Several FDA advisors said there could be a significant safety issue after two vaccine recipients out of about 20,000 developed Guillain-Barre syndrome.
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Pfizer's vaccine contains both strains of RSV, which circulate at the same time during fall and winter. The shot is administered as a single 120 microgram dose.The FDA considers the two Guillain-Barre cases during the trial as possibly linked to the vaccine, said Dr. Nadine Peart Akindele, an agency official. The FDA has asked Pfizer to develop a safety study that will monitor Guillain-Barre risks after an approval, which the company has agreed to do.
"It seems to me that one case is a red flag. Two cases is very concerning and it's concerning to me that Pfizer doesn't think that there are any safety concerns," said Griffin, a professor of health policy at Vanderbilt University Medical CenterDr. Hana El Sahly, who chairs the FDA advisory committee, also said the Guillain-Barre cases raise a significant safety concern.
Dr. Jay Portnoy, an FDA committee member, said he concluded the safety data was adequate because Guillain-Barre syndrome is rare, and otherwise adverse events in the trial occurred at about the same rate among people who received the vaccine and those who did not.
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