Coronavirus: FDA sees ‘no specific safety concerns’ for Pfizer, BioNTech vaccine, analysis shows

Officials with the Food and Drug Administration released an analysis Tuesday of the COVID-19 vaccine developed by Pfizer and BioNTech which found “no specific safety concerns” that could keep health officials from approving the drug for emergency use.

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The 53-page analysis suggests the FDA will move to approve of the historic drug, which has already been approved for emergency use in the United Kingdom. The FDA’s Vaccines and Related Biological Products Advisory Committee is set to meet Thursday to discuss the efficacy of the vaccine and the strength of the scientific data from Pfizer and BioNTech.

The FDA typically follows the committee’s recommendations and is expected to release a decision on whether to allow for emergency use of the drug in the days after Thursday’s meeting, according to The Associated Press.

>> Read the full analysis from the FDA

The committee will debate whether the benefits of the drug outweigh the risks in preventing COVID-19 in people 16 years old and older. Previously, officials said the companies’ drug was shown to be 95% effective in its clinical trial. Data released Thursday showed that, in a trial involving 36,600 participants, eight people who were given the vaccine developed COVID-19 while 162 people who were given a placebo got the virus.

>> Related: Pfizer says vaccine 95% effective in final analysis of clinical trial

Most people who had adverse reactions to the COVID-19 vaccine reported injection site reactions, fatigue and headaches, according to the FDA’s analysis. Some trial participants also reported muscle pain, chills, joint pain and fever. Severe adverse reactions were reported in less than 5% of the drug trial’s participants, most often after the second dose of the drug.

Officials said they expect the first vaccine doses to be delivered by Dec. 15, if the FDA authorizes emergency use of the Pfizer and BioNTech vaccine.

>> Related: First shipments of Pfizer vaccine could be delivered by Dec. 15

Last week, biotechnology company Moderna asked the FDA to approve of emergency use of its COVID-19 vaccine. The company previously announced that a clinical trial found the drug to be 94% effective.

Experts are scheduled to meet Dec. 15 to review the company’s data.

>> Related: Moderna says new results show vaccine 94% effective; company seeking emergency OK

The U.S. continues to lead the world in COVID-19 cases, with more than 14.9 million reported as of Tuesday morning, according to a tally from Johns Hopkins University. More than 283,000 people in the U.S. have died of the viral infection.

Worldwide, more than 67.7 million cases of COVID-19 have been reported since the virus was first detected in December 2019, resulting in over 1.5 million deaths.

Cox Media Group