[ad_1]
On Thursday, a panel of independent advisers to the Food and Drug Administration unanimously recommended approval of the antibody nirsevimab to protect infants against respiratory syncytial virus, the leading cause of hospitalizations among newborns.
If the FDA approves nirsevimab, the antibody will become the first medical intervention available in the United States that can protect all children from RSV. The FDA, which is not required to follow its advisory committee’s recommendations, is expected to make a final decision on nercivimab in the third quarter.
Nirsevimab is a monoclonal antibody made from AstraZeneca. The drug will be marketed by Sanofi.
The advisory committee voted 21-0 to recommend approval.
In a separate vote, the advisors also recommended the use of nirsevimab in children up to 2 years of age who remain susceptible to infection with the virus in the second RSV season. This vote was 19-2.
rsv Kill Nearly 100 children in the United States die each year, according to scientists.
Children hospitalized with RSV often need oxygen support and intravenous fluids and are sometimes placed on a ventilator to support their breathing.
The virus is a major threat to public health. An increase in RSV cases in the past year has overwhelmed children’s hospitals leading to calls for the Biden administration to declare a public health emergency in response.
RSV is spreading at the same time as influenza and Covid-19, putting additional pressure on hospitals.
There is another monoclonal antibody used against RSV called palivizumab. But this antibody is only intended for premature infants and those with congenital lung and heart conditions who are at risk of severe disease. Palivizumab must also be administered monthly.
By contrast, nercivimab will be given to healthy infants, who make up the majority of hospitalizations. It is also given as a single dose, which makes administration easier.
Nirsevimab is not a vaccine because it is a monoclonal antibody.
It’s not clear if the federal pediatric vaccine program would provide nirsevimab to uninsured and uninsured children for free because the antibody is regulated as a drug.
Nirsevimab is already approved in Canada, Europe and the United Kingdom.
Nimish Patel, an expert in drugs for infectious diseases, said nercivimab was performing “very well” in both premature babies and term babies.
“One-time seasonal dosing is a huge advance and this is probably the closest thing to our RSV vaccine really moving the field forward,” said Patel, an FDA committee member and professor of clinical pharmacology at the university. California, San Diego.
effectiveness
Nirsevimab was up to 75% effective in preventing lower respiratory tract infections requiring medical attention and 78% effective in preventing hospitalization, according to a review by the Food and Drug Administration.
A more conservative estimate by the Food and Drug Administration puts the antibody’s efficacy at about 48% against lower respiratory tract infections that require medical attention. This estimate assumed that patients without data on their health outcomes had lower respiratory tract infections that required medical attention.
Nercivimab is given as a single injection, at a dose based on the infant’s weight. Infants weighing less than 5 kilograms will receive a 50-mg injection in their first RSV season, and those weighing 5 kilograms or more will receive a 100-mg injection.
Children under 2 years of age who remain at high risk of RSV infection in their second season will receive a single 200-mg injection of nirsevimab.
safety
The Food and Drug Administration did not identify any safety concerns in its review of nercevimab.
Other monoclonal antibodies have been associated with serious allergic reactions, skin rashes, and other hypersensitivity reactions.
The FDA found no cases of serious allergic reactions in trials of nercivimab and the incidence of rash and hypersensitivity reactions was low in infants who received the antibody. But Dr. Melissa Baylor, an official with the Food and Drug Administration, said cases of these side effects would likely occur if nercivimab was approved.
Twelve infants who received nercevimab died in the trials. None of these deaths were related to antibodies, according to the FDA review.
Four died from heart disease, two died from gastroenteritis, two died of unknown causes but were most likely cases of sudden infant death syndrome, one died from a tumor, one died from covid, one died from a skull fracture, and one died from pneumonia.
“Most deaths were due to an underlying disease,” Baylor said. None of the deaths appeared to be related to nercivimab.
There has been intense concern for safety due to historical failures in developing RSV vaccines. Scientists first attempted to develop a vaccine in the 1960s with an inactivated virus, but this shot made the disease from RSV worse in some children when they received their first natural infection, resulting in two deaths.
Manish Shroff, chief patient safety at AstraZeneca, said the company will closely monitor the safety of nercivimab through a large global monitoring system: “Safety is of the utmost importance,” he said.
Baylor said there are also unanswered questions about how nercivimab might interact with vaccines in development that deliver protective antibodies to a fetus by administering the vaccine to the mother.
It’s unclear whether giving nercivimab to infants whose mothers received RSV vaccines would provide additional protection or create potential safety issues, Baylor said.
Advisers to the U.S. Food and Drug Administration approved Pfizer’s maternal respiratory syncytial virus (RSV) vaccine that protects infants in May. The agency is expected to make a decision on the Pfizer shot in August.
[ad_2]
