Pfizer-BioNTech announced its COVID-19 vaccine results have shown more than 91% effectiveness against any symptoms through six months of its ongoing “Phase 3” study.
The study has followed more than 46,000 volunteers, 927 of which tested positive for COVID-19. Of those positive cases, 850 were shown to be from a placebo group, while 77 were part of the vaccinated group.
All of the recorded “severe cases” were also found in the placebo group.
“The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA),” Pfizer and BioNTech said in a joint statement.
In an interview with CNN, Dr. Anthony Fauci said he believes the vaccine will ultimately show effectiveness for longer than six months. Fauci added that he believes the Moderna and Johnson & Johnson vaccines will yield similar results.
The efficacy announcement comes a day after Pfizer said its vaccine showed 100% effective on 2,260 volunteers between the ages of 12 and 15. The results showed more effective in that age group than ages 16 to 25.
While the “Phase 3” trials in the 12 to 15 age group continue, the current vaccine is only authorized for people 16 and older.
Now Pfizer seeks full FDA approval, as the vaccines are currently being administered under “Emergency Use Authorization.” In order to get full approval, or a license, Pfizer must show that “manufacturing and facility information assure product quality and consistency,” according to the FDA.
The vaccine will then go through a team of physicians, chemists, statisticians, pharmacologists/toxicologists, microbiologists, experts in postmarketing safety, clinical study site inspectors, manufacturing and facility inspectors, and labeling and communications experts. The team will weigh the risks and benefits, as it did when giving the vaccines Emergency Use Authorization.
As of Thursday, The U.S. has distributed more than 99 million doses of COVID-19 vaccines to more than 56,000 people, good for 17% of the country’s population.