Jeremy Vine: Malone clashes with Stadlen over vaccine
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As the vaccine rollout steams ahead, possible side effects seen in the original trials have been kept largely under wraps. Although very rare, facial paralysis could occur as was seen in seven individuals in the third phase of the Pfizer vaccine trials.
According to the UK Government, the most common side effects (affecting more than one in 10 people) of the Pfizer vaccine:
- Pain at the site of injection
- Fatigue
- Headache
- Muscle pain
- Chills
- Joint pain
- Fever
Very rare side effects (affecting around one in 1,000 people) include temporary one-sided facial drooping.
Bell’s palsy is a weakness or paralysis of one side of the face which is usually temporary.
Reports during the third phase of Pfizer and Moderna trials saw seven cases of facial paralysis or Bell’s palsy being reported.
A causal relationship was not established, but the Food and Drug Administration (FDA) recommended that vaccine recipients be monitored.
In a study published in the US National Library of Medicine National Institutes of Health, Bell’s Palsy incidence report after a second dose of Pfizer vaccine was analysed.
The case study patient had no history of recurrent Bell’s palsy prior to vaccination.
The study noted: “In both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine clinical trials, incidents of Bell’s Palsy were cited as medically attended adverse events (MAAE).
“In the Pfizer-BioNTech COVID-19 Vaccine trials, Bell’s Palsy was reported by four vaccine participants.
“From dose one through one month after dose two, there were three reports of Bell’s Palsy in the vaccine group and none in the placebo group.
“This observed frequency of reported event is consistent with the expected background rate in the general population, which suggests that a causal relationship to the vaccine cannot be made.
“With the dissemination of the COVID-19 Vaccine to the general population, it will be important to monitor individual response to determine side effect profile and any contraindications that may not have been previously elucidated.”
As more of the population becomes vaccinated, more information will likely be validated regarding cases of Bell’s Palsy added the study.
Given these considerations, the Centers for Disease Control and Prevention (CDC) recommends it is important for everyone to monitor their symptoms after being vaccinated and report findings to the Vaccine Adverse Event Reporting System (VAERS).
The study added: “The case study patients’ response to the Pfizer-BioNTech COVID-19 Vaccine warrants some attention.
“With previous association found between the administration of the inactivated Influenza Vaccine and onset of Bell’s Palsy symptoms, there remains the possibility of a causal association between these symptoms and the COVID-19 vaccine.
“The Pfizer data did not indicate if any of the four patients in their trial had previous history of Bell’s Palsy or the time frame of these occurrences.
“Our patient does not have the triad of Melkersson-Rosenthal Syndrome.
“Generally, no particular etiologies have been identified for people with recurrent Bell’s Palsy.
“In our patient, although Bell’s Palsy recurrence took place within 36 h after the second dose of Pfizer COVID-19 vaccination, proof of association as well as exact pathophysiology await further investigation.
“Whether history of Bell’s Palsy predisposes a person to a higher chance of recurrence after COVID-19 vaccination is also to be determined.”
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