Image by Angelo Esslinger from Pixabay
CDC and FDA have committed to monitoring recipients of two COVID-19 vaccines for Bell’s palsy, a type of facial paralysis.
FDA, however, concluded that there is insufficient data to determine whether the mRNA-based vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE)/BioNTech (NSDQ:BNTX) are linked to the condition, which is often temporary.
Both vaccines use messenger RNA technology, which is novel for vaccines.
In Phase 3 clinical trials from Pfizer-BioNTech and Moderna, a handful of patients developed the condition. Four patients in the vaccine arm of the Pfizer-BioNTech trial developed Bell’s palsy and none in the placebo group. Three patients in the Moderna trial’s vaccine arm developed the condition, and one in the placebo arm.
“We don’t know really if these Bell’s palsy [cases] ended up happening coincidentally in the vaccine group. We’ll have to see,” said Abinash Virk, an infectious disease specialist at the Mayo Clinic, last week before FDA released its assessment of the Moderna Phase 3 trial.
A limited number of COVID-19 patients have developed Bell’s palsy as well.
An FDA briefing document for Moderna’s vaccine stated that one case in the vaccine group was a serious adverse event. A “67-year-old female with diabetes was hospitalized for stroke due to new facial paralysis 32 days after vaccination,” according to the report. “This case was reported as resolving,” it continued.
The Bell’s palsy cases in the Pfizer-BioNTech and Moderna trials will “create some ongoing discussion,” concluded a briefing note from UBS analysts Navin Jacob and Dr. Jonathan Lim.
But some degree of Bell’s palsy would be expected in a large clinical trial, according to UBS. The background rate of the condition in the general population is 25 to 35 per 100,000 people, which would imply eight to 12 cases across the Pfizer-BioNTech and Moderna trials, which involved approximately 44,000 and 30,000 participants, respectively. There were a total of eight Bell’s palsy cases across both trials.
While the cause of Bell’s palsy is unclear, reactivation of a dormant viral infection could be the principal cause of the disorder, according to the NIH. Reactivation of herpes simplex virus may be the most common cause. Pregnancy and diabetes can increase the risk of the condition.
Researchers have linked Bell’s palsy to other vaccine studies. In Switzerland, health authorities pulled an inactivated intranasal flu vaccine linked to the condition from the market in the early 2000s. One study conservatively estimated that recipients of that vaccine were 19 times more likely to develop Bell’s palsy than the general population.
FDA researched similar conclusions about the situation in its briefing documents for the Pfizer-BioNTech and Moderna vaccines. “Considering the temporal association and biological plausibility, a potential contribution of the vaccine to the manifestations of these events of facial palsy cannot be ruled out,” the agency concluded in its notes on the Moderna vaccine. The agency is recommending surveillance for Bell’s palsy as both vaccines reach the public.
FDA authorized the Pfizer-BioNTech vaccine last week. It could authorize the Moderna vaccine as soon as Dec. 18.
Filed Under: clinical trials, Drug Discovery, Infectious Disease
My aunt had bell’s palsy. She passed September 30th from leukemia. Is it safe for her nieces and nephews to get the vaccine?
Hi Kathy, to date, there is no causal link between the vaccine and Bell’s palsy although FDA and CDC will monitor recipients of the vaccine. FDA said there was “a numerical imbalance” in the clinical trial results. That is, the rates of Bell’s palsy were higher in the vaccinated arms of the Pfizer and Moderna trials. But as things stand now, scientists don’t know if there is a very small risk of Bell’s palsy from the vaccine or if the cases were unrelated to the vaccine. More monitoring should shed light on that question, but in general both the Moderna and Pfizer vaccines have been well-tolerated by most patients.
