RSV Vaccines Linked to Increased Risk of Rare Neurological Disorder GBS in Elderly
GSK
Pharmaceutical R&D Manufacturer
Warning from the U.S. FDA and CDC, Respiratory Syncytial Virus (RSV) Vaccines may increaseElderly Patients with Rare Autoimmune DiseasesRisk of Guillain-Barré Syndrome (GBS)。But there is not enough data to draw a definitive conclusion at present.GBS is a rare autoimmune disease where the immune system attacks the nerves., symptoms include muscle weakness, and paralysis in rare cases.
As of February 16, 2024, the CDC had identified23 casesVerifiedGBS Cases, all occurred within 22 days after the administration of the RSV recombinant protein subunit vaccine.
Since the two vaccines were approved for marketing in the U.S. in the first half of 2023, more than 3 million people have been vaccinated with Pfizer's RSV vaccine, and over 6.5 million people have been vaccinated with GSK's RSV vaccine.
Of the 23 cases of GBS reported, 13 occurred in elderly individuals who received Pfizer's RSV vaccine Abrysvo (RSVPreF), and no more than 11 were in elderly individuals who received GSK's RSV vaccine Arexvy (RSVPreF3+AS01).
Within 21 days after vaccination,Per 1 million doses of PfizerRSV 25.1 Cases of GBS Reported After Vaccination；GSK'sRSV 10.0 cases of GBS per 1 million vaccine doses administered。
GSK's RSV VaccineGBS Incidence Rate Ratio (IRR) Compared with the unvaccinated population, it did not reach statistical significance; andPfizer RSV VaccineGBSIRR Compared with those who have not been vaccinatedCompared with the population, it reached statistical significance.Under the current data scale, Pfizer's RSV vaccine increases the risk of GBS, but there is no evidence that GSK's RSV vaccine increases the risk of GBS.
In addition to the elderly, Pfizer's Abrysvo alsoApproved for use in pregnant women from 32 weeks to 36 weeks of gestation, to enhance infants' immunity against RSV.
Pfizer is continuing to develop Abrysvo for the prevention of RSV in children aged 2 to 17 years and adults aged 18 to 60 years through clinical trials.
There are precedents of other vaccines being withdrawn from the market due to causing rare diseases.: The first rotavirus vaccine was withdrawn from the market in 1998 due to rare cases of intussusception.
If RSV vaccineCauseIncreased GBS risk has been established, and if regulatory authorities assess that the risks outweigh the benefits, it could potentially lead to the withdrawal of marketing approval.
The RSV recombinant protein subunit vaccines from Pfizer and GSK are both based on the RSV F protein mechanism. If the incidence of GBS is related to the RSV F protein, it may face challenges regarding the safety principle of the RSV F protein.
Do you thinkWill the RSV vaccine become history?
