Moderna says shot is 100% effective in teens, plans to ask FDA for OK in June

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Moderna said on Tuesday that its Covid-19 vaccine was 100% effective in a study of adolescents aged 12 to 17, making it the second move behind Pfizer to demonstrate high effectiveness in younger age groups .

The company said it plans to ask the Food and Drug Administration to expand emergency use of its Covid vaccine to adolescents early next month. If approved, it would likely significantly increase the number of plans available to middle and high school students before the next school year. Pfizer and its German partner BioNTech were cleared to use their vaccine for children ages 12 to 15 earlier this month.

“We are encouraged that mRNA-1273 has been very effective in preventing COVID-19 in adolescents,” Moderna CEO Stephane Bancel said in a press release. “We remain committed to doing our part to help end the COVID-19 pandemic.”

The two-dose vaccine, given four weeks apart, is already authorized for adults.

The Phase 2/3 study that the company cites on Tuesday included more than 3,700 adolescents. No cases of Covid were seen in participants who received two doses of the vaccine, while four cases were seen in the placebo group, according to the company.

No significant safety concerns have been identified and the side effects are generally consistent with those seen in a previous trial in adults, the company said. The most common side effects after the second dose were headache, fatigue, muscle aches and chills, Moderna said.

The new data comes less than three weeks after the company revealed in a findings report that the first data showed the vaccine was 96% effective in protecting against Covid in adolescents aged 12 to 17. These data were based on those who had received at least one dose of the vaccine.

The company said on Tuesday that the shot was found to be 93% effective after one dose. Because children are less likely to become seriously ill, Moderna used the Centers for Disease Control and Prevention’s definition of Covid-19 to calculate this number. It only requires one symptom and a positive Covid test.

US regulators are expected to accept Moderna’s request for use in adolescents. The approval process could take about a month, just in time for some summer activities and fall courses if Moderna submits the data in early June. Pfizer and BioNTech requested increased use of their injection in adolescents on April 9, for example, and were cleared by the FDA on May 10.

Immunizing children is considered essential to end the pandemic. The country is unlikely to achieve herd immunity – when a sufficient number of people in a given community have antibodies to a specific disease – until children can get vaccinated, officials say. health and experts.

Children make up about 20% of the total United States population, according to government data. According to medical experts, 70 to 85% of the US population must be vaccinated against Covid to gain herd immunity, and some adults may refuse to be vaccinated. Although more and more experts are now saying herd immunity looks increasingly unlikely as the variants spread.

Immunizing children may also speed up the return of in-person learning and the green light for after-school extracurricular activities such as sports, art and other in-person activities, according to health experts.

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