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Astra zeneca covid vaccine

B NICHOLLS made this Rhyddid Gwybodaeth request to Medicines and Healthcare Products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,
What trials have been done on those who have had anaphalatic shock in the past and what reassurances can you give that this vaccine is safe in these circumstances. How many people in trials and those with adverse reactions are documented, what can of trials used in the UK

Yours faithfully,

B nicholls

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 21/199

Dear B Nicholls,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 22 February 2021.

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

dangos adrannau a ddyfynnir

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/199
 
Dear B Nicholls,
 
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 on 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 healthcare professionals 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...
 
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...
 
The Information for Healthcare Professionals for each vaccine, accessible
via the above links, contains a list of the ingredients in each vaccine
(section 6.1). Prospective vaccine recipients should share this with their
healthcare professional to ensure that they are not allergic to any of
these ingredients. Anyone due to receive their vaccine should continue
with their appointment and discuss any concerns or medical history of
serious allergies with the healthcare professional prior to
administration.
 
MHRA will be collecting data concerning any adverse reactions observed to
vaccine treatment through our Yellow Card Scheme
[5]https://coronavirus-yellowcard.mhra.gov.... 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
[6]https://www.gov.uk/government/publicatio...
 
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.
 
The following Department of Health and Social Care (DHSC) webpage for the
independent report ‘Optimising the COVID-19 vaccination programme for
maximum short-term impact’ from the Joint Committee on Vaccination and
Immunisation (JCVI) provides the rationale for the government’s
implemented dosing strategy: 
[7]https://www.gov.uk/government/publicatio...
 
Further, the scientific basis from the JCVI concerning the current
evidence on efficacy after single doses of the Pfizer/BioNTech,
Oxford/AstraZeneca and Moderna vaccines is available in the public domain
and is provided below:
[8]https://www.gov.uk/government/publicatio...
 
Regarding your specific questions concerning recipients who have
experienced anaphylactic shock in the past, through the clinical trials
and the post authorisation rollout of the vaccines, the adverse events
experienced by recipients of the vaccine have led to the current advice in
the Information for Healthcare Professionals. This advice states for the
Oxford/AstraZeneca vaccine:
"As with all injectable vaccines, appropriate medical treatment and
supervision should always be readily available in case of an anaphylactic
event following the administration of the vaccine."
 
Further, the Oxford/AstraZeneca vaccine is contraindicated in anyone with
a "hypersensitivity to the active substance or to any of the excipients
listed in section 6.1" (of the Information for Healthcare Professionals).
 
Regarding adverse events experienced during the clinical trials, these are
presented in the PAR for the Oxford/AstraZeneca vaccine, a link to this is
provided above.
 
Regarding adverse events experienced after the vaccine was authorised we
can confirm that we have published the data and this is available to view
at the following links of our website page below, please note this
information will be published weekly moving forward:
 
[9]https://www.gov.uk/government/publicatio...
 
[10]https://www.gov.uk/government/publicatio...
 
As with any vaccine or medicine, COVID-19 vaccines require continuous
safety monitoring and that the benefits in protecting people against
COVID-19 outweigh any side effects or potential risks. This is a process
known as safety monitoring (pharmacovigilance). This ensures that any
potential medium and long term safety issues are promptly and adequately
evaluated. As part of our signal detection processes, all adverse reaction
reports received are individually assessed and cumulative information
reviewed at regular intervals. Be reassured that the MHRA is working in
collaboration with partners in the health system to rapidly assess all
available safety data in real time and communicate any emerging issues, as
necessary.
 
If you have a query about the information provided, please reply to this
email.
 
If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
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Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review. The Information
Commissioner can be contacted at:
 
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Cheshire
SK9 5AF
 
Yours sincerely
 
 
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000
 

dangos adrannau a ddyfynnir

Nid ydym yn gwybod a yw'r ymateb mwyaf diweddar i'r cais hwn yn cynnwys gwybodaeth neuai peidio - os chi ywB NICHOLLS mewngofnodwch a gadael i bawb wybod.