On interrogation Tuesday from the senator. Patty Murray (D-Wash.), FDA chief vaccine regulator Peter Marx told lawmakers that the agency plans to publish an indicative timetable next week, which will show when it plans to hold meetings of the Advisory Committee on Vaccines for Young Children – a step that could offer more a clear idea of ​​when the agency plans to authorize the filming.

“Just remember that we can’t finish our reviews until we get full applications from the FDA,” Marx told the Senate’s HELP committee. “We will act at full speed as soon as we receive full applications, some of which are complex because they cover a relatively larger proportion of the child population than others,” he added.

Moderna is also expected to receive a permit for children aged 6 to 11 soon submit an update to the Emergency Permit for Adolescents aged 12 to 17 said people aware of it, but it is unclear when they will be officially filed. Currently, the only vaccine against Covid-19, available for children aged 5-11 years, is produced by Pfizer and BioNTech.

Filing an application is likely to increase pressure on the FDA over the timing of vaccine approval, after the POLITICO report Last week, the agency discussed a postponement of the verdict until pharmaceutical company Pfizer requests permission for a competing injection.

“We recognize that parents are concerned that their young children will be vaccinated against Covid-19,” a spokesman for POLITICO said on Thursday. “While the FDA cannot predict how long it will take to evaluate its data and information, we will consider any request from the EUA that it receives as soon as possible using a science-based approach.”

Some federal regulators have privately argued that the simultaneous authorization of competing vaccines would make it easier for the agency to distribute them to the public and reduce the likelihood of confusion. Unlike Moderna, the Pfizer vaccine is a triple treatment.

But it will also likely mean waiting until June, extending the wait for the first Covid injection for millions of children and causing an unpleasant reaction from parent groups and lawmakers.

“Many families of young children are reluctant to resume their activities until the vaccine is available to their children,” Colorado Gov. Jared Polis said in an interview. “Just put the facts in front of the parents and let them make that decision.”

Criticism sparked a behind-the-scenes fight to eliminate the consequences, said two people familiar with the dynamics, and health officials discussed exactly how to proceed as soon as full Moderna documentation is presented in early May.

“Let me be very clear: being accurate does not mean that we are postponing consideration of these vaccines,” Marx said. video published by the FDA on Tuesday, stressing the importance of parents trusting any permitted vaccines. “We are going to act with all expediency, without sacrificing our standards, to complete our assessments.”

The White House, for its part, has made it clear that the decision remains solely with the FDA, people said. Some officials over the past week have even gone so far as not to discuss vaccines with FDA regulators for fear of being accused of political interference.

The application is based on evidence from clinical trials of approximately 6,700 children and requires permission to use the vaccine for children 6 months to 2 years of age and 2 years to 6 years of age.. In March, Moderna reported that two-quarters of doses of the Covid-19 vaccine elicited an immune response in children under 6 years of age, along with an immune response in young adults who received two full doses of the vaccine. Actual data collected during Omicron showed that the vaccine reduced the incidence of Covid-19 symptoms by 43.7 percent among children aged 6 to 24 months; this figure was 51 percent when the company used only PCR test data. For children aged 2 to 6, the figures were 35.7 per cent and 37 per cent respectively. These levels of protection were comparable to adult protection at the time.

Children who received the vaccine experienced mild side effects, and none of the children in the study developed a severe form of Covid-19.

The FDA originally told vaccine manufacturers that their products should reduce the incidence of Covid symptoms by 50 percent for adults. For children or other groups that are more difficult to study in large numbers, the agency has issued instructions stating that this will allow manufacturers to use a metric called immunomoddingwhich compares the immune response created by vaccines.



https://www.politico.com/news/2022/04/27/moderna-authorize-covid-19-vaccine-kids-00028481

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