Pfizer Vaccine Nears Approval in U.S.

The new treatment is already being administered in the U.K.

An independent advisory panel to the FDA has recommended the emergency approval of the first COVID-19 vaccine for Americans.

In a 17-4 vote with one abstention, the Vaccines and Related Biological Products Advisory Committee concluded that the vaccine developed by Pfizer and BioNTech appears safe and effective in people 16 years old and older. Thousands tuned into the day-long panel livestream, which was broadcast on YouTube, to watch the FDA’s expert advisers discuss data on efficacy and safety before casting their votes. 

While the FDA is not obligated to follow the committee’s advice, it’s widely anticipated that the board will approve the vaccine as soon as Friday, Dec. 11. 

According to data released in the New England Journal of Medicine, the Pfizer vaccine was 95 percent effective in a randomized controlled trial of over 43,000 people. Currently known side effects include fever, fatigue, headaches, and muscle and joint pain. 

The vaccine uses messenger RNA technology — a first for modern vaccines — and requires two doses administered three weeks apart. It must be stored at -94F and transported on dry ice in specialized containers by trained staff, which presents logistical challenges for distribution.

Bay Area hospitals and health departments have already started purchasing the specialized refrigeration equipment needed to store the vaccines, as well as developing plans to administer shots to high-priority healthcare professionals. According to Governor Gavin Newsom, California is scheduled to get 327,000 doses of the Pfizer vaccine in mid-December.

What does that mean for the average Bay Area resident? Because there are extremely limited supplies of the Pfizer vaccine, only 20 million people will be vaccinated in the first run. A CDC advisory committee has recommended that states prioritize health workers and elderly individuals living in long-term care facilities. Other vulnerable groups are next in line until the vaccine becomes widely available, which most likely won’t be until next spring or summer. 

In the meantime, a separate COVID-19 vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases is slated for a hearing by the same FDA advisory board on Dec. 17
“If people get vaccinated, by the end of the second quarter of the year, you could have enough protection in this country that the pandemic as we know will be well, well suppressed below the danger level,” Dr. Anthony Fauci said in a recent interview.

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