10/26 the FDA vaccine committee vote on Pfizer mRNA vaccine EUA for 5-11 age group



10/26/2021, 10:53:43 PM

The VRBPAC vote passes. The committee was under pressure to collect more data which this EUA allows

The voting question was: Based on the totality of scientific evidence available, do the benefits of the Pfizer- BioNTech Covid-19 vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11 years of age? Yes: 17 No: Abstain: 1(quoted above in the video)

Effectively, parents who will elect to vaccinate their children are enrolling them in the phase 3 study to investigate short and long term risks as collected data is insufficient.

It’s important to emphasize that no transmissibility study was conducted and no data supports vaccines effect on transmission reduction.

Majority of voting members noted that THERE is NO sufficient safety data along with unclear Benefits and estimate of risks of myocarditis. Note that only data for small group of 2238 participants was presented. the myocarditis data was only for 12-18 year old group while the vote was for DIFFERENT younger AGE group!

Majority of hospitalizations occurred over 69% for other causes than covid but with covid with serious underlying conditions.

It was also noted that more than 40% but more likely as high as 80-90% of children had natural post infection immunity and no adverse events or long term safety risks assessment or studies were conducted to investigate long term effects or need for vaccine for majority of children who are ALREADY immune.