The FDA announced this week that two trial participants have died after receiving their coronavirus vaccine, according to Reuters.
One of the deceased was reportedly immunocompromised (meaning their immune system’s defenses were low, affecting its ability to fight off infections and diseases–this can be temporary or permanent).
This information was obtained from documents released on Tuesday ahead of an upcoming emergency approval meeting on Thursday.
The FDA announced on Tuesday that currently there is not enough research to guarantee the vaccine’s safety for immunocompromised groups, pregnant women and children–yet it is still expected to gain approval on Thursday, and is already being rolled-out across the UK.
Four Pfizer trial volunteers developed Bell’s Palsy
Four people who got Pfizer’s coronavirus vaccine in the firm’s trial developed Bell’s palsy, a form of temporary facial paralysis, according to U.S. regulators’ report on the shot, and as reported by the Daily Mail.
Among the four people who developed Bell’s palsy, one saw facial paralysis or weakness within three days after they received the shot, but has since “returned to normal”.
A second person developed Bell’s palsy nine days after receiving the shot, and the others’ faces grew weak 37 and 48 days after vaccination, respectively. All three had recovered from the facial paralysis within 10 to 21 days.
Bell’s palsy comes on suddenly, and looks alarmingly like a stroke. Most sufferers notice that one side of their face starts to droop, and the muscles grow weak. In rare cases, both side of the face may become temporarily paralyzed.
Bell’s palsy is also known as cute peripheral facial palsy. No one knows the cause, but it is more common in pregnant women, especially during their third trimester, or shortly after birth. Having an upper respiratory infection, such as the cold or the flu is also a risk factor.
Suspicion had already been raised that inactivated versions of some of flu vaccines can cause Bell’s palsy — enough concern had been expressed that a number of studies were conducted.
Ultimately, it was concluded the jabs weren’t the root cause of Bell’s palsy, with one exception: Berna Biotech’s “Nasalflu”–an inhaled flu vaccine made and sold in Switzerland. It was made with inactivated flu virus and a form of E. coli (a bacterium commonly used to develop vaccines and pharmaceuticals).
So far, the FDA has said there isn’t any clear way Pfizer’s COVID-19 vaccine caused Bell’s palsy, but also hinted that, if the panel set to meet on Thursday do indeed green-light the jab, that Pfizer may be required to closely track data on whether more vaccine recipients develop the temporary facial paralysis.
Not all that reassuring…
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