Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Jan 12, 2022 • 4:38 pm CST

The World Health Organization (WHO) issued Influenza Update N° 410 on January 10, 2022, which says 'influenza activity remains low but continued to increase in the temperate zones of the Northern Hemisphere, such as the U.S.'

In the temperate zones of the Southern Hemisphere, influenza activity remained low overall, although increased detections of influenza A(H3N2) were reported in temperate South America.

The WHO National Influenza Centres and other laboratories from 110 countries, areas, or territories reported data to FluNet as of 2022-01-07 11:00:29 UTC.

These laboratories tested more than 522,595 specimens during the last period.

A total of 27,153 were positive for influenza viruses, reflecting a 0.05% positivity rate.

Of the confirmed specimens, about 73% were typed as influenza A. And of the sub-typed influenza A viruses, 95.6% were influenza A(H3N2).

The WHO advised 'Clinicians to consider influenza in differential diagnosis especially for high-risk groups for influenza, and test and treat according to national guidance.'

From a regional perspective, the WHO disclosed:

  • In North America, influenza virus detections of predominately A(H3N2) among the subtyped increased, and hospitalizations are increasing but remain low overall.
  • RSV activity decreased in the USA and Canada.
  • In Europe, Influenza A(H3N2) was predominated.
  • In East Asia, influenza activity continued increasing in China, while influenza illness indicators and activity remained low in the rest of the subregion.
  • In the Caribbean and Central American countries, some countries increased influenza A(H3N2) and B virus detections. 
  • In tropical South America, influenza A(H3N2) detections increased overall, with severe acute respiratory infection levels were reported at extraordinary levels in Bolivia (Plurinational State). 
  • In tropical Africa, overall influenza activity continued on a decreasing trend.
  • In Southern Asia, influenza virus detections of predominately influenza A(H3N2) increased overall, although decreasing in a few countries. 
  • In South-East Asia, sporadic influenza detections were reported in the Philippines.

Within the U.S., the Centers for Disease Control and Prevention (CDC) released its weekly update on January 7, 2022, saying 'influenza activity is increasing, with the eastern and central parts of the country seeing the majority of viruses reported.'

The majority of influenza viruses detected are A(H3N2).

So far, most of the H3N2 viruses are genetically closely related to the flu vaccine virus, but some antigenic differences have developed as H3N2 viruses have continued to evolve.

Separately on January 12, 2022, the CDC's Advisory Committee on Immunization Practices reviewed updated presentations, such as 'Influenza Vaccines for Older Adults,' presented by Lisa Grohskopf, CDC Vaccine Policy Unit.

Additional flu vaccine news is published on this Precision Vaccinations webpage.

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Jan 12, 2022 • 1:30 pm CST

The U.S. CDC's Emergency Preparedness and Response team today presented: 'What Clinicians Need to Know About the New Oral Antiviral Medications for COVID-19.'

The Clinician Outreach and Communication Activity digital meeting on January 12, 2022, reviewed emergency use authorizations for the new oral antiviral medications molnupiravir and Pfizer Inc.'s Paxlovid™, therapeutic efforts to decrease hospitalizations and prevent severe COVID-19 and death.

During today's digital meeting, presenters from the U.S. Centers for Disease Control and Prevention, Office of the Assistant Secretary for Preparedness and Response, Food and Drug Administration, and the National Institutes of Health described recent treatment guidelines, patient prioritization, and resources for healthcare providers.

Subject matter experts reviewed when to prescribe antiviral medications, including patient assessment, a risk-benefit discussion to address patient questions or concerns, and prioritizing patients if medications are in short supply.

On January 11, 2022, the U.S. government distributed 99,960​ Paxlovid and 399,920​ Molnupiravir doses to states, territories, and agencies.

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Jan 12, 2022 • 8:23 am CST

Pennsylvania-based Ocugen, Inc. and Bharat Biotech today announced results from a study conducted at Emory University in Atlanta, GA, demonstrating that sera from subjects who received a booster dose of candidate vaccine COVAXIN™ (BBV152) six months after getting a primary two-dose series of COVAXIN neutralized the SARS-CoV-2 Omicron and Delta variants.

