USFDA Advisory Committee Meets to Discuss and Vote on Pfizer Vaccine for Emergency Approval

USFDA Advisory Committee Meets to Discuss and Vote on Pfizer Vaccine for Emergency Approval

With the United Kingdom’s recent rollout of the Pfizer/BionTech Covid-19 vaccine, and Canada expecting to follow suit before the end of December, the U.S. Food and Drug Administration will meet today on whether the vaccine should be approved for use in the U.S.

The meeting consists of a panel of outside experts that advises the government. The experts will discuss the efficacy of the vaccine in terms of safety and effectiveness. One of the issues that is likely to be discussed is adverse allergic events and how to address them, after two nurses in the UK had severe allergic reactions to the vaccine.

There also will be a public hearing, followed by a committee discussion and vote.  The meeting is expected to take the entire day.

If the FDA clears the drug for use, the rollout for administration  could come as early next week.

Two UK Nurses Presented with Severe Allergic Reactions Following Administration of the Pfizer Covid-19 Vaccine

Just a day after the United Kingdom implemented its national rollout of the Pfizer/ Covid-19 vaccine, health officials warn people with a history of severe allergic reactions not to participate. This warning came after two nurses suffered an allergic reaction to the vaccine.

The nurses experienced an “anaphylactoid” reaction characterized by rashes and shortness of breath. Both nurses have a history of allergic reactions and carry an EpiPen, which is a device that looks like a fat pen and delivers a dose of epinephrine. People with severe allergic reactions keep EpiPens nearby for emergency use. Both nurses recovered quickly.

The UK health officials reacted immediately with the following guidance: those with significant allergies to food, medicine, and vaccines, should not take the Pfizer vaccine. There are no preservatives in the vaccine, so more studies will be needed to determine possible causes since the clinical trials did not study individuals with a history of severe allergies.

As other companies are also producing a Covid-19 vaccine, people with severe allergic reactions may tolerate one of the other vaccines. Meanwhile, in the US, the Food and Drug Administration will convene an expert panel meeting on December 10, 2020, to determine if emergency use of the Pfizer vaccine should be approved, given its high effectiveness rate. If approved, health officials are likely to disseminate similar warnings.