FDA Releases More Vaccine Data

Following detailed analysis, the Food and Drug Administration has concluded that the Pfizer coronavirus vaccine meets the “prescribed success criteria” in a clinical study, suggesting the agency will soon green-light the historic vaccine product.

Ahead of an advisory meeting on Dec. 10, the FDA has released documents pertaining to the effectiveness and safety of the new vaccine from Pfizer and its partner BioNTech.

Data from the FDA shows that the vaccine was 82% effective after the first dose and could reduce confirmed severe coronavirus cases. Pfizer has recommended that people get two doses of the vaccine roughly three weeks apart. The FDS added that two doses of the vaccine were “highly effective” in preventing confirmed cases of Covid-19 at least seven days following the second dose.

The reference made by the FDA to the reduction in confirmed severe instances of the virus is a crucial confirmation for the vaccine. Early critics of some of the various vaccine trials were concerned that only mild to moderate disease cases would be prevented by the vaccine.

The FDA also reported on the known side effects that can result from inoculation with the vaccine. Instances of certain side effects occurred in greater numbers with patients administered the vaccine than with patients taking a placebo. The most common side effects were injection site reactions, fatigue, headache, muscle pain, chills, joint pain, and fever.

Instances of severe adverse reactions were incredibly low for the vaccine. Instances of severe adverse reactions occurred in 0.0% to 4.6% of participants and were more frequent after the second dose than after the first. They also occurred more often in patients over the age of 55.

The FDA concluded that there were “no specific safety concerns identified that would preclude issuance” of the vaccine, despite the side effect data.

The FDA has indicated that it would grant emergency authorization for a coronavirus vaccine that’s safe and at least 50% effective. This is a higher benchmark than for the flu vaccine, which is generally effective anywhere from 40% to 60% of the time.

“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency said on its website.

The report also indicated that the vaccine would require testing in larger numbers of coronavirus patients to confirm that it effectively prevents death from the virus. However, the FDA did note that vaccines that fight against influenza and lower the infection rate also lower the disease-related death rate.

The FDA will determine if it will grant emergency authorization to Pfizer to begin distributing the vaccine at the advisory meeting. The company just began distribution of the vaccine after it received emergency authorization on Dec. 2.

“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” said Albert Bourla, Chairman and CEO of Pfizer.

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