In keeping with Moderna, the shot is 100% efficient in youngsters and plans to repair the FDA in June
A young man receives his Covid-19 vaccination in a vaccination clinic. People are receiving the Moderna vaccine in Milford, Pennsylvania.
Preston Ehrler | LightRocket | Getty Images
Moderna said Tuesday that its Covid-19 vaccine was 100% effective in a study in adolescents ages 12 to 17. This makes it the second attempt after Pfizer that has demonstrated a high level of effectiveness in younger age groups.
The company plans to ask the Food and Drug Administration to expand emergency use of its Covid vaccine to teenagers early next month. If approved, it would likely dramatically increase the number of recordings available to middle and high school students before the next school year. Pfizer and German partner BioNTech were approved to use their vaccine for 12 to 15 year olds earlier this month.
“We are encouraged that mRNA-1273 is highly effective in preventing COVID-19 in adolescents,” said Stephane Bancel, CEO of Moderna, in a press release. “We continue to strive to do our part to end the COVID-19 pandemic.”
The two-dose vaccine, given four weeks apart, is already approved for adults.
The phase 2/3 study the company cited on Tuesday included more than 3,700 teenagers. No cases of Covid were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, according to the company.
No significant safety concerns were identified, and the side effects are generally consistent with those seen in a previous adult study, the company said. The most common side effects after the second dose were headache, fatigue, muscle pain, and chills, Moderna said.
The new data comes less than three weeks after the company announced in an earnings report that early data showed the shot was 96% effective against Covid in teens ages 12-17. These data were based on those who had received at least one dose of the vaccine.
The company said Tuesday that the shot in the study was 93% effective after one dose. For this it used the definition of Covid-19 from the Centers for Disease Control and Prevention, which only requires one symptom and a positive Covid test.
US regulators are expected to approve Moderna’s application for teenage use. The approval process could take about a month, in time for some summer activities and fall courses, if Moderna delivers the dates by early June. Pfizer and BioNTech, for example, filed for expanded use of their shot in teenagers on April 9th and were approved by the FDA on May 10th.
Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.
According to the government, children make up around 20% of the total US population. According to medical experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity, and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.
According to health experts, vaccinating children can also accelerate the return of personal learning and enable after-school activities such as sports, arts, and other personal activities after school.