In teens, the Moderna COVID-19 vaccine was shown to be ‘safe and effective'

In a clinical trial, Moderna's COVID-19 vaccine was demonstrated to be successful in adolescents aged 12 to 17, with no new or serious safety issues, the company said on Tuesday, potentially paving the way for a second vaccine for school-aged youngsters to be approved in July.

In teens, the Moderna COVID-19 vaccine was shown to be ‘safe and effective.'

Moderna said it will submit the findings of its teen research to the US Food and Drug Administration and other regulators for emergency use authorisation in early June. The vaccine is approved for adults 18 and older.

A similar study from Pfizer/BioNtech, which was approved for ages 12-15 on May 10, took about a month to evaluate by US regulators. If Moderna receives the same treatment, it will be approved in early July.

The majority of children with COVID-19 experience relatively minor symptoms or none at all. Children, on the other hand, are still at risk of becoming extremely ill and of spreading the infection. By vaccinating all 12- to 18-year-olds, schools and summer camps in the United States may be able to relax the masking and social distancing precautions recommended by the CDC.

Moderna's chief executive, Stéphane Bancel, said in a statement, "We are encouraged that mRNA-1273 proved highly efficient at avoiding COVID-19 in teenagers."

The vaccination was tested in 3,732 teenagers aged 12 to 17, two-thirds of whom received the vaccine and one-third of whom received a placebo. The major goal was to elicit an immunological response similar to that shown in the company's major, Phase 3 trial in adults, which showed COVID-19 prevention to be 94.1 percent successful.

Based on case definitions from the company's adult trial, researchers detected no cases of COVID-19 in the vaccine group two weeks after the second dose, compared to four cases in the placebo group, resulting in a vaccine efficacy of 100 percent.

The vaccine was proven to be 93 percent effective using a case definition from the US Centers for Disease Control and Prevention that only required one COVID-19 symptom, implying that the vaccine may be protective against instances with weaker symptoms, according to the company.

There were no new safety concerns discovered by the researchers. Headache, weariness, body aches, and chills were the most common side effects following the second dose.

The business stated that it is still gathering safety information. After their second treatment, all trial participants will be observed for 12 months to determine long-term protection and safety.

Moderna intends to publish the data in a peer-reviewed journal. The vaccination is currently being tested in youngsters as young as six months old.

Pfizer's vaccine is also approved for use in younger teens aged 12 to 15 in Canada and Algeria, in addition to the United States.

Post a Comment