Freedom of Information request on authorisations of COVID-19 vaccines, hospitalisations and deaths of unvaccinated people with confirmed COVID-19 re-infection, long-term trials and spike proteins (FOI 21-662)
Published 13 August 2021
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23rd June 2021 FOI 21/662
Dear
With regards to your email of 11 June 2021, we have answered the questions that you asked previously:
1) Do you tell people/provide guidance for doctors to inform people that the Covid-19 vaccinations have not completed Phase 3 trials and is under emergency licencing only?
The bases for their authorisations and the information published by MHRA for the Covid-19 vaccinations have already been provided to you. We have clarified that none of the vaccines are considered to be “experimental” and that the Pfizer, Moderna and Janssen vaccines now have marketing authorisations (please see our response, dated 10 June 2021).
2) What additional immunological benefit would I get from a vaccination (having had symptomatic Covid-19)? So can you let me know how many hospitalisations/deaths have occurred in unvaccinated people with confirmed Covid-19 re-infection?
MHRA holds no information on the rates of reinfection from Covid-19, i.e. numbers of people who have had Covid-19 infection for a second time. However, we have provided you with published information that shows that the authorised vaccines reduce the incidence of deaths and hospitalisations from Covid-19 infection. MHRA is not aware of any data that have shown that natural immunity has reduced the number of hospitalisations or deaths from Covid-19 infection.
3) What about the fact that no long term trials have been completed so long term illnesses may not have been identified?
MHRA has published their assessment of the safety of all the authorised vaccines, which were provide to you in our previous response. In addition, we work closely with its international counterparts including the EMA to understand the global safety experience of COVID-19 vaccines. During signal detection activities, we take into account the international experience based on data from other countries using the same vaccines. For further information on how we use and assess the data we collect please view our COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk). This strategy currently in place is working as designed, allowing us to fully review and identify any issues that may arise.
4) Where are the spike proteins produced? Are they produced all throughout the body? And what stops the production of the spike proteins?
Information on how the vaccines work and the bases for their authorisations have already been provided to you via links to the Public Assessment Reports for the vaccines. At the current point in time we have no further information available to share.
5) Where do the spike proteins travel in the body once produced? Do they travel all around the body?
See response to question 4.
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU