Letter to ATAGI – Reconsider Pfizer for 5-11 year olds

My letter to ATAGI asking that they reconsider the decision to approve the Pfizer vaccine for 5-11 year olds.
It is my view that our children will be exposed to unnecessary and unknown risks for very limited short term benefits.

The Australian Technical Advisory Group on Immunisation
Department of Health GPO Box 9848 Canberra ACT 2601
20 December 2021

Dear ATAGI,

RE: Concerns with the Pfizer vaccine for children aged 5 to 11

I write to respectfully request that you reconsider the decision to approve the Pfizer vaccine or postpone its rollout to children aged between 5 and 11 years for the following reasons.

1. The Doherty modelling made no recommendation for vaccination of the 5-11 age group. Furthermore, it noted that even expanding the vaccine program to the 12-15 age group has minimal impact on transmission and clinical outcomes for any achieved level of vaccine uptake. If the benefits of the vaccine rollout for older children is virtually non-existent, then there is no need to expose even younger children to the risk of injury from the vaccine. 
2. ATAGI noted in their review that the trial was not powered to detect any rare unanticipated adverse events or to assess rates of myocarditis and pericarditis following immunisation in this age group. Given this, parents cannot fully or accurately assess the risk of immunisation, especially for immunocompromised children or those with background autoimmune disease. 
3. ATAGI also noted clinical trials were conducted prior to the emergence of the Omicron variant, and the results reflect vaccine efficacy against older strains of SARS-CoV-2. Given the efficacy against Omicron is not yet known, injecting children with a vaccine that is no longer fit-for-purpose and based on bare minimum trial data seems unnecessary at this stage. 
4. Pfizer is proposing to use a new formulation (using a tris buffer;41 replacing the current phosphate-buffered saline) in the proposed age group. However, the trial study was conducted using the old formulation. While this may or may not be medically significant, the TGA noted this will result in extensive changes in the Product Information, including storage and dilution requirements, which can lead to significant confusion, especially if the current vaccine stock (phosphate-buffered saline formulation) is also being used simultaneously. This is a significant risk at a time when the vaccine is being administered to a highly vulnerable age group. 
5. The TGA noted the following data limitations around Pfizer’s trial the 5-11 age group:
   i. Safety follow up is currently limited to median 2.4 months post Dose 2 in cohort 1 and 2.4 weeks for the safety expansion cohort.
   ii. Safety sample size is small.
   iii. The duration of immune response and vaccine protection is not currently known in the proposed age group.
   iv. Vaccine efficacy against asymptomatic infection and viral transmission are not known for the proposed age group.
   v. The data in immunocompromised individuals are lacking.
   vi. Efficacy against the currently circulating variants of concern is not known yet.
   vii. No data on co-administration of Comirnaty with other vaccines in the 5 to 11 years of age group (such as seasonal flu vaccines).
   viii. There are no data available on the interchangeability of Comirnaty with other COVID-19 vaccines to complete the vaccination series.

The TGA notes that participants must be followed for a median of at least 2 months after receiving their final dose and a longer follow-up period of 6 months for some trial participants is preferred to assess the potential risks of late-onset adverse events. Given the safety expansion cohort had not yet met these minimum thresholds, only the data from cohort 1 is applicable, which noted 1518 in the safety population (who received the vaccine, not the placebo). The TGA notes several times that this sample size is small and at 2.4 months the safety follow up is at bare minimum.

Furthermore, efficacy analysis was based on only 19 cases (3 in the Comirnaty group and 16 in the placebo group).
Given these facts, it seems children aged 5 to 11 are being exposed to unnecessary and unknown short- and long-term risks for a limited short-term benefit.

I respectfully urge a much greater degree of caution regarding COVID-19 immunisation for children.

I look forward to your reply.

Kind regards,
Gerard Rennick
LNP Senator for Queensland

Cc:
Prime Minister
Minister for Health