FOI release

Freedom of Information request on the COVID-19 vaccines and lateral flow tests (FOI 22/649)

Published 27 March 2023

FOI 22/649

16th May 2022

Dear

Thank you for your email.

Please find below answers to the questions you have raised.

1.Sars Cov 2 Covid 19 has been isolated and proven to cause coronavirus symptoms.

2.Please provide the scientific evidence to show that remaining 2 meters from another man or women who subsequently tested positive with a lateral flow test will prevent the transmission of live virus.

3.Please provide the scientific evidence to show that asymptomatic spread occurs in reference to Sars Cov 2 Covid 19.

For Q1 – 3 - We confirm this not for MHRA

4)

a. Does a positive lateral flow test only test for SARS Cov 2 Covid 19?

b. What is the accuracy of a Lateral Flow Test?

4a Does a positive lateral flow test only test for SARS Cov 2 Covid 19?

Lateral Flow Devices(LFD) are a type of testing device, there are many different LFDs on the market for COVID, manufactured by different companies. Each device must be accompanied by the information needed to use it safely and properly and also state the intended purpose of the LFD and what claims the manufacturer makes .It is very important that you follow the information in the instructions for use provided with the kit.

If you get a positive result from these self-tests, it is extremely likely you are currently infected with COVID-19 and risk infecting others.

DHSC have published lateral flow performance data concerning the devices they manufacture and use, which can be found at Lateral flow device performance data - GOV.UK (www.gov.uk) . The following link  explains how LFD test device works How to do a coronavirus (COVID-19) rapid lateral flow test - GOV.UK (www.gov.uk)

b. What is the accuracy of a Lateral Flow Test?

As above, the DHSC have published lateral flow performance data concerning the devices they manufacturer and use, which can be found at Lateral flow device performance data - GOV.UK (www.gov.uk).  Furthermore, there are several rolling systematic reviews ongoing at the moment, please see https://pubmed.ncbi.nlm.nih.gov/34383750/ and https://pubmed.ncbi.nlm.nih.gov/33760236/

MHRA has published guidance on the use of Lateral flow antigen self- test which can be found at: For patients, the public and professional users: a guide to COVID-19 tests and testing kits - GOV.UK (www.gov.uk

5.Please advise

a. on what date did Pfizer-BioNTech vaccine receive approval to be administered in the UK?

b. on what date did AstraZeneca vaccine receive approval to be administered in the UK?

c. on what date did Moderna vaccine receive approval to be administered in the UK?

d. on what date did Janssen vaccine receive approval to be administered in the UK

e. Please advise how it is possible for these four products to receive full approval to be administered within the UK, when the phase 3 clinical trials do not end until later this year or even into 2023?

f. Is this a common occurrence that medical drugs receive full approval to be administered to patients in the United Kingdom prior to the completion of a phase 3 clinical trial?  Please provide the data to show how many times this has happened in the previous 10 years.

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:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

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:

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

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:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen

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:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

A marketing authorisation was granted for Valneva suspension for injection (PL 43185/0002) on 13 April 2022. A Public Assessment Report will be published in the next 20 working days. Further information can be obtained from the links below:

https://www.gov.uk/government/news/valneva-covid-19-vaccine-approved-by-mhra

https://products.mhra.gov.uk/search/?search=PL+43185%2F0002&page=1

The main efficacy and safety results for the Phase I, II and III trials for all authorised vaccines have been submitted to MHRA, sufficient that these vaccines can be authorised for use in the patient populations stated in the Information for Healthcare Professionals/Summary of Product Characteristics for each vaccine. These studies are currently ongoing to follow-up vaccine recipients to collect additional safety data, in the same way that all clinical trials for new medicines follow up their study subjects after the main results of the study have been reported. Other studies that are currently in progress are to investigate the use of vaccines outside of the current authorisations (such as giving different brands of vaccine for the first and second doses).

Please review the following information links on MHRA and EMA conditional marketing authorisation.

https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: info@mhra.gov.uk

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Experience Centre