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CDC Gives Pfizer’s COVID-19 Vaccine Final Approval

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December 14, 2020 -- The CDC signed off on the Pfizer-BioNTech COVID-19 vaccine, the agency announced on Sunday afternoon, completing the final approval for people to receive the first doses.

Health care workers and residents of long-term care facilities will be vaccinated first, the CDC said. Distribution sites shipped the first batches on Sunday morning, and some locations will administer the first shots Monday.

The FDA issued an emergency use authorization for Pfizer’s vaccine on Friday evening, and the CDC’s Advisory Committee on Immunization Practices recommended the vaccine for ages 16 and older on Saturday.

The CDC then accepted the ACIP recommendations and published the committee’s report in an early release of the Morbidity and Mortality Weekly Report on Sunday.

“Last night, I was proud to sign the Advisory Committee on Immunization Practices’ recommendation to use Pfizer’s COVID-19 vaccine in people 16 and older,” Robert Redfield, director of the CDC, said in a statement to CNBC.

Since June, ACIP has held nine meetings to review data on COVID-19 and potential COVID-19 vaccines, including the Pfizer vaccine. The committee’s COVID-19 Vaccines Work Group also held 27 meetings this year to review clinical trial data and discuss vaccine safety and efficacy.

Clinical trials show the vaccine to be 92 percent effective across age, sex, race, and ethnicity categories. It is also effective for people with underlying medical conditions and trial participants with evidence of previous SARS-CoV-2 infection, the committee wrote.

Side effects were mild to moderate and associated with reactogenicity, or the body’s reaction to the vaccine to build immunity, the committee wrote. The most common symptoms were fatigue, headache, muscle pain, chills and pain at the injection site. Reactions were more common after the second dose of the vaccine and were more frequent among those between ages 18-55. The committee also provided a detailed summary of safety data, including information about reactogenicity.

The committee will soon issue additional considerations for specific groups, including those who are pregnant, immunocompromised or have severe allergies.

Ongoing studies will inform future ACIP recommendations, the committee wrote, because clinical trial data doesn’t yet show whether the vaccine can prevent asymptomatic COVID-19 infections.

“COVID-19 is a major public health problem and use of the Pfizer-BioNTech COVID-19 vaccine is a reasonable and efficient allocation of resources,” the committee wrote. “For most populations, the desirable effects outweigh the undesirable effects.”

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Sources

CDC, “Twitter post at 1:21 p.m. on December 13, 2020.”
Morbidity and Mortality Weekly Report, “The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020.”
CNBC, “CDC director signs off on Pfizer vaccine, allowing shots to move forward Monday.”
CDC, “Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events: Pfizer-BioNTech COVID-19 Vaccine.”
CDC, “Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine.”
 

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