On Monday, U.S. regulators, the FDA, approved the first Respiratory Syncytial Virus (RSV) vaccine for expectant women, protecting their newborns from the dangerous respiratory infection.
Every fall and winter, hospitals are flooded with wheezing infants who have contracted RSV.
The next stage is for the CDC to provide guidance on when and how pregnant women should have the Abrysvo vaccine. Also at high risk are elderly persons, who will begin receiving vaccinations this fall with both the Pfizer vaccine and a competing vaccine from GSK.
Dr. Elizabeth Schlaudecker of Cincinnati Children's Hospital, a researcher in Pfizer's international investigation of the vaccine, said, "Maternal vaccination is an incredible way to protect the infants. If shots begin soon, “I do think we could see an impact for this RSV season.”
Although most healthy adults find RSV to be little more than a source of irritation it can be fatal for infants and young children. It causes inflammation of the infant airways, making breathing difficult, and can even lead to pneumonia. Each year, respiratory syncytial virus causes the hospitalization of 58,000-80,000 children under the age of 5 in the United States and the deaths of several hundred of these youngsters.
Children in the United States started getting sick from RSV last summer, which is much earlier than normal.
Newborns have an underdeveloped immune system and need their mothers' protection for the first few months of life. Vaccination against RSV and how it will work: After a single injection late in pregnancy, the mother's virus-fighting antibodies cross the placenta and are ready to protect her unborn child as soon as she gives birth.
Almost 7,400 mothers and their newborns participated in Pfizer's study. While maternal immunisation did not protect infants from mild RSV infection, it reduced the risk of a severe illness by 82% in the first three months of life. As of 6 months of age, it had a 69% success rate against fatal illness.
Injection-site soreness and weariness were the most common adverse responses to vaccines. Pfizer claims the study's findings of a statistically significant difference in the rate of preterm birth between vaccinated and dummy shot mothers were attributable to chance. To prevent this, the FDA recommended that the vaccination be administered between weeks 32 and 36 of pregnancy, a few weeks after the end of the experiment.
Pfizer estimates that if all pregnant women in the United States were vaccinated, 20,000 newborn hospitalizations and 320,000 medical visits may be avoided annually.
The only other way to protect infants from RSV is to administer lab-made antibodies. A new medicine, the first one-dose version, was just approved by the FDA and is now recommended for all infants younger than 8 months before the first RSV season begins. Sanofi and AstraZeneca's Beyfortus is slated for release this fall.
A paediatric infectious disease specialist in Cincinnati named Schlaudecker said both the new antibody medication and the maternal vaccine are highly anticipated, and he speculated that doctors may try a combination to provide the best protection for babies based on their age and risk during RSV season.
Another doctor at Cincinnati Children's who has treated patients with severe RSV infections consented to take part in Pfizer's vaccination study because she was expecting a child.
“The last thing a parent wants to see is their kid struggling to breathe,” Dr. Maria Deza Leon said. “I was also at risk of being the person that could get RSV and give it to my son without even realising.”
Deza Leon's son Joaquin was born in February 2022, a month after she had her vaccination. Joaquin is now a perfectly healthy kid who has never been diagnosed with RSV, but his mother doesn't know if she had the vaccine or a fake shot.
