Pfizer vaccine can cause 'rare brain condition' - American health officials issue shock warning

The FDA asked Pfizer to carry out a safety study if the shot is approved for use.
The FDA asked Pfizer to carry out a safety study if the shot is approved for use.
Dan Kitwood
George McMillan

By George McMillan


Published: 25/02/2023

- 12:07

Pfizer has insisted that the vaccine is safe and that there are other explanations for the cases

American health officials have issued a warning after two people who took a Pfizer vaccine as part of a trial were later diagnosed with a rare brain condition.

The US Food and Drug Administration has asked Pfizer to carry out a safety study if the shot is approved for use.


Documents released on Friday showed the FDA reported two cases of Guillain-Barre syndrome after individuals took Pfizer’s respiratory syncytial virus (RSV) vaccine.

The NHS describe GBS as “a very rare and serious condition that affects the nerves.

Vaccinator Rosie Buchanan prepares a vial of the Pfizer/BioNTech COVID-19 vaccine at the COVID-19 vaccination centre at Dundonald Hospital in Belfast, Northern Ireland.
American health officials have issued an urgent warning
Liam McBurney

“It mainly affects the feet, hands and limbs, causing problems such as numbness, weakness and pain.

“It can be treated and most people will eventually make a full recovery, although it can occasionally be life-threatening and some people are left with long-term problems.

Guillain-Barré syndrome affects people of all ages but it is more common in adults and males.”

The FDA explained: “There were 2 GBS cases among 19,942 vaccinated participants in the clinical studies submitted to the BLA.

“To assess the risk of GBS and other immune-mediated demyelinating conditions among RSVpreF recipients post-licensure, FDA has requested that the Applicant propose a postmarketing safety study.”

It added: “Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine.

"Therefore, [Guillain-Barre] is being considered an important potential risk,” the FDA says in the documents, which were released ahead of a meeting of its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee.

The two adults were in their 60s and among 20,000 others who took part in the Pfizer’s Phase 3 clinical trial.

The FDA report described one of the adults as: “A 66-year-old male with a past medical history of hypertension developed GBS, graded as life-threatening in severity, with onset of symptoms 7 days after receipt of RSVpreF.

“Prior to the onset of these symptoms, the participant had experienced a non-ST elevation myocardial infarction, not considered related to vaccination, on Day 7.

FILE PHOTO: A woman receives a booster dose of Pfizer-BioNTech vaccine against the coronavirus disease (COVID-19) at the Police hospital in Bangkok, Thailand, January 5, 2023. REUTERS/Athit Perawongmetha/File Photo
Guillain-Barré syndrome affects people of all ages but it is more common in adults and males.
ATHIT PERAWONGMETHA

“He was hospitalised on Days 7-8 for cardiac catheterisation and angioplasty and on Day 8 developed lower back pain.

“On Day 14, he developed bilateral lower extremity weakness, and due to a fall, he was hospitalised.”

No individuals who received a placebo shot were diagnosed with GBS.

Pfizer has insisted there are other explanations for the cases, and said the shot is a “well-tolerated and safe vaccine, with a benefit-to-risk ratio that is favourable.”

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