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________________________________________ From: Miriam Stevenson
<[FOI #847598 email]> Sent: Friday, March 25, 2022
9:01:32 PM To: MHRA Customer Services Subject: Freedom of Information
request - Risk Management. Did MHRA request to see raw data for mRNA
vaccine trials prior to approval? Dear Medicines and Healthcare Products
Regulatory Agency, 1. What specific criteria are used by the MHRA to
determine the appropriate circumstances for an Emergency Use Authorisation
in respect of non-licensed/experimental drugs? i.e. What specific
conditions constitute an "emergency" situation which warrants the
authorisation of unlicensed medicines/drugs/vaccines? 2. What is the
MHRA's accepted structure for a comprehensive risk assessment in respect
of unlicensed medicines? i.e. What questions should the risk assessment
address? 3. Did anyone working within the MHRA actually request to see ANY
raw data (i.e. data that is collected from a source, but in its initial
unprocessed state) associated with any and/or all Covid-19 mRNA vaccine
trials PRIOR to MHRA approval under EUA? 4. If the answer to question 3 is
"yes", what was the response to the request (or what were the responses)
from the vaccine manufacturers? Yours faithfully, Dr Miriam Stevenson
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FOI 22/602
 
 
Dear Dr Miriam Stevenson,
 
Thank you for your email of 25^th March where you have asked about “Risk
Management. Did MHRA request to see raw data for mRNA vaccine trials prior
to approval?"
 
1. What specific criteria are used by the MHRA to determine the
appropriate circumstances  for an Emergency Use Authorisation in respect
of non-licensed/experimental drugs? i.e. What specific conditions
constitute an "emergency" situation which warrants the authorisation of
unlicensed medicines/drugs/vaccines?
 
2. What is the MHRA's accepted  structure for a comprehensive risk
assessment in respect of  unlicensed medicines? i.e. What questions should
the risk assessment address?
 
3. Did anyone working within the MHRA  actually request to see ANY raw
data (i.e.  data that is collected from a source, but in its initial
unprocessed  state) associated with any and/or all Covid-19 mRNA vaccine
trials PRIOR to MHRA approval under EUA?
 
4. If the answer to question 3 is "yes", what was the response to the
request (or what were the responses) from  the vaccine manufacturers?
 
Please see the information requested below.
 

 1. What specific criteria are used by the MHRA to determine the
appropriate circumstances  for an Emergency Use Authorisation in
respect of non-licensed/experimental drugs? i.e. What specific
conditions constitute an "emergency" situation which warrants the
authorisation of unlicensed medicines/drugs/vaccines?

 
An Emergency Use Authorisation (EUA) is a regulatory mechanism to
facilitate the availability and use of medical countermeasures, including
unapproved or investigational health products, during public health
emergencies, such as the current Covid-19 pandemic. National Regulatory
Authorities (NRAs) can issue an EUA when certain legal criteria have been
met such as a national health emergency and/or no adequate, approved, and
available alternatives. It is not just NRAs that can use emergency use
mechanisms.  After the experience during the West African Ebola outbreak
from 2013-2016, the World Health Organisation (WHO) developed the
Emergency Use Assessment and Listing (EUAL) procedure for health products
which was updated in January 2020 with the Emergency Use Listing (EUL)
procedure3.
 
The specific conditions of emergency use mechanisms may differ among
jurisdictions and in some jurisdictions similar regulatory mechanisms may
have different names. A common element of most emergency use procedures is
an assessment of whether submitted (and frequently limited) data
demonstrate a reasonable likelihood that a product’s quality, safety, and
efficacy are acceptable, and that the benefits outweigh potential risks
and uncertainties in the context of a public health emergency of national
or international concerns.
 

 1. What is the MHRA's accepted  structure for a comprehensive risk
assessment in respect of  unlicensed medicines? i.e. What questions
should the risk assessment address?

 
As we have stated above in Q1 “an assessment of whether submitted (and
frequently limited) data demonstrate a reasonable likelihood that a
product’s quality, safety, and efficacy are acceptable, and that the
benefits outweigh potential risks and uncertainties in the context of a
public health emergency of national or international concerns.”
 

 1. Did anyone working within the MHRA  actually request to see ANY raw
data (i.e.  data that is collected from a source, but in its initial
unprocessed  state) associated with any and/or all Covid-19 mRNA
vaccine trials PRIOR to MHRA approval under EUA?

 
It is a requirement for any company seeking authorisation of their
medicinal product by MHRA to provide all data from clinical studies
conducted.
 

 1. If the answer to question 3 is "yes", what was the response to the
request (or what were the responses) from  the vaccine manufacturers?

 
Please see above, all data from clinical studies conducted must be
submitted to MHRA in order for MHRA to assess and authorise that medicinal
product for use. MHRA does not request the data, as it is a mandatory
requirement.
 
If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review will be carried out by a senior member of the Agency
who was not involved with the original decision.
 
If you have a query about the information provided, please reply to this
email.
 
Yours sincerely
 
 
 
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
 
 
 
 
 

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