The vaccine against coronavirus de Moderna was shown to be effective in teens ages 12 to 17 and showed no new or major safety concerns in a clinical trial, the firm said Tuesday, which could set the stage for a second inoculation of school-age children to be authorized. in July.

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Modern, whose vaccine is licensed for adults 18 and older, said it will present the findings of its adolescent study to the U.S. Food and Drug Administration (FDA). USA and other regulators for emergency use authorization in early June.

It took US regulators about a month to review a similar study from Pfizer / BioNtech, which was licensed for ages 12-15 on May 10. Yes Modern receives the same treatment, his authorization would arrive at the beginning of July.

Most children with COVID-19 they develop only mild or no symptoms but are at risk of becoming seriously ill and can transmit the virus. Widely vaccinating youth ages 12 to 18 could allow America’s schools and summer camps to relax the CDC’s suggested mask use and social distancing measures.

We are encouraged that mRNA-1273 was very effective in preventing COVID-19 in adolescents.”Said Stéphane Bancel, Moderna’s CEO, in a statement.

The essay of Modern evaluated the vaccine in 3,732 adolescents between the ages of 12 and 17, two-thirds of whom received the vaccine and one-third a placebo. The primary 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% effective in preventing COVID-19.

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

Using a case definition from the Centers for Disease Control and Prevention from USA, which requires only one symptom of COVID-19, the vaccine was found to be 93% effective, suggesting it may protect against cases with milder symptoms, the company said.

The researchers found no new security problems. The most common side effects after the second dose were headache, fatigue, body aches, and chills.

The company indicated that it is still accumulating safety data. All study participants will be observed for 12 months after their second dose to determine long-term protection and safety.

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Modern said it plans to submit the data to a peer-reviewed publication. The company is currently testing its vaccine in children up to 6 months of age.

Besides in USA, the Pfizer vaccine is also licensed for use in adolescents 12-15 years of age in Canada and Algeria.



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