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Clinical trial data

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Dear Medicines and Healthcare Products Regulatory Agency,

The following statement was attributed to June Raine on the Government website on 4th June 2021:
"We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk."

Please provide, or provide a link to, the aforementioned 'clinical trial data'.

Yours faithfully,

Mark Roberts

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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References

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/777
       
Dear Mark Roberts,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 5th July 2021.
  
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Medicines and Healthcare products Regulatory Agency
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Telephone 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mark Roberts,

 

Thank you for your email.

 

We have carefully reviewed clinical trial data for the Pfizer/BioNTech
vaccine in over 2000 children aged 12 to 15 years of age and have
concluded that that the benefits of this vaccine outweigh any risk and
that it is effective and acceptably safe in this age group. This data has
also been reviewed by the independent Commission on Human Medicines (CHM),
its COVID-19 vaccine benefit-risk expert working group, as well as the
Paediatric Medicines Expert Advisory Group.

 

No new side effects were identified and the safety data in children was
comparable with that seen in young adults. As in the young adult age
group, the majority of adverse events were mild to moderate, relating to
reactogenicity (e.g. sore arm and tiredness.)

 

The Commission on Human Medicines (CHM) met on 27 May 2021 to discuss the
request to vary the existing authorisation to extend the approval to apply
to children aged 12 – 15 years old.

 

The CHM considered the results of randomised, placebo-controlled clinical
trials in over 2000 children aged 12 – 15 years.

 

The immunogenicity results (showing how well the vaccine works), studied
in approximately 200 children, demonstrated similar neutralising antibody
levels in adolescents aged 12-15 years compared with the levels in young
adults aged 16-25 years.

 

These results are supported by a very high level of short-term efficacy
data in adolescents against symptomatic disease after 2 doses of vaccine
21 days apart.

 

In participants with no prior evidence of infection there were no cases of
COVID-19 in the vaccinated group from 7 days after the second dose
compared with 16 cases in the placebo group.

 

Consistent with what was seen in adults there was evidence that the
vaccine provides protection even before the administration of dose 2.
There were no cases seen in the vaccine group from 11 days after dose 1
compared to 31 in the placebo group. Prior to day 11 there were 3 cases in
the vaccine group and 4 on placebo.

 

Safety data in children aged 12-15 years is available from one clinical
trial. This safety data is supported by the safety data from the clinical
trials in individuals aged 16 years and over, together with a large amount
of real-world data on the safety of the Pfizer/BioNTech COVID-19 vaccine.
This has been closely monitored as the vaccine has been rolled out both in
the UK and internationally. This experience has reinforced the conclusion
that the benefits of the Pfizer/BioNtech COVID-19 vaccine continue to
outweigh any possible side effects.

 

The MHRA’s assessment of the use of the Pfizer/BioNTech vaccine in
adolescents is available in Annex 1 of the below-linked Public Assessment
Report (PAR):

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

 

Furthermore, the study of the safety, immunogenicity, and efficacy of the
Pfizer/BioNTech vaccine is published in a peer-reviewed journal, the link
to this is also provided below:

[2]https://www.nejm.org/doi/full/10.1056/NE...

 

You may be interested to know that other regulatory authorities around the
world, including the European Medicines Agency (EMA), US FDA and Health
Canada, have also approved the use of the vaccine in 12 – 15 year olds. 
Nearly 5 million 12 – 15 year olds in the USA have now received the
vaccine, of whom 3.5 million have received both doses [3]CDC COVID Data
Tracker .  In Canada, 1.5 million 12 – 17 year olds have received the
vaccine

[4]COVID-19 vaccination coverage in Canada - Canada.ca

 

Kind regards,

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

[5]gov.uk/mhra

[6]Stay connected

 

For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [7]MHRA,
[8]CPRD and [9]NIBSC.

 

 

 

 

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Dear MHRA Customer Services,

Thank you for the reply.

Please provide the safety data from the only clinical trial conducted on children aged 12-15 years.

Yours sincerely,

Mark Roberts

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 Mark Roberts,

Thank you for your email.

This can be found in Annex 1 of the Public Assessment Report for the Pfizer vaccine which can be found at the below link:
https://www.gov.uk/government/publicatio...

Kind regards,

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
 

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