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,
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.
• 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,
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,
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,
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
