Pfizer likely to be first to gain FDA approval for new RSV vaccine

pharmafile | February 22, 2023 | News story | Research and Development  

The FDA is expected to approve Pfizer’s new respiratory syncytial virus (RSV) vaccine this summer following its acceptance of the company’s fast-track license application for the new product.

Pfizer’s jab is administered to pregnant women in the second or third trimester and can protect the infant from RSV, as antibodies triggered by the vaccine are passed on to the foetus, meaning they are protected against RSV from birth until they are around six months old.

A clinical trial run by the company found the vaccine to be 82% effective in preventing severe disease from RSV in newborn infants during their first 90 days of life. Infants are particularly vulnerable to RSV, with it being the leading cause of hospitalisation for infants in the US, causing inflammation of small airways in the lungs and pneumonia.

Various other pharma companies are also aiming to develop new RSV vaccines, including Moderna, GSK, Johnson & Johnson and Janssen. However, many are aiming to protect the other significant at-risk group, the elderly, specifically those with underlying health conditions such as lung disease, heart disease or weakened immune systems.

Annaliesa Anderson PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, commented: “If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which thought well-known, has been particularly evident throughout this RSV season. We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.”


Betsy Goodfellow

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