FDA authorizes COVID vaccines for kids under 5

The FDA extended emergency use authorization for Pfizer and Moderna’s COVID-19 vaccines to children 6 months and older. Here’s what parents should know.

The U.S. Food and Drug Administration granted emergency use authorization for the first COVID-19 vaccine for people ages 16 and older in December 2020.

Eligibility has since expanded to other age groups, including some young children, but those under the age of 5 have so far been unable to get vaccinated. The conversation on social media has recently turned to the availability of vaccines for children as young as 6 months.

THE QUESTION

Has the FDA Approved COVID-19 Vaccines for Children 6 Months and Older?

THE SOURCES

THE ANSWER

This is true.

Yes, the FDA has approved COVID-19 vaccines for children 6 months and older.

WHAT WE FOUND

On Friday, June 17, the FDA extended emergency use approval for Pfizer and Moderna’s COVID-19 vaccines to children ages 6 months and older.

Centers for Disease Control and Prevention (CDC) director Rochelle Walensky, MD, later endorsed the recommendation that all children ages 6 months to 5 years should get a COVID-19 vaccine, bringing eligibility to nearly 20 million additional children was expanded.

Pfizer’s vaccine was previously approved for people ages 5 and older, while Moderna’s vaccine was approved for use in adults 18 and older.

“As we have seen with older age groups, we expect that younger children’s vaccines will provide protection against the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, MD, in a statement.

The FDA says children’s immune response to the vaccines is “comparable to the immune response of adults.”

The Pfizer vaccine for children aged 6 months to 4 years is given as a primary series of three doses. The first two doses are given three weeks apart, followed by a third dose at least eight weeks after the second, according to the FDA.

In a clinical study of 4,526 children aged 6 months to 4 years, children received the third dose of the COVID-19 vaccine at least two months after the second when the Omicron variant was predominant. The vaccine elicited a “strong immune response” in this age group after a third dose, Pfizer said.

Moderna’s vaccine is given to people aged 6 months to 17 years as a primary series of two doses, one month apart. Some immunocompromised people in this age group may receive a third baseline dose at least a month after the second, the FDA says.

The CDC says everyone ages 5 and older should receive a COVID-19 vaccine booster at least five months after completing their primary vaccination course. Booster shots are not currently approved for children under 5 years of age.

RELATED: VERIFY Fact Sheet: COVID-19 Booster Shots

Ashish Jha, MD, the White House coronavirus response coordinator, said children under the age of 5 could start vaccination as early as June 21. The federal government’s online vaccine finder can show parents where vaccinations are available for their children.

Are infant doses the same as adults?

The vaccine doses for children are not the same as for adults.

Each of the three doses of Pfizer’s vaccine given to children under the age of 5 is three micrograms, compared to 10 microgram doses for children ages 5 to 11 and 30 microgram doses or those 12 and older.

For the Moderna vaccine, children under the age of 6 will receive two doses of 25 micrograms and children aged 6 to 12 will receive two doses of 50 micrograms. People 12 years and older will receive two 100 microgram doses in their first vaccination series.

Should my child be vaccinated if they already have COVID-19?

A CDC study found that as of late February 2022, 75% of children already had COVID-19. But the public health agency and other medical experts say children should still get the vaccine, even if they already have the virus.

“It’s the same response as in adults,” said Dr. Leslie Sude, pediatrician at Yale Medicine. “The immunity we get from natural infection has some benefits that vaccine immunity cannot provide, and the reverse is also true. There is evidence that hybrid immunity, or natural infection combined with vaccination, may be the best form of immunity. But measuring hybrid immunity is complex and much is still unknown – for example how long hybrid immunity lasts.”

RELATED: Key context omitted from claims of natural immunity to COVID-19 after CDC study was released

The CDC says people should wait until they have recovered from COVID-19 and completed their isolation phase before getting vaccinated. People should isolate themselves for five days if they don’t have symptoms or if their symptoms go away.

People who have recently had COVID-19 may consider postponing their next vaccine by 3 months after their symptoms start, or when they first test positive for those who have not had symptoms, the health agency said.

“Reinfection is less likely in the weeks to months after infection. However, certain factors, such as personal risk of serious illness, the level of the local COVID-19 community, and the most common COVID-19 variant currently causing disease, could be reasons to get a vaccine sooner rather than later.” , says the CDC.

RELATED: Yes, the CDC has changed its definition of a vaccine to be more “transparent.”

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