- Inquiry was based on fewer than two dozen cases of the syndrome
- But the numbers are higher than expected, launching an investigation
- READ MORE: Largest Covid vaccine study ever links shots to various conditions
Health officials are probing a possible link between two new RSV vaccines and cases of a rare nervous system disorder in older adults.
The inquiry is based on fewer than two dozen cases of Guillain-Barre syndrome among more than 9.5million over-60s who got the vaccine.
But the numbers, although very low, are higher than expected and officials are gathering more information to determine whether the vaccines are causing the problem.
The data was presented at a meeting of an expert panel that provides vaccine policy advice to the Centers for Disease Control and Prevention.
The RSV vaccine may be linked to a small increase in the risk of a rare neurological disorder, health officials say (stock image)
Guillain-Barre syndrome (GBS) is a rare condition in which the immune system starts to damage a person’s nerve cells, causing muscle weakness and paralysis.
Normally, two cases per million people are recorded of the condition.
But among those who got the Pfizer RSV vaccine, data showed four cases per million were recorded.
Iraq war veteran claims Covid vaccine gave him GBS
Drew – who prefers not to share his last name – says he was an ‘otherwise healthy 36-year-old’ before he received the mRNA Pfizer vaccine in April 2021.
Among those who GSK’s vaccine the rate was even lower than two cases per million.
Officials said the data still highlights that the condition is extremely rare, but that the shift in figures was high enough to prompt an investigation.
Among those who had received GSK’s vaccine, which had also developed a shot against RSV, the rate was even lower than two cases per million.
An estimated 3,000 to 6,000 people develop GBS in the US each year, and it’s more commonly seen in older people, according to the CDC.
Most people fully recover from the syndrome, but a number are left with permanent nerve damage.
The syndrome can occur in people after they are infected with a virus.
But it has also been recorded after vaccination in cases where people’s immune systems have a strong or abnormal reaction.
RSV, or respiratory syncytial virus, is a common cause of cold-like symptoms but it can be dangerous for infants and the elderly.
Last year, the CDC signed off on a recommendation made by the advisory panel, aimed at Americans age 60 and older. It was for a single dose of RSV vaccine.
Officials were aware that instances of Guillain-Barre had been identified in clinical trials done before the shots were approved for sale, and that different systems were watching for signs of problems.
At a meeting of the expert panel on Thursday, CDC officials presented an analysis of the reports taken in by those systems.
About two-thirds of the cases occurred in people who got a version of the vaccine made by Pfizer, called Abrysvo. But officials are also doing follow-up tracking in people who got Arexvy, made by GSK.
Data from the Food and Drug Administration also showed an above-expected number of Guillain-Barre cases being reported in RSV vaccine recipients, with more among Pfizer shot recipients.
‘Taken together, these data suggest a potential increased risk’ in RSV vaccine recipients 60 and older that must be explored, said Dr. Tom Shimabukuro, a CDC vaccine safety monitoring official.
Officials from GSK and Pfizer made brief statements during the meeting, noting that sorting out a safety signal is complicated.
‘Pfizer is committed to the continuous monitoring and evaluation of the safety of Abrysvo’ and is conducting four safety studies to look into the possibility of vaccine-related GBS, said Reema Mehta, a Pfizer vice president.
CDC officials also presented estimates that the vaccines have prevented thousands of hospitalizations and hundreds of deaths from RSV, and that current data indicates the benefits of vaccination outweigh the possible risks.
It comes after warnings that Covid vaccines could also trigger Guillain-Barre syndrome in vanishingly rare cases.
The warning came from the European Medicines Regulator, which required the warning to be added to the label of the Johnson and Johnson vaccine.
Experts stressed that the risk of severe illness or long-term complications from Covid infections was much higher, however, and that vaccines still remained the best option.
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