There follows an open letter from 76 medics, scientists and healthcare professionals to the Medical and Healthcare products Regulatory Agency (MHRA) and other Government officials setting out comprehensive reasons why the recent U.S. FDA decision authorising Covid vaccinations in infants must not happen here.
Dr. June Raine, CEO MHRA
Professor Lim Wei Shen, Chairman JCVI COVID-19 vaccines sub-committee
Professor Chris Whitty, Chief Medical Officer
Dr. Jenny Harries, CEO, UKHSA
Hon Sajid Javid, MP, Secretary of State for Health & Social Care
June 30th 2022
Dear Dr. Raine,
Re: COVID-19 vaccines for six months to four years age group
We are writing to you urgently concerning the announcement that the FDA has granted an Emergency Use Authorisation for both Pfizer and Moderna COVID-19 vaccines in preschool children.
We would urge you to consider very carefully the move to vaccinate ever younger children against SARS-CoV-2 despite the gradual but significant reducing virulence of successive variants, the increasing evidence of rapidly waning vaccine efficacy, the increasing concerns over long-term vaccine harms, and the knowledge that the vast majority of this young age group have already been exposed to SARS-CoV-2 repeatedly and have demonstrably effective immunity. Thus, the balance of benefit and risk which supported the rollout of mRNA vaccines to the elderly and vulnerable in 2021 is totally inappropriate for small children in 2022.
We also strongly challenge the addition of COVID-19 vaccination into the routine child immunisation programme despite no demonstrated clinical need, known and unknown risks (see below) and the fact that these vaccines still have only conditional marketing authorisation.
It is noteworthy that the Pfizer documentation presented to the FDA has huge gaps in the evidence provided:
- The protocol was changed mid-trial. The original two-dose schedule exhibited poor immunogenicity with efficacy far below the required standard. A third dose was added by which time many of the original placebo recipients had been vaccinated.