Moderna reports trial data that shows its vaccine is safe and effective in children aged 5 to 11

Moderna believes its COVID-19 vaccine is safe and effective for children aged five to 11, and the company will submit data from recent clinical trials to global regulators.

The news comes as a panel of government advisors was preparing to meet Tuesday on the question of whether to authorize the Pfizer vaccine in kids aged five to 11, as Moderna hopes its vaccine could soon follow.

The Cambridge, Massachusetts, based company reports its vaccine showed effectiveness in young children after receiving two half-doses of the shots.

Momentum for COVID-19 vaccines among children has picked up in recent days, with both Dr Anthony Fauci and former U.S. Food and Drug Administration commissioner and current Pfizer board member Scott Gottlieb both said over the weekend they expect the jabs to be available to young children in the near future.

‘We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,’ Stephane Bancel, Moderna CEO, said in a statement.

An interim analysis from a mid-to-late stage clinical trial of 4,753 children showed that two doses of vaccine produced a high level of neutralizing antibodies.

The vaccine was dosed at 50 micrograms, which is half of what is used among adults, but still produced on average 1.5 times as many antibodies in children as it did in young adults given the higher dose.

The same smaller dose is also being used for the company’s Covid booster shot.

The majority of adverse events were mild or moderate, including fatigue, headache, fever, and injection site pain.

These early results, released via a press statement, do not yet include a vaccine efficacy estimate, which may be expected at a later time once cases have accrued.

Moderna’s shot is currently available to all Americans aged 18 or older, though the company hopes to soon expand that eligibility. 

A briefing document posted on the FDA’s website indicated the agency believes benefits outweigh the most worrying side effect for this age group, namely myocarditis, or heart inflammation.

‘The overall analysis predicted that the numbers of clinically significant Covid-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases,’ the document said.

But it acknowledged the benefit-risk calculus would differ when community transmission is very low, as was the case in the United States in June 2021.

The FDA also uploaded Pfizer’s efficacy analysis, with the company estimating a two-dose course of its vaccine at 10 micrograms was more than 90 percent effective in preventing symptomatic disease.

Overall, more than 150 children aged 5 to 11 have died from Covid in the United States since the start of the pandemic, according to official data.

‘If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible, if not very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,’ Fauci told ABC News Sunday.

Gottlieb told CBS’ Face the Nation that if the jab gets authorization from regulators on Tuesday then the shots could rollout for the youth as early as November 4.

The Pfizer jab is currently the only one approved for minors in the U.S., with the FDA authorizing the shots for all Americans 12 or older.