FDA Panel Recommends Approval of Pfizer Virus Vaccine

A pharmacist labels syringes in a clean room where doses of Covid-19 vaccines will be handled at Mount Sinai Queens hospital in New York on Wednesday. (AP Photo/Mark Lennihan)

(CN) — A committee of advisers to the Food and Drug Administration voted Thursday to recommend Pfizer’s Covid-19 vaccine for emergency use nationwide to fight the pandemic that has killed nearly 300,000 Americans since March.   

The FDA could adopt the recommendations and order emergency authorization of the vaccine as early as Thursday night, but it could take up to a week. The first doses would begin shipping immediately after approval. 

At the close of an eight-hour meeting to discuss the safety and efficacy of the two-dose vaccine developed by Pfizer and German partner company BioNTech, the advisory panel greenlit the shot based on data showing it is 95% effective at preventing Covid-19 at least seven days after the second dose.  

The question before members of the Vaccines and Related Biological Products Advisory Committee boiled down to whether the benefits of the vaccine outweighed its risks for individuals 16 years of age and older.  

Seventeen advisers voted to recommend the vaccine. Four voted against and one abstained. 

In a statement Thursday, President-elect Joe Biden called the panel’s decision “a bright light in a needlessly dark time.” 

“We are grateful to the scientists and researchers who developed this vaccine. And, we are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence. The integrity of science led us to this point,” Biden said. 

The FDA released data on the vaccine trials ahead of the committee meeting showing that the vaccine “met the prescribed success criteria” in a clinical study with over 38,000 participants aged 16 years and older. 

The analysis found that while it prevented Covid-19 in 95% of participants at least seven days after the second dose, the first dose alone prevented severe bouts of the respiratory disease about 89% of the time. 

But the panel’s endorsement did not come without some push-back.  

Thursday’s polling was preceded by discussions on whether there was sufficient data to safely recommend authorizing the shots for children aged 16 and 17.  

Experts noted that more research is needed to determine the safety of the vaccine for pregnant women, people who are immunocompromised and children under the age of 16. 

Questions have also been raised about allergic reactions suffered by two people in the United Kingdom this week, where the first round of Pfizer-BioNTech vaccines were distributed to the country’s oldest citizens and its frontline workers Tuesday.

Pfizer representatives told the panel that they have not observed signs of allergic reactions in their trial. 

The FDA’s analysis found that the most common side-effects observed during the trials were skin reactions at the injection site, fatigue, headaches, muscle and joint pain, chills and fever. 

Although few serious side effects were observed in the participants, twelve experienced appendicitis and four developed cases of Bell’s palsy, a temporary form of facial paralysis. According to documents released by the FDA, those numbers are in line with the frequency seen in the general population. 

Representatives for Pfizer reassured the committee Thursday that the company plans to continue its clinical trials even after distribution of the vaccine begins.  

Pfizer also plans to explore a refrigerator-stable second-generation formulation of the vaccine. The current vaccine must be stored at sub-zero temperatures, creating unique supply-chain challenges for states as they prepare for distribution. 

If the FDA moves forward with the recommendation, the United States will become the fourth country to approve the Pfizer-BioNTech vaccine.  

Approval can’t come quickly enough. The U.S. reached a new milestone Wednesday, with deaths from Covid-19 setting an all-time, one-day record of more than 3,000. 

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