NEW YORK — Health officials say Two new respiratory syncytial virus vaccines Cases of rare neurological disorders in older adults in the United States.
Health officials announced Thursday that the study was based on fewer than 20 confirmed cases among more than 9.5 million vaccinated people. The researchers added that the information available is too limited to establish whether the shot caused the illness.
But the numbers are higher than expected, and authorities are gathering more information to determine whether the vaccine is causing the problem. The data was presented at a meeting of an expert panel that provides advice on vaccine policy to the Centers for Disease Control and Prevention.
Officials said they were investigating more than 20 cases of Guillain-Barre syndrome. Guillain-Barre syndrome is a rare disease in which a person's immune system damages nerve cells, causing muscle weakness and paralysis. According to the CDC, GBS affects an estimated 3,000 to 6,000 people in the United States each year and is more common among older people.
Most people recover completely from this syndrome, but some are left with permanent nerve damage. Guillain-Barre can develop after being infected with the virus, but in some cases it is also associated with vaccination.
respiratory syncytial virus, or RS virusa common cause of cold-like symptoms, can be dangerous for young children and the elderly.
Last year, the CDC approved recommendations by an advisory panel for Americans 60 and older. It was for a single dose of RSV vaccine. There were two options, one made by Pfizer and the other made by his GSK.
The CDC said patients should discuss the vaccine with their doctors and then decide whether to receive it.
Officials were aware that Guillain-Barre cases had been identified in clinical trials before the vaccine was approved for sale, and that various systems were monitoring for signs of trouble.
At Thursday's expert panel meeting, CDC officials presented an analysis of the reports captured in these systems.
About two-thirds of the cases occurred in people who received the Pfizer vaccine called Abrysvo. But authorities are also tracking down people who were infected with the GSK Alexbee.
Health officials estimate that there are about two cases of Guillain-Barre symptoms for every million people vaccinated. The CDC analysis found that GSK's incidence was lower, with 4.6 cases per million people reported among Pfizer vaccine recipients.
Data from the U.S. Food and Drug Administration also showed that more Guillain-Barre cases were reported in people who received the RSV vaccine than expected, with higher numbers among people who received the Pfizer vaccine.
“Taken together, these data suggest a potential increased risk in RSV vaccine recipients over the age of 60 that warrants investigation,” said Dr. Tom Shimabukuro, CDC's Vaccine Safety Monitoring Officer. There is,” he said.
Officials from GSK and Pfizer issued brief statements during the meeting, noting that determining safety signals is complex.
Pfizer Vice President Reema Mehta said, “Pfizer is committed to continued monitoring and evaluation of the safety of Abrisvo,” and has conducted four safety studies to examine the potential for vaccine-related GBS. He said he is doing so.
CDC officials also say the vaccine has prevented thousands of hospitalizations and hundreds of deaths from RSV, and current data shows the benefits of vaccination outweigh the potential risks. Estimates were also presented.
