Home > Business > Four COVID-19 vaccines are being tested in children and teens. Here’s when different age groups could become eligible for shots.

Four COVID-19 vaccines are being tested in children and teens. Here’s when different age groups could become eligible for shots.

226 Views

The Food and Drug Administration is expected to grant emergency-use 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 younger 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 single-dose 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.

Below is a timeline of when to expect clinical data and emergency authorization going forward.

This story will be updated on a rolling basis.

BioNTech SE
BNTX,
+9.35%

and Pfizer Inc.’s
PFE,
+1.00%

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, 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,
+1.65%

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, with Moderna having 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, with further 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-olds 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,
+0.45%

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,
+2.02%

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

Source link

TAGS , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
Hi guys, this is Kimmy, I started LicensetoBlog to help you with the latest updated news about the world with daily updates from all leading news sources. Beside, I love to write about several niches like health, business, finance, travel, automation, parenting and about other useful topics to keep you find the the original information on any particular topic. Hope you will find LicensetoBlog helpful in various ways. Keep blogging and help us grow as a community for internet lovers.