FOI release

Freedom Information request on the evidence that proves that face coverings prevent transmission (FOI 21/867)

Published 27 April 2022

9th August 2021 FOI 21/867

Dear

Thank you for your email.

Please find below answers to the questions you have raised.

• The evidence that proves that face coverings prevent transmission

As face coverings are not medical devices, we do not hold the information you have requested. You may wish to contact Department of Health and Social Care for more information via their website

• The evidence of Kochs postulates have been fulfilled for Covid-19

MHRA hold no information.

• The evidence that Covid-19 has been purified and isolated.

MHRA holds no information on the isolation of the Covid-19 virus. We suggest that you consult the Scientific Advisory Group for Emergencies (SAGE) website that we have provided below.
https://www.gov.uk/government/organisations/scientific-advisory-group-for-emergencies which includes information supporting the governments’ decision making on the Covid-19 pandemic, including information on the isolation of the Covid-19 virus.

Please note that information on the isolation of the Covid-19 virus is also available in the public domain through scientific papers.

-The false positive rates for the PCR test when being used for detecting Covid-19

We can confirm that the MHRA do not currently hold any information on the false positive rates for the PCR tests when being used for detection COVID-19 because MHRA does not review or approve RT-PCR tests before they are placed on the market, as they are self-certified under MDR 2002 and EU IVDD.

You may find helpful the Cochran review of molecular based tests for SARS-CoV-2 which is high quality evidence in the public domain : https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013705/full

• The evidence that asymptomatic transmission is prevalent.

We suggest you can contact the following for information.

• NHS Test and Trace https://www.england.nhs.uk/contact-us/ • Public Health England Email: enquiries@phe.gov.uk • Department of Health and Social Care Web contact form - https://contactus.dh.gov.uk/?openform

• The number of deaths within 28 days of vaccination in the UK

Death statistics are not held by the MHRA and as such we would advise you to contact the Office for National Statistics Contact us - Office for National Statistics (ons.gov.uk)

The Yellow Card scheme is run by the MHRA and is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. Reports received through our Yellow Card scheme include some fatality reports and these can be viewed by following the link below: https://www.ons.gov.uk/aboutus/contactus](https://www.ons.gov.uk/aboutus/contactus)

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: info@mhra.gov.uk

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