FDA staff recommended monitoring people receiving coronavirus vaccine shots of Moderna and Pfizer for possible Bell’s palsy cases. Bell’s palsy is not a necessary side effect of the vaccine but the FDA has warned to monitor people because few trial participants received the condition which disables your facial muscles.
On Tuesday, a staff report announced that in over 30,000 trial participants of Moderna, four reported Bell’s palsy cases have been found. Out of the four participants, three of them received a vaccine shot instead of the placebo shot. Out of 43,000 trial participants of Pfizer, four reported Bell’s palsy cases have been found. All four Pfizer trial participants receive the vaccine instead of the placebo. The staff, endorsing EUA for Moderna coronavirus vaccine stated that there is no data to suggest a link between the shots and the cases. The trial participants getting the condition experienced this paralysis from 22 to 32 days after inoculation.
What Is Bell’s Palsy?
Mayo Clinic stated that Bell’s palsy results in a weakness or sudden freezing of the facial muscles of a person which is a temporary condition for most people. The exact reason remains unclear however it is thought to arrive from one viral infection. It can also happen from inflammation and swelling of the nerve controlling the facial muscles on the side of one’s face. The FDA declared that there is insufficient information for linking the condition with the vaccine shots. There appears no other numerical imbalances and notable patterns between treatment groups including other neuro-inflammatory, thrombotic and neurologic events which suggest one casual relationship with Moderna’s vaccine.
According to Dr. Marks, Director, FDA Center For Research and Biological Evaluation, said on Monday in the JAMA interview that the agency will quickly and easily access Bell’s palsy cases data after administration of the vaccine shots. Their working hypothesis points towards an imbalance inside background rates like other trials.