I’m a 73 year old male who has had two previous onsets of Bell’s Palsy in the last 20 years. Both resolved within two weeks with no lingering impact. My last onset was 10 years ago. I can not find any data on onset of Bell’s Palsy with AstraZeneca or J & J vaccines. Has there been any data released ? Has any US cases of Bell’s Palsy been reported since 12/10/20 from the Moderna or Pfizer? Thanks
I’d like an answer to Ken’s question also. I think it’s troubling that 7 of the 8 people who got Bell’s Palsy in the Moderna and Pfizer trials were in the vaccine group, and only one in the placebo group. I’m always amazed by how little is known about the causes of Bell’s Palsy, which I got two weeks before my 60th birthday, 5 and 1/2 years ago, and never fully resolved.
I would very much like to know if there are similar instances of Bell’s palsy with the Astra Zeneca or J&J vaccines. I had B/P 21 years ago and again 15 years ago. I have never fully recovered. It is not a minor concern.
I have had Bell’s Palsy four times in the 1960s and 1970s. I have a small amount of permanent damage from my first case in 1966 when we could not find a doctor until five weeks into it who knew what it was. Now I am almost 70. Having had Bell’s four times was traumatic. Having it again at my age with a decreased chance for complete resolution is, to me, absolutely terrifying.
I have had Bell’s Palsy 3 times and have not gotten a vaccine yet due to possibility of getting it again. I have some facial drooping and don’t want to have it again. I too am very worried about getting the vaccine. Have there been any answers yet found on the Johnson and Johnson vaccine????
Hi Rose, the number of people in the J&J trial who had Bell’s palsy was equal across the vaccine and placebo groups. The Pfizer and Moderna trials had a “numerical imbalance” — both had higher rates in the vaccine arms of their studies. Both also concluded their is insufficient data to link Bell’s palsy with their vaccines.
I recently put together this summary on the topic (link below). I found a recent Lancet source that stipulates that the mRNA vaccines could lead to a potentially elevated risk of Bell’s palsy (more data are needed to say for sure), but it also stresses that such vaccines lead to a “substantial net benefit to public health.”
https://www.drugdiscoverytrends.com/is-there-a-link-between-bells-palsy-and-covid-19-vaccines/
My daughter,now in her 20s, had Bell’s palsy some time ago. She does not want it again. She would like to be protected from Covid and the new variants.She is a college student and restaurant worker. Which shot is her best bet for not getting Bell’s palsey from the vaccination?
I am 55. To date, I have not had nor been diagnosed with Covid. On March 24, 2020 I woke up with right side Facial paralysis, right side drooping mouth and eye, right ear hearing issues, debilitating vertigo, and 4 canker sores on the right side of my tongue, and pain in my ear, jaw, and neck. I was considered to have Bell’s palsy at first but the canker sores led my specialists to believe I had a shingles outbreak (Ramsey Hunt Syndrome) due to having the chicken pox virus when I was 5 years old. The dormant virus attacked the cranial nerve bundles in my head and I did not ever present with shingles lesions anywhere on my skin, trunk, face or ears. It’s been one year and I continue to struggle in my healing process. My mouth has returned to its normal position but my eye has not nor has my hearing or the heaviness I feel inside of my head on the right side and I still experience sensations of vertigo, but not as severe as onset . In being concerned about contracting covid in my position, i scheduled my covid vaccine for April 15th. I am terrified to receive the covid vaccine as I fear it will awaken a shingles response and make my facial palsy worse. I called my pcp doctor about this today and she suggests I receive a shingles vaccine prior to receiving a covid vaccine, but to still receive the covid vaccine in May instead of April. After further thought, I don’t think I feel comfortable anymore considering a covid vax ever. It was suggested I wait a year to receive the shingles vaccine after an episode of facial paralysis and I have had to emotionally gear up for even it. My anxiety is full blown and I am afraid of the shingles vaccine now, too. Any feedback would be helpful. I really do worry about the covid vaccine bringing life back to my shingles virus and facial paralysis. I was in PT for 8 months just to re-teach my brain how to walk a straight line. I couldn’t drive during those months either. Wearing a mask with facial and mouth paralysis was the best thing ever for my ego 😂