FDA advisers vote to recommend Moderna Covid EUA vaccine for children 6-17 years old

Moderna vaccine effectiveness ranged from about 77 percent in children from 6 to 11 to 93 percent of 12-17 year olds. But those studies were conducted where the Delta and Alpha strain variants, respectively, were prominent, raising questions about how the main two-dimensional series works against Omicron.

Committee members have called on state health officials to discuss the benefits of the third dose – which has not yet been considered by the parties in connection with the modern shooting – in protecting the recipients from the devastating effects of Omicron and its subordinates.

The Advisory Committee will consider the Moderna vaccine for children aged 6 to 5 months, a dose of 25 micrograms, on Wednesday with Pfizer-BioNTech’s request for vaccination for children under 5 years.

The FDA is not required to follow its recommendations to advisory committees, but usually does. If the FDA approves the shooting this week, an independent advisory team from the Centers for Disease Control and Prevention may consider authorizing its administration during meetings on Friday and Saturday.

It is unknown at this time what he will do after leaving the post.

Only 29 percent of US children aged 5 to 11 are completely vaccinated against Covid, compared to nearly 56 percent of 12- to 15-year-olds and 67 percent of 16- and 16-year-olds -17 years old, according to CDC data ending April 30..

Asked how the product could help improve vaccination, Rituparna Das, vice president of modern development at the clinic, said the company was in contact with pediatricians and other policy managers to answer questions.

“I think the aim would be for all of us to increase access to the vaccine, but I can’t predict what the authorization will do exactly,” he said.

A recent poll by the Kaiser Family Foundation recommends about 20 percent of parents eager to vaccinate their children under 5 as soon as they are approved, while about 40 percent plan to “wait and see” how the vaccine works in other children and another 40 percent are reluctant to vaccinate. at all.

No cases of myocarditis or pericarditis – inflammation of the heart tissue or membranes, respectively – have been reported in Moderna pediatric trials. Both of these conditions are a known risk factor for Covid-19 enzyme RNA vaccines, especially for males 12 to 39 years of age.

Data from international vaccine safety monitoring programs have suggested that higher heart rates occur after being vaccinated with Moderna vaccines than with Pfizer-BioNTech’s. That information, along with the discovery of Pfizer’s youth policy, prompted the FDA to eventually drop out of the EUA and then for children aged 12 to 17, the organization said in a forum statement.

But analyzing US data on active and inactive surveillance programs conducted in April and May “does not support differences in the risk of myocarditis / pericarditis [Moderna] as compared [Pfizer-BioNTech] or suggest small differences due to uncertainty, ”says the FDA, which later called the evidence for risk differences between the two products“ flawless. ”

Committee members signed to continue to worry about the negative impact but agree with the FDA that the apparent risk difference between the Moderna and Pfizer policy is still unclear.

FDA advisers vote to recommend Moderna Covid EUA vaccine for children 6-17 years old

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