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References

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1. https://www.gov.uk/government/collection...

Our Ref: FOI 21/905
       
Dear Adrian McErlean,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 6th August 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.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...
        
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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Dear Adrian McErlean

Thank you for your email.

The temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca
and Moderna 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.

The temporary authorisations for use of the 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:

[1]https://www.gov.uk/government/publicatio...

[2]https://www.gov.uk/government/publicatio...

[3]https://www.gov.uk/government/publicatio...

Please note that a marketing authorisation was granted for the
Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC)
decision on 21 December 2020 (PLGB 53632/0002). Further information is
available on the European Medicines Agency (EMA) website, a link to this
is provided below:

[4]https://www.ema.europa.eu/en/medicines/h...

Please also note that a marketing authorisation was granted for the
Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB
53720/0002). Further information is available on the MHRA website and the
EMA website, links to these are provided below:

[5]https://www.gov.uk/government/publicatio...

[6]https://www.ema.europa.eu/en/medicines/h...

A marketing authorisation has been granted for the Janssen Covid-19
vaccine on 28 May 2021. Further information is available via the below
link:

[7]https://www.gov.uk/government/publicatio...

In addition, a marketing authorisation was granted for the
Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance
Procedure (PLGB 17901/0355). Further information is available on the MHRA
website and the EMA website, links to these are provided below:

[8]https://www.gov.uk/government/publicatio...

[9]https://www.ema.europa.eu/en/medicines/h...

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.

We publish a weekly summary of Yellow Card reports which we receive which
can be found at the following link:

[10]Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK
(www.gov.uk)

A PAR is available for the assessment by MHRA of the Pfizer/BioNTech
vaccine in adolescents, please refer to Annex 1 in the above-linked PAR
for the Pfizer/BioNTech vaccine.

Regarding the estimated dates for the end of completion of the clinical
trials are as follows:

AstraZeneca Phase I/II Estimated Study Completion Date: November 15, 2021
[11]https://clinicaltrials.gov/ct2/show/NCT0...

AstraZeneca Phase III Estimated Study Completion Date: February 14, 2023
[12]https://clinicaltrials.gov/ct2/show/NCT0...

Pfizer/BioNTech PHASE 1/2/3, Estimated Study Completion Date: April 6,
2023 [13]https://clinicaltrials.gov/ct2/show/NCT0...

Moderna Phase 2a Estimated Study Completion Date: November 1, 2021
[14]https://clinicaltrials.gov/ct2/show/NCT0...

Moderna Phase 3 Estimated Study Completion Date: October 27, 2022
[15]https://clinicaltrials.gov/ct2/show/NCT0...

The main efficacy and safety results for the Phase I, II and III trials
for all authorised vaccines have been submitted to MHRA, sufficient that
these vaccines can be authorised for use in the patient populations stated
in the Information for Healthcare Professionals/Summary of Product
Characteristics for each vaccine. These studies are currently ongoing to
follow-up vaccine recipients to collect additional safety data, in the
same way that all clinical trials for new medicines follow up their study
subjects after the main results of the study have been reported. Other
studies that are currently in progress are to investigate the use of
vaccine outside of the current authorisations (such as giving different
brands of vaccine for the first and second doses).

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
submitted within two months of the date you receive this response and
addressed to: [16][MHRA request email]

Due to the ongoing Covid-19 situation, we are not able to accept delivery
of any documents or correspondence by post or courier to any of our
offices

Please remember to quote the reference number above in any future
communications.

If you were to remain dissatisfied with the outcome of the internal
review, you would have the right to apply directly to the Information
Commissioner for a decision. Please bear in mind that the Information
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:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

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