The Centers for Disease Control and Prevention (CDC) will monitor for Bell’s palsy among Pfizer vaccine recipients.
The announcement came after four cases of Bell's palsy were reported among clinical trial participants. However, the vaccine reportedly does not appear to cause the condition.
The four cases were noted as “consistent with the expected background rate in the general population” and “there is no clear basis upon which to conclude a causal relationship at this time,” the Food and Drug Administration said in its briefing documents before its Vaccines and Related Biological Products Advisory Committee meeting Thursday.
According to Dr. Sara Oliver, an officer at the Centers for Disease Control and Prevention, there is “no known or expected causal relationship between the vaccine and Bell’s palsy.” The ACIP presents recommendations on how to use vaccines to control diseases in the U.S.
“Post authorization safety and effectiveness studies will be critical as well. Specifically, surveillance for Bell’s palsy could help determine any possible causal relationship,” Oliver said.
U.S. authorities plan to monitor for any adverse reactions to Pfizer’s vaccine in the health-care workers and nursing home residents who take it, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Disease, said during a meeting of the FDA.
Bell’s palsy refers to sudden freezing or weakness in a person’s facial muscles, according to the Mayo Clinic. A
Allergic reactions
People with a history of allergic reactions should not take Pfizer’s coronavirus vaccine, according to the U.K. drug regulator.
The U.K’s Medicines and Healthcare products Regulatory Agency issued an updated version of its guidance to British health service trusts on who must take the vaccine after two members of Britain’s National Health Service had allergic reactions to Pfizer’s vaccine.
“Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer BioNtech vaccine,” the regulatory agency said.
Stephen Powis, national medical director for the NHS, explained that such a precaution “is common with new vaccines.”
“We know from the extensive clinical trials that this was not a feature, but if we need to strengthen our advice now that we have had this experience in vulnerable populations, the groups selected as a priority, we get that advice to the field immediately,” Dr. June Raine, head of the MHRA, told a U.K. government select committee on Wednesday.
Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center, pointed out that vaccine trials do not usually include people with chronic underlying health conditions or those who may have severe allergic reactions.
The allergic reactions should not hinder the vaccine’s authorization, he stressed. Such issue is one of those that the committee “deals with routinely because lots of vaccines are associated with allergic reactions in some small percentage of the population,” he said.
