Moderna seeks FDA approval of Covid vaccine for children aged six months to five years old

Moderna has requested for emergency use authorisation (EUA) for its Covid-19 vaccine for children ages six months through five years to the US Food and Drug Administration, Politico first reported first late on Wednesday night.

“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release issued on Thursday.

“We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”

The pharmaceutical company’s emergency request arrives one month after it released findings from a clinical trial that showed that its two-dose regimen generated immune protection in the youngest children comparable to that of young adults.

In the clinical trial, researchers tested a group of 2,500 children aged six months through 24 months and 4,200 children aged two through five. The company said that providing the youngest age group with two 25-microgram doses of its vaccine produced a similar result as providing two 100-microgram doses to adults aged 18 to 25.

At this point, no vaccine for children under the age of five has been approved in the US, making the recent request from Moderna a hotly anticipated one among lawmakers and parents of young children who have been anxiously waiting for a lifesaving jab to be greenlit for months.

“The EUA submission for children ages 6 months to under 6 years will be complete next week,” the company said in the statement, adding that they are also studying booster doses for “all paediatric cohorts”.

Pfizer has also indicated that its vaccine for children younger than five, a group that represents about 18 million people in the US, should be available by June.

There has been no timeline provided by Moderna about when the vaccine could be made available to the young age group, but officials told CNN they believe that they expect the FDA to move fast.

As noted in the press release, however, the company won’t complete its EUA filing with the FDA till next week, when they’ve sent over the final datasets from their trial.

Dr Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said this week that the agency plans to publish a timeline next week of when its independent advisory committee would begin to hold meetings on providing vaccines for the country’s youngest remaining age group, and added that getting the shots in their arms was “one of our highest priorities”.

“We will proceed with all due speed, once we have complete applications, some of these are complicated because they are relatively covering larger swaths of the paediatric population than others,” Dr Marks said while testifying in front of the Senate Committee on Health, Education, Labor and Pensions (HELP).

The results presented in Thursday’s news release from Moderna included a revised analysis, as the results released in March included confirmed positive cases from at-home tests taken during the peak of the Omicron wave.

In that data, the company found that for children aged six months to under two years, the two-dose regimen was 51 percent effective at preventing symptoms while for children ages two through five, it was 37 per cent effective.

Results from Pfizer’s low-dose version of their vaccine regimen for young children, which requires three-doses as opposed to Moderna’s two, have yet to be submitted to the FDA. The two-dose regimen that the company previously tested on young children proved to be ineffective for generating significant immune protection.

Though some US parents are quite anxious to get this young group vaccinated, and fast, the numbers in the next age group up doesn’t necessarily suggest that the uptake will be that strong.

Currently, one third of parents of children ages five to 11 have vaccinated their children, despite the programme being open to them since November.

The Centers for Disease Control and Prevention, which strongly recommends parents to consider vaccinating their children, challenged the commonly held perception by some that tots needn’t worry about getting the jabs since they’re risk of becoming severely ill is so low.

In the study, released in March, the federal agency found that during the winter Omicron wave, children under five were hospitalised at nearly five times the rate they were during the delta wave.

And just this week, the CDC released a separate study that found most Americans have had Covid-19, including nearly three out of four children and about 60 per cent of adults, by the end of February 2022.

Speaking to NBC News, Dr Paul Burton, Moderna’s chief medical officer, reassured vaccine hesitant parents that the findings from the trial showed that most of the side effects from the vaccine were “mild or moderate”, with no instances of myocarditis, a rare heart inflammation, being reported.