The US Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended the Emergency Use Authorization (EUA) for a booster dose of Pfizer and BioNTech’s mRNA Covid-19 vaccine Comirnaty.
Pfizer and BioNTech have submitted the supplemental Biologics License Application (sBLA) for use of Comirnaty booster dose in people aged 16 years and above.
VRBPAC did not vote in favour of Comirnaty booster dose for the full population.
It recommended the booster dose in people aged 65 years and above, along with certain high-risk populations, administered at least six months after the two doses.
Healthcare workers and other professionals who are at elevated risk for occupational exposure to Covid-19 will also be included in the EUA.
The FDA is expected to announce its decision in few days, which could make Comirnaty the first Covid-19 vaccine authorised in the US, along with a booster.
The companies have recently been submitted the same data to the European Medicines Agency (EMA) and will submit to other regulatory authorities in few weeks.
Pfizer vaccine research and development head and senior vice president Kathrin U Jansen 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.”
VRBPAC recommendation was based on scientific evidence shared by the companies, including data from their clinical programme evaluating booster dose of Comirnaty.
Booster dose of the vaccine triggered significantly high neutralising antibody titers against the SARS-CoV-2 virus, along with the Beta and Delta variants, compared to two-dose vaccine.
Its reactogenicity profile was typically mild to moderate within seven days and the adverse event profile was generally consistent with other clinical safety data for Comirnaty.
VRBPAC also considered real-world surveillance data presented by the Israel Ministry of Health, including an analysis in 1.1 million people aged 60 years and above.
The analysis demonstrated that a booster dose restored levels of protection against Covid-19 and severe disease, when Delta was the dominant strain.
BioNTech co-founder and chief medical officer Özlem Türeci said: “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.”
