ability to operate effectively in the Japanese market," said John C. Jacobs, President and Chief Executive Officer, Novavax. "This partnership further validates our cutting-edge technology platform and proprietary Matrix-M® adjuvant and our efforts to become a partner of choice."

April 15, 2025 - "The risk of side effects or reactogenicity is a major decision factor for those opting to get vaccinated. Our findings of lower frequency and intensity of reactogenicity symptoms from the protein-based COVID-19 vaccine observed in SHIELD-Utah add valuable insights to the public debate weighing choice and value of COVID-19 vaccination," said Sarang K. Yoon, DO, MOH, Principal Investigator, University of Utah Health.

February 28, 2025 - Novavax, Inc. announced its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2024.

December 10, 2024 - "A combination vaccine for two vaccine-preventable diseases is an important step forward for public health, and the trial start is a key step in advancing our late-stage pipeline, which we plan to progress through strategic partnerships," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President, Head of Research and Development, Novavax. "Our goal is to get these assets to market as soon as possible, and we will work with the U.S. FDA to assess the possibility of an accelerated approval pathway."

November 12, 2024 - "Novavax continues to focus on our corporate growth strategy of driving value from additional business development activities and organic R&D using our proven technology platform," said John C. Jacobs, President and Chief Executive Officer of Novavax.

August 8, 2024: Novavax generated a total revenue of $415 million in the second quarter of 2024 and ended the period with $1.1 billion in Cash.

June 24, 2024—John C. Jacobs, President and CEO of Novavax, stated, "Our updated COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3."

June 14, 2024 - "Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," said John C. Jacobs, President and Chief Executive Officer, Novavax. 

February 28, 2024—John C. Jacobs, President and Chief Executive Officer of Novavax, commented, "Moving into the next chapter of our business journey as a more lean and agile organization, we are laser-focused on improving our commercial performance in 2024 and 2025 and diversifying our revenue opportunity with our potential combination vaccine launch, which we expect in the fall of 2026."

January 31, 2024 - John C. Jacobs, President and Chief Executive Officer of Novavax, commented in a press release, "We are redefining how we do business and are purposefully focusing on the critical activities needed to achieve our objectives and strengthen the Company's financial performance."

January 3, 2024: Florida State Surgeon General Dr. Joseph A. Ladapo published an open letter stating that providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines.

December 19, 2023 - The French Ministry of Health had the new (Novavax) vaccine available primarily in retail pharmacies by 2023.

November 28, 2023 - "The WHO Emergency Use Listing of our updated protein-based non-mRNA COVID-19 vaccine enables expedited regulatory approvals for its 194 member states and UN procurement agencies, such as UNICEF, thereby supporting equitable access to our vaccine around the world," said John C. Jacobs, President and Chief Executive Officer, Novavax.

November 9, 2023 - The Company announced that its total revenue for the third quarter of 2023 was $187 million, compared to $735 million in the same period in 2022.

October 3, 2023 - Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, commented in a press release, "Today's (Novavax) authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

June 15, 2023: Novavax confirmed it is prepared to deliver a Protein-based Monovalent XBB COVID Vaccine Consistent with the FDA VRBPAC Recommendation for Fall 2023.

May 25, 2023 - "The positive CHMP Opinion for full Marketing Authorization for our COVID vaccine brings us one step closer to full authorization and will provide an approval pathway for an updated vaccine in time for the fall," said John C. Jacobs, President and Chief Executive Officer of Novavax.

April 8, 2020 - Novavax, Inc. announced it had identified a coronavirus vaccine candidate, NVX-CoV2373. The clinical development plan combines Phase 1 and Phase 2 approaches to allow rapid advancement.

Novavax Clinical Trials

The NVX-CoV2373 vaccine is currently being evaluated in multiple clinical trials.

A Phase 4 study, published in September 2024, confirmed that NVX-CoV2372 is suitable for boosting humoral immune responses in individuals primed with AZD1222. Compared to mRNA vaccines, it induces fewer acute side effects and more sustained levels of anti-spike IgG antibodies.

On March 6, 2024, The Lancet Infectious Diseases published results from an interim analysis of phase 3, a randomized, observer-blinded study focused on the immunogenicity and safety of a saponin-adjuvanted, protein-based, omicron-BA.5-containing bivalent vaccine (NVX-CoV2540 plus NVX-CoV2373) versus the prototype vaccine alone (NVX-CoV2373) when used as the more significant greater. Booster dose (Novavax). These findings show that the bivalent vaccine booster induces more robust immune responses than the prototype booster against clinically relevant variants of interest. Boosting with the monovalent BA.5-containing vaccine alone resulted in the highest neutralizing titers against Omicron BA.5. Part 2 of the ongoing 2019nCoV-311 study met all three coprimary endpoints. It did not raise any new safety concerns, supporting the use of omicron-based booster vaccines.

