Covid vaccine Immune enhancement diseases

Chris R made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,

Regarding The University of Oxford, AstraZeneca vaccine that aims to protect against COVID-19

I am writing to find out what Immune enhancement diseases also known as (Antibody dependence enhancement or Pathogenic priming) during animal testing were found? Also any incomplete tests that are still ongoing that could be of concern?

Please provide me with ‘Known’ and ‘Unknowns’

Yours faithfully,

Mr Christopher Richings

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency


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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/001

Dear Mr Christopher Richings

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 1 January 2021 and 4 January is the start date.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/001
 
Dear Mr Richings,
 
Thank you for your email.
 
The authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca
vaccines was done through an expedited rolling review. A ‘rolling review’
can be used to complete the assessment of a promising medicine or vaccine
during a public health emergency in the shortest time possible. This is
done as the packages of data become available from ongoing studies on a
staggered basis. The temporary authorisation under Regulation 174 permits
the supply of identified vaccine batches, based on the safety, quality and
efficacy data submitted to MHRA. These authorisations do not constitute a
marketing authorisation.
 
All vaccines are tested through three phases of clinical trials to ensure
they meet the gold standard. Phase 1 trials are with a small group of
people to make sure there are no safety concerns and determines the
appropriate dosage for the best immune response. Phase 2 trials are
conducted on a larger group of people to check the vaccine works
consistently and that the immune response is sufficient. Phase 3 trials
test the vaccines on thousands of people for scientists to assess if the
vaccine is producing immunity that will prevent disease. Usually, these
phases are run in sequence, but in an effort to find a safe and effective
Covid-19 vaccine as quickly as possible, once safety has been ascertained
through Phase 1, Phases 2 and 3 are being run in parallel. Extensive
checks and balances are required at every stage of the development of a
vaccine, and this is no different for a Covid-19 vaccine. No stages in the
vaccine development processes were bypassed.
 
Information on the study conducted using the Pfizer/BioNTech vaccine and
its results are available in a peer-reviewed journal, the New England
Journal of Medicine. A link to this is provided below:
[1]https://www.nejm.org/doi/full/10.1056/NE...
 
The approval for use of the Pfizer/BioNTech and Oxford/AstraZeneca
COVID-19 vaccines in the UK followed a rigorous scientific assessment of
all the available evidence of quality, safety and effectiveness by the UK
regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA expert scientists and clinicians reviewed data from the
laboratory pre-clinical studies, clinical trials, manufacturing and
quality controls, product sampling and testing of the final vaccine, and
also considered the conditions for its safe supply and distribution. The
decision was made with advice from the Commission on Human Medicines
(CHM), the government’s independent expert scientific advisory body.
Regarding the MHRA approval of the Pfizer/BioNTech and the
Oxford/AstraZeneca COVID-19 vaccines, further information (including
information for physicians and recipients of the vaccine, and Public
Assessment Reports [PARs] for each vaccine) are available on the MHRA
website. Links to these are provided below:
[2]https://www.gov.uk/government/publicatio...
[3]https://www.gov.uk/government/publicatio...
 
Please note that the PARs include the MHRA’s assessment of the
non-clinical data submitted with these applications.
 
Further to the above, the Moderna vaccine has also recently been
authorised for use. Further information on this is provided below:
[4]https://www.gov.uk/government/publicatio...
 
MHRA will be collecting data concerning any adverse reactions observed to
vaccine treatment through our Yellow Card Scheme. The MHRA will be
publishing Yellow Card data associated with COVID-19 vaccinations. Yellow
Card data for drugs is routinely published on the Yellow Card website,
with vaccine data available on request. However, for COVID-19 vaccinations
we will be proactively publishing details of adverse drug reactions
received, including MHRA assessment of the data to provide context.
 
Throughout this global pandemic, we have always been guided by the latest
scientific advice. Having studied evidence on both the Pfizer/BioNTech and
Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and
Immunisation (JCVI) has advised that we should prioritise giving as many
people in at-risk groups their first dose, rather than providing two doses
in as short a time as possible.
 
The four UK Chief Medical Officers agree with JCVI that at this stage of
the pandemic prioritising the first doses of vaccine for as many people as
possible on the priority list will protect the greatest number of at risk
people overall in the shortest possible time and will have the greatest
impact on reducing mortality, severe disease and hospitalisations and in
protecting the NHS and equivalent health services.
 
This is because the evidence shows that one dose of either vaccine
provides a high level of protection from Covid-19. 
 
For both vaccines, data provided to MHRA demonstrate that whilst efficacy
is optimised when a second dose is administered both offer considerable
protection after a single dose, at least in the short term. For both
vaccines the second dose completes the course and is likely to be
important for longer term protection.
 
The NHS across the UK will prioritise giving the first dose of the vaccine
to those in the most high-risk groups. Everyone will still receive their
second dose and this will be within 12 weeks of their first. The second
dose completes the course and is important for longer-term protection.
 
The JCVI’s independent advice is that this approach will maximise the
benefits of both vaccines allowing the NHS to help the greatest number of
people in the shortest possible time.  It will ensure that more at-risk
people are able to get meaningful protection from a vaccine in the coming
weeks and months, reducing deaths and starting to ease pressure on our
NHS.
 
Further information concerning the JCVI’s recommendations is provided
below:
[5]https://www.cas.mhra.gov.uk/ViewandAckno...
 
 
Kind Regards
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
 

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