A: SOON! FDA authorization is expected *next week* for ages 12-15 in the U.S., and Canada’s regulator has already given approval.
Pfizer previously announced results from its Phase III trial in 2,260 adolescents.
➡️ There were 18 cases of COVID-19 in the trial….. ALL in the placebo group.
➡️ That’s a big fat ZERO in the vaccine group!
➡️ Neutralizing antibody levels to SARS-CoV-2 measured in the blood of vaccine recipients were as high or higher than those seen for those ages 16-25 in previous studies.
➡️ The vaccine was “well-tolerated”- side effects similar to other age groups.
Based on these results Pfizer submitted to the FDA to extend Emergency Use Authorization (EUA) and the FDA is ready to announce a decision next week, according to Federal officials.
Trials at younger ages are also on-going for the Moderna, Johnson and Johnson, and Astrazeneca vaccines.
In additional good Pfizer news:
💥 The company announced they expect to have data available from their on-going trial of children ages 2-11 by September and could submit for EUA at that time.
💥 Readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.
➡️ Something we are hearing a lot: if kids are low risk, why should they be vaccinated?
✔️ Kids are low– but not no– risk. There have been close to 300 official COVID-19 deaths in children 0-17 reported in the US, and well over 200,000 hospitalizations.
For comparison, 198 deaths in children were reported during the 2019-20 flu season (and flu vaccination is strongly recommended for this age group).
✔️ In rare cases, MIS-C, or Multisystem Inflammatory Syndrome has been seen in children after COVID-19. This is when kids get really sick and different body parts (like the lungs, heart, kidneys, brain, or gut) become inflamed and damaged. See DP post on MIS-C here.
✔️ Close to 8% of children ages 2-16 still reported COVID-19 symptoms up to 12 weeks after testing positive (in a nationally representative study in the UK with random testing).
✔️ New variants *may* cause more serious disease in the young (jury is still out), but vaccines are very effective against these variants.
✔️ Despite the rumors circulating, there is NO evidence or biological mechanism by which the vaccines affect future fertility.
✔️ Kids, especially adolescents and teens have more social contact and risk of spreading the virus. Vaccinating young people will be an important contributor to the herd immunity that will ultimately snuff out the virus and protect everyone.
➡️ Vaccinated younger people will protect both kids themselves and their communities.
➡️ The Pfizer approval is another step towards building our collective COVID-19 firewall.
Those Nerdy Girls
FDA expected to OK Pfizer vaccine for teens within week
Approval for ages 12-15 in Canada
COVID vaccines and kids: five questions as trials begin
Pfizer to seek authorization for Covid-19 vaccine for children ages 2 to 11 in September
SciMoms’ great post on vaccines and kids
COVID-19 symptoms continue after 12 weeks
Hospitalizations (through December 2020)
Claims vaccinations harm fertility unfounded: