FDA asks Covid-19 vaccine makers to increase number of children in testing



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The Food and Drug Administration has increased the minimum number of young children who should participate in Covid-19 vaccine trials to better detect side effects, people familiar with the matter said.

One of the main reasons for the change, said one of the people, was to look for side effects such as the rare heart disease known as myocarditis which surfaced in a small number of people who took any of the messenger RNA vaccines after authorization.

The FDA recently asked Pfizer Inc.

and Moderna Inc.

to increase the size of their studies in children aged 5 to 11 to at least 3,000, from 1,000, said people familiar with the request.

The New York Times reported the change earlier on Monday.

“While we cannot comment on individual interactions with sponsors, we generally work with sponsors to ensure that the number of clinical trial participants is of sufficient size to detect safety signals,” a door said. -fda speech.

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The Covid-19 vaccine from Pfizer and its partner BioNTech SE is licensed for use in children as young as 12 years old, while Moderna’s vaccine is licensed for those 18 and over.

Both injections, which use new gene-based messenger RNA technology, are being tested in younger people.

Moderna said it was expanding its vaccine trial for children aged six months to 12 years to increase the chances of finding rarer results in recipients. The trial began in March with the goal of recruiting 6,750 subjects, and the company will now increase that target, a company spokesperson said.

Moderna expects to be able to seek emergency clearance for her shooting in young children at the end of this year or early next year, the spokesperson said. “The goal is to register a larger safety database, which increases the likelihood of detecting rarer events,” she said.

Pfizer said it expects results and asked the FDA to allow its vaccine for use in children five to 12 years old in September.

The company is also studying shooting in children six months to five years old and said it expects results and submission for this age group in the fourth quarter.

Pfizer began testing the vaccine in children aged 5 to 11 on June 8, with children under 5 included from June 21, according to a company spokesperson. The study will involve up to 4,500 subjects from the United States, Finland, Poland and Spain.

The company declined to say whether the recent FDA request would change the timing of clearance applications.

The risk of myocarditis, although very low, has been a source of concern for some parents who are considering whether to vaccinate their teenagers.

Health officials have received reports of inflammatory heart disease after the authorization of the messenger RNA vaccines. The rare side effect was not reported in testing.

Young people, especially young men, are at increased risk for myocarditis, although it is extremely rare, according to the United States Centers for Disease Control and Prevention.

For every million boys aged 12 to 17 who received two doses of a Covid-19 vaccine, there have been about 67 cases of myocarditis, according to data released in June by the CDC. The rate among girls of the same age was nine per million.

None of the cases of myocarditis resulted in death, according to the CDC, and most were mild and resolved quickly. Health experts advising the CDC said the benefits of the vaccination outweigh the risk of myocarditis.

Write to Felicia Schwartz at [email protected], Thomas M. Burton at [email protected] and Jared S. Hopkins at [email protected]

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