Earlier studies demonstrated the neutralizing potential of COVAXIN against SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Zeta, and Kappa.

"As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern," said Mehul Suthar, Ph.D. Assistant Professor, Emory Vaccine Center, and who led the laboratory analysis.

"Data from this preliminary (phase 1/2) analysis show individuals receiving a booster dose of COVAXIN have a significant immune response to both the Omicron and Delta variants."

"These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations," concluded Dr. Suthar's press release comments.

COVAXIN is formulated uniquely such that the same dosage can be administered to adults and children alike. In addition, the same vaccine doses can also be used for two-dose primary immunization in adults and children and booster dose vaccinations, making it truly a universal vaccine.

COVAXIN is an investigational vaccine candidate product in the U.S, currently under review by the U.S. Food and Drug Administration for emergency use authorization (EUA) for children 2-18 years of age.

With more than 180 million doses administered to adults and children outside the U.S., COVAXIN is currently authorized under emergency use in more than 20 countries, and emergency use authorization is in process in more than 60 other countries.

The World Health Organization recently added COVAXIN to its list of vaccines authorized for emergency use. 

Ocugen, Inc. is a biopharmaceutical company located in Malvern, PA, focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19.

Jan 12, 2022 • 7:03 am CST

New York-based Pfizer Inc. today announced positive top-line results from a Phase 3 clinical study describing the safety and immunogenicity of the PREVNAR 20™ vaccine when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) or when each vaccine was given with placebo.

PREVNAR 20 contains the broadest conjugate serotype coverage and helps protect against more strains of the bacteria that cause pneumococcal pneumonia than any other conjugate vaccine available.

Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a Pfizer-BioNTech COVID-19 vaccine dose (n=190) or with placebo (n=191).

Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo (n=189).

And the safety profile of co-administering PREVNAR 20 with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed with the Pfizer-BioNTech COVID-19 Vaccine booster dose.

"Pfizer is steadfast in its commitment to address the burden of certain respiratory diseases while raising awareness of the importance of adult immunizations," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer, in a press statement issued on January 12, 2022.

"These new safety and immunogenicity data provide further evidence supporting the potential to administer PREVNAR 20 and the Pfizer-BioNTech COVID-19 Vaccine at the same time."

At this time, no coadministration data are included in the PREVNAR 20 or Pfizer-BioNTech COVID-19 Vaccine prescribing information.

PREVNAR 20 is Pfizer's next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the thirteen serotypes already included in PREVNAR 13®.

The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes that cause invasive pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

Pfizer has recently submitted a supplemental Biologics License Application to the U.S. FDA to include data in the PREVNAR 20 prescribing information for adults age 18 years or older regarding coadministration of PREVNAR 20 with a seasonal inactivated influenza vaccine.

Jan 12, 2022 • 5:54 am CST

Maryland-based Novavax, Inc. and SK bioscience, Co. Limited today announced that South Korea's Ministry of Food and Drug Safety had approved a Biologics License Application from SK bioscience for Nuvaxovid™.

Novavax's COVID-19 vaccine is also known as NVX-CoV2373, and Covovax™ is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience.

SK bioscience has an agreement with the South Korean government to supply 40 million doses of Nuvaxovid.

Novavax previously announced conditional marketing authorization in the European Union and emergency use listing from the World Health Organization. 

"Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold," said Stanley C. Erck, President, and CEO, Novavax, in a press release issued on January 12, 2022.

Previously, on September 7, 2021, Takeda announced that the Government of Japan's Ministry of Health, Labour, and Welfare would purchase 150 million doses of Novavax's vaccine candidate (TAK-019) manufactured in Japan by Takeda, subject to licensing and approval. 

NVX-CoV2373 was created using Novavax's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax's patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 contains purified protein antigen and can neither replicate nor cause COVID-19.

