Coronavirus Watch: FDA authorizes Pfizer/BioNTech vaccine
The Food and Drug Administration has authorized the COVID-19 vaccine by Pfizer and BioNTech for emergency use. Here's what to know:
- What is Emergency Use Authorization? It's not the same as FDA licensing or "approval," which requires additional data and monitoring. To win FDA "authorization," companies have to show three things: their vaccine is safe, it's more than 50% effective, and it can be produced reliably and safely. The vaccine by Pfizer/BioNTech has been shown to be 95% effective and and hasn't caused long-lasting health problems.
- How did Pfizer's clinical trial go? The trial included 44,000 participants worldwide, half of whom received the vaccine. There were 170 cases of COVID-19 – eight in the vaccine group and 162 in the placebo group. There were ten total severe cases of COVID-19, including one person who had received the vaccine.
- Which age groups can get the vaccine? The vaccine has been authorized in people ages 16 and up. The companies have begun testing the vaccine in ages 12-15 but have not yet accumulated enough data.
- What are the side effects? The most commonly reported side effect among vaccine recipients under age 55 was a sore arm, followed by fatigue (60% after the second shot); headache (52% after the second shot); other muscle aches (37%); and chills (35%). About 28% took pain medication after the first shot and 45% after the second shot.
- How many doses is the Pfizer vaccine? It's two doses, given 21 days apart.
- Does the vaccine prevent infection or just symptoms? Right now, all we know is that the vaccine prevents COVID-19 symptoms and serious disease. It's not clear whether someone could catch the virus and pass it on to someone else, even without becoming ill.
So what happens now? An advisory committee to the Centers for Disease Control and Prevention meets on Saturday (originally Sunday) to make a final recommendation on who should get the vaccine first, and Americans could start getting vaccinated as soon as "Monday, Tuesday of next week," Health and Human Services Secretary Alex Azar said Friday. First in line? Health care workers and nursing home residents. Here's what we know about how the vaccine will be delivered.
Have more vaccine questions? Ask us through this online form, and we'll answer them here. You can also see our Q&As with FDA Commissioner Dr. Stephen Hahn and former FDA Commissioner Dr. Scott Gottlieb.
– Grace Hauck, Paste BN breaking news reporter, @grace_hauck