Pfizer RSV vaccine 82% effective vs severe infection in infants, final
data shows
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[April 06, 2023]
(Reuters) - Pfizer Inc's experimental respiratory syncytial virus
(RSV) vaccine was 82% effective in preventing severe infections in
infants when given to expecting mothers in the second half of their
pregnancy, according to trial details published on Wednesday that
confirm preliminary data from the study.
Final data from the study that was halted early when it became clear the
vaccine was effective was published in the New England Journal of
Medicine.
Pfizer in November released initial trial results on the vaccine that is
currently under review by health regulators in both the United States
and Europe. The U.S. Food and Drug Administration is expected to decide
on its use by August.
FDA approval could make Pfizer's shot the first maternal vaccine
available to prevent the disease in infants.
Sanofi and AstraZeneca are developing a single-dose antibody, nirsevimab,
for RSV prevention in infants, which is also under FDA review.
![](http://archives.lincolndailynews.com/2023/Apr/06/images/ads/current/farmersgrain_sda_SFARM_2023.png)
Pfizer's vaccine, RSVpreF, met one of the two main goals of the
late-stage study. It was nearly 82% effective in preventing severe lower
respiratory tract illness, such as very low oxygen levels or need for
ventilator support, in infants in the first 90 days of life.
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![](../images/040623PIX/health83.jpg)
The Pfizer logo is pictured on their
headquarters building in the Manhattan borough of New York City, New
York, U.S., November 9, 2020. REUTERS/Carlo Allegri
![](http://archives.lincolndailynews.com/2023/Apr/06/images/ads/current/debbies_lda_032222.png) Pfizer said severe illness occurred
within three months in 6 infants whose mothers received the vaccine,
compared with 33 infants from the placebo group who contracted
serious RSV infections. The company evaluated 3,570 infants as part
of the study.
The shot was 69.4% effective in preventing severe infections in the
first 180 days. Severe illness occurred within six months in 19
infants born to mothers in the vaccine group, compared with 62
infants in the placebo group.
The shot failed to meet a second main goal of reducing non-severe
illness in infants.
About 58,000 to 80,000 children younger than 5 years old are
hospitalized due to RSV infection every year in the United States,
according to government data, and infants are among those at
greatest risk for severe illness.
(Reporting by Bhanvi Satija in Bengaluru; editing by Caroline Humer
and Bill Berkrot)
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