Moderna is asking the FDA to approve its COVID vaccine for children ages 5 and under

Moderna says it has formally submitted a request to the Food and Drug Administration for approval of two doses of their COVID-19 vaccine for children under 6 years of age, setting in motion a long-awaited federal review process that may soon give the green light for the first vaccinations for these youngest Americans.

“We believe in mRNA-1273 [the Moderna vaccine] will be able to safely protect these children from SARS-CoV-2, which is so important in our continued fight against COVID-19, and which will be especially welcomed by parents and caregivers, “says St├ęphane Bancel, Modernas CEO, in a statement.

Modern request is based on data the company first announced back in March to study two 25-microgram doses of its vaccine in the age group. These doses are less than the two 100 microgram doses given to adults.

The company says that by testing the shots among two groups of children – from 6 months to 23 months as well as from 2 years to under 6 years – they found a “robust neutralizing antibody response” and a “favorable safety profile.”

In a preliminary analysis of laboratory tests collected during the Omicron wave, Moderna says its vaccine efficacy against infection was 51% among children under 2 and 37% among children aged 2 to 5 years.

“These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses,” the company said in a statement.

KidCOVE Phase Three Clinical Trials of Modern COVID Vaccine for Children Aged 2 to 5 Years, University of Wisconsin School of Medicine and Public Health.

Courtesy: John Maniaci / UW Health

Next step: How long will it take?

Modern features mark the biggest tangible step in the process of making vaccines ready for young children since the FDA postponed a scheduled meeting of its external vaccine advisers to discuss the issue back in February.

At the time, officials had been preparing for the possibility that two doses of Pfizer and BioNTech’s COVID-19 vaccine formulated for the youngest children could be rolled out by spring.

But after a disappointing display of the immune response triggered by two doses of their vaccine among the youngest children, companies are now waiting for results from three doses that they say they expect will offer “a higher level of protection.” Data are expected from the clinical trial in June.

Moderna also says it is working on expanding its own booster-shot studies to evaluate a third dose for children as young as 6 months old.

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As with older age groups, the FDA must now work to investigate Moderna’s submission before authorizing emergency use. Thereafter, the Centers for Disease Control and Prevention must also sign updated recommendations before the shots can be distributed, in accordance with federal delivery agreements that regulate the use of the shots.

Spokesmen for both agencies say they plan to convene a meeting with their external vaccine advisers before cleaning Moderna’s shots.

The FDA’s top vaccine official, Dr. Peter Marks, told a Senate hearing Tuesday that the agency will announce a “preliminary” schedule for their Vaccines and Related Biological Products Advisory Committee meeting over the next week.

However, the company must first complete its submission to the FDA, gathering piles of data on its clinical trials and manufacture.

“The FDA can not make a decision on any vaccine without a completed EUA request, which allows us to make a thorough review, which includes a comprehensive review of all the adverse events and replication of the key analyzes,” Abby Capobianco, a FDA spokesman, said in a statement.

Moderna said Thursday that their submission “will be completed next week.”

“We recognize that parents are eager to get their young children vaccinated against COVID-19, and although the FDA can not predict how long its evaluation of data and information will take, we will review any EUA request we receive. as quickly as possible using a science-based approach, “said Capobianco.

The whole process of clearing Pfizer-BioNTech’s images for children ages 5 and up took about 27 days to complete last year, from the time they finished submitting their request on October 6 to the CDC director, who signed the updated recommendations on the 2nd. November.

Federal health officials have warned that clearing Moderna’s shots may not happen as quickly.

In an interview with CNN last week, asked about reports that the FDA could delay its decision on Moderna’s submission, the president’s chief medical adviser, Dr. Anthony Fauci that the regulators wanted to avoid confusion between the two vaccines that were given the green light within a few weeks in a row.

“So it’s going to be two separate companies, two products that are similar but not identical, especially in terms of dosage. And what the FDA wants to do is get it so we do not confuse people into saying that this is dose, this is the dosing regimen for children within the age group of 6 months to 5 years, “said Fauci.

The FDA has downplayed proposals that it delays the review of COVID-19 vaccines for the youngest children. Asked at the Senate hearing on the subject, Marks suggested that Moderna’s application may simply take longer for regulators to find through.

“Some of these are complicated because they are relatively larger and cover larger sections of the pediatric population than others,” Marks said.

While Moderna is already approved for use in several countries for children as young as 6 years of age, only adults are allowed to receive 100 micrograms of shots in the United States. rare cardiac inflammation side effects associated with the shots.

In recent weeks, Moderna says it has also submitted FDA data from its 6- to 11-year submission for other countries, as well as safety follow-up data for adolescents covering 6 months after being vaccinated.

The company’s executives told investors earlier this year that they had agreed with the FDA to study a smaller 50 microgram primary series in adolescents, but insisted that the company remained convinced of the “strong efficiency profile” of 100 micrograms that outweighs the risks in the age group.

“We are deeply concerned about children’s health and well-being. So making a safe and effective COVID-19 vaccine available to children under the age of 5 is definitely one of our top priorities. But simply making a vaccine available is equally important , whose parents are hesitant to get their children vaccinated, “Marks said in a video released by the FDA on Tuesday.

Only about 28% of children aged 5 to 11 are fully vaccinated, and vaccination dust among parents in this age group has increased in recent months. Close to four out of 10 parents of children in this age group say they are likely or definitely not going to get their children vaccinated, according to the CDC’s latest immunization study.

“But let me be very clear, being thorough does not mean that we are delaying the review of these vaccines. We are going to move with all appropriateness, without sacrificing our standards, to complete our evaluations,” Marks added. later.

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