Novavax is a biotechnology company located in Gaithersburg, MD that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

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Jan 12, 2022 • 4:58 am CST

Bloomberg Law confirmed on January 11, 2022, European Medicine Agency (EMA) regulators warned that frequent COVID-19 vaccinations could adversely affect the human immune response.

Boosters "can be done once, or maybe twice, but it's not something that we can think should be repeated constantly," Marco Cavaleri, the EMA head of biological health threats and vaccines strategy, said at a recent press briefing.

"We need to think about how we can transition from the current pandemic setting to a more endemic setting."

This EMA advice follows different tactics/advice announced by Israel, the United Kingdom (U.K.), and the World Health Organization, which stated on January 11, 2022, 'a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.'

In December 2021, Israel became the first country to administer a second booster, or fourth mRNA vaccination, to Israelis over the age of 60.

However, the U.K. stated there is no need for a second booster.

The Joint Committee on Vaccination and Immunisation chair of COVID-19 immunization, Professor Wei Shen Lim, said in a media statement issued on January 7, 2022: 'The current data shows the booster dose continues to provide high levels of protection against severe disease, even for the most vulnerable older age groups.'

'For this reason, the committee has concluded there is no immediate need to introduce a second booster dose.'

In the U.S., the Food and Drug Administration recently amended the emergency use authorization for mRNA COVID-19 vaccines to shorten the time between completing a two-dose primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. 

Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, commented in a media statement, "We encourage everyone to get vaccinated—it's never too late to get your COVID-19 vaccine or booster." 

The EMA currently authorizes five COVID-19 vaccines. 

Maryland-based Novavax Inc.'s Nuvaxovid vaccine was recently authorized for adults in Europe.

The EMA is a decentralized agency of the European Union located in Amsterdam. It began operating in 1995 and is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in Europe.

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Jan 11, 2022 • 11:13 am CST

The U.S. HHS Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) today confirmed the continued implementation of the State and Territory-Coordinated Distribution System for COVID-19 related monoclonal antibodies (mAbs) and oral antivirals.

As of January 11, 2022, HHS/ASPR distributed 726,876​ doses to U.S. states, territories, and agencies for local allocations.

Of these doses, the oral antiviral Paxlovid (99,960) and Molinupivir (​399,920) were distributed.

And the four authorized mAbs, a total of 226,996 were distributed this week.

The HHS published the 'Outpatient administration guide for healthcare providers' on December 29, 2021. These COVID-19 products are being evaluated for effectiveness against the SARS-CoV-2 betacoronavirus variant known as Omicron.

In addition, the U.S. NIH OpenData portal publishes real-time data focused on Omicron.

Additional mAbs news is published on this Precision Vaccinations webpage.

Jan 11, 2022 • 9:31 am CST

Pennsylvania-based NRx Pharmaceuticals today confirmed new information regarding the BriLife™ investigational vaccine for COVID-19.

Last week, NRx met with experts from the Israel Institute for Biological Research (IIBR) to review data and research related to the ability of the BriLife vaccine to induce neutralizing antibodies against the Omicron variant.

Based on the preliminary findings, NRx is currently designing a phase 2b/3 study of the BriLife vaccine as a booster to protect against COVID-19 variants of concern, including the Omicron variant.

Patients in the late-stage study will be fully vaccinated with mRNA vaccines.

NRx stated it anticipates that the study will begin in the first quarter of 2021 in Israel and will be expanded in coordination with the health ministries of several countries.

Prof Jonathan Javitt, M.D., MPH, Chairman and CEO of NRx Pharmaceuticals, commented in a press statement issued on January 11, 2022, “We are working closely with the experts at the IIBR to design a study that we hope increases BriLife’s accelerated path to regulatory approval.”

In further news, the Israel Ministry of Health recently approved a study investigating the NanoPass MicronJet™ intradermal injection system for the BriLife vaccine.

