Pfizer Pediatric Data 5-11

Remember, this is data by press release. Full data has not yet been released.

N=2268, 2/3rd received Pfizer vaccine

Dose: 10mcg (vs 30mcg for 12+), every 3 weeks

Data showed robust neutralizing antibodies, similar to that in the positive control group (people aged 16-25 who received 30mcg vaccine dose)

Data on vaccine efficacy not yet available

The vaccine was well-tolerated, no new side effects were identified.

Data is very re-assuring. At this point, the manufacturer will submit data to various regulators for authorization.

It is yet to be seen whether this data will be sufficient for the FDA to grant EUA. In July, some members of the FDA recommended a larger trial size and duration of these trials.

However, this was based on concerns for myocarditis, which is a rare occurrence and would either not show up in clinical trials or occur in very small numbers. It also typically occurs within 4 weeks of getting the vaccine, and most side effects are apparent within 8 weeks. Myocarditis also occurs more frequently with Covid-19 infections vs vaccines.

In response, the AAP wrote a strong letter to the FDA urging expedited approval.

Health Canada does not have to follow FDA, and in fact approved the vaccine for ages 12-16 before the FDA did.

If data is accepted by the regulators and no concerns have been identified, approval could occur as early as end of October,

This does not mean due diligence is compromised. In fact, Health Canada began reviewing data from the early days of when the trials were initiated due to rolling reviews and also consider the totality of evidence available.

Delta is causing a huge surge in pediatric hospitalizations, ICU admissions and deaths across the US. With school starting, we are likely to see similar surges in Canada and in fact, are in Alberta. The Alberta Children’s Hospital, for instance, has stopped 75% of operating rooms, is triaging pediatric patients and limiting services to ‘life or limb’.

It is critical to prioritize the review of approval of the vaccine in the pediatric age groups to prevent unnecessary illness and death.

Vaccine doses are not weight based. This is because your immune response is not weight dependent.

Dosage is determined based on stepwise de-escalation studies and is the dose that creates a strong immune response with minimal side effects.

This is different from regular medications, where weight plays a role in both physiologic effects as well as metabolism and clearance.

NACI will likely provide more recommendations for use once Health Canada approves.