COVID Vaccine For PA Children Takes Key Step Forward

PENNSYLVANIA — The Moderna COVID-19 vaccine has shown positive and safe results in trials for children ages 6 to 11, the company announced Monday, reinforcing previously stated estimates that vaccines may be approved for that age group in November.

The Pennsylvania Department of Health has said that they have made preparations to widely distribute the vaccine as soon as federal approval is granted.

On Monday, Moderna said it saw positive interim data from its Phase 2/3 KidCOVE study. The trial analyzed the vaccine in 4,753 participants who were 6 to less than 12 years of age, and found the body produced a robust immune response after 2 doses, with a “favorable safety profile.”

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The news comes as COVID-19 cases continue to spike among schoolchildren. Compared to this point in 2020, cases have been between 6 and 10 times higher in Pennsylvania children over the past several weeks. During the week of Oct. 13 to Oct. 19 of 2020, there were 1,052 cases in schoolchildren; during the same week this year, there were 5,877 cases.

Moderna said it plans to submit its findings to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators soon.

The FDA is set to review Pfizer’s request for emergency use authorization for their COVID-19 vaccine for children ages 5 to 12 on Tuesday.

If approved, top U.S. infectious disease expert Dr. Anthony Fauci told ABC’s This Week that the COVID-19 vaccine would likely become available for children ages 5 to 12 in the first two weeks of November.

The FDA said late last week that Pfizer’s vaccine appears to be highly effective in preventing symptomatic infections in elementary school-aged children, according to The Associated Press.

Pfizer already has a COVID-19 vaccine for ages 12-and-up. Moderna and Johnson & Johnson have only been authorized for use by adults ages 18-and-up.

The Pfizer vaccine is already available for ages 12-and-up in Pennsylvania.

In the Moderna study, two 50-microgram doses of the vaccine were given to children 28 days apart. The doses are smaller than the 100-microgram doses adults receive.

The study’s findings were consistent with those found in the Phase 3 study for adolescents and adults, the company said.

“The majority of adverse events were mild or moderate in severity,” Moderna officials said in the statement. “The most common solicited adverse events were fatigue, headache, fever, and injection site pain.”

An independent safety monitoring committee will continue to monitor the study, with participants being monitored over the next year to assess their long-term safety and protection, Moderna said. The Phase 2/3 portion of the study continues for children ages 6 months to under 6 years old.

As of Monday morning, 71.8 percent of all Pennsylvanians 18 and over have been fully vaccinated.

Pennsylvania's plan follows the Biden administration's announcement last week of its vaccine rollout plan for children in the 5-to-11-year-old age group.

School districts in Pennsylvania have already been told by state officials to work with vaccine providers to schedule clinics at local schools. Vaccine providers have been ordered by the Department of Health to cooperate.

65 million doses of the Pfizer vaccine intended for the age group — a total amount enough to inoculate 28 million individuals — have already been procured by the Biden administration, according to a statement.

The White House also added that it informed providers that, within a week of FDA approval, the vaccine (packaged in 10-dose vials in cartons of 10 vials each, delivered in a "newly updated product shipper") would be delivered to thousands of sites.

With reporting by Alexis Tarrazi and Anthony Bellano