Health
FDA Officials Support Pfizer’s RSV Vaccine Safety Data to Protect Newborns
/cloudfront-us-east-2.images.arcpublishing.com/reuters/ZVPMKK5DIZOJZFWCQ4HHFM6KYU.jpg "FDA Officials Support Pfizer’s RSV Vaccine Safety Data to Protect Newborns")
May 16 (Reuters) – U.S. Food and Drug Administration staff reviewers said on Tuesday safety data for Pfizer’s products. (PFE.N) An respiratory syncytial virus (RSV) vaccine in pregnant women was “generally good.”
Pfizer is seeking approval for the use of its vaccine in pregnant women to protect newborns to six-month-olds from complications of respiratory syncytial virus infection. If approved, it could be the first maternal vaccine against this virus.
Although participants who received the Pfizer vaccine had more preterm births than the placebo group, FDA staff said in a briefing that the difference did not appear to be statistically significant.
The reviewers’ comments will be released ahead of a meeting of FDA’s external advisers on Thursday, at which non-binding recommendations will be submitted to health regulators.
If FDA approval is obtained, the U.S. Centers for Disease Control and Prevention will need to approve the vaccine for use so that it is widely available to expectant mothers.
Pfizer’s vaccine showed a near-zero chance in late-stage studies. 82% effective Effective in preventing serious lower respiratory tract disease caused by RSV. RSV is a major cause of potentially fatal pneumonia in infants and the elderly.
FDA staff also noted that the safety and efficacy results from the vaccine development program may also apply to trans men who may be pregnant.
The development of an effective RSV vaccine began after researchers better understood the structure of the virus and were able to stabilize a type of protein on the surface of the virus that could activate the body’s immune response. has accelerated in recent years.
Rival GSK (GSK.L) recently first company to receive US approves RSV vaccine for older adults. Pfizer is expected to make a decision later this month on RSV vaccination for seniors.
Reported by Raghab Mahobe and Mariam Sunny of Bangalore.Editing: Krishna Chandra Elli
Our criteria: Thomson Reuters Trust Principles.
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Sources 2/ https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-say-safety-data-favorable-pfizers-rsv-vaccine-protect-newborns-2023-05-16/ The mention sources can contact us to remove/changing this article |
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