Freedom of Information request updating the Regulation 174 authorisations for the COVID-19 vaccines made by Pfizer and AstraZeneca in relation to booster doses (FOI 21/1177)
Published 26 May 2022
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FOI 21/1177
19th November 2021
Dear,
Thank you for your email.
In updating the Regulation 174 authorisations for the COVID-19 vaccines made by Pfizer and AstraZeneca in relation to booster doses, MHRA reviewed published data on immunocompromised patients, data from the manufacturers’ trials, data from the UK COV-Boost and ComFluCOV trials conducted by UK University Hospitals, and a summary of published and Public Health England (PHE) data regarding waning vaccine effectiveness. These data were reviewed by the independent Commission on Human Medicines (CHM). These data are not published yet, however, MHRA is currently updating the relevant Public Assessment Reports with these changes to the Regulation 174 authorisations. Unfortunately, due to this the information is exempt from release under section 22:
Section 22 – Information intended for future publication: the information you have requested is due to be published. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information.
Since the launch of the COVID-19 immunisation campaign the MHRA is proactively monitoring the safety of all COVID-19 vaccines approved by the MHRA in near real-time safety monitoring at population level. A COVID-19 booster vaccine dose helps improve the protection obtained from the first two doses of the vaccine. It helps give longer-term protection against getting seriously ill from COVID-19. Safety monitoring plans have been agreed to ensure action can be taken on any emerging safety concerns from supplementary or booster doses. For transparency, the MHRA publish adverse reaction assessment report weekly which can be found here: Coronavirus (Covid-19) vaccine adverse reactions - GOV.UK (www.gov.uk). This public summary provides an overview of the numbers and types of all UK suspected Adverse Drug Reactions (ADRs) received by the MHRA associated with the new COVID-19 vaccines and information on doses given as a booster.
Within your correspondence you reference vaccine related deaths as well as other suspected ADRs that have been reported to the Yellow Card scheme. Please note that a report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. All reports are kept under continual review in order to identify possible new risks. Regarding events with a fatal outcome specifically, review of specific fatal reports is provided within our summary of Yellow Card reporting referenced above. The patterns of reporting for all other fatal reports does not suggest the vaccines played a role in these deaths.
In regards to your query on updating patient consent forms and vaccine leaflets, it’s important to note that the product information, the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL) are for recognised side effects only. For a list of the recognised side effects to each of the vaccines please refer to the product information.
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Yours sincerely,
MHRA Customer Service Centre