The NanoPass system, invented in Israel, uses a patented microneedle system to deliver the vaccine into the skin with minimal discomfort.

This approach is especially promising for the BriLife vaccine because it binds to angiotensin-converting ACE2 receptors, which are present in significantly larger quantities in human skin cells than in muscle cells where traditional vaccines are injected.

In addition, early data with other vaccines suggests that intradermal delivery of BriLife may result in a more robust immune response at substantially lower vaccine dosing.

Furthermore, NRx continues technology transfer and scale-up activities to anticipate commercial-scale manufacture of Brilife by Q4 2022.

NRx Pharmaceuticals, located in Radnor, PA, is developing the BriLife™ Covid vaccine, developed by the Israel Institute for Biological Research, under an exclusive license from the Israel Ministry of Defense. 

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Jan 11, 2022 • 7:48 am CST

London-based GSK and Vir Biotechnology, Inc. today announced that the U.S. Government would purchase in the first quarter of 2022 an additional 600,000 doses of sotrovimab, an investigational monoclonal antibody (mAbs) for the early treatment of COVID-19.

Including the U.S. government's commitments announced on January 11, 2022, GSK and Vir have received binding agreements to sell approximately 1.7 million doses of sotrovimab worldwide.

The companies are forecasting manufacturing approximately 2 million sotrovimab doses globally in the first half of 2022.

However, data for GSK and Vir indicate this mAbs will remain in limited supply.

As of January 10, 2022, the U.S. government only distributed 52,128​ Sotrovimab treatments throughout the U.S.

And in total, the U.S government distributed 726,876 mAbs and antiviral treatments this week.

Sotrovimab, which the U.S. FDA granted Emergency Use Authorization in May 2021, is an investigational single-dose intravenous (IV) infusion SARS-CoV-2 mAbs to treat mild-to-moderate COVID-19 in certain adults and pediatric patients.

George Scangos, Ph.D., CEO of Vir, said in a related press statement, "As the Omicron variant continues its rapid spread alongside the still prevalent Delta variant, we are pleased to once again work with the U.S. government to provide more access to sotrovimab for people in the U.S. at high risk of progression to severe COVID-19."

"Data from multiple pseudo-virus and live virus preclinical studies, generated by industry and academia, continue to demonstrate that sotrovimab retains activity against all tested variants of concern and interest."

"We are proud of our ongoing contributions to the fight against the COVID-19 pandemic here in the U.S. and around the world."

GSK and Vir confirmed preclinical pseudo-virus data demonstrate that sotrovimab retains activity against all tested variants of concern and interest of the SARS-CoV-2 virus as defined by the World Health Organization, including, but not limited to, Omicron (B.1.1.529), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621).

Preclinical live virus testing has also been completed, with data further demonstrating that sotrovimab retains activity against the Omicron variant.

Sotrovimab is an investigational SARS-CoV-2 neutralizing mAbs. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, making it more challenging to resist resistance develop. 

The U.S. NIH's OpenData Portal publishes real-time information regarding mAbs effectiveness against the Omicron virus variant.

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Jan 10, 2022 • 2:36 pm CST

British Columbia-based AbCellera and its collaborators released new preclinical data on January 9, 2022, showing the pseudovirus neutralization status of its two monoclonal antibodies, bamlanivimab, and bebtelovimab, against the Omicron variant.

The data confirmed that the investigational antibody bebtelovimab, currently in Phase 2 clinical trials with Eli Lilly and Company, maintains full and potent neutralization activity against the Omicron variant and all other known SARS-CoV-2 variants of concern.

The data also confirmed that the neutralization activity of bamlanivimab with etesevimab is not effective against the Omicron variant.

However, Lilly has confirmed that bamlanivimab with etesevimab retains neutralization activity against the Delta variant.

Both bamlanivimab and bebtelovimab were co-developed with Lilly, responsible for clinical and commercial development. 

Lilly recently stated that it is in discussion with regulators to understand the potential need for additional therapies, including bebtelovimab.

