With the Food and Drug Administration expected to authorize the Pfizer-BioNTech COVID-19 vaccine for adolescents 12 to 15 years old sometime next week, here’s a look at what’s coming up next:
The Booster Shot
Both Pfizer and Moderna say a booster shot will be needed within 12 months of your initial vaccination, despite some health experts suggesting a high protection rate after six months and the significant immune response make it unlikely a third dose would be needed so quickly. Pfizer expects to apply for an Emergency Use Authorization from the Food and Drug Administration in July that would protect against COVID variants.
Pfizer, Moderna Study COVID Vaccine in Kids as Young as 6 Months
Pfizer started a 2.5-year trial in late March with more than 4,600 participants to determine, in Phase 1, an appropriate vaccine dosage for three age groups:
- 6 months to 1 year old.
- 2 to 4 years old.
- 5 to 11 years old.
A Phase 2 and 3 placebo-controlled trial will include 450 randomized participants from each age group.
Pfizer said it will seek an Emergency Use Authorization for its vaccine for use in toddlers (ages 1 to 3) and younger children in September and infants (birth to 1 year old) in November.
Moderna, meanwhile, began a similar randomized, placebo-controlled trial in mid-March with more than 6,700 participants as young as 6 months that will last two years.
Why is it important for the under-18 population if it represents only 0.1 percent of COVID-19 deaths? That same population accounts for 12 percent of all cases. The trials will determine what, if any, vaccine side effects this age group will experience. A child’s immune system, still developing, is not comparable to an adult’s immune system.
Pfizer To File for Full FDA Approval of Vaccine: What It Means
Pfizer said Tuesday it would seek full approval of its vaccine, developed with BioNTech, by the end of the month. This would allow Pfizer, which hopes to deliver 300 million doses by the end of July, to market the vaccine directly to consumers. The vaccine has been available through the FDA’s Emergency Use Authorization, a conditional approval based on two months of data, sidestepping FDA protocols that usually take at least a year to determine if a drug is safe and effective for public use.
“There are very good reasons to get the vaccine,” says Keith Grant, APRN, Hartford HealthCare’s Senior Director of Infection Prevention. “What we saw in the trials are consistent with what we’re seeing in the real world, in the operational world. So after hundreds of millions of vaccines being given, it’s still safe and very effective.”