FDA Grants Approval to First Maternal RSV Vaccine, Boosting Infant Protection
The Food and Drug Administration has approved the first maternal vaccine to help protect newborns against respiratory syncytial virus (RSV).
The vaccine would be administered in late pregnancy to reduce the risk of severe RSV infection in newborns. However, the vaccine won’t immediately be available on pharmacy shelves for pregnant women.
It is still awaiting review by an expert panel at the Centers for Disease Control and Prevention and approval from the CDC director. This regulatory process could take months.
In the meantime, infants will have access to nirsevimab, a monoclonal antibody shot recommended for all infants under 8 months.
“We’re hopeful that these two [immunizations] will work together so that we can provide the most protection to the most individuals possible,” Dr Elizabeth Schlaudecker, medical director in the division of infectious disease at Cincinnati Children’s Hospital who was involved in the maternal vaccine clinical trial, told ABC News.
RSV, a common respiratory illness, can be fatal for infants due to their susceptibility to bronchiolitis, inflammation of the smallest airways that make it difficult for babies to breathe and is a leading cause of infant pneumonia.
Two to three of every 100 infants with an RSV infection may require hospitalization, and according to the CDC, 58,000 to 80,000 children younger than 5 years old are hospitalized annually due to the virus.
The newly approved Abrysvo vaccine, manufactured by Pfizer, is already available at major pharmacies for adults aged 60 and older at risk for severe RSV infection.
The vaccine stimulates the immune system to produce antibodies against the F protein, which RSV employs to infect human cells by attaching to them.
The idea behind the maternal vaccine is that when administered during the third trimester of pregnancy, there is enough time to develop immunity to RSV and pass it on to the infant before birth.
This immunity won’t last forever but can help protect the youngest babies when they are the most vulnerable in the first six months of life.
“The great news about this vaccine is without even having to vaccinate a baby before they’re born, they are starting to receive protection against one of our most feared viruses,” said Schlaudecker.
This is not the only vaccine that functions in this way. Tdap, a booster of tetanus, diphtheria, and pertussis vaccine, is also recommended for pregnant women between 27 and 36 weeks of gestation, so protective antibodies can be transferred to the infant before birth.
According to clinical trial results, the maternal RSV vaccine from Pfizer is more than 80% effective at preventing severe illness that necessitated a doctor’s visit in infants during the first three months of life and continues to reduce risk up to 6 months.
While no major safety concerns or serious adverse events were discovered during the clinical trials, four of the fourteen experts on an independent FDA advisory committee who met in May this year said the data presented was insufficient to vote in favor of vaccine safety.
Pfizer said in a press release that they “plan to conduct post-marketing studies and surveillance programs to further describe the vaccine’s safety.”
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is set to convene from October 25-27 for the purpose of providing a recommendation concerning the utilization of Abrysvo among expectant mothers.
Now that the FDA has approved two RSV immunization products for infants, the CDC committee will likely need to establish recommendations for both products.
RSV typically causes a mild illness in most people. However, it can be dangerous for the elderly, infants, and babies, with some vulnerable children at an even greater risk of severe illness, including premature babies, immunocompromised children, and those with congenital heart and lung diseases, CDC stated.
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Dr Maria Deza Leon, a mother enrolled in the clinical trial and pediatric infectious disease fellow at Cincinnati Children’s Hospital, told ABC News that she wanted to participate in the trial as an additional means of protecting her unborn son after witnessing countless infants in the hospital struggling to breathe due to RSV.
Deza Leon stated that receiving the shot was comparable to receiving the Tdap booster during pregnancy. However, she has not yet been informed whether she received the placebo shot or the maternal RSV vaccine.
Since enrolling in the clinical trial, she has given birth to a healthy 18-month-old son who, to her knowledge, has never had RSV.
Deza Leon hopes that her story will help more mothers want to get the vaccine when it’s available.
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Source: abc NEWS
