People who received the COVID-19 vaccine aren’t more likely to develop facial paralysis than people who didn’t receive the vaccine

BEHAUPTUNG
“13 Israelis suffer FACIAL PARALYSIS after taking Pfizer Covid jab”
DETAILS
What is Accurate: The claim that 13 Israelis who received the Pfizer-BioNTech COVID-19 vaccine is accurate and confirmed by the Israeli Ministry of Health.
What is Missing: The claim fails to mention that two million people received the COVID-19 vaccine in Israel. It also overlooks the fact that the number of facial paralysis cases among vaccinated individuals is lower than what would be expected in the general population that is not vaccinated so there is no support for a link between the two.
WICHTIGSTE SCHLUSSFOLGERUNG
Incidental illnesses are expected to occur at a certain rate in the general population, even among people who aren’t vaccinated against COVID-19 or any other disease. The incidence of Bell’s palsy, a transient form of facial paralysis, is not higher among people who received the Pfizer-BioNTech COVID-19 vaccine in Israel than in the unvaccinated general population. There is no data to support claims that the Pfizer-BioNTech COVID-19 vaccine causes Bell’s palsy.

BEHAUPTUNG: “13 Israelis suffer FACIAL PARALYSIS after taking Pfizer Covid jab, amid influx of reports detailing adverse effects”

REVIEW


To date, there have been 95 million cases and two million deaths from COVID-19 worldwide. To curb the spread of the disease, several governments initiated massive vaccination campaigns using some of the recently developed and approved vaccines against COVID-19. These large-scale vaccine rollouts have been accompanied by viral claims about the vaccines’ safety and alleged side effects.

The claim that 13 people in Israel developed Bell’s palsy, a transient form of facial paralysis, after they received the Pfizer/BioNTech COVID-19 vaccine was published in early January 2020 and went viral on social media outlets including Facebook. The claim was published in several articles, including this one by Russia Today (RT), which is a state-owned media outlet. The U.S. Department of State identified RT as part of the Russian government’s “disinformation and propaganda ecosystem”.

While the claim that 13 Israelis developed Bell’s palsy after receiving the COVID-19 vaccine is accurate, the report lacks context, and in doing so, can mislead readers into thinking that the vaccine is unsafe and caused these cases of Bell’s palsy. For instance, the RT article’s headline implied these cases could show that the Pfizer-BioNTech COVID-19 vaccine is unsafe. However, the article didn’t inform readers of the total number of people who received this vaccine, nor the expected occurrence of Bell’s palsy in the general population.

According to a Times of Israel article, the Israeli Ministry of Health reported 13 cases of Bell’s palsy among the 1,992,806 Israelis who received the COVID-19 vaccine, accurately conveying the vaccine’s high level of safety.

Given that the COVID-19 vaccination campaign in Israel started on 19 December 2020, the incidence of Bell’s palsy among the vaccinated population is 0.65 cases per 100,000 people per month (from 19 December to 15 January). By comparison, in a general population, the scientific literature estimates that there are 11 to 40 cases of Bell’s palsy per 100,000 people per year, or 0.91 to 3.3 cases per 100,000 people per month[1,2,3]. Therefore, the occurrence of Bell’s palsy among the population who received COVID-19 vaccines is not higher than the published incidence estimates of Bell’s palsy in the general population, who did not receive the vaccine.

The U.S. Food and Drug Administration (FDA) assessed the efficacy and safety of the Pfizer-BioNTech COVID-19 vaccine for emergency use approval. The FDA Briefing Document for the Pfizer-BioNTech COVID-19 vaccine mentioned four cases of Bell’s palsy among the group of 18,801 volunteers who received the vaccine. As Health Feedback explained, the FDA committee reviewing the data noted that the occurence of Bell’s palsy in that group was similar to the occurrence in the general population who did not receive the vaccine and concluded:

Bell’s palsy was reported by four vaccine participants. From Dose 1 through 1 month after Dose 2, there were three reports of Bell’s palsy in the vaccine group and none in the placebo group. This observed frequency of reported Bell’s palsy is consistent with the expected background rate in the general population.

However, in the interests of safeguarding public trust and vaccine safety, the FDA announced that it would continue monitoring cases of Bell’s palsy in people who received the vaccine, although it did not consider it an obstacle to the vaccine rollout.

In summary, it is accurate that 13 Israelis who received Pfizer-BioNTech’s vaccine against COVID-19 developed Bell’s palsy. However, claims reporting this number without reporting the total number of people who received the vaccine in Israel and the occurrence of Bell’s palsy in the general population overlook the fact that the incidence of Bell’s palsy is much lower in the vaccinated population than in the unvaccinated population. Public health authorities approved the use of Pfizer-BioNTech’s COVID-19 vaccine only after reviewing data from clinical trials that demonstrated the vaccine’s efficacy and safety.

ACKNOWLEDGEMENTS

This article was reviewed for accuracy by Sarah Gilbert, professor of vaccinology at the University of Oxford. In the interest of full disclosure, Professor Gilbert is leading the development of the AstraZeneca-Oxford COVID-19 vaccine.

UPDATE (5 Feb. 2021):

The review was corrected to state that the available data for Bell’s Palsy among the vaccinated Israelis is consistent with the number in the general population as per Prof. Gilbert’s recommendation (and not “lower” as stated before).

After our review was published, RT corrected their article to provide more context by clarifying in the headline that no link to vaccination was identified in these cases of Bell’s palsy (see archive of the corrected article).

REFERENCES

     

Veröffentlicht am: 19 Jan 2021 | Editor:

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