The U.S. Centers for Disease Control and Prevention on Thursday recommended that all infants under the age of 8 months be given a new antibody shot to help guard against severe respiratory syncytial virus (RSV).
The antibody shot, sold as Beyfortus, has been shown to reduce the risk of both hospitalizations and health care visits for RSV in infants by about 80 percent, the CDC said in a news release announcing the new recommendation.
“This new RSV immunization provides parents with a powerful tool to protect their children against the threat of RSV,” said CDC Director Dr. Mandy Cohen. “RSV is the leading cause of hospitalizations for infants and older babies at higher risk and today we have taken an important step to make this life saving product available.“
“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” Cohen added. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”
Cohen’s announcement was preceded by an unanimous vote backing the shot from the Advisory Committee on Immunization Practices (ACIP), an expert panel that makes recommendations for the CDC on the use of vaccines.
“I’m very excited about this. I think this is going to be incredible,” ACIP member Dr. Helen Talbot, a pediatrician at Vanderbilt University in Tennessee, said after the vote, CNN reported. “I think this is life-changing and I’m very excited. I just hope we can get through the hurdles,” to get it to patients.
The ACIP also recommended unanimously that infants ages 8 to 19 months with underlying health issues should get a second dose of the shot for their second RSV season. The shot will also be added to the federally funded Vaccines for Children Program, CNN reported.
Two companies are making the antibody used in the shot, Sanofi and AstraZeneca. It should be available in a few months, CNN reported.
“Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population,” Thomas Triomphe, executive vice president for vaccines at Sanofi, said in a company news release. “The ACIP’s unanimous recommendations for routine use of Beyfortus and inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the U.S. with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease.”
“I do believe that in terms of the innovation of this, this is a really important step forward,” ACIP Chair Dr. Grace Lee, a pediatrician at the Stanford University School of Medicine said, CNN reported.
However, insurance companies have a year to plan for coverage, and that may not start until 18 months from now.
Sanofi said during the ACIP meeting that the charge would be $495 per dose for private payers and $395 a shot for the government’s Vaccines for Children program.
The vaccine’s approval “is a spectacular advancement,” ACIP member Dr. Jamie Loehr, a family physician in New York said, told CNN. “It’s going to help families and offices, and keep kids out of the hospital. And two years from now, it’ll be covered by insurances and all the implementation will be in place. So, there will be growing pains, but I don’t want to lose sight of how important this advancement is.”
Infants who are born during or before RSV season begins should get a shot in their first week of life, the CDC recommends. Those under 8 months who haven’t had a shot should get one before RSV season.
Once immunized, the antibody will only be effective for five to six months, the CDC noted.
In the United States, RSV season typically runs from October to March. It tends to strike certain racial and ethnic groups harder, including American Indian and Alaska Native children. That group has hospitalization rates for RSV that are 4 to 10 times higher than the general population. The CDC recommends they also get a second shot, CNN reported.
The American Lung Association has more on respiratory syncytial virus (RSV).
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