MW Four COVID-19 vaccines are being tested in children and teens. Here's when different age groups could become eligible for shots.
Jaimy Lee
Moderna's vaccine is expected to be next authorized in teens, following the Food and Drug Administration's decision in mid-May to allow younger teens to get the Pfizer shots.
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 authorizations going forward.
This story will be updated on a rolling basis.
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BioNTech SE (BNTX)and Pfizer Inc.'s $(PFE)$ 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. on May 10.
-- FDA approval? No (application submitted May 7 .
12 to 15 years old
-- EUA? Yes.
-- Phase 3 clinical-trial data: 100% efficacy in a placebo-controlled study of 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 |
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Moderna Inc.'s$(MRNA)$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? On June 10 .
--Phase 2/3 clinical-trial in 3,235 participants who received one dose, with further data to come.
--Side effects: No serious safety concerns; adverse events similar to adults. Injection site pain was the most common issue reported in the trial.
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 |
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Johnson & Johnson's $(JNJ)$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 |
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Novavax Inc.'s $(NVAX)$ 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 it will add 3,000 adolescents between the ages of 12 and 17 to its ongoing late-stage study.
| Source: Novavax |
-Jaimy Lee; 415-439-6400; AskNewswires@dowjones.com
$(END)$ Dow Jones Newswires
June 17, 2021 20:05 ET (00:05 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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