Moderna seeks approval for COVID-19 vaccine in young children

Thursday, March 24, 2022

After months of stops and starts, Moderna announced today it seeks emergency use authorization from the Food and Drug Administration (FDA) of a two-dose primary series of its COVID-19 vaccine for children ages 6 months to 6 years.

The company said positive interim analysis of a phase 2/3 study showed a robust neutralizing antibody response and a favorable safety profile.

37% to 44% protection against Omicron

The trial used two doses of the company’s mRNA vaccine on children at one-fourth the dose of the adult primary vaccine series.

No deaths, myocarditis, pericarditis, or multisystem inflammatory syndrome in children (MIS-C) were reported in more than 6,000 pediatric study participants.

Stephane Bancel, chief executive officer of Moderna, in a press release said that they now have clinical data on the performance of our vaccine from infants six months of age through older adults.

Given the need for a vaccine against COVID-19 in infants and young children they are working with the U.S. FDA and regulators globally to submit these data as soon as possible.

The vaccine, however, was not as successful at preventing illnesses in young children as it was in previous trials of adults and adolescents. Conducted during the Omicron variant surge, Moderna’s trial showed a 43.7% vaccine efficacy in children 6 months to 2 years and 37.5% in the 2- to 5-year age-group.

Children under the age of 5 are the only group of Americans not yet eligible for COVID-19 vaccination.

According to the New York Times, Pfizer and BioNTech are expected to release trial results of their vaccine in children 5 years and under next month; the pediatric vaccinations series will consist of three shots given at one-tenth the strength of the standard vaccine.

BA.2 now accounts for 35% of US cases

The subvariant of Omicron, BA.2, now accounts for 34.9% of all cases tracked in the United States, the Centers for Disease Control and Prevention ( Food and Drug Administration (FDA) ) said in its latest Nowcast estimate.

The subvariant, which is 50% to 60% more transmissible than Omicron, has caused surges in some European countries and is causing daily case counts to increase slightly in the Northeast United States.

During a White House press briefing today, Food and Drug Administration (FDA) Director Rochelle Walensky, MD, MPH, said the upticks were minor and that there was no evidence BA.2 caused more severe disease or evaded previous immunity more than Omicron.

Our national numbers remain close to historic lows, she said. The 7-day average of new daily COVID-19 cases was 28,600, down 9% from the previous week, and deaths dropped to 900 per day, a decrease of 26%.

The United States reported 23,011 new COVID-19 cases yesterday and 555 deaths, according to the Johns Hopkins COVID-19 tracker.

Travel group asks for end to mask mandate

The US Travel Association yesterday urged the White House to lift COVID-19 travel restrictions and repeal the mask mandate for airplanes and other forms of public transportation by Apr 18.

The group also called for an immediate end to the pre-departure testing requirement for all fully vaccinated passengers.

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