Pfizer’s COVID-19 vaccine.
The U.S. Food and Drug Administration (FDA) on Friday (Dec. 11) officially approved Pfizer’s (Pfizer) and BioNTech’s application for an Emergency Use Authorization (EUA) for the vaccine against the Chinese communicable virus (Wuhan pneumonia).
Federal officials said the vaccination will begin next week and is expected to be distributed first to health care workers, residents and staff of long-term care facilities, and others.
The FDA’s decision to formally approve the vaccine makes the U.S. the fourth country in the world to approve emergency use of the vaccine, following the United Kingdom, Bahrain and Canada.
When an FDA advisory panel met on Thursday regarding the risks of the vaccine, an overwhelming majority of members agreed that the vaccine is sufficiently safe for the population over the age of 16, and the vote ultimately passed 17-4.
According to Fox News, several members of the advisory panel remained uncertain about the risks of the vaccine for people 16 and 17 years old because of limited evidence. But others believe that 16- and 17-year-olds will not be the first to receive the vaccine and that there is time to study the possible effects of the vaccine on this age group.
The companies announced late last month that the vaccine had proven 95 percent effective in late-stage clinical trials. Pfizer and BioNTech were the first companies to apply to the FDA for emergency use authorization. Another vaccine candidate, developed by Moderna, is following suit and is applying for emergency use.
The FDA will meet on Dec. 17 to review the Moderna vaccine.
A third vaccine candidate is from Johnson & Johnson. This is followed by a late-selected vaccine from the development teams of AstraZeneca and Oxford University.
U.S. health experts hope that the combination of vaccines will eventually enable the United States to beat the outbreak.
No specific safety issues have been identified with the Pfizer vaccine, but it does list several unknowns that need further investigation, including the duration of immunity, its effectiveness in certain high-risk populations, etc.
The vaccine may cause some mild or moderate uncomfortable reactions, such as fatigue, headache, muscle pain, chills, joint pain and fever. Serious adverse events remain uncommon.
In the United Kingdom, a mass vaccination program began this week, and on the first day, there were at least two adverse reactions. UK health authorities recommend that people with a “history of severe allergic reactions” should avoid the Pfizer vaccine.
In addition, Pfizer must prove whether the vaccine is effective for children under 16 and pregnant women.
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