For the authorization of a third or booster dose, Pfizer and BioNTech have submitted phase I data to the FDA.
Pfizer, BioNTech Expecting Phase III Trial Results For Booster Dose
NEW YORK — Pfizer and BioNTech are making a strong case for the authorization of a third or booster dose of the companies’ Covid-19, for which they have submitted the phase I data of clinical trials evaluating the safety and immunogenicity of the dose.
The data will also be submitted to the European Medicines Agency and other regulatory authorities in the coming weeks, Pfizer said in a statement released on Aug. 16.
“Vaccination is our most effective means of preventing Covid-19 infection—especially severe disease and hospitalization—and its profound impact on protecting lives is indisputable,” Albert Bourla, chairman and chief executive officer, Pfizer, said in the statement.
“Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus.”
“The data we’ve seen to date suggests the 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 US Food and Drug Administration [FDA] as we continue working together to address the evolving challenges of this pandemic,” he said.
Pfizer and BioNTech have submitted phase 1 data—part of their phase 1/2/3 clinical trial program—evaluating the safety, tolerability, and immunogenicity of a third dose of the Covid-19 vaccine in adult participants from the United States from the phase 1 trial of the two-dose series, the statement said.
Participants received a 30-ug booster dose of BNT162b2 about nine months after receiving the second dose. Results from this participant group show that the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild-type) compared to the levels observed after the two-dose primary series and against the Beta variant and the highly infectious Delta variant.
“We continuously strive to stay at least one step ahead of the virus,” said Ugur Sahin, managing director and co-founder of BioNTech.
“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.”
Sahin suggested that if the initial data is to be trusted, a third dose of the vaccine could preserve—at the least—and even exceed the already high existing protection levels against the “wild-type virus and relevant variants.”
“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.”
The companies are expecting phase III results of the evaluation of the third dose soon, which will be submitted to the US FDA, the European Medicines Agency, and other regulatory authorities worldwide.
In the United States, Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application in individuals 16 years of age and older, pending US FDA approval of the primary application submitted in May 2021.
A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the States. However, under the current amended Emergency Use Authorization, it has been authorized on Aug. 12 for administration to individuals aged 12 and above who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent “level of immunocompromise,” as per the statement.
This authorization is based on information from an independent report evaluating the safety and effectiveness of a third dose in people who received solid organ transplants, the statement said.
(With inputs from ANI)
Edited by Amrita Das and Krishna Kakani