Pfizer develops RSV vaccine for infants given during pregnancy
Pfizer says study shows RSV vaccine had 82% efficacy rate for infants up to 90 days and 69% up to 6 months
Pfizer announced the development of an experimental vaccine administered to pregnant women in order to protect infants from severe illness.
The pharmaceutical company announced in a statement that the vaccine was effective at protecting infants and mothers against respiratory syncytial virus, or RSV, in phase 3 of the company's study.
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Administered during pregnancy, the vaccine demonstrated an efficacy at around 82% from birth to the first 90 days of life; afterward, the efficacy lowered to about 69% for the first six months of life. Overall, the mothers and their infants received the vaccine well and displayed no evidence for a cause of concern for safety.
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"These data reinforce Pfizer’s resolve to bring our expertise in the research and development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants. We would like to thank the pregnant women who volunteered for this trial, along with their infants, and all the investigators around the world who participated in the study for their contribution to this landmark research," said Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development at Pfizer, in a statement on Tuesday.
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The findings of the study have not yet been published in any academic peer-reviewed journal.
Pfizer intends to submit a biologics license application to the U.S. Food and Drug Administration by the end of 2022. If approved, it would mark the first maternal vaccine to protect infants from a life-threatening respiratory illness.
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