3 yıl önce

Moderna: Covid-19 vaccine highly effective for 12 to 17-year-olds

Drugmaker says it will submit findings of its adolescent study to US regulators for emergency use authorisation in early June.

AFP

In this April 20, 2021 file photo Moderna vials sit on a table before they are loaded into syringes at a mobile Covid-19 vaccination clinic in Bridgeport, Connecticut.

Moderna's Covid-19 vaccine has been shown to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial, the developer has said, potentially setting the stage for a second vaccine for school-aged children to be authorised in July.

Moderna Inc, whose vaccine is authorised for adults 18 and older, said it will submit the findings of its adolescent study to the US Food and Drug Administration and other regulators for emergency use authorisation in early June.

US regulators took about a month to review a similar study from Pfizer/BioNtech, which was authorised for ages 12-15 on May 10.

If Moderna gets the same treatment, its authorisation would come in early July.

Most children with Covid-19 develop only mild symptoms or no symptoms.

Yet children remain at risk of becoming seriously ill, and they can spread the virus.

Widely vaccinating 12- to 18-year olds could allow US schools and summer camps to relax masking and social distancing measures suggested by the CDC.

“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents," Stephane Bancel, Moderna's chief executive, said in a statement.

Moderna's trial evaluated the vaccine in 3,732 adolescents aged 12 to 17, two thirds of whom got the vaccine and one third of whom got a placebo.

The main goal was to produce an immune response on par with that seen in the company's large, Phase 3 trial in adults, which was 94.1 percent effective at preventing Covid-19.

We just announced that the Phase 2/3 study of our COVID-19 vaccine in adolescents has met its primary immunogenicity endpoint. In the study, no cases of COVID-19 were observed in participants who had received 2 doses of the vaccine: https://t.co/SHTokbDhKR pic.twitter.com/rqHEfmi9s9
— Moderna (@moderna_tx) May 25, 2021

Two weeks after the second dose, researchers found no cases of Covid-19 in the vaccine group compared to 4 cases in the placebo group, resulting in a vaccine efficacy of 100 percent, based on case definitions from the company's adult trial.

Using a case definition from the US Centers for Disease Control and Prevention, which requires only 1 Covid-19 symptom, the vaccine was found to be 93 percent effective, suggesting the vaccine may be protective against cases with milder symptoms, the company said.

The researchers found no new safety issues.

The most common side effects after the second dose were headache, fatigue, body aches and chills.

The company said it is still accumulating safety data.

All study participants will be monitored for 12 months after their second dose to determine long-term protection and safety.

Moderna said it plans to submit the data to a peer-reviewed publication.

Jab being tested on 6-month-olds

The company is currently testing its vaccine on children as young as 6 months of age.

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