Pfizer-BioNTech Releases Newest Topline Data for COVID-19 Vaccine

Pfizer and BioNTech announced today topline results from an analysis spanning through March 13, which in part showed their COVID-19 vaccine to be 91.3% effective against the virus for up to 6 months after the second dose.

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The analysis, which incorporated 927 confirmed symptomatic cases of COVID-19, also determined the vaccine to be 100% effective against severe manifestations of COVID-19 according to the CDC’s definition and 95.3% effective when aligning with the FDA’s definition of severe disease.

Investigators updated vaccine safety data from more than 12,000 participants and demonstrated a favorable safety and tolerability profile.

Related: Pfizer-BioNTech COVID-19 Vaccine Shows High Efficacy in Adolescents

The Pfizer-BioNTech vaccine has now been evaluated in upwards of 44,000 participants, 12,000 of whom received the vaccine and had follow up at least 6 months after their second dose. Recent reports have asserted that the vaccine, named BNT162b2, is safe and effective in adolescents, as well as in pregnant and lactating women.

BNT162b2 showed consistent efficacy across age, gender, race and ethnicity demographics, and across participants with a variety of comorbid conditions, the news release said.

The clinical trial included a total of 697 COVID-19 cases in the United States, 647 of which were observed in the placebo group and 50 in the vaccine group.

The FDA granted an emergency use authorization (EUA) to BNT162b2 back in December 2020. Now, given the vaccine favorable profiles, including its 100% (95% CI, [53.5, 100.0]) efficacy against emerging variant B.1.351 in South Africa, the pharmaceutical companies are forging ahead and seeking a biologics license from the FDA.

“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the US FDA,” said Albert Bourla,chairman and chief executive officer, Pfizer. “The high vaccine efficacy observed through up to 6 months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”

“It is an important step to further confirm the strong efficacy and good safety data we have seen so far, especially in a longer-term follow-up,” said Ugur Sahin, CEO and cofounder of BioNTech. “These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population.”

Pfizer and BioNTech intend to submit more detailed data for scientific peer review in the upcoming weeks.

Reference

1. Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up To Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study. News Release. Pfizer; April 1, 2021. Accessed April 1, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-confirm-high-efficacy-and-no-serious.