On Thursday, a panel of independent experts will consider whether the Food and Drug Administration should approve an RSV vaccine designed to protect infants by vaccinating pregnant women, potentially paving the way for the first RSV vaccine for infants in a few weeks. after the agency approved the country’s first vaccination. common but potentially fatal infection.
KEY FACTS
FDA advisors are ready to review data on Pfizer’s RSV vaccine, Abysvo, intended to protect infants from complications of the infection by vaccinating pregnant women.
RSV, which stands for respiratory syncytial virus, is a common respiratory infection that usually causes mild illness in healthy adults but can cause severe, possibly fatal illness in young children, the elderly, and people with underlying medical conditions.
Because protective antibodies can be passed from mother to developing fetus, a maternal injection given to pregnant women between 24 and 36 weeks of pregnancy also protects babies in their first months of life.
Data from Pfizer’s late stage clinical trials, which involved approximately 7,400 pregnant women, showed that the vaccine was 82% effective in preventing serious illness during the first three months after birth and 69% during the first six months.
The study found that the vaccine was also 51% more effective at preventing medical visits for RSV-related illnesses during the first six months of life.
The vaccine’s safety data is also “generally favorable,” according to an FDA briefing released ahead of the meeting, with relatively standard side effects such as pain at the injection site, muscle pain, and headache, although FDA experts noted a slightly higher rate of preterm birth. births among vaccine recipients.
WHAT WE DON’T KNOW
Based on the analysis in its briefing, the FDA wants to hear its advisers’ thoughts on the number of preterm births seen in Pfizer’s trials. While agency analysts note that the overall rate of preterm birth during the trial—both vaccine recipients and placebo recipients—was below baseline rates in all countries where the study was conducted, it was somewhat higher among vaccine recipients. This difference, 5.7% in vaccinated pregnant women versus 4.7% in the placebo group (common in the US is about 10%), was not statistically significant, and it is not clear if the vaccine played a role. However, the issue is acute, and the prospect of preterm birth has already loomed in the minds of FDA advisors and officials after Pfizer competitor GlaxoSmithKline (GSK) terminated its own trials of a maternal RSV vaccine after noticing early evidence of preterm birth. births and neonatal deaths.
WHAT YOU MUST LOOK FOR
The FDA still has to approve the vaccine, and a decision is likely to be made in a few more months. The agency is not required to follow the advice of its advisers, but it almost always does, and the committee’s decision will carry significant weight. Going forward, Pfizer is also seeking FDA approval for its RSV vaccine, which will be used in the elderly. A number of other companies are also in the process of completing late-stage trials of their own vaccines, and the FDA is in the process of reviewing an antibody injection to protect babies against RSV, which is being jointly developed by European pharmaceutical heavyweights Sanofi and AstraZeneca. . The European Union’s regulator, the European Medicines Agency, has already given its consent to the prophylactic injection.
NEWS PEG
The FDA approved the RSV vaccine from GSK in early May. The agency’s green light was the culmination of decades of hard work by scientists and followed by numerous setbacks. It also marked a major upheaval for GSK, whose shotgun, Arexvy, beat out stiff competition from an increasingly crowded market that includes the likes of Pfizer, Moderna and Johnson & Johnson. However, if approved, Pfizer’s vaccine would still be a milestone, as the GSK vaccine is intended for seniors aged 60 and over.
BASIC INFORMATION
RSV is a very common respiratory virus that infects almost everyone by the age of two. According to the CDC, healthy adults typically experience nothing more than mild cold symptoms such as a runny nose, cough, and fever, and barring any other health problems, most recover quickly and easily. However, the infection may be more deadly for other groups, especially for very young children, the elderly, and those with conditions such Idea.
