Is Pfizer’s COVID-19 Vaccine Safe and Effective?

Pfizer is developing its COVID-19 vaccine in partnership with German company BioNTech. Pfizer is seeking emergency use authorization in people 16 and older. There were a total of six deaths in the late-stage clinical trial for Pfizer's COVID-19 vaccine. So, is Pfizer’s COVID-19 vaccine safe and effective?

The FDA could authorize a COVID-19 vaccine as early as this week. The move would be a critical moment amid the coronavirus pandemic. Public health officials expect the U.S. to experience its worst public health crisis in history this winter. On Dec. 10, the FDA will hold a Vaccines and Related Biological Products Advisory Committee meeting to review Pfizer’s coronavirus vaccine for emergency use authorization.

In November, Pfizer submitted data to the FDA about its experimental COVID-19 vaccine. Based on the data, the two-dose regimen was 95 percent effective against the coronavirus and had no major safety issues. On Dec. 8, the FDA published a 53-page briefing document on Pfizer’s coronavirus mRNA vaccine candidate. The FDA said that the vaccine showed “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.”

On Dec. 10, the FDA’s vaccine advisory panel will hear from Pfizer’s executives and discuss the briefing documents. The panel of vaccine experts, doctors, and statisticians will vote on whether to approve Pfizer’s coronavirus vaccine for emergency use.

The briefing document highlighted that there were a total of six deaths in Pfizer’s late-stage clinical trial of the vaccine. Two deaths were among patients who received the vaccine and four were in the placebo group. However, none of the deaths have been linked to the COVID-19 vaccine. 

Earlier in December, the U.K. and Canada approved the use of Pfizer’s COVID-19 vaccine. The team responsible for developing COVID-19 vaccines can start administering them.

The FDA briefing document indicates that four clinical trial volunteers who received Pfizer’s coronavirus vaccine developed Bell’s palsy. There were no cases of Bell’s palsy in the placebo group. Bell’s palsy causes temporary weakness in the facial muscles. Usually, it happens when a nerve that controls the muscles becomes swollen, inflamed, or compressed.

The FDA stated that there wasn't any evidence that the vaccine caused Bell’s palsy. However, the FDA cautioned that doctors should monitor the alarming side effects. Also, Pfizer should keep track of how many people developed Bell’s palsy.

Pfizer hasn't reported any serious side effects associated with its COVID-19 vaccine. The most common side effects were redness, pain, or swelling at the injection site. Some recipients experienced flu-like symptoms including fatigue, muscle aches, or fever, especially after the second dose.

Pregnant women and individuals under 16 years old were excluded from the clinical trial. So, the Pfizer vaccine won’t be approved for these groups yet.

COVID-19 vaccines are also being developed by Moderna, AstraZeneca, and Johnson & Johnson. Moderna has filed for emergency use authorization with the FDA for its COVID-19 vaccine candidate.