According to agency briefing slides released on Friday, the Food and Drug Administration sees a potential risk of Guillain-Barre syndrome with Pfizer’s RSV vaccination for older persons and has urged the company to do a safety study if the injection is approved this spring.
Out of around 20,000 vaccination participants in the phase three trial, two patients in their 60s who received Pfizer’s injection were found to have Guillain-Barre syndrome, according to the FDA filing. In the placebo group of the trial—those who did not receive the shot—there were no cases.
A rare condition known as Guillain-Barre syndrome, also known as inflammatory neuropathy, occurs when the body’s immune system accidentally attacks the nerves.
The National Institutes of Health describe a variety of symptoms, including short-term weakening and eventual paralysis. Even in the worst circumstances, most people bounce back.
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In its briefing material, Pfizer stated that there may be more causes for the occurrences. However, it stated that following a prospective approval, a safety study to further evaluate Guillain-Barre syndrome would be carried out. The business claimed that the trial revealed no safety issues and that the vaccination was well received.
Also, there may have been a case of Guillain-Barre syndrome in GSK’s RSV vaccination studies, but the company argued that there wasn’t enough information to make a diagnosis.
According to the FDA, GSK has identified Guillain-Barre as a significant possible risk in its safety surveillance plan. According to the agency, it will assess the strategy and offer suggestions as necessary.
The FDA made the briefing materials available ahead of the advisory committee meetings the following week. On Tuesday, the advisors will decide whether the FDA would be supported in approving Pfizer’s efficacy and safety findings. On Wednesday, they will also vote on the GSK RSV vaccination for senior citizens.
There is no licensed RSV vaccination. Although mortality varies from season to season, the virus is responsible for 6,000 to 10,000 fatalities per year among the elderly.
According to an FDA evaluation of the firms’ data, Pfizer’s vaccination was 85% effective at preventing lower respiratory tract sickness while GSK’s shot was 83% effective.
The Cases of Guillain-Barre
Seven days after receiving the vaccine in Pfizer’s experiment, a 66-year-old American man with a history of hypertension experienced signs of Guillain-Barre.
The man was admitted to the hospital, had an angioplasty, and had a heart attack before the symptoms appeared. The RSV vaccine was not a factor in the heart attack, according to the FDA.
Eight days after receiving the vaccination, the man started experiencing lower back pain, and on the fourteenth day, he started to feel weak in his lower extremities.
After falling, he had to go back to the hospital, where Guillain-Barre Syndrome was discovered. According to the FDA, his symptoms began to go better following treatment and were gone six months after they first appeared.
A second instance was a 66-year-old Japanese woman who had a history of type 2 diabetes and who later experienced a severe case of Miller-Fisher syndrome, a kind of Guillain-Barre. Nine days following the immunization, she felt tired, the next day she had a sore throat, and on the tenth day, she had weak muscle control.
Although she was admitted to the hospital 19 days following the immunization, three months later all of her symptoms were gone. The FDA stated that it concurs with the investigators’ theory that the incidents may have been connected to Pfizer’s vaccinations.
Yet, Pfizer stated in its briefing document that there may be additional causes. The business emphasized the man’s heart attack while asserting that the wife displayed signs of an upper respiratory infection.
Nonetheless, the FDA stated that Pfizer should consider the instances as a significant potential risk in its safety surveillance considering that the incidence of Guillain-Barre syndrome in the general population is roughly 3 cases per 100,000 persons yearly.
“Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine,” the agency said.
According to an FDA briefing paper, in the case of GSK, a 78-year-old lady in Japan had lower limb weakness nine days after getting the first dosage of the RSV vaccine. She was taking part in an open-label study with no control group receiving a placebo.
The next day, the woman had trouble walking, and over the next three days, she began to lose strength in her upper limb and respiratory muscles. She underwent hospitalization and Guillain-Barre syndrome treatment. The instance is regarded by the FDA and the study’s investigator as being connected to the vaccine.
Nevertheless, GSK stated in its briefing document that a Guillain-Barre diagnosis was not established because there were no exam findings and no details on whether alternate reasons had been looked into. After six months, the business said that the patient’s case was closed.
@NaturallyFTW tweeted on Twitter related to the RSV vaccine, you can see below:
🚨 Media will NOT tell you:
• The new RSV vaccines showed a 🚩 SAFETY problem so Alarming, GlaxoSmithKline had to Abruptly End all clinical trials.
• 1 of ~600 young healthy people DIED in a Pfizer RSV study.
— Natural Immunity FTW (@NaturallyFTW) February 24, 2023
CDC Advisors Weigh the Advantages and Risks
In a meeting that was open to the public on Thursday, the committee of independent vaccine advisors for the Centers for Disease Control and Prevention discussed the three cases of Guillain-Barre syndrome.
A CDC representative, Dr. Michael Melgar, told the committee that it is challenging to assess whether the cases reflect a genuine safety concern related to the shots or if they are purely coincidental occurrences.
Measures of relative and absolute risk were not estimated, Melgar informed the committee, “because of the limited number of incidents.” Yet if the vaccinations are approved by the FDA, safety monitoring would be crucial, according to a workgroup of doctors and health experts who analyzed the data.
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According to Melgar, the majority of the workgroup believed that for persons 65 and older, the vaccinations’ potential advantages would outweigh any potential hazards. A small percentage of people believed that the risk-benefit ratio was questionable in part because of the Guillain-Barre instances.
The CDC panel broadly supported a proposal for seniors age 65 and older, despite the fact that Pfizer and GSK have requested that the FDA approve their respective vaccinations for persons age 60 and older. This week, there were no recommendations for the RSV vaccination put to the CDC advisory committee’s vote.
The cases, according to workgroup member Dr. Sarah Long, give her pause since seniors may be more at risk if there is any evidence linking the vaccine to Guillain-Barre syndrome because its prevalence rises with age.
Further information is required, according to Dr. Grace Lee, the leader of the CDC advisory committee, because respiratory virus diseases can also lead to Guillain-Barre syndrome. By guarding against RSV illness, immunizations may be able to stop more occurrences of Guillain-Barre syndrome.
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