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This 1981 photo provided by the Centers for Disease Control and Prevention (CDC) shows an electron micrograph of respiratory syncytial virus, also known as RSV.
CDC via AP
The Food and Drug Administration sees a possible risk of Guillain-Barre syndrome in PfizerRSV vaccine for older adults and has asked the company to conduct a safety study if the vaccine is approved this spring, according to agency documents released Friday.
Two people in their 60s who received the Pfizer vaccine were diagnosed with Guillain-Barre syndrome out of about 20,000 vaccine recipients in the third phase of the trial. according to an FDA document. There were no cases in the placebo group in the trial ie. people who have not received the vaccine.
Guillain-Barre syndrome, or inflammatory neuropathy, is a rare disorder in which the body’s immune system mistakenly attacks the nerves. Symptoms range from short-term weakness to paralysis, according to the National Institutes of Health. Most people recover, even after severe cases.
Pfizer, in its briefing paper, said the cases have other possible explanations. But he said he would conduct a safety study to further evaluate Guillain-Barre syndrome after potential approval. The company said it found no safety concerns during the trial and that the vaccine was well tolerated.
There was also a possible case of Guillain-Barre syndrome in GSKtesting the RSV vaccine, but the company said there was insufficient evidence to confirm the diagnosis. GSK listed Guillain-Barre as a significant potential risk in its safety surveillance plan, the FDA reported. The agency said it would review the plan and make recommendations as needed.
The FDA released briefing papers ahead of next week’s advisory committee meetings. Advisers will vote Tuesday on whether Pfizer’s efficacy and safety data support FDA approval. GSK’s RSV vaccine for older adults will also be voted on Wednesday.
There is no approved vaccine against RSV. The virus causes 6,000 to 10,000 deaths a year among the elderly, although mortality varies from season to season.
Pfizer’s vaccine was 85 percent effective in preventing lower respiratory tract disease, and GSK’s vaccine was 83 percent effective, according to an FDA review of the companies’ data.
Cases of Guillain-Barre
In a Pfizer trial, a 66-year-old US man with a history of hypertension developed Guillain-Barre symptoms seven days after vaccination. The man had a heart attack before symptoms appeared and was hospitalized and underwent angioplasty. The FDA does not consider the heart attack to be linked to the RSV vaccine.
The man developed pain in his lower back eight days after vaccination, and then felt weakness in his lower limbs on day 14. After the fall, he was re-hospitalized and later diagnosed with Guillain-Barre syndrome. His symptoms began to improve after treatment and disappeared six months after starting, according to the FDA.
In another case, a 66-year-old woman in Japan with a history of type 2 diabetes developed a severe case of Miller Fisher syndrome, a variant of Guillain-Barre syndrome. She experienced fatigue nine days after vaccination, a sore throat the next day, and poor muscle control on the 10th day. She was hospitalized 19 days after vaccination, but her symptoms completely disappeared within three months.
The FDA said it agreed with investigators that the cases may have been linked to the Pfizer vaccines. But Pfizer cited other possible explanations in its briefing paper. The company warned of the man’s heart attack and said the woman had symptoms of an upper respiratory infection.
But the FDA said that given the incidence of Guillain-Barre syndrome in the general population of about 3 cases per 100,000 people annually, Pfizer should consider these incidents as a significant potential risk in its safety monitoring.
“Given the temporal relationship and biological plausibility, FDA agrees with the investigators’ assessment that these events may have been related to the study vaccine,” the agency said.
In the GSK case, a 78-year-old woman in Japan developed lower-extremity weakness nine days after receiving the first dose of the RSV vaccine, according to the FDA document. She participated in an open-label study without a placebo for comparison.
The next day, the woman had difficulty walking, and over the next three days, upper limb and respiratory muscle weakness appeared. She was hospitalized and treated for Guillain-Barre syndrome. The FDA and the study’s researcher believe the case is related to the vaccine.
But GSK said in its briefing paper that the diagnosis of Guillain-Barre was not confirmed due to the absence of examination results and because there was no information on whether alternative causes had been investigated. The patient’s case was considered resolved after six months, the company announced.
CDC advisors grapple with the risks and benefits
The Centers for Disease Control and Prevention’s Independent Advisory Committee on Vaccines tackled three cases of Guillain-Barre syndrome at a meeting open to the public Thursday. dr. Michael Melgar, a CDC official, told the committee that it is difficult to determine whether the cases represent an actual safety concern related to lightning or if they are random events.
“Due to the small number of events, measures of relative and absolute risk were not calculated,” Melgar told commission members.
But a working group of doctors and health workers who reviewed the available data agreed that monitoring safety will be critical if the vaccines are to be approved by the FDA, Melgar said.
Most of the task force felt that the potential benefits of the vaccines would outweigh the possible risks for people age 65 and older, Melgar said. A minority considered the risk-benefit ratio to be uncertain, in part because of the Guillain-Barré cases.
Although Pfizer and GSK asked the FDA to approve their vaccines for people 60 and older, the CDC task force generally favored a recommendation for seniors 65 and older. The CDC advisory committee did not vote on any RSV vaccine recommendations this week.
dr. Sarah Long, a member of the task force, said the cases gave her pause because the incidence of Guillain-Barre syndrome increases with age, meaning the elderly could be at greater risk if a link to the vaccine is ever discovered.
dr. Grace Lee, chairwoman of the CDC’s advisory committee, said more data is needed because respiratory viral illnesses also cause Guillain-Barre syndrome. It is possible that vaccines could prevent more cases of Guillain-Barre syndrome by protecting against RSV disease.
“You may be preventing more, and we don’t know for sure what the rate is, but I think that balance will be really helpful, at least for me to be able to understand how to think about the benefit-risk balance,” said Lee, the assistant chief medical officer. an employee at Stanford Children’s Health. “Then I can understand whether a 60-year-old or a 65-year-old makes sense or not.”
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