Four trail volunteers administered with Pfizer COVID shot develop temporary facial paralysis

According to the US Food and Drug Administration (FDA) Regulators, four volunteers who got the COVID-19 vaccine shot developed by Pfizer-BioNTech, have developed Bell’s palsy.

However, the FDA Regulators stated that there wasn’t any clear way that the vaccine caused Bell’s palsy, a form of temporary facial paralysis. “But the doctors and Pfizer have been warned anyway to keep a tab.”

Bell’s palsy causes temporary inability to control facial muscles on the affected side. The cause of this condition is unknown and it usually resolves in its own within six months.

On December 8th FDA issued a brief document saying the vaccine is “safe and effective”.  They confirmed that it offers “strong protection”. As per the FDA document, data from 38,000 US trial participants suggest a “favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA (emergency use authorisation)”.

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A meeting was fixed for Thursday of the FDA’s advisory panel that will look at all the data to decide whether the shot is safe to be administered for emergency use. This would be the last step before the US decision to start shipping doses.

UK issues allergy warning

Meanwhile, theBritain’s medicine regulator has issued a warning saying anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine.

Anaphylaxis is a severe, potentially life-threatening allergic reaction to venom, food, or medication.

According to Reuters, The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since rollout began.

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“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.

Last week, the MHRA became the first in the world to approve the Pfizer-BioNTech vaccine for COVID-19.

(With agency inputs)

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