"Approval" of Moderna Vaccine "spikevax" for 12-17 year olds

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Our Ref: FOI 21/972
       
Dear Barbara Jones,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 21st August 2021.
  
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Dear Barbara Jones,

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, Moderna 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.

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.

The original data submitted for the authorised vaccines is available from
the EMA via the following link:

[10]https://clinicaldata.ema.europa.eu/web/c...

The MHRA has published the pharmacovigilance strategy for the COVID-19
vaccines which outlines how the MHRA is monitoring the safety of the
vaccines. This can be found here:
[11]https://www.gov.uk/government/publicatio...
This surveillance startegy includes close and continual monitoring of the
safety data in the 12- to 15-year age group.

Regarding the question “Has the MHRA any evidence of the genetic sequence
of Covid19 and the basis of the naming of each variant?”, we do not hold
any information on this.

If you have a query about the information provided, please reply to this
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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: [12][MHRA request email]

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Commissioner can be contacted at:

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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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