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A panel of independent advisers to the Food and Drug Administration unanimously recommended Thursday that the antibody nirsevimab be approved for use to protect infants. respiratory polynuclear virusLeading cause of hospitalization among newborns.
If the FDA approves nirsevimab, the antibody would become the first medical intervention available in the US that can protect all babies. RSV, The FDA, which is not bound to follow its advisory panel’s recommendation, is expected to make a final decision on nirsevimab in the third quarter of this year.
Nirsevimab is a monoclonal antibody designed astrazeneca, The drug will be marketed by sanofi,
The advisory panel voted 21-0 to recommend its approval.
In a separate vote, the advisories also recommended the use of nirsevimab in children up to two years old who are vulnerable to the virus in their second RSV season. That vote was 19-2.
RSV kills About 100 children each year in the United States.
Babies hospitalized with RSV often require oxygen support, intravenous fluids and are sometimes placed on a ventilator to help them breathe.
Viruses are a major public health threat. A surge in RSV infections last year overwhelmed children’s hospitals, leading to calls for the Biden administration to declare public health emergency In reply.
RSV circulates at the same time as flu and COVID-19, which puts additional strain on hospitals.
Another monoclonal antibody used against RSV is called palivizumab. But this antibody is only for preterm infants and people with lung and congenital heart conditions who are at high risk of severe disease. Palivizumab is also to be administered monthly.
Nirsevimab, in contrast, will also be administered to healthy infants, who are most hospitalized. It is also given as a single dose, which will make administration easier.
Nirsevimab is not considered a vaccine because it is a monoclonal antibody.
It is unclear whether the federal Vaccines for Children program will provide nirvemumab for free to uninsured and underinsured children because the antibody is regulated as a prescription drug.
Nirsevimab is already approved in Canada, Europe and the United Kingdom.
Nimish Patel, an expert in drugs for infectious diseases, said nirsevimab performed “exceptionally well” in both premature and premature babies.
“The one-time seasonal dose is a huge advance and it’s probably the closest thing we have to an RSV vaccine and it really advances the field,” said Patel, an FDA committee member and professor of clinical pharmacy at UC San. Diego.
Effect
Nirsevimab was 75% effective at preventing lower respiratory tract infections that required medical attention and was 78% effective at preventing hospitalization, according to an FDA review.
A more conservative estimate by the FDA placed the effectiveness of the antibodies at about 48% against lower respiratory tract infections that required medical attention. This estimate assumed that patients with missing data on health outcomes had lower respiratory tract infections that required medical attention.
Nirsevimab is given as a single injection with the dosage based on the weight of the baby. Babies weighing less than 5 kg will be given a 50 mg injection for their first RSV season, and babies weighing 5 kg or more will be given a 100 mg injection.
Children under the age of two who are at risk of severe RSV in their second season will be given a single injection of 200 milligrams of nirsevimab.
Security
The FDA did not identify any safety concerns in its review of nirsevimab.
Other monoclonal antibodies have been associated with severe allergic reactions, skin rashes, and other hypersensitivity reactions.
The FDA found no cases of serious allergic reactions in nirsevimab trials and there were fewer cases of skin rash and hypersensitivity reactions in infants who received the antibody. But an FDA official, Dr. Melissa Baylor said cases of these side effects will likely occur if nirsevimab is approved.
Twelve infants who received nirsevimab died in the trials. None of these deaths were related to the antibodies, according to the FDA’s review.
Four died of heart disease, two died of gastroenteritis, two died of unknown but probable cases of sudden infant death syndrome, one died of tumor, one died of covid, one of skull fracture Died, and one died of pneumonia.
“Most of the deaths were due to an underlying disease,” Baylor said. “None of the deaths appear to be related to nirsevimab.”
Due to historical failures in the development of RSV vaccines, much attention has been paid to safety. Scientists first tried to develop a vaccine with an inactivated virus in the 1960s, but that shot actually made illness from RSV worse in some babies when they got their first natural infections, resulting in the deaths of two infants. died.
Manish Shroff, head of patient safety at AstraZeneca, said the company would closely monitor the safety of nirsevimab through a large global surveillance system: “Safety is of the utmost importance,” he said.
Baylor said there are also unanswered questions about how nirsevimab will interact with vaccines in development that provide protective antibodies to the fetus by giving the shot to the mother.
It is unclear whether giving nirsevimab to infants whose mothers have received such RSV vaccines will provide additional protection or pose potential safety issues,” Byler said.
FDA advisers in May endorsed Pfizer’s maternal RSV vaccine protecting infants. The agency is expected to make a decision on Pfizer’s shot in August.