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Covid-19 resources: Medicines and Healthcare products Regulatory Agency

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Page last updated 5 July 2021.

The MHRA concludes positive safety profile for Pfizer/BioNTech vaccine in 12- to 15-year-olds

  • Government response – Following a satisfactory review, MHRA extends authorisation of NHS Test and Trace lateral flow devices

Information for the public about lateral flow devices (LFDs) provided by NHS Test and Trace

Previous posts

The safety of the public will always come first.

  • News story – Oxford/AstraZeneca COVID-19 vaccine: MHRA statement confirming letter received

The safety of the public will always come first.

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

  • Decision – Regulatory approval of Pfizer / BioNTech vaccine for COVID-19.

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

  • News story – June Raine: How we backed a COVID-19 vaccine before rest of the West

MHRA Chief Executive Dr June Raine explains the process behind the Agency’s approval of the Pfizer/BioNTech vaccine

  • Press release – Confirmation of guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine

Statement by Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency on the guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine

Tariffs suspended on a wide range of goods in the fight against Covid-19 including face masks, gloves and other protective equipment.

  • News story – Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC

The National Institute for Biological Standards and Control will carry out independent testing in the UK for any potential

  • Press release – Oxford University/AstraZeneca COVID-19 vaccine approved

The new vaccine has been approved after meeting the required safety, quality and effectiveness standards.

  • Decision – Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

  • News story – Access Consortium regulators pledge support to tackle COVID-19

The Access Consortium regulatory authorities have pledged our collective support in countering the COVID-19 global pandemic.

  • Press release – Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator

The vaccine has been approