Volunteers develop facial paralysis symptoms after taking Covid-19 vaccine
As the UK began administering people with the Pfizer-BioNTech vaccine, four people who got Pfizer's coronavirus vaccine in the firm's trial developed Bell's palsy, a form of temporary facial paralysis.
Bell's palsy is a form of temporary facial paralysis.
According to the reports, the US FDA regulators have noted that it was still unclear how Bell's palsy was caused in these volunteers due to the Pfizer vaccine. The US regulators stressed that doctors should closely monitor the side effect of the vaccine and continue to watch how many people it strikes.
The FDA uncovered no major safety issues in its review of the coronavirus vaccine - Pfizer's 44,000-person study, including no allergic reactions of the type reported in the UK. But such studies can't detect rare problems that might only affect a tiny slice of the general population.
FDA reviewers noted four cases of Bell's palsy that all occurred among people getting the vaccine. They concluded the cases were likely unrelated to the vaccine because they occurred at rates that would be expected without any medical intervention. But the agency did say cases of the nerve disorder should be tracked, given that other vaccines can cause the problem.
"I think we have to be upfront, without scaring people, that we don't know yet about any potential, rare, long-term adverse events," Moss said.
Bell's palsy is also known as "acute facial palsy of unknown cause." It's a condition in which the muscles on one side of your face become weak or paralyzed. It affects only one side of the face at a time, causing it to droop or become stiff on that side.
Besides the weakness and drooping of facial muscles, you may also experience the following conditions:
#Feel pain in your jaw or behind your ear on the side that's affected
#Acute headache that will leave you banging your head
#Be more sensitive to sound on the side that's affected
#You may also have trouble eating and drinking
The FDA found the vaccine highly effective across various demographic groups. But it's unclear how well the vaccine works in people with HIV and other immune-system disorders.
The study excluded pregnant women, but experts will tease apart the data for any hints in case women get vaccinated before realizing they're pregnant. However, a study of children as young as 12 is underway.
Answering some of these questions will require keeping Pfizer's study going for many more months. When the FDA panel met in October, experts warned against allowing trial participants who received placebos to switch and get the real vaccine immediately after it receives the FDA's emergency OK. Doing that could make it impossible to get answers to long-term questions, including how long the protection lasts.
Pfizer and BioNTech say they want to allow such participants to get the vaccine either upon request or, at the latest, after six months of follow-up.
The FDA still hasn't made clear if it will accept that approach. "FDA is adamant that they want these trials completed," said Norman Baylor, former director of FDA's vaccine office, adding that its expert panel members "know that too."
(With inputs from Agencies)
