Pfizer/BioNTech Could File for Full Vaccine Approval in April, with Trial Showing High Efficacy After Six Months

April 5, 2021

Pfizer and BioNTech have accrued the data necessary to submit a biologics license application (BLA) for their COVID-19 vaccine and are seeking full approval as soon as this month, following a recent analysis from their phase 3 trial showing the vaccine held 91.3 percent efficacy up to six months after the second dose.

According to the two drugmakers, an analysis of 927 confirmed symptomatic COVID-19 cases seen in the late-stage study through March 13 showed the continued effectiveness against the virus up to six months after the second dose. Of the confirmed cases, 850 were in the placebo group while just 77 were in the vaccinated group.

The vaccine also proved fully protective against severe disease as defined by the Centers for Disease Control and Prevention (CDC). A single severe case, according to the FDA’s definition, was seen in the vaccine group, indicating a 95.3 percent efficacy against severe COVID-19. The FDA’s definition of severe COVID-19 includes an increased respiratory rate of 30 breaths or more per minute, an increased heart rate of 125 beats or more per minute and oxygen saturation levels of 93 percent or lower.

Additionally, the trial saw only nine cases of COVID-19 out of its 800 participants in South Africa, where a concerning viral mutation has spread and has raised fears it could evade vaccine protection. The nine cases were all in the placebo group, indicating the vaccine demonstrated 100 percent efficacy against the South Africa strain.

The companies said they have also collected safety data from more than 12,000 vaccinated participants with at least six months of follow-up and seen favorable safety and tolerability for the vaccine, with no serious safety concerns identified. They now have the data they need to file for full approval and plan to submit it for peer review and potential publication “in the near future.”

In additional good news, a real-world study of the vaccine led by the UK’s University of Birmingham found that two doses generated strong immune responses in elderly patients. Specifically, of the 100 patients age 80 to 96 years, 98 percent of them showed a strong antibody immune response. The vaccine took a hit against the virus’ Brazilian mutation, but still appeared to likely provide adequate protection. — James Miessler