The US Food and Drug Administration (FDA) has recommended monitoring a possible outcome of facial paralysis, Bell’s palsy, after distribution of any of the vaccines in large populations.
The agency says although there is no clear basis upon which to conclude a causal relationship with vaccines at this time, surveillance should still be placed on Bell’s palsy.
Whether the same implications will apply for Africans who receive the vaccine is yet unclear.
Experts also say it is too early to attribute the condition to the vaccine.
“The information we have is insufficient to say that there is a causal relationship between Bell’s palsy and the vaccine. If we look at the incidence of Bell’s palsy among both Moderna’s and Pfizer’s participants, the number is, as the FDA mentioned, “consistent with the expected background rate in the general population,” Irene Kim, assistant professor of Head and Neck Surgery and director of the Facial Nerve Centre in the Division of Facial Plastic Surgery at UCLA, told Forbes in a monitored report.
The announcement comes on the heels of a viral picture with three people claimed to have developed facial paralysis during the trials.
Although fact-checked to be partly false, it has been stirring public concerns on the risks likely involved in taking the vaccines.
The FDA says Bell’s palsy was reported in four vaccine participants and none in the placebo group, out of the 44,000 total participants of the late-stage vaccine trial.
In the Moderna group, four individuals out of 30,000 reported facial paralysis, three who had received the vaccine, and one who received the placebo.
Four of the 43,000 participants in the Pfizer trial developed facial nerve paralysis. All of these were in the vaccine arm of the trial.
According to Johns Hopkins Medicine, Bell’s palsy is an episode of facial muscle weakness, which “usually resolves on its own and causes no complications.”
While its cause is unknown, it is thought to be caused by “inflammation affecting the body’s immune system”. It is associated with the body’s response to viral infection, and with other conditions such as diabetes.
The symptoms of the condition, which include headache and pain, twitching or weakness in one side of the face, begin suddenly and it usually worsens within the next 48 hours, leading to the face drooping and a lopsided smile.
Experts note that in most cases, the weakness is temporary and significantly improves within weeks, “with full recovery in about six months”.
