Four COVID-19 vaccines are being tested in children and teens. Here’s when to expect a shot for different age groups

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The Food and Drug Administration is expected to grant emergency authorization to Pfizer’s COVID-19 vaccine for 12 to 15-year-olds within the week. If that occurs, it will be the first shot authorized for this group of teens.

There are three COVID-19 vaccines authorized in the U.S., primarily for adults. They are BioNTech and Pfizer’s shots, Moderna Inc.’s COVID-19 vaccine, and the Johnson & Johnson jab. All of those companies, along with Novavax Inc., which has not yet received authorization for its COVID-19 vaccine, have started to test their shots in teens and children.

Here is a timeline on when to expect clinical data and emergency authorization going forward. (This story will be updated on a rolling basis.)

BioNTech SE
BNTX,
+9.13%
and Pfizer Inc.’s
PFE,
+0.17%
COVID-19 vaccine

Type of vaccine: mRNA, two doses spaced three weeks apart

FDA emergency-use authorization: 16 years old and older, as of Dec. 11, 2020 

FDA approval? No (Application submitted May 7)

12 to 15 years old

Submitted application to the FDA for expanded EUA? Yes

Phase 3 clinical-trial data: 100% efficacy in 2,260 teens who have had or not had COVID-19

Side effects: They are similar to the study testing the vaccine in people between the ages of 16 and 25 years old, according to Pfizer

5 to 11 years old

EUA? Expected to be submitted in mid-September

• Clinical-trial data: Expected in mid-September

2 to 5 years old

• EUA? Expected to be submitted in mid-September

• Clinical-trial data: Expected in mid-September

6 months to 2 years old

EUA? Expected submission to FDA in late November

• Clinical-trial data: Expected in early November

Source: Pfizer

Moderna Inc.’s
MRNA,
+2.66%
COVID-19 vaccine

• Type of vaccine: mRNA, two doses, spaced four weeks apart

FDA emergency-use authorization: 18 years old and older, as of Dec. 18, 2020

FDA approval? No

12 to 17 years old

Submitted application to the FDA for expanded EUA? Not yet. Moderna said in May it is “in discussions” with regulators about an amended authorization.

Phase 2/3 clinical-trial data: initial 96% efficacy in 3,235 participants who received one dose; more data to come

Side effects: no serious safety concerns; adverse events similar to adults

6 months to 11 years old

EUA? No

Phase 2/3 clinical trial: 6,750 participants being enrolled; ongoing. This study has two parts and will evaluate three smaller doses for 6 month to 2-year-olds and two different dose levels for 2 year-olds to 11 year-olds. The trial will then evaluate a selected dose for each age group against a placebo.

Source: Moderna

Johnson & Johnson’s
JNJ,
+0.39%
COVID-19 vaccine

• Type of vaccine: adenovirus vector-based, one dose

FDA emergency-use authorization: 18 years old and older, as of Feb. 27, 2021

FDA approval? No

12 to 17 years old

Submitted application to the FDA for expanded EUA? No

Phase 2 clinical trial: J&J said in April that it had started to enroll teens in the ongoing Phase 2a clinical study assessing its COVID-19 shot. It has not said how many teens are enrolled in the study, only that the shot is being tested in a small group of adolescents before it is expanded to a large group.

Source: Johnson & Johnson

Novavax Inc.’s
NVAX,
+2.67%
experimental COVID-19 vaccine

Type of vaccine: recombinant protein, two doses, three weeks apart

FDA emergency-use authorization: no

• FDA approval: no

12 to 17 years old

Submitted application to the FDA for expanded EUA? No

Phase 3 clinical trial: Novavax said May 3 it will add 3,000 adolescents between the ages of 12 and 17 to its ongoing late-stage study.

Source: Novavax



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