Health
Sanofi plans to vaccinate infants with RSV before virus season this fall
A doctor is injecting a vaccine to a baby boy
Karl Tapales | Moments | Getty Images
Sanofi expecting a baby RSV Scheduled to be rolled out in the US prior to respiratory system virus It will be in the fall season, a company spokesperson said Friday.
The Food and Drug Administration approved Monday bay fortusis a monoclonal antibody given in a single dose to infants before or during the first season of respiratory syncytial virus.
A Sanofi spokeswoman said the company expects no manufacturing or capacity issues to meet demand this year’s RSV season.French pharmaceutical company co-developed with Bayfortas AstraZenecaWe are based in the UK.
A panel of independent advisers to the Centers for Disease Control and Prevention will meet on August 3 to make recommendations on how to administer the vaccine.
A Sanofi spokesperson said Sanofi is working with the committee to include Bayfortus in the U.S. childhood vaccination schedule. The Affordable Care Act requires most private insurance to cover vaccinations on this list at no cost to the family.
Beyfortus works like a vaccine, but is regulated as a drug because it is a monoclonal antibody. This has created uncertainty as to whether Bayfortus will be included in the federal children’s vaccine program, which provides free vaccinations to economically disadvantaged families.
Sanofi wants Bayfortus to be included in the program, a spokeswoman said. CDC advisers will vote on whether to include the shot in the program at their August meeting.
While vaccines stimulate the body’s immune system to produce antibodies that defend against viral infections, Beyfortus injects these protective antibodies directly into the bloodstream.
Bayfortus is the first vaccine approved in the United States and protects all infants, healthy or ill, from RSV. Another vaccine called palivizumab is also available, but it is mainly for premature babies and babies with heart or lung problems.
In clinical trials, Bayfortus was up to 75% more effective in preventing treatable lower respiratory tract infections in injected infants compared with those who did not.
RSV is the leading cause of hospitalization in infants in the United States, according to scientists. Nearly 100 infants die from the virus each year in the United States, According to last year’s study.
RSV hit children’s hospitals last fall, prompting calls for the Biden administration to declare a public health emergency in response to the wave of infections.
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