FDA Staff Review Confirms: Pfizer-BioNTech COVID-19 Vaccine Safe and Highly Effective

It is likely to be approved for distribution by the end of the week.


The Food and Drug Administration (FDA) today released its staff evaluation report on the safety and efficacy of the Pfizer/BioNTech COVID-19 vaccine. It says the data "suggest a favorable safety profile, with no specific safety concerns identified that would preclude" an Emergency Use Authorization (EUA).

It also says the vaccine is highly effective at preventing COVID-19 infections. The vaccine's efficacy for the prevention of COVID-19 disease after just the first of two doses appears to be 82 percent. After both doses, the rate rises to 95 percent. For comparison, the Centers for Disease Control and Prevention (CDC) estimates the efficacy of seasonal influenza vaccines at around 50 percent.

The COVID-19 vaccine's side effects appear to basically be the same as those experienced from influenza vaccines, including pain and redness at the injection site, fatigue, headache, muscle pain, and fever.

Meeting this Thursday, the FDA's independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) will take this report and other information into account when recommending whether the agency should issue an EUA for the vaccine.

In November, Gen. Gustave Perna, who is overseeing vaccine logistics, stated that the government "will begin distribution of the vaccine within 24 hours after Emergency Use Authorization is approved." In July, the federal government contracted to buy 100 million doses (enough for 50 million people) from Pfizer/BioNTech for $1.95 billion, with the option to acquire up to an additional 500 million doses.

The companies apparently offered then to sell 100 million more doses, but the Trump administration turned them down. Since then, other countries have signed contracts for those vaccines. Although negotiations for future supplies are ongoing, the companies are reportedly saying they cannot supply additional doses for distribution in the U.S. until this summer.

On the other hand, next week the FDA is scheduled to consider Moderna's submission for an EUA for its COVID-19 vaccine, which works the same way as does the Pfizer/BioNTech vaccine. In in preliminary reports, the Moderna vaccine has a similar safety profile and is also 95 percent effective in preventing COVID-19 infections. The government has contracted with the company to buy 100 million doses of these for $1.5 billion. Under the contract, the feds reportedly have the option to buy up to 400 million additional doses. Like Pfizer/BioNTech, Moderna has contracted with other countries, including deals to sell 160 million doses to the European Union and 50 million to Japan.

Yet more COVID-19 vaccines, by AstraZeneca and Johnson & Johnson, are still in clinical trials. The companies' results could be available by the end of January. If they prove to be safe and effective, their vaccines could contribute toward making sure that most Americans are inoculated against the disease by this summer.