2023-07-24 19:34:56
EMA Recommends Approval of Pfizer’s RSV Vaccine for Pregnant Women
The European Medicines Agency (EMA) has announced its recommendation for the approval of Pfizer’s Abrysvo vaccine, which is designed to protect newborns from Respiratory Syncytial Virus (RSV) infections. RSV can cause serious infections, including pneumonia, in children, making this vaccine a potential game-changer in infant healthcare.
The clinical studies conducted for the vaccine showed promising results, with the vaccine based on proteins of the virus demonstrating a good effect. In the trial, 3,695 women received a dose of 120 micrograms of the vaccine during their last trimester of pregnancy, while a control group of 3,697 pregnant women received a placebo. The researchers then monitored the number of RSV infections in the children within three and six months after birth.
The results were impressive, with only 6 babies in the vaccinated group developing severe RSV infections within 90 days, compared to 33 babies in the placebo group. This translates to a calculated protection of 81.6 percent against serious illness. At the six-month mark, the effectiveness decreased slightly to 69.4 percent, with 19 children of vaccinated mothers falling ill compared to 62 in the placebo group.
However, when it came to mild infections, the vaccine demonstrated less efficacy. 24 children of vaccinated mothers fell ill compared to 56 children of unvaccinated mothers, resulting in a calculated protection rate of only 57.1 percent.
The unique aspect of this vaccine is that it provides passive immunization to the children. Pregnant women who receive the vaccine form antibodies against the RSV virus, which they then pass on to their children either in the womb or via breast milk. This effectively protects the children from the virus in the first few months of their lives.
In addition to its potential benefits for infants, the RSV vaccine has also been approved for adults over 60 years old. Like children, adults can also lose their immunity to RSV over time if they haven’t had contact with the virus. The vaccine has shown promise in reducing the severity of symptoms in adults.
Adverse reactions to the vaccine were primarily mild, including pain at the injection site, headache, and muscle pain. The study doctors did not identify any serious safety risks associated with the vaccination.
The recommendation for approval of the RSV vaccine for pregnant women by the EMA is a significant step in preventing serious RSV infections in newborns. The vaccine offers hope for improved infant healthcare and could potentially save lives.+
This topic in the program: MDR NEWS | March 01, 2023 | 4:55 p.m
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