OPQ-2917: Safety of the PfizerBioNTech COVID-19 vaccine in 12-15 year olds.
I was recently informed about the OPQ response which I found very important to read for the safety of my children. I invite you to read it too. The information may be not easily found as one may wish, but it is there.
Thank you to MPs who seek answers for such important questions.
Question:
With regard to Health Canada's (HC) establishing the safety of the Pfizer/BioNTech COVID-19 vaccine in 12-15 year olds:
(a) what serious adverse events (SAEs) did the pharmaceutical company disclose to Canada's health agencies for this age group pre-authorization;
(b) since approving the product in this age group, has the Public Health Agency of Canada (PHAC), the National Advisory Committee on lmmunization (NACI) or HC become aware of additional adverse events (AEs) or SAEs that the pharmaceutical company had not disclosed during the initial authorization process;
(c) if the answer to (b) is affirmative, (i) what AEs and SAEs has the PHAC, the NACI and HC become aware of, (ii) when were they discovered, (iii) what are the means by which Canada's health agencies were provided this information;
(d) prior to authorizing this product in this age group, was the PHAC, HC or the NACI given information about (i) the SAEs of a 12-year-old trial participant named Maddie de Geray who was diagnosed with chronic inflammatory demyelinating polyneuropathy which rendered her reliant on a wheelchair and feeding tube, (ii) any other specific SAE cases in this cohort following the Pfizer inoculation;
(e) if the answer to (d) is affirmative, what was the date and means by which the PHAC, the NACI or HC became aware of these cases;
(f) if the answer to (d) is negative, has Ms. De Geray's diagnoses been added to HC's list of SAEs on the HC website in this age group;
(g) has the PHAC, HC or the NACI been aware that the adverse events experienced by trial participant Maddie de Geray were not properly disclosed within their trial studies as described in the scientific publication of said trial (i.e. NEJM - Frenck et al. 2021);
(h) did the PHAC, HC or the NACI take any action after discovering the lack of proper disclosure of Maddie de Geray's SAEs by Pfizer;
(i) what was the age stratified risk-benefit analysis for 12-15 year olds in relation to the Pfizer/BioNTech COVID-19 vaccine at the time of authorization, on May 5, 2021;
(j) what was the data and calculations for quantifying the risks and benefits that Canadian health agencies used to authorize or approve the product in this age group;
(k) what data indicated that the benefits of the vaccine outweighed the risks at the time of authorization;
(l) since the roll-out of the Pfizer/BioNTech COVID-19 vaccine in this age group, (i) what are the top ten SAEs identified in this cohort, (ii) how have these SAEs been communicated to the medical community and the public at large;
(m) what type and frequency of SAEs in 12-15-year-old would invoke an unfavourable benefits-risk ratio for healthy children and for children with underlying medical conditions; and
(n) is HC, the PHAC or the NACI aware of any other jurisdictions worldwide that no longer recommends the mRNA COVID-19 vaccines in children at (i) six months of age, (ii) between six months and two years (iii) between two to five years, (iv) between five to 12 years, (v) between 12-15 year, (vi) between 15-18 years?