Pfizer’s COVID Vaccine Inches Closer to Emergency Approval Following FDA Panel’s Recommendation

December 10, 2020 – Today, the USFDA advisory panel of 23 members voted 17-4 in favor of approving Pfizer’s coronavirus vaccine for emergency use, adjudging it is more beneficial than risky. However, the emergency use authorization (EUA) will be granted only after the FDA accepts the panel’s nonbinding recommendation. If Pfizer’s vaccine bags the EUA, it will mark a pivotal moment in the fight against the pandemic, which has infected more than 15.4 million people and killed roughly 290,000 people in the US in less than a year.

Pfizer and BioNTech’s BNT162b2 is an mRNA-based vaccine that uses the genetic material of the virus to trigger the immune response. Late-stage clinical trial data show that the vaccine is 95% effective in the younger population (16-55 years) and 93-95% effective in the older population and people with comorbidities with two doses taken 21 days apart.

Additionally, the vaccine was 88.9% effective in fending severe COVID-19 infections with just one dose. Overall, the vaccine shows a good safety profile, and the most commonly reported systemic events were fatigue and headache. However, there are cases of vaccine-related serious events that are worth noting. Sixty-four vaccine recipients and six placebo recipients reported lymphadenopathy. Four vaccine-related serious adverse events, including shoulder injury, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia, were reported among vaccine recipients.

 

Conditions of Emergency Use

With the EUA, only a limited population will get the vaccine, specifically the ones who are at high risk, including elderly Americans living in long-term care homes and healthcare workers. However, whether this population will include pregnant women and young children is still under the wraps. Despite the disagreements amongst the committee members, the recommendation is to include children aged 16 or 17 for vaccination.

An emergency approval is different from the final full approval. So far, Pfizer is asking for EUA based on two months of safety data. However, full approval typically requires six months of data. This will take at least a few months.

The Federal officials at the Centers for Disease Control and Prevention (CDC) are prepared to distribute the vaccine within 24 hours of EUA. Pfizer plans to have 6.4 million doses ready for the US in its first rollout round in late December. This will be enough for 3 million people in the country. However, it is expected that 100 million Americans will be immunized by the end of February and the entire US population by the end of June. Pfizer said last week that it is confident it will be able to supply the targeted doses as its full-scale production in the US and Europe are now complete.

 

Allergy Issues

Last week the UK’s MHRA gave emergency authorization to Pfizer’s coronavirus vaccine. However, two NHS workers who received the vaccine developed severe allergic reactions. Both the individuals had a known history of allergies. The UK MHRA has advised people with a known history of allergies to avoid taking the vaccine. This, however, could be a problem for the US population, where more than 20 million people experience some form of allergy every year. To be on the safe side, the FDA has included warning information related to an allergic reaction on the vaccine label and has advised people with a history of allergic reaction to avoid taking the vaccine.

By Ruchi Jhonsa, Ph.D.

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