Coronavirus: Pfizer, BioNTech submit initial data to FDA supporting booster vaccine dose

Officials with Pfizer and BioNTech on Monday announced that they’ve submitted initial data to the Food and Drug Administration showing that a booster dose of the vaccine developed by the companies “may help maintain a high level of protection against COVID-19.”

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In a news release, officials with the companies recommended that a booster dose be given to people vaccinated with the Pfizer-BioNTech vaccine six to 12 months after they’ve gotten their second dose. As evidence, they pointed to preliminary data made public last month that showed that when tested against the delta variant, a third dose of the Pfizer-BioNTech vaccine produced neutralizing antibody titers that were as many as 11 times as strong in people as after a second vaccine dose.

“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,” Ugur Sahin, CEO and co-founder of BioNTech, said Monday. “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.”

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Officials with Pfizer and BioNTech said the companies expect to submit results from a Phase 3 trial evaluating the safety and efficacy of a booster vaccine dose to the the FDA “shortly.”

“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 CEO of Pfizer, said in a statement.

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“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 suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.”

Last week, the Centers of Disease Control and Prevention recommended that people who are moderately to severely immunocompromised get an additional vaccine dose if they’ve received either the Pfizer-BioNTech or the Moderna vaccines. Officials said recommendations for those who got the Johnson & Johnson vaccine were not immediately available due to a lack of sufficient evidence.

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The additional dose was recommended based on studies which showed that the initial immune response to the vaccine in immunocompromised people often fell below levels seen in their peers. Booster doses are recommended in cases where an initial immune response is deemed sufficient, but when it is likely to have waned over time, according to the CDC.

The FDA issued emergency use authorization in December 2020 for the two-dose Pfizer-BioNTech vaccine against COVID-19. Since then, 200.5 million doses of the vaccine have been administered nationwide, according to data from the CDC.

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As of Sunday, the last date for which data was available, about 50% of all Americans, or 168.3 million people, have been fully vaccinated. Research has also shown that fully vaccinated people can spread the highly transmissible delta variant of the virus, which accounts for more than 80% of all COVID-19 cases reported nationwide; however, officials have noted that vaccination protects well against severe and life-threatening symptoms of the viral infection.

Since the start of the pandemic, officials have confirmed more than 36.6 million infections and reported more than 621,000 deaths across the U.S., according to numbers compiled by Johns Hopkins University. More than 207.4 million COVID-19 cases have been reported worldwide, resulting in 4.3 million deaths, according to Johns Hopkins.

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