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Lowering Age for COVID-19 Vaccine Sparked Higher Demand for Shots

If pharmacists have been especially busy administering COVID-19 vaccines in the last few weeks, after a brief lull, it likely is because they are seeing a lot more young people. Public health officials said about 2.5 million youngers in the 12-15 age group – included in the expanded emergency use authorization for the Pfizer-BioNTech vaccine– have gotten their first shot since the FDA acted on May 10. Here is more information.

ATLANTA – With more than 2 million youngsters getting shots after recently being authorized to receive COVID-19 vaccines, immunization rates are up substantially over the last few weeks, according to public health officials.

In addition, the emergency use authorization of another COVID-19 vaccine could soon be expanded to include Americans as young as 12-years-old.

Moderna Inc. announced recently that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents met its primary immunogenicity endpoint. In fact, in that study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.

Furthermore, the company announced, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary national Centers for Disease Control and Prevention (CDC) case definition of COVID-19, which tested for milder disease. The TeenCOVE study enrolled more than 3,700 participants 12 to younger than 18 years old in the United States.

The company said it plans to submit the data to regulators globally early this month. Currently, the EUA allows use of the vaccine in people as young as 18, compared to 16 the Pfizer-BioNTech mRNA vaccine.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Moderna CEO Stéphane Bancel. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”

In TeenCOVE, the mRNA-1273 vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. No significant safety concerns have been identified thus far, although, as with adults, younger vaccine recipients reported injection site pain and, in some cases after the second dose, headache, fatigue, myalgia and chills.

In May, the Food and Drug Administration authorized use of the Pfizer-BioNTech mRNA vaccines for youths as young as 12, and uptake appeared to be robust.

“Last week, FDA authorized and CDC recommended use of the Pfizer vaccine for adolescents,” CDC Director Rochelle Walensky said at a May 18 White House COVID-19 briefing. “In less than one week, we have vaccinated more than 600,000 12 to 15-year-olds. And in total, more than 4.1 million adolescents aged 12 to 17 have been vaccinated so far. My own son was one of them.”

That trend has continued, with vaccinations of 12-15-year-olds helping to reverse the trend of falling rates in April and May, according to CDC data.

By the end of May, about 2.5 million young people in that age group had been immunized against COVID-19, representing about one-fourth of new vaccinations administered.