F.D.A. advisers recommend that the agency authorize vax for 6 mos - 4/5 yr olds

[hpjet]

"Outside advisers [VRBPAC] to the Food and Drug Administration voted unanimously on Wednesday to recommend that the agency authorize the Moderna and Pfizer-BioNTech coronavirus vaccines for very young children. ...Pfizer’s three-dose vaccine would cover children 6 months through 4 years old, while Moderna two-dose vaccine would be for children 6 months through 5 years old."
https://www.nytimes.com/2022/06/15/us/politics/covid-vaccine-kids-fda.html

[hpjet]

Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting brief June 15, 2022
https://www.fda.gov/media/159195/download

Briefing begins with general post-EUA Pfizer vaccine efficacy and safety information

Post-EUA Pfizer Vaccine efficacy against Omicron:
Adults - 8.8% at Week 25+
Children Age: 12 - 15 year olds after dose 2:
            59.9% during month 1
            16.6% during month 2
              9.6% during month 3
Children Age: 5 - 11 year olds after dose 2:
            60.1% during month 1
            28.9% during month 2

Post-EUA Pfizer Vaccine safety:
"Anaphylaxis, myocarditis, and pericarditis are existing safety concerns that have been added to the product Fact Sheets. ...
Reporting rates for medical chart-confirmed myocarditis and pericarditis in VAERS have been higher among males under 40 years of age ...
Information is not yet available about potential long-term sequelae and outcomes in affected individuals, or whether the vaccine might be associated initially with subclinical myocarditis [i.e. early stages of myocarditis with no outward manifestations] (and if so, what are the long-term sequelae). ...The Sponsor is conducting additional post-authorization/post-marketing studies to assess known serious risks of myocarditis and pericarditis as well as to identify an unexpected serious risk of subclinical myocarditis."  i.e. study is ongoing. no long term data available.

___________________________________________________________________________________

Next, the briefing goes onto cover efficacy and safety information on young children ages 6 months to 4 year olds:

Age 6 months - 4 years:
"... had at least 2 months (blinded and open-label)  safety follow-up after completing a three-dose primary series."  i.e. no long term data available.


Starting at P. 39 Pfizer efficacy for young children:

For doses 1 and 2, there were more vaccinated children who caught Covid than unvaccinated children (or about the same % relative to participant size). After dose 3, the number of Covid cases were the same between vax'd and unvax'd for ages 6 - 23 months and there were 3 more Covid cases in the unvax'd compared to the vax'd for ages 2 to < 5 year olds.

Participants 6-23 Months of Age (participants:  1178 vax'd and 598 unvax'd):
Number of Covid cases between dose 1 and dose 2 ->  vax'd 13 cases vs unvax'd 5 cases
Number of Covid cases between dose 2 and dose 3 -> vax'd 80 cases vs unvax'd 48 cases
Number of Covid cases after dose 3 -> vax'd 2 cases vs unvaxed 2 cases

Participants 2 to <5 Years of Age (participants:  1835 vax'd and 915 unvax'd):
Number of Covid cases between dose 1 and dose 2 ->  vax'd 21 cases vs unvax'd 8 cases
Number of Covid cases between dose 2 and dose 3 -> vax'd 104 cases vs unvax'd 79 cases
Number of Covid cases after dose 3 -> vax'd 2 cases vs unvaxed 5 cases

Based upon the above data, it is concluded that: "COVID-19 disease onset appears to occur similarly for both BNT162b2 and placebo groups until after Dose 3, at which time point, the curves begin to diverge."  It is interesting to note that recently approved vaccines such as Zostavax (approved 2006 with over 40,000 phase 2/3 participants) and Gardasil (approved 2006 with approx 27,000 phase 2/3 participants) had markedly higher number of trial participants (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3551877/) and took years for design and testing.

After the efficacy data, the document details the adverse events including serious adverse events such as convulsions.  It is noted that some parents withdrew their children from the trial due to adverse events.  According to the document these events comprised a little less than 2% of the vaccinated participants and serious adverse events occurred in approximately 1 - 2 children per 100 children vaccinated.

           

[best_potsticker_in_town]

I have a 20-month-old and will not be vaccinating my toddler. Both my wife and I are vaccinated as well as our extended families. Vaccinating our little one seems a bit excessive at this point - even if the data above was more convincing.

[hpjet]

FDA amends the emergency authorization for Moderna and Pfizer to include young children:

June 17, 2022 - "FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age ...Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) was consulted...""
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

[hpjet]

"FDA Open to Less Than 50 Percent Efficacy in COVID Vaccines for Smallest Kids
...FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold...[Marks] added that 'the goal here is to get some protection in sooner rather than later.'"  https://www.fdanews.com/articles/207761-fda-open-to-less-than-50-percent-efficacy-in-covid-vaccines-for-smallest-kids 

______________________________________________________________

The "50 percent efficacy threshold" referenced above comes from the guidance on: "Emergency Use Authorization for Vaccines to Prevent COVID-19" by the FDA and U.S. Department of HHS (updated March 2022):

FDA: minimum efficacy for EUA:
FDA set a 50% efficacy minimum for the Covid EUAs. ("...issuance of an EUA would include ...meeting the prespecified success criteria for ...a point estimate for a placebo-controlled efficacy trial of at least 50%,...")  Note that how long a vaccine must have 50% efficacy is not clarified.
https://www.fda.gov/media/142749/download (pp. 10-11)

FDA: minimum safety follow up for EUA:
FDA also set a shortened 2 month minimum safety follow up for Covid EUAs. ("...Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,") https://www.fda.gov/media/142749/download (pp. 10-11)