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What we know about the COVID-19 vaccines for children under 5 years old

What we know about the COVID-19 vaccines for children under 5 years old

Here’s an overview of the path to vaccines for this age group — and why they’re stalling.

What clinical trials are underway?

Pfizer-BioNTech and Moderna are both conducting a clinical trial for children 6 months to 4 years old.

As of now, only the Pfizer vaccines are available to Americans between the ages of 5 and 17. The Centers for Disease Control and Prevention recommends that children over the age of 12 also receive a Pfizer booster dose, at least five months after their second injection.

Johnson & Johnson has not yet started testing its vaccine for children under the age of 12. (In December, the CDC and Prevention released guidelines suggesting that people prefer the mRNA vaccines over J&J’s one-time option.)

How long does it take for the vaccines to be approved?

The hope for manufacturers (and many families) is early 2022.

In a December earnings call, Pfizer executives said they expect to be able to provide data from the trial to regulators in the first half of the year. About the Moderna vaccine, Dr. Bill Hartman, who runs the company vaccine trial for children ages 6 months to 5 years at the University of Wisconsin-Madison, told CNN last month that he thinks shots could be available as early as next month.

The Pfizer Trial had a setback in mid-December when it announced that its two-dose vaccine regimen was performing poorly against the virus in preschool-age children.

The company had tested 3 micrograms of the vaccine – one-tenth the adult dose – in the subjects. After two doses, children between 6 months and 2 years did produce a protective immune response. But not children between 2 and 5.

Pfizer then changed its research to include a third dose for children 4 years and younger.

Stéphane Bancel, the CEO of Moderna, said earlier this week that the company’s data for testing on younger children threatening. But it’s unclear when a vaccine would be ready.

What’s next?

Once the regimen is adjusted to adequately protect children under the age of 5, manufacturers will be subject to an authorization process involving the Food and Drug Administration and the CDC — a path followed with every other vaccine measure last year.

The FDA will be tasked with issuing an emergency clearance. The decision will then be weighed by a CDC advisory committee and its director, Dr. Rochelle Walensky.

If passed, the fate of the vaccines will rest in the hands of the company and their ability to distribute the doses to pharmacies and clinics across the country. In the past, vaccine delivery sites were quickly filled with doses after an authorization announcement.

Are children at risk of getting COVID-19?

Children make up a small proportion of COVID cases and hospitalizations.

That being said, pediatric hospitalization According to the CDC, it is now the highest percentage since the start of the pandemic. Children under the age of 5 who do not qualify for the vaccine are most likely to be hospitalized.

“Most of these hospitalizations are because of COVID-19, although some are children admitted for other reasons but tested positive for COVID-19 when they were admitted or during their hospital stay,” the CDC wrote.

In Massachusetts, schools saw record numbers among students and staff earlier this month. State education leaders reported: 41,063 new COVID-19 cases among public school students and 7,351 cases among staff for the week ending Wednesday. The total number of cases, 48,414, represents a drop of 2,686, or about 5 percent, from the number reported last week.

Yet children are much less likely to die from the virus. they are doing all right less than 1 percent of American deaths, the CDC found.


Diti Kohli can be reached at [email protected] her on Twitter @ditikohli_.


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