Pfizer Covid Vaccine Status

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Dear Medicines and Healthcare Products Regulatory Agency,

Can you confirm that the Covid-19 vaccines being offered in the UK are still in phase 3 trials?

If so when do the trials end?

Also can you please send me links to all the current covid-19 trials currently active in the UK?

Yours faithfully,

stephen-ciaran mccann

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
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London 
E14 4PU
gov.uk/mhra
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The UK has left the EU, and the transition period ends on 31 December
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Dominique Anderson left an annotation ()

Pfizer won’t be complete till January 27th 2023
https://clinicaltrials.gov/ct2/show/NCT0...
The Moderna trials come to a close on December 2023
https://clinicaltrials.gov/ct2/show/NCT0...
The AstraZeneca trials will reach completion in February 2023
https://clinicaltrials.gov/ct2/show/NCT0...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/871

Dear Stephen-Ciaran McCann,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 2 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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/871
 
Dear Stephen-Ciaran McCann
 
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."
 
Regarding your specific questions, 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
[10]https://clinicaltrials.gov/ct2/show/NCT0...  
 
AstraZeneca Phase III Estimated Study Completion Date: February 14, 2023
[11]https://clinicaltrials.gov/ct2/show/NCT0...
 
Pfizer/BioNTech PHASE 1/2/3, Estimated Study Completion Date: April 6,
2023 [12]https://clinicaltrials.gov/ct2/show/NCT0...
 
 
Moderna Phase 2a Estimated Study Completion Date: November 1, 2021
[13]https://clinicaltrials.gov/ct2/show/NCT0...
 
 
Moderna Phase 3 Estimated Study Completion Date: October 27, 2022
[14]https://clinicaltrials.gov/ct2/show/NCT0...
 
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Yours sincerely
 
 
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 MHRA Customer Services,

Thank you for your reply.

However, maybe I was specific enough. Are the tens of millions who have got vaccinated part of the ongoing clinical trials for the vaccines since they are still under emergency use authorisation?

Yours sincerely,

stephen-ciaran mccann

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

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

Dear Medicines and Healthcare Products Regulatory Agency,

You were quite quick to answer my 1st question. Why so long with the second?

Is it because they are still in trial and the 10's of millions getting jabbed are the trial subjects?

If I do hear back from you I will accept your silence as acquiescence that the statement is true.

Yours faithfully,

stephen-ciaran

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

Dear Stephen-Ciaran McCann,

 

Thank you for your email.

 

Those who have been vaccinated as part of the roll out to the general
public are not part of a clinical trial.

 

As noted in our previous response, the temporary authorisations under
Regulation 174 have now be superseded by market authorisations. Details of
this can be found in the links in our response to FOI 21/871.

 

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

Dear Stephen-Ciaran,

Thank you for your email.
 
We have chased your enquiry with our experts and we can only apologise that you have not yet received a response. We have notified the team concerned and they will respond to you as soon as they can.
 
Please note we work to an 18 working day response time.
 
In the meantime should you require any further advice or assistance on this matter please feel free to call us on 020 3080 6000 or reply to this email.
 
Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)
 
With regards,

Ella
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
gov.uk/mhra
Stay connected
 
For information on how the Agency uses your personal data and your data protection rights, please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC.

Your enquiry was passed to the relevant team to provide you with a response.

We work to an 18 working day response time

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