Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously favoured that the FDA grants an Emergency Use Authorization (EUA) for a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) for individuals 65 years of age and older, as well as those at high risk of developing the severe COVID-19.
Pfizer tweeted on Saturday:
The booster dose is meant to be given at least six months following the two-dose sequence, according to the committee. The panel also decided that this EUA should include healthcare professionals and others who are at increased risk of exposure.
VRBPAC is a group of independent specialists that advise the FDA on scientific and regulatory issues, including vaccine safety and effectiveness evaluations. VRBPAC did not vote in support of approving a booster dose for the whole population for which Pfizer and BioNTech submitted their supplementary Biologics License Application, which included those aged 16 and up.
FDA decision is anticipated within days
The same information was recently given to the European Medicines Agency (EMA), and it will be presented to additional regulatory bodies in the coming weeks. The companies are remaining attentive and continuing to develop appropriate COMIRNATY® booster dosage data for future licensing in additional cohorts, as well as to address emerging variants of concern. In the coming days, the FDA is anticipated to reach a decision. This decision may render COMIRNATY® the first COVID-19 vaccination with a booster approved in the United States.
Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer said:
“Today the VRBPAC reviewed data from our clinical program showing a favorable safety profile and strong immune responses against SARS-CoV-2 after a booster dose of our vaccine. These data, and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters can be a critical tool in the ongoing effort to control the spread of this virus. We thank the committee for their thoughtful review of the data and will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population.”
Özlem Türeci, M.D., Co-founder and Chief Medical Officer of BioNTech added:
“We are committed to support the ongoing efforts to reduce infections and COVID-19 cases. The data we submitted to the FDA, EMA and other regulatory authorities underline that a booster induces a strong immune response against all tested variants of concern and may contribute to address a public health need.”
VRBPAC has made its decision based completely on scientific evidence, introduced by the companies as a clinical program testing results of the safety, tolerability, and immunogenicity of a booster dosage of COMIRNATY®. When compared to the levels seen following the two-dose primary series, a booster dose of the vaccine resulted in considerably greater neutralizing antibody titers against the original SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants.
Clinical data shows a booster dosage of COMIRNATY® induces strong neutralization titers against SARS-CoV-2 and all already tested mutations
Within seven days of receiving the booster dosage, the reactogenicity profile was generally mild to moderate, and the frequency of responses was similar to or lower than after dose two. The adverse event profile for COMIRNATY® was mostly comparable with other clinical safety data.
The Israel Ministry of Health also presented real-world monitoring data to the VRBPAC, adding to the evidence for boosters’ public health impact. An analysis published this week in The New England Journal of Medicine was among the data given from Israel. Approximately 1.1 million people aged 60 and over who were eligible for a booster dose of the vaccination between July 30 and August 31, 2021 were included in the study. There were no new safety signals and reported adverse events were fewer than those seen following the second dosage. A booster dosage restored extremely high levels of protection against COVID-19 infections and severe illness in this period, according to the research. The main strain was Delta. When compared to those who were previously fully vaccinated but did not receive a booster dose, those who received the booster dose were less likely to develop a confirmed infection by a factor of 11.3 (95 percent CI: 10.4, 12.3) and less likely to develop severe illness by a factor of 19.5 (95 percent CI: 12.9, 29.5).
After receiving a booster, the increased protection led to vaccination efficacy equivalent to levels seen early in the country’s vaccine rollout (an estimated 95 percent), when the Alpha variety was the most widespread. A third dosage was previously allowed under the EUA of the Pfizer-BioNTech vaccine in the United States for persons over the age of 12 who have had a solid organ transplant or who have been diagnosed with diseases that are deemed to have a comparable level of immunocompromise.
This approval of the third dosage for immunocompromised people is independent and apart from the booster dose that VRBPAC is considering today. The third dosage for immunocompromised people is designed to address the problem that after two doses of the vaccine, some people still don’t have enough protection. In contrast, the booster dosage for EUA advised by VRBPAC today refers to an extra dose of the vaccine given to those who have built up adequate immunity following the original two-dose vaccination series, but whose protection has waned over time due to declining immunity.
BioNTech and Pfizer collaborated to create COMIRNATY, which is based on BioNTech’s unique mRNA technology. BioNTech holds marketing authorizations in the US, the European Union, the United Kingdom, and Canada, as well as emergency use authorizations or equivalents in the US (jointly with Pfizer) and other countries. Applications will be made to seek regulatory clearance in countries where emergency use authorizations or equivalents were first obtained.
Original Source – Press Release: https://www.businesswire.com/news/home/20210917005545/en/FDA-Advisory-Committee-Votes-Unanimously-in-Favor-Of-COMIRNATY®-Booster-for-Emergency-Use-in-People-65-and-Older-and-Certain-High-risk-Populations