Pfizer-BioNTech Covid-19 Vaccine for Young Children Supported by FDA Advisors
The expert vaccine panel voted 17 to 0, with one abstention, approving that the vaccine be permitted for children aged 5 to 11 and concluding that the benefits of the vaccine outweigh the risks.
The positive recommendation will likely soon lead to an extension of the US vaccination campaign to millions of young children.
The FDA is expected to decide in the coming days or weeks whether to allow injections for young children, and U.S. health officials have said injections will likely be available in November.
The expert group, called the Advisory Committee on Vaccines and Related Biologics, reviewed the scientific evidence on the vaccine’s safety and effectiveness in children before voting.
“Severe pediatric Covid is not as common as it is in adults, but it does happen and it is not negligible,” said Dr Ofer Levy, panel member and director of the Precision Vaccines program at Boston Children’s Hospital. “I think this vaccine will likely be effective in reducing pediatric Covid in this age group, and may also help reduce transmission.”
The FDA, which regulates medical products, must clear a vaccine before it can be used outside of testing. After the FDA’s action, the Centers for Disease Control and Prevention, which offers advice to doctors, pharmacies and vaccination sites, would set the policy for young children to be vaccinated.
The FDA is not required to accept the panel’s decisions, but generally does. Panel members – who have weighed in before all major FDA decisions on the Covid-19 vaccine – include infectious disease experts, professors and medical practitioners.
The panel discussed the risk of myocarditis, an inflammatory heart disease, which has been found in a small number of young men and adolescent males who have received messenger RNA vaccines. Pfizer-BioNTech and Moderna Inc.
the injections use mRNA technology. U.S. health officials have said the risk of heart disease appears highest in young men and adolescents after their second dose of one of the vaccines.
No cases of myocarditis were found in the study in children, although it was too small to detect the potential risk, according to Pfizer and BioNTech.
Some members said they were concerned about myocarditis and other potential side effects, but wanted to make sure the vaccine was available for children most at risk of getting sick. Earlier in the meeting, U.S. health officials told the panel that two-thirds of children hospitalized had underlying health issues.
James Hildreth, a panel member and president of Meharry Medical College in Nashville, Tenn., Said he had voted in favor of the authorization to ensure that “those who really need it get it.”
He said that while some children are unlikely to get sick, many black or other minority children are likely to need the vaccine. He said he hoped CDC advisers would recommend prioritizing vaccines for children who need them most.
The panel had been informed by the CDC during a presentation that a higher percentage of hospitalized children with Covid-19 are minorities.
Panel members said it would be important for the US government to monitor potential side effects that were not seen or found in the Pfizer-BioNTech study.
Several panelists said they were concerned that schools are establishing immunization mandates for children when the evidence may not justify such widespread use, as not all children are at serious risk of falling. sick.
Peter Marks, director of the FDA’s Biologics Assessment and Research Center, said he didn’t expect an FDA decision to clear the vaccine to spur extended mandates, in especially because the agency would not give full approval.
“In general, people have not made warrants with emergency use authorizations, and there are some governors who have announced that they will not do warrants until there is an emergency. ‘approval,’ he said.
Dr Michael Kurilla, director of the National Institutes of Health’s National Center for Advancing Translational Sciences, abstained from voting. Before the vote, he questioned whether all children needed two doses and whether previously infected children might need only one dose or no dose at all. He pointed to CDC data that 40% of children between the ages of 5 and 11 had already been infected.
“We need to more carefully assess the immunization programs we want for the future and we just don’t have the data at the moment to make those decisions,” he said.
States and healthcare providers are gearing up for what will be the largest vaccination campaign since the first adult doses were made available almost a year ago. Clinics are planned at pediatricians’ offices, schools, community health facilities and pharmacies, according to federal and state officials.
Children face a relatively low risk of serious illness and death from Covid-19, but more have been hospitalized than at the start of the pandemic and since the highly contagious Delta variant swept the country. Doctors and doctors say immunizing children is important to protect them and those around them.
A green light from the FDA would extend vaccine availability to about 28 million additional children.
If the vaccine is authorized, young children will be given two injections three weeks apart. Each shot would contain a third of the dose used for adolescents and adults.
Many parents are waiting for the vaccines, hoping to protect their children during the school year and as the holiday season approaches. Yet polls also show that there are a large number of parents who are unsure of whether to immunize their children.
Pfizer and BioNTech this month asked the FDA to clear the vaccine for young children. The vaccine is fully approved for people 16 years of age and older and cleared for use in children 12 years of age and older.
In a study of 2,268 children aged 5 to 11, the vaccine was generally well tolerated and generated levels of neutralizing antibodies comparable to those seen in subjects aged 16 to 25, according to the companies.
Pfizer and BioNTech are the furthest ahead of companies with approved Covid-19 vaccines to advance a vaccine for young children.
Moderna said on Monday that his vaccine was generally safe and induced immune responses in children aged 6 to 11 in a clinical trial. Johnson & Johnson has yet to study whether the vaccine works in young children.
—Felicia Schwartz contributed to this article.
Write to Jared S. Hopkins at [email protected]
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