Pfizer made a major stride forward in the race for an RSV vaccine on Tuesday, as the US Food and Drug Administration (FDA) accepted its Biologics License Application and granted the candidate priority review. The development could mean a much-needed breakthrough in the quest to develop a vaccine to combat Respiratory Syncytial Virus (RSV), which is especially dangerous to pregnant women and infants.
August 2023 could be a groundbreaking date for maternal and infant health if RSVpreF is approved as the first vaccine administered to pregnant women to prevent RSV in infants. This groundbreaking decision lies in the hands of the regulator, and RSVpreF will have to beat its competitors to the finish line if it hopes to achieve this historic milestone.
In the United States, the race to approval for RSV preventative options is heating up with four candidates designed specifically for young children. Pfizer is one of the frontrunners, but GSK, AstraZeneca and Sanofi are close behind. According to PATH’s RSV clinical trial tracker, these companies are actively working to make their products available as soon as possible. Who will be the first to get the green light? Stay tuned to find out!
Nirsevimab, the long-acting antibody or prevention developed by AstraZeneca and Sanofi, made history when it became the first candidate to be accepted for review by the FDA in January. The FDA has set a third-quarter 2023 action date, marking a major milestone in the global fight against the virus.
GSK, a British pharma giant, was a top contender in the race for a COVID-19 vaccine, until February 2022 when the trials studying its candidate were paused due to safety concerns. Despite the setback, GSK remains hopeful that the trials may yet resume and that its vaccine will be a successful contender in the race for a COVID-19 vaccine.
In January, the FDA accepted AstraZeneca and Sanofi’s nirsevimab candidate for review, making it the first RSV prevention candidate specifically designed for young children. The FDA has set a target action date in the third quarter of 2023. This innovative drug has the potential to help protect vulnerable children from the dangerous respiratory infection.
Nirsevimab, an investigational single-dose antibody injection, could revolutionize the way infants are protected from birth to 24 months of age. The potential of Nirsevimab has been validated by data from the Phase III MELODY and Phase II/III MEDLEY trials, which indicated a consistent protection rate of around 80% against medically attended lower respiratory tract infections.
Pfizer recently announced the results of their Phase III MATISSE trial, which studied the efficacy of their RSVpreF vaccine in infants from birth to six months – and the news is exciting! The trial showed that the vaccine had an impressive 81.8% efficacy rate in preventing severe medically attended lower respiratory tract illness due to RSV in the infants studied – a major breakthrough in the fight against this virus.
On February 23, the full results from the trial will be unveiled at two major events: the CDC’s Advisory Committee on Immunization Practices (ACIP) and the ReSViNET Foundation’s 2023 Global Conference. Attendees of both events will be among the first to learn the complete findings from the trial.