On March 16, 2024, the journal Vaccine published a positive benefit-risk assessment for the Novavax COVID-19 vaccine (NVX-CoV2373). On April 6, 2024, MDPI's journal Vaccines published the results of a Real-World Retrospective Study in Germany, funded by Novavax Europe. These researchers stated that the Tolerability and COVID-19 protection support the use of NVX-CoV2373 as a primary or booster vaccination for all authorized populations, including high-risk individuals. On April 24, 2024, the JAMA Network published an Original Investigation that found no statistically significant signal for seizures when analyzing 2019 or 2022 background-rated data.

On October 3, 2022, the peer-reviewed journal The Journal of Clinical Investigation published a study that found the protein-based vaccine NVX-CoV2373 induces robust T-cell immunity capable of recognizing SARS-CoV-2 antigens and supporting humoral immune responses. On October 25, 2022, a non-peer-reviewed study reported that after the third dose of NVX-CoV2373, titers against Omicron BA.1 (GMT: 1,197) and BA. 4/BA.5 were observed.5 (GMT: 582), with responses similar in magnitude to those triggered by three doses of an mRNA vaccine. On November 8, 2022, the Company reported the Novavax BA.1 vaccine candidate (NVX-CoV2515) met its primary strain-change endpoint, allowing for the development of variant vaccines, if necessary; Novavax's prototype vaccine induced a broad immune response against the original Wuhan, BA.1, and BA.5 strains; and the phase 3 trial showed no benefit for a bivalent vaccine utilizing Novavax' recombinant protein/adjuvant technology.

Plaquenil (Hydroxychloroquine) 2024

Plaquenil (Hydroxychloroquine) is U.S. FDA-approved to treat certain types of malaria and autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis, says the U.S. Centers for Disease Control and Prevention (CDC). The U.S. HHS Secretary Alex Azar clarified on June 15, 2020, that hydroxychloroquine remains FDA-authorized for various use cases. People with lupus should follow their doctor's guidance and the CDC's safety guidelines for people with compromised immune systems. Plaquenil (Hydroxychloroquine) is in a class of drugs called antimalarials. Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20%; chemically, the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Plaquenil (Hydroxychloroquine) is a more soluble and less toxic metabolite of chloroquine, which causes fewer side effects and is, therefore, assumed to be safer.

Plaquenil is a longer-acting medication that can take months to become effective. Conversely, the medicine can take weeks to "leave the body." Although hydroxychloroquine has a longer half-life -- around 40-45 days – than many medications, it is most effective and safe at its prescribed dosage. Therefore, it is essential to continue the prescribed dosage unless your prescribing doctor says otherwise, according to Lupus.org.On April 7, 2020, the U.S. Food and Drug Administration (FDA) approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine (Plaquenil) Sulfate Tablets USP, 200 mg treatment uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults treat acute and chronic rheumatoid arthritis in adults. 

Hydroxychloroquine is registered in approximately 60 countries under different trade names: Plaquenil®, Quensyl®, and Plaquinol®, says Sanofi. Hydroxychloroquine was granted FDA approval in April 1955. Hydroxychloroquine's Accession Number is DB01611.

Plaquenil (Hydroxychloroquine) Indication

Studies indicate chloroquine prevents and treatment for malaria. Hydroxychloroquine is FDA-approved to prevent and treat certain types of malaria. It has a long elimination half-life of 30–45 days, allowing for weekly dosing when used to avoid malaria and a short 48-hour treatment course when used to treat malaria. Chloroquine is a lysosomotropic antimalarial drug that neutralizes lysosomal acidification, thus blocking autophagosomal degradation. Chloroquine use for influenza prevention has been researched for years and can effectively treat rheumatoid disease manifestations, such as joint pain and rashes, reduce thrombotic events, and prolong survival.

Plaquenil (Hydroxychloroquine) COVID-19

The World Health Organization (WHO) does not recommend hydroxychloroquine to prevent COVID-19. This recommendation is based on findings from six clinical trials with over 6,000 participants who did not have COVID-19 and received hydroxychloroquine.

A February 2024 study found HCQ use was associated with an 11% increase in the mortality rate in a meta-analysis of randomized trials. The number of hydroxychloroquine-related deaths in hospitalized patients is estimated at 16,990 in six countries. This study has some limitations, as some of the results should be taken cautiously, particularly those obtained in France, Turkey, and Belgium.

A study published in August 2023 concluded: The present report unveils the ultrastructural proof to complement the paradox regarding the role of prophylactic HCQ in COVID-19 patients. This study highlighted the level of SARS-CoV-2 infection and ultrastructural alteration in the preventive HCQ+ group in comparison to the HCQ group of the ciliated epithelium, type II pneumocytes, alveolar macrophage, neutrophil, and anucleated granulocytes individually. We found the significant antiviral activity of HCQ to have a protective role rather than a degenerating effect on the ciliated epithelium and type II pneumocytes in which low infection levels and relatively intact cellular ultrastructure were observed. The ultrastructure of alveolar macrophages and neutrophils was degenerated in ARDS patients of both the HCQ+ and HCQ− groups. However, enucleated fragments of granulocytes showed a higher tendency of phagocytosis of the mature SARS-COV-2 virus in the HCQ+ group.

A study published by New Microbes and New Infections on October 7, 2023, concluded that treating COVID-19 using a combination of hydroxychloroquine plus azithromycin was safe and was associated with a statistically significant mortality benefit in hospitalized patients - the OR for mortality in the treatment group was 0.635 vs. controls. These researchers analyzed raw data collected from a cohort of 30,423 patients with COVID-19 cared for at IHU Méditerranée Infection in Marseille, France, and extracted from the DRYAD open data platform and performed univariate and multivariable logistic regressions with all-cause mortality within six weeks. Multivariable logistic regressions were adjusted for sex, age group, variants, and type of patient management.

The RECOVERY and SOLIDARITY clinical studies did not demonstrate any benefit of treating COVID-19 with hydroxychloroquine. Both suffer from significant methodological problems, as the HCQ doses during the first 24 ​h (2400 ​mg) were four times higher than the highest recommended dose of 600 ​mg. 

Mayo Clinic's hydroxychloroquine webpage was removed in September 2023. However, that page was republished on September 26, 2023.

Plaquenil (Hydroxychloroquine) Side Effects

Side effects of Plaquenil (hydroxychloroquine) include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy, and neuropathy, neuropsychiatric events, and hypoglycemia. The FDA has published a Frequently Asked Questions document and added clinical trials studying HCQ.

Plaquenil (Hydroxychloroquine) Ingredients

PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg basre for oral administration. Inactive Ingredients: Dibasic calcium phosphate USP, hypromellose USP, magnesium stearate NF, polyethylene glycol 400 NF, polysorbate 80 NF, corn starch, titanium dioxide USP, carnauba wax NF, shellac NF, black iron oxide NF.

Plaquenil (Hydroxychloroquine) News

August 17, 2022 - UCLA Health published: Lupus is an autoimmune disease with several forms.

March 3, 2022 - The WHO reconfirmed its recommendation not to use hydroxychloroquine or chloroquine for COVID-19 treatment.

October 20, 2021 - The European Review published a new study: Safety profile of chloroquine and hydroxychloroquine: a disproportionality analysis of the FDA Adverse Event Reporting System database. Conclusions: Our results confirm previously published evidence and suggest that HCQ has a safer clinical profile than CQ and, thus, could serve as the drug of choice for future therapeutic purposes.

September 24, 2020 - A study found HCQ administration is safe for short-term treatment for patients with COVID-19 infection regardless of the clinical setting of delivery, causing only modest QTc prolongation and no directly attributable arrhythmic deaths.

August 3, 2020 - The Henry Ford Health System issued an open letter about its study, saying, "the political climate that has persisted has made any objective discussion about this drug impossible." The health system said in the letter that it would no longer comment.

July 9, 2020 - A study published in The Lancet stated: Recent randomized clinical trials have confirmed that hydroxychloroquine does not reduce mortality of hospitalized patients with severe cases of COVID-19 disease. And the risk of heart-related events is associated.

June 15, 2020 - The US FDA has concluded that it is no longer reasonable to believe that HCQ and CQ oral formulations may effectively treat COVID-19 disease patients in a hospital setting. Accordingly, the FDA revoked the EUA for emergency use of HCQ and CQ to treat COVID-19.

June 9, 2020 -  Study: Hydroxychloroquine inhibits trained immunity - implications for COVID-19 

June 3, 2020 - The World Health Organization (WHO) leader announced it would resume testing an experimental COVID-19 disease treatment, Plaquenil (Hydroxychloroquine).

May 27, 2020 - European Countries Ban Hydroxychloroquine Treatments for COVID-19 Patients.

May 22, 2020 - The Indian Council of Medical Research, India's apex body in the field, has found that consuming hydroxychloroquine reduces the chances of getting infected with COVID-19.

May 22, 2020 - A study published by The Lancet was retracted because the study authors could not assure the integrity of this observational study's data.

May 20, 2020 - Brazil's Health Ministry issued new guidelines for further use of antimalarial drug hydroxychloroquine in mild coronavirus cases.

On May 14, 2020, the U.S. FDA issued an ANDA for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and acute and chronic rheumatoid arthritis in adults. The full name of this applicant holder is HAVIX GROUP INC DBA.

May 5, 2020 - Early treatment of COVID-19 patients with hydroxychloroquine and azithromycin: A retrospective analysis of 1061 cases in Marseille, France.

April 17, 2020 - The Indian Council of Medical Research, under the Ministry of Health and Family Welfare, has recommended chemoprophylaxis with hydroxychloroquine (400 mg twice on day 1, then 400 mg once a week thereafter) for asymptomatic healthcare workers treating patients with suspected or confirmed COVID-19 and for asymptomatic household contacts of confirmed cases.

April 11, 2020 - A new study was performed by researchers at IHU Méditerranée Infection, Marseille, France, of the 1,061 coronavirus-infected patients treated entirely with hydroxychloroquine and azithromycin, mortality is around 0.5%, and that the cure rate is extremely high. It avoids worsening and clears virus persistence and contagiously in most cases.

April 9, 2020 - The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

April 8, 2020 - The ORCHID trial (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease), funded by the National Heart, Lung and Blood Institute of the National Institutes of Health, enrolled its first patient on April 2 and will include hundreds of patients to determine if hydroxychloroquine is an effective treatment against the virus projected to hospitalize thousands of U.S. residents in the coming weeks.

April 7, 2020 - The FDA approved an Abbreviated New Drug Application for Hydroxychloroquine Sulfate Tablets USP, 200 mg.

April 2, 2020 - Henry Ford Health System led a national study to determine the drug's effectiveness in preventing COVID-19 disease.

March 29, 2020: Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit's malaria, lupus, and arthritis drug hydroxychloroquine plans to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses. Narasimhan also said Novartis supports the clinical trials needed before the medicine against the coronavirus can be approved.

March 28, 2020:  The FDA issued an Emergency Use Authorization for the use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19 when administered by a healthcare provider according to a valid prescription of a licensed practitioner as described in the Scope of Authorization (section II) of this letter.

March 25, 2020:  The FDA added hydroxychloroquine sulfate to category one under the Interim Policy on Compounding Using Bulk Drug Substances, Section 503B of the Federal Food, Drug, and Cosmetic Act.

March 25, 2020: The WHO urges countries to ensure the continuity of malaria service during the COVID-19 pandemic.

March 22, 2020: India's Secretary of Health stated that the National Task Force for COVID-19 disease officially recommends prophylactic hydroxychloroquine for healthcare workers and families of laboratory-confirmed positive COVID-19 patients.

January 7, 2019 - Study: Calcium pyrophosphate disease (CPPD) is caused by the deposition of calcium pyrophosphate (CPP) crystals in the joint tissues, particularly fibrocartilage and hyaline cartilage. Several mechanisms of action have been suggested for Hydroxychloroquine (HCQ) in the context of CPPD treatment, all of which signify its capability to immunomodulate and reduce inflammation. HCQ blocks T-cells' activity and reduces the release of various cytokines (interleukin-1, interleukin-6, and tumor necrosis factor-alfa). It has also been demonstrated to inhibit matrix metalloprotease activity in experimental animals. In a double-blinded, prospective six-month trial, HCQ was beneficial specifically for chronic CPPD-related arthropathies.

August 22, 2005: Chloroquine is a potent inhibitor of SARS coronavirus infection and spread.

March 1, 2015 - HCQ triggers the host defense machinery by inducing ROS- and MAVS-mediated innate immune activation against DENV infection and may be a candidate drug for DENV infection.

Plaquenil Antiviral Medication Clinical Trials

Clinical Trial NCT04341441: Will Hydroxychloroquine Impede or Prevent COVID-19 (WHIP COVID-19).

Clinical Trial NCT04332991: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID) (Phase 3).

Clinical Trial NCT04308668: Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP) (Phase 3)

Clinical Trial NCT04333654: Hydroxychloroquine in Outpatient Adults With COVID-19 (Phase 1).Primary Objective: To assess hydroxychloroquine versus placebo effect on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19.

Clinical Trial NCT04321278: Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Phase 3).

Clinical Trials NCT04358068: Evaluating Hydroxychloroquine and Azithromycin's Efficacy to Prevent Hospitalization or Death in Persons With COVID-19.

Note: This content is aggregated from the CDC, WHO, clinical studies, and the Precision Vax news network. This information is fact-checked by healthcare professionals, such as Dr. Robert Carlson.