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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.)
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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
• 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
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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? 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
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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: 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
