The status of COVID vaccine authorization for kids

The CDC has released a guide saying states can begin ordering COVID-19 shots intended for children younger than 12 on Oct. 20, but the FDA and CDC have yet to authorize any vaccine for use in children under 12. Only Pfizer's vaccine is authorized for use in people under age 18. 

Here is a breakdown of where each COVID-19 vaccine stands when it comes to authorization for use in children: 

Pfizer

Pfizer submitted to the FDA an emergency authorization request for use of its COVID-19 vaccine in children ages 5 to 11 on Oct. 7. 

The FDA's vaccine advisory committee, called the Vaccines and Related Biological Products Advisory Committee, has scheduled a meeting Oct. 26 to review Pfizer's request. 

The CDC's Advisory Committee on Immunization Practices has scheduled meetings on Nov. 2 and Nov. 3 to discuss pediatric COVID-19 vaccines. 

Pfizer released data in September showing that its vaccine demonstrated "favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age" in a trial that included 2,268 children. The dosage for children under 11 would be a third of the dosage of the vaccine for everyone older than 12. 

Pfizer submitted an emergency use authorization request to the FDA for use of its vaccine in kids as young as 12 on April 9, and the request was granted May 10. 

Moderna

Moderna filed an emergency use authorization request for its COVID-19 vaccine in kids as young as 12 in June, but the FDA has yet to make a decision. The vaccine is currently authorized only for people ages 18 and older. 

Sources familiar with the matter told The Wall Street Journal Oct. 15 that the FDA has delayed making a decision on Moderna's shot for kids as young as 12 so it can assess whether the shot could increase the risk of myocarditis, a rare inflammatory heart condition. 

The FDA hasn't made a public comment on the status of its decision for Moderna's vaccine in children, but said in a Sept. 10 statement that it is "working around the clock" to get COVID-19 vaccines available for young children. 

Moderna said in May that its vaccine was 100 percent effective at preventing symptomatic COVID-19 in kids ages 12 to 17.  

Johnson & Johnson

Johnson & Johnson launched a trial testing its COVID-19 vaccine in adolescents in April. The drugmaker said it would begin vaccinating kids ages 16 and 17 before expanding to include younger children. 

Johnson & Johnson has announced plans for four clinical trials testing its vaccine in adolescents. The first will test the vaccine in kids ages 12 to 17; another will test the shot in kids ages 2 to 11; the third will test it in kids younger than 2; and the fourth will test it in immunocompromised children ages 1 to 17. 

The drugmaker said it plans to enroll at least 4,500 people across the four studies, but it hasn't released a timeline on when the trial results will be published or when it expects to file for authorization from the FDA.

 

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