A potential vaccine for pregnant mothers could quell the surge of serious RSV cases
On Tuesday Pfizer reported positive outcomes from trials for their respiratory virus (RSV ) vaccination). The vaccine is available to pregnant mothers in the third trimester . The vaccine’s goal is to protect infants from the virus within the first six months of their birth. This is when infants are most at risk of severe illness from RSV.
RSV, a common respiratory disease, is most commonly seen in the fall and winter. Most of those who contract it have similar symptoms to the common cold, but the virus can be life-threatening in young infants who have smaller airways. It is also a leading cause of hospitalization for babies. RSV is currently causing an unusually early spike in cases, overwhelming hospitals in many states. “It all has a very COVID-esque feel to it,” Meghan Bernier, the medical director of the pediatric intensive care unit at the Johns Hopkins Children’s Center in Baltimore, told The New York Times. “This is the pediatrician’s COVID. This is our March 2020.”
[Related: Is it flu or RSV? It can be difficult to tell. ]
According to the trial results, the vaccine appeared to be roughly 80 percent effective at preventing severe RSV disease infants in the first three months of life. It also cut a baby’s risk of needing to see a doctor due to infection in the first six months by half, and was 69 percent effective in preventing severe cases over six months.
The pharmaceutical company plans to apply for approval by the Food and Drug Administration (FDA) before the end of the year, with hopes that the vaccine could be available as early as next winter.
If approved, the vaccine will be the first RSV vaccine and the first new product related to the virus in more than 20 years. In March, the FDA designated Pfizer’s RSV vaccine a breakthrough therapy–a status that should speed up the review.
“These data are exciting as this is the first-ever investigational vaccination to protect newborns from severe RSV-related respiratory illnesses immediately after birth,” Annaliesa A. Anderson, senior vice president of vaccine research and development at Pfizer stated in an . statement. “These data reinforce Pfizer’s resolve to bring our expertise in the research and development of innovative vaccines to address critical public health needs using new approaches and technologies.”
Pfizer stated in the release there were no safety concerns for both vaccinated adults and babies. The data would be closely examined.
A total of 7,400 pregnant people participated in the trial, and the infants were followed for at least a year. Babies were considered to have severe RSV if they were breathing very rapidly (more than 70 breaths per minute in a 2-month-old), if their blood oxygen levels fell below 93 percent, if they required high-flow oxygen, if they were admitted to the intensive care unit (ICU), or if they lost consciousness.
The trial’s researchers also evaluated whether the shots prevented RSV-related medical visits in infants. It cut the need for infants to need to see a doctor by an average of more than 50 percent when compared with a placebo, which is not statistically significant. In the release , the company acknowledged that the vaccine had not met that goalpost.
However, in an interview with CNN, William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, said that a 50 percent reduction in doctor visits due to RSV is still likely to be a noticeable and important benefit in the real world. He stated that this was clear enough and, frankly, great news for us to file for our approval.
Maternal vaccines like this one provide an unborn baby with antibodies naturally passed down during pregnancy and provides a temporary, but immediate, bit of protection. Vaccines for diphtheria and tetanus can be given to mothers during pregnancy.
Major pharmaceutical groups may soon make two additional tools to prevent RSV infection in infants, provided that regulators agree they are safe and effective. In trials of a treatment from AstraZeneca and Sanofi called nirsevimab, a single dose of a monoclonal antibody could protect infants from RSV for five months. The drug was recently recommended for approval in Europe, according to a statement from AstraZeneca.
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