Separately, the U.S. NIH OpenData Portal reported bebtelovimab displayed positive in vitro therapeutic activity against Omicron as of January 10, 2022.

Additional mAbs news is published on this Precision Vaccinations webpage.

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Jan 10, 2022 • 10:02 am CST

Washington-based CytoDyn Inc. today announced that a research paper entitled “Leronlimab (PRO 140) activity against 4-class drug-resistant HIV-1 from Heavily Treatment Experienced Subjects” has been accepted, peer-reviewed, and is available as a journal pre-proof on ScienceDirect.

The Leronlimab study was conducted as an in-vitro clinical study of 25 HIV-1-infected patients harboring a documented 4-class drug-resistance nucleoside reverse transcriptase inhibitors (“NRTIs”), non-nucleoside reverse transcriptase inhibitors (“NNRTIs”), protease inhibitors (“PIs”), and integrase strand transfer inhibitors (“INSTIs”) enrolled in the Italian PRESTIGIO Registry.

Significant findings from the study and observations from the authors include:

  • Leronlimab maintained total activity in the presence of extensive resistance to the four main antiviral classes.
  • Leronlimab IC50 did not appear significantly altered by previous or current exposure to maraviroc.
  • In vitro, leronlimab and maraviroc have been reported to have synergistic activity, further corroborating the different mechanisms of the two drugs despite the same CCR5 target.
  • In vitro susceptibility to leronlimab is not affected by extensive drug resistance and exposure to maraviroc.
  • Leronlimab may have some advantages over maraviroc as a clinically valuable CCR5 antagonist, including lower toxicity, less drug-drug interaction issue, and less frequent dosing.
  • Leronlimab can play a key role in subjects with minimal therapeutic options and CCR5-tropic virus.

“We would like to thank our Italian colleagues for understanding the importance of leronlimab in the treatment of HIV. This is further proof that leronlimab can benefit CCR5 tropic HIV patients, including those patients with multidrug resistance. HIV patients deserve the opportunity for multiple, effective treatment options,” stated CytoDyn’s Chief Medical Officer, Scott A. Kelly M.D., in a press release issued on January 10, 2022.

Leronlimab, among various potential applications, is a viral-entry inhibitor in HIV/AIDS.

It binds to CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab does not work on other strains of HIV (for example, X4). However, R5 is the most dominant strain of HIV.

Five clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. In addition, the leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies.

CytoDyn is a late-stage biotechnology company located in Vancouver, WA, developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. 

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Jan 10, 2022 • 9:14 am CST

Massachusetts-based Moderna Inc. today announced it had shipped about 807 million doses of Moderna's COVID-19 SpikeVax vaccine in 2021. These shipments produced approximately $17.5 billion in revenue (unaudited).

About 25% of those SpikeVax vaccine doses were shipped to low- and middle-income countries.

Furthermore, Moderna has signed Advanced Purchase Agreements that could generate approximately $18.5 billion in SpikeVax revenues and approximately $3.5 billion in options, including any potential updated COVID-19 vaccine booster candidates.

"While our COVID-19 vaccine is our first medicine to market, we have made significant progress across our pipeline of 40 development programs and now have 23 mRNA programs in clinical trials," stated Moderna's CEO Stéphane Bancel, in a press release.

Bancel is scheduled to present a Company update and its pipeline of mRNA vaccine development programs on Monday, January 10, 2022, at the 40th Annual J.P. Morgan Healthcare Conference. 

Jan 10, 2022 • 7:01 am CST

A non-peer-reviewed study published on January 4, 2022, reported a large-scale randomized, controlled clinical trial of heterologous prime-boost vaccination with an inactivated vaccine followed by a recombinant protein subunit vaccine.

Compared to homologous boost, the heterologous boost with Sinopharm's new NVSI-06-07 in BBIBP-CorV recipients elicited significantly higher immunogenicity against the SARS-CoV-2 prototype strain against Omicron and other variants of concern (VOCs).

'Our findings indicated that the heterologous boost with NVSI-06-07 was safe, well-tolerated, and immunogenic in adults primed with a full regimen of BBIBP-CorV,' wrote these researchers.

Compared to a homologous boost with a third dose of BBIBP-CorV, incremental immune responses were achieved.

The optimal booster strategy was the heterologous boost with NVSI-06-07 over six months after priming with two doses of BBIBP-CorV.

The heterologous BBIBP-CorV / NVSI-06-07 prime-boosting vaccination may be valuable in preventing the pandemic of Omicron.

'Due to no Omicron-specific vaccine available currently, the BBIBPCorV/NVSI-06-07 heterologous prime-boost might serve as an effective strategy combating Omicron variant.'

These researchers cautioned that it's still unclear how long the effects of the NVSI-06-07 booster will last. And 'further studies are needed to assess the long-term protection of BBIBP-CorV / NVSI-06-07 prime-booster vaccination.'

Sinopharm's NVSI-06-07 protein-based vaccine was authorized in December 2021 as a booster in the United Arab Emirates.

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Jan 10, 2022 • 6:03 am CST

The UK Health Security Agency announced on January 7, 2022, data shows COVID-19 vaccine booster doses (3rd) are continuing to provide high levels of protection against severe disease from the Omicron variant among older adults.

The latest study looked at booster doses in those over 65, who were among the first to be eligible when the booster rollout began in mid-September 2022.

'Whilst with a booster dose, the duration of protection against severe COVID-19 remains high, protection against mild symptomatic infection is more short-lived and drops to around 30% by about three months.'

The Joint Committee on Vaccination and Immunisation (JCVI) chair of COVID-19 immunization Professor Wei Shen Lim said in a media statement: 'The current data shows the booster dose continues to provide high levels of protection against severe disease, even for the most vulnerable older age groups.'

'For this reason, the committee has concluded there is no immediate need to introduce a second booster dose, though this will continue to be reviewed.'

'The data is highly encouraging and emphasizes the value of a booster jab.'

'With Omicron continuing to spread widely, I encourage everyone to come forward for their booster dose, or if unvaccinated, for their first two doses, to increase their protection against serious illness.'

The JCVI advises that at this present time, there is no immediate need to introduce a second booster dose, or fourth jab, to the most vulnerable (care home residents and those aged over 80).

Update: If you travel to the UK and qualify as 'fully vaccinated,' you can take either a rapid lateral flow or PCR test within two days of arriving in England. If you have a positive result on the rapid lateral flow test, you must take a PCR test.

And you must have had a complete course of one of the following COVID-19 vaccines at least 14 days before you arrive in England.

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Jan 10, 2022 • 5:25 am CST

Pennsylvania-based Ocugen, Inc. announced on January 8, 2022, that its partner in India, Bharat Biotech, posted positive results from a Phase 2 analysis of the COVAXIN™ (BBV152) vaccine booster program.

Study participants ages 12-64, receiving a booster dose six months following a second dose, saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

And, the booster dose analysis also found no serious adverse events, including hospitalization or death, were reported.

COVAXIN is an investigational vaccine candidate product in the U.S., but 180 million doses have been administered in 17 countries.

Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen, Inc., stated in a press release, "These booster data provide critical information about how COVAXIN™ can be used in the ongoing battle against COVID-19."

"We are encouraged by these results which continue to suggest that COVAXIN™ remains an important, broad-spectrum vaccine candidate with durability."

Additional data from the analysis found that more than 75% of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN.

Wild-type neutralizing antibodies (PRNT50) GMTs at one month after a booster dose against Alpha, Beta, Delta, and Delta plus variants were increased ten ·9, 161·0, 264·7, and 174·2 fold from baseline at six months post the second dose, respectively.

"Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection," commented Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

COVAXIN was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. COVAXIN is a highly purified and inactivated vaccine manufactured using a vero cell manufacturing platform.

Ocugen, Inc. is a biopharmaceutical company located in Malvern, PA, focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. 

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