Initial data was submitted from Phase 1 of the Phase 1/2/3 clinical trial programme, evaluating the third dose of Covid-19 vaccine in the US
Pfizer, BioNTech seek FDA authorisation for Covid-19 vaccine booster dose. (Credit: pearson0612 from Pixabay.)
Pfizer and BioNTech have submitted initial data to the US Food and Drug Administration (FDA) seeking authorisation for the booster dose of their Covid-19 vaccine (BNT162b2).
The companies submitted the data from the Phase 1 study, a part of their Phase 1/2/3 clinical trial programme evaluating the third dose Pfizer-BioNTech Covid-19 vaccine in the US.
Adult participants from the Phase 1 trial of the two-dose vaccine received a 30-µg booster dose of BNT162b2, within eight to nine months after receiving the second dose.
In the study, the third dose resulted in the enhanced immune response against the initial SARS-CoV-2 virus, along with the Beta and the Delta variants, compared to the two-dose vaccine.
The companies intend to submit the data from early-stage trials to the European Medicines Agency (EMA) and other regulatory authorities within few weeks.
Pfizer chairman and CEO Albert Bourla said: “Vaccination is our most effective means of preventing Covid-19 infection, especially severe disease and hospitalisation – and its profound impact on protecting lives is indisputable.
“The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.
“We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.”
BNT162b2 vaccine has been developed by both BioNTech and Pfizer, based on mRNA technology from BioNTech.
The Pfizer-BioNTech Covid-19 vaccine was authorised in the US, under FDA Emergency Use Authorisation (EUA), for use in people aged 12 years and above.
With the amended EUA, a booster dose of the vaccine will be allowed for use in people, aged 12 years and above, who have undergone organ transplantation, or immunocompromised.
Pfizer and BioNTech expect results from the Phase 3 study evaluating their third dose soon, with the plan to submit to the FDA, the EMA and other regulatory authorities worldwide.
In the US, the companies submitted a supplemental Biologics License Application (BLA) for the third dose in May 2021, for use in people aged 16 years and above.
BioNTech CEO and co-founder Ugur Sahin said: “We continuously strive to stay at least one step ahead of the virus. This is why we aim to expand access to our vaccine for people around the world and are working on various approaches as part of our comprehensive strategy to address the virus and its variants today as well as in the future.
“This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine.
“A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.”