A man will receive the first of two Pfizer / BioNTech Covid-19 stitches on December 8, 2020 at Guy’s Hospital in London.
Victoria Jones | AFP | Getty Images
The U.S. federal government will continue to monitor the incidence of Bell’s palsy – a partial paralysis of the face – in people receiving Pfizer’s Covid-19 vaccine after four cases were reported among subjects, even though the vaccine did not appear to cause the disease .
Dr. Sara Oliver, a staff member with the Centers for Disease Control and Prevention, said Friday on the agency’s Advisory Committee on Immunization Practices that “there is no known or expected causal link between the vaccine and Bell’s palsy”. The ACIP is developing recommendations for the use of vaccines to fight disease in the US, according to the CDC.
“Post-approval safety and efficacy studies will also be critical. Monitoring for Bell’s palsy in particular could help identify a possible causal link,” said Oliver.
U.S. officials plan to continue to monitor for side effects of the Pfizer vaccine among the health care workers and nursing homes who receive it, said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a Food and Drug Administration meeting Thursday.
The officers will use an SMS system called v-safe, which is designed to provide early warning of possible side effects of the vaccines.
Bell’s palsy is a sudden freeze or weakness in a person’s facial muscles, and for most people, it’s temporary, according to the Mayo Clinic. A member of the group on Friday’s ACIP call confirmed that there were four cases of “facial paralysis” among those who received the vaccine. In one of the participants, paralysis appeared as early as three days after the dose, while in another recipient, the paralysis appeared only 48 days after inoculation.
The four cases of Bell’s palsy in vaccine recipients were considered “consistent with the expected background rate in the general population” and “there is currently no clear basis for establishing a causal link,” the FDA said in its briefing documents prior to the advisory meeting Committee on Vaccines and Related Biological Products on Thursday.
During Thursday’s meeting, FDA vaccine investigator Dr. Susan Wollersheim found that the study data showed a “numerical imbalance” in Bell’s palsy.
Wollersheim said there were four cases in the vaccine group and none in the placebo group. While the incidence of the cases was no higher than that of the general population, the FDA recommended further surveillance if the vaccine is approved for wider use.
The VRBPAC voted 17 to 4 with one abstention on Thursday to recommend the vaccine that the company developed with BioNTech for emergency approval. The FDA is expected to issue Pfizers emergency coronavirus vaccine approval at any time after the recommendation.