Four volunteers who were given Pfizer’s coronavirus vaccine in clinical trials developed facial paralysis.
The U.S. Food and Drug Administration (FDA) reported that the four participants experienced Bell’s palsy, a rare condition in which one side of the face is temporarily paralyzed.
While the FDA did not state that the vaccine directly caused the paralysis, it warned that doctors should watch out for the side effect and promised to observe cases closely.
The FDA revealed this side effect in a report about Pfizer’s vaccine, which was made in partnership with German firm BioNTech. The report was released days before the U.S. regulator was scheduled to review the pharmaceutical firm’s emergency use authorization.
According to the FDA, less than 0.5 percent of trial participants — including the four cases of Bell’s palsy — experienced serious side effects. One experienced facial weakness within three days after immunization, but was back to normal after a few days.
Another participant developed Bell’s palsy nine days after receiving the jab, while two others experienced facial paralysis 37 and 48 days following vaccination. These three volunteers eventually recovered from Bell’s palsy after 10 to 21 days.
The National Institute for Neurological Disorders and Stroke defines Bell’s palsy as a form of temporary facial paralysis or weakness on one side of the face resulting from the dysfunction of the facial nerve, which is in charge of facial muscles.
It generally affects only one side of the face but has been known to affect both sides in rare cases.
Most people who experience Bell’s palsy notice that one side of their face starts to droop and their facial muscles weaken. Some get headaches or experience pain around the jaw or ear of the paralyzed side.
In other cases, people lose their sense of taste or become more sensitive to sound.
The exact cause of Bell’s palsy is unknown, but it usually goes away by itself. However, muscle weakness stemming from the condition may be permanent in some cases.
The U.S. and the U.K. approved the Pfizer / BioNTech vaccine for emergency use – despite the risks it may carry
Despite the risk of developing Bell’s palsy, the FDA authorized the Pfizer/BioNTech BNT162b2 vaccine for emergency use in the U.S. on Dec. 11.
In a statement, the U.S. vaccine regulator said it has “determined that the … vaccine has met the statutory criteria [for approval].”
According to the FDA, there was more than enough data proving that BNT162b2 may be effective at preventing COVID-19. The agency also said that the potential risks associated with the vaccine do not outweigh its potential benefits based on the data presented, which supports the jab’s use in people 16 years old and above.
FDA Commissioner Dr. Stephen Hahn said that the emergency use authorization for the Pfizer/BioNTech jab “is a significant milestone in battling [the] devastating [Wuhan coronavirus] pandemic that has affected so many families in the U.S. and around the world.”
Prior to the FDA’s authorization, the United Kingdom gave BNT162b2 the go signal to be used for vaccination. Mass immunization for COVID-19 in the country commenced on Dec. 8.
The Wall Street Journal reported that two National Health Service (NHS) workers experienced anaphylactic reactions after receiving the Pfizer vaccine. Both workers were found to have a history of allergy and have been using adrenaline autoinjectors to deal with their allergic reactions.
As a result, the U.K.’s vaccine regulator Medicine and Healthcare products Regulatory Agency (MHRA) updated its warning and advised people who have a history of significant reaction to medicines, foods or vaccines to avoid immunization with the Pfizer/BioNTech COVID-19 jab.
The U.K.’s health system previously warned against vaccinating pregnant and lactating women with the BNT162b2 jab as its effects on fertility are still unknown.
Ex-Pfizer Chief Science Officer: COVID-19 Vaccine Can Make Females Infertile
Meanwhile, the NHS has announced that it would make resuscitation facilities available at all times for vaccinations and that immunization should only be carried out in facilities where resuscitation measures are available.
By Ramon Tomey, Guest writer