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When can children under 12 get the COVID-19 vaccine?  What parents need to know

Some 28 million American children between the ages of 5 and 11 may soon receive their first doses of Pfizer Covid-19 vaccine. A panel of Food and Drug Administration external vaccine advisors voted Tuesday to support shooting authorization for children as young as 5 years old, and the final steps are only a few days away.

The first injections of the smaller doses of Pfizer formulated for children could be given as early as Wednesday, November 3.

But first, the shot must clear three other key regulatory hurdles at the FDA and the Centers for Disease Control and Prevention before it can be deployed to young children:

  • This week, the FDA is expected to issue an emergency use authorization for the injections.

  • Next, the CDC’s own group of external vaccine advisers are due to meet on Tuesday to discuss the COVID-19 vaccine for children.

  • Finally, the director of the CDC must formally issue directives adopting the recommendations of the committee.

Here’s what we know from the rest:

CDC could restrict shooting eligibility

When asked if the benefits “outweigh its risks of use” in children as young as 5 years old, the FDA’s external vaccine advisers voted in favor of extending the vaccine. emergency authorization for pediatric injections of Pfizer, with one abstention. However, some expressed reservations.

Several FDA advisers have said they hope their counterparts on the CDC’s external expert panel, the Advisory Committee on Immunization Practices, will further refine or reduce eligibility for injections.

“I think we need to monitor the safety profile of this vaccine very carefully in the future, if ACIP recommends it, and hopefully it will be for children who have other risk factors,” he said. said Dr. Cody Messiner, one of the FDA officials. advisers.

The expert panel’s decision came after a day-long meeting weighing the risks of rare side effects like myocarditis and pericarditis, types of heart inflammation that have been seen in most young men receiving the vaccines. based on mRNAs manufactured by Pfizer and Moderna. People with the side effect are usually hospitalized, but often feel better within a day.

FDA advisers agreed it was clear that many children need to be vaccinated, especially those at high risk for severe COVID-19 due to exposure or underlying conditions. Widespread vaccination could also help curb transmission of the virus in schools, minimizing disruptive closings and the risk of new outbreaks of a disease that has disproportionately impacted families of color.

But some committee members expressed concern over the uncertainty over the vaccine’s benefits for healthy children who had already recovered from a COVID-19 crisis. Data presented to the panel by the CDC suggests that more than 40% of children in the United States may have antibodies to the virus from a previous infection.

“I want to make sure that the kids who really need this vaccine, mainly the black and brown kids in our country, get the vaccine. But to be honest, the best way to protect some children’s health would be to do nothing. do all of them, because they’re going to be doing great, ”said Dr. James Hildreth, one of the FDA advisers.

FDA is expected to “authorize”, not “approve” the shots

Some FDA advisers said at Tuesday’s meeting they were “torn” by the decision, caught between a desire for access for high-risk children who urgently need vaccines and concern about the ability to sweep post-authorization vaccine requirements.

Dr Peter Marks, the FDA’s top vaccine official, sought to “reassure” the panel that he thought schools were unlikely to impose warrants because the agency was only considering one. emergency use authorization – not full approval – for the vaccine.

“In general, people didn’t do warrants with emergency use authorizations. And there are some governors who have already announced that they won’t be doing warrants until there is had approval, as opposed to emergency use authorization, ”Marks said.

This includes California Governor Gavin Newsom, who announced plans to require the vaccine for schoolchildren only after obtaining full approval.

So far, the first two doses of Pfizer’s COVID-19 vaccine for Americans 16 and older have has obtained formal FDA approval to treat. Adolescents from 12 to 15 years old can receive it under emergency use authorization. Other vaccine brands and regimens, including Pfizer’s vaccine booster shots, have only been granted emergency use approval.

Obtaining a full license is a rigorous process that can take months, from resolving potential issues reported during thorough inspections of manufacturing sites to triple-checking data collected during clinical trials.

The FDA is also expected to analyze data from real-world vaccine use to inform its approval decision, particularly on the unanswered questions regarding the measurement of the vaccine’s rare side effects and its ability to curb the spread of the vaccine. sickness.

The rates of myocarditis and pericarditis in young children were probably too low to be accurately assessed in clinical trials, Pfizer and the FDA said, but data from adolescents suggests they may be even rarer in ages 5 to 11 years old. Pfizer’s decision to reduce its children’s dose size to 10 micrograms could also reduce the risk, the company said.

“The safety monitoring of this vaccine will continue. It has actually been quite intense, with a small army of people very committed to this area, and they will continue to do so,” Marks said, describing her as “one. of our greatest responsibilities “.

Millions of doses will be shipped immediately after FDA clearance

From local health departments to the Biden administration, officials have been preparing for months for the possibility that Pfizer’s vaccine for young children will soon be licensed and recommended.

Unlike the 30 microgram doses that have been approved for Americans 12 years and older, Pfizer has developed a new formulation for young children at a lower dose of 10 micrograms.

While the vaccine’s “active ingredient” remains the same, Pfizer says it has altered the vaccine’s “buffer” to extend its shelf life in pediatrician refrigerators. The drug maker will also pack the vial in different colors to avoid confusion with full strength doses, and has a new procedure for preparing the injections that will make it easier to prepare the doses.

The first orders for Pfizer’s new pediatric vaccine have already been placed, according to White House officials, with millions of doses ready to ship immediately after the injections are cleared by the FDA.

Under federal supply agreements, vaccinators will still have to wait until the CDC officially recommends the use of vaccines before they can administer them. This decision could be made after Tuesday’s meeting.

“Ultimately, we will be ready immediately following FDA and CDC decisions so parents can get their children immunized quickly, easily and conveniently,” Jeff Zients, the COVID-19 czar of the House, told reporters. White.

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