FDA approves COVID-19 vaccines for youngest kids

FDA headquarters building
FDA headquarters building


Accepting a recommendation this week from its independent advisory committee, the Food and Drug Administration (FDA) today authorized emergency use of Moderna and BioNTech COVID-19 vaccines for children as young as 6 months.

In global developments, World Health Organization (WHO) advisers today weighed in on the composition of modified COVID-19 vaccines, which comes as some countries are reporting case rises due to the more transmissible BA.4 and BA.5 Omicron subvariants.

ACIP starts deliberating recommendations

In its announcement today, the FDA said it amended Moderna's emergency use authorization (EUA) to include children ages 6 months through 17 years old. The FDA amended Pfizer's EUA to include kids 6 months through 4 years of age.

In two meetings this week, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended approval Moderna for use in kids ages 6 though 17 years, then the next day recommended approval for kids as young as 6 months old for the Moderna and Pfizer-BioNTech vaccines.

In a related development, the Center for Disease Control and Prevention (CDC) vaccine advisory group began discussing recommendations for use of the two vaccines in kids as young as 6 months old. The Advisory Committee on Immunization Practices (ACIP) will vote on its recommendations tomorrow, and the CDC must formally accept them before immunization of young kids can begin.

Following the FDA's approval, though, shipments are on their way to states.

Robert Califf, MD, the FDA's commissioner, said in a statement, "Many parents, caregivers and clinicians have been waiting for a vaccine for younger children, and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death."

He added that caregivers can have confidence in the safety and effectiveness of the vaccines and that the agency thoroughly evaluated the data.

In its statement, the FDA said FDA and CDC surveillance systems have identified increased risks of myocarditis for both mRNA vaccines, mainly in young adult males who received Moderna and adolescent and teen boys who received Pfizer. Most cases resolved rapidly with conservative care.

Chances dim further for fresh COVID funding

In other US developments, at a Senate committee hearing on the pandemic response yesterday, Sen Mitt Romney (R-Utah), who has been leading stalled talks on a $10 billion COVID-19 response funding proposal, accused the White House of misleading Congress about the urgency of the situation, according to Stat. The White House has declined to comment.

In May, a senior White House official projected that 100 million COVID-19 infections could occur over fall and winter, which was met with skepticism and questions about modeling transparency.

Last week, White House officials signaled that they would shift $10 billion away from some parts of the COVID-19 response to allow the government to buy vaccines and treatments.

COVID vaccine composition guidance

WHO technical advisers today issued an interim statement on the make-up of future COVID-19 vaccines. Given uncertainties on how SARS-CoV-2 will evolve, they said modified vaccines may be necessary to prompt a broader immune response against circulating and emerging variants, while still retaining protection against hospitalization and death.

The group said adding Omicron to updated vaccines will probably be helpful, but they don't advise using a monovalent Omicron vaccine for people who haven't had their primary series.

In other global developments, some parts of Europe are experiencing summer rises in cases. Danish health officials are reporting a rise in cases and hospitalizations due to BA.5 activity, and Germany's health minister is recommending boosters and indoor masking, according to Reuters.

Also, the United Kingdom is reporting rising cases in the wake of Queen Elizabeth Jubilee celebrations, partly driven by BA.4 and BA.5 subvariants, according to the BBC.

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