COVID-19 Vaccine For WI Children Takes Key Step Forward

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

The Wisconsin Department of Health Services is working with doctors, pediatricians and others across the state to prepare for inoculating the new population, health services spokesperson Elizabeth Goodsitt told Patch.

Moderna said on Monday that 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 12 years of age and found a robust immune response after two doses, with a "favorable safety profile."

COVID-19 cases have been a third higher in Wisconsin children over the past month compared to 2020. In the week of Oct. 11 to Oct. 18, 2020, there were 2,529 cases in people under 18. In the same week this year, there were 3,521 cases.

Moderna said it planned to submit its findings to the U.S. Food and Drug Administration, European Medicines Agency and other global regulators soon.

If the Food and Drug Administration authorizes the vaccine for young children, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will review it next, Goodsitt said.

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

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

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

Pfizer already has a COVID-19 vaccine for people 12 and older. Moderna and Johnson & Johnson vaccines have only been authorized for use in adults 18 and older.

The Pfizer vaccine is available for people 12 and older in Wisconsin, state health services said.

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

The study's findings were consistent with those of 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 a 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 over the next year to assess the long-term safety and protection, Moderna said. The Phase 2/3 portion of the study continues for children 6 months to 6 years old.

As of Tuesday morning, 65.7 percent of all Wisconsinites 18 and over were fully vaccinated.

Wisconsin's plan follows the announcement by President Joe Biden's administration last week of a vaccine rollout plan for children 5 to 11 years old.

State health services is assessing doctors and vaccinators for their readiness to serve children 5 to 11, Goodsitt said. Health services will also reinforce systems required to ensure equitable distribution of the vaccine across the state.

The Biden administration has already procured about 65 million doses of the Pfizer vaccine intended for the age group, enough to inoculate 28 million individuals, according to a statement.

The White House informed providers that the vaccine for children would be delivered to thousands of sites within a week of FDA authorization, it said.

Patch Editors Justin Heinze, Alexis Tarrazi and Anthony Bellano contributed to this story.