With news breaking that Pfizer’s COVID-19 vaccine is going to start being administered as soon as this month, FDA reports are coming out about some concerning findings from clinical trials.
The staff did note “a numerical imbalance of four cases of Bell’s palsy” among people given the vaccine compared with no cases in the placebo group. The “four cases in the vaccine group do not represent a frequency above that expected in the general population,” the FDA staff said.
According to Health.com, a document released on December 8, ahead of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 10, revealed more details about the Pfizer COVID-19 vaccine—which is expected to be the first to be authorized for emergency use in the US.
The document revealed that four cases of Bell’s palsy, a condition that causes temporary facial paralysis, were identified in study participants who received the vaccine—but in none of the participants who received a placebo. At least one of the patients has recovered, and there’s no evidence that the vaccine caused the problem.
According to the Mayo Clinic, Bell’s palsy, also known as acute peripheral facial palsy of unknown cause, can occur at any age. The exact cause is unknown. It’s believed to be the result of swelling and inflammation of the nerve that controls the muscles on one side of your face. Or it might be a reaction that occurs after a viral infection.
Although a chronic condition when active, it can be temporary for most people. Symptoms usually start to improve within a few weeks, with complete recovery in about six months. A small number of people continue to have some Bell’s palsy symptoms for life. Rarely, Bell’s palsy can recur.
According to NINDS, Bell’s palsy usually affects only one side of the face, but it’s possible that it could spread to the other side as well. This shows up in the form of sudden weakness on one side of the face, a drooping eyelid or corner of the mouth, drooling, an inability to close the eye or mouth, weakened taste buds, and excessive tearing of the eye. Symptoms usually appear out of nowhere and reach peak severity within three days of their onset.
Usually, the condition is treated with steroids and antiviral medications. Physicians would also recommend retraining the eyelid muscles by utilizing an eye patch in the event that eye nerves are damaged and can’t close properly. NINDS also recommends analgesics such as aspirin, acetaminophen, or ibuprofen to relieve pain.
Per the FDA’s report released on December 8, their team said that research data from their 38,000 participant study “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA” for Pfizer’s vaccine.
“Otherwise, there were no notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic, neuroinflammatory, and thrombotic events) that would suggest a causal relationship to BNT162b2 vaccine,” as the Pfizer/BioNTech vaccine is called, the FDA staff wrote per the report.
The FDA also said it will review the advisory committee’s recommendations as it deliberates on the validity of the Pfizer vaccine. The FDA is expected to move swiftly as medical professionals are eager to flatten the COVID-19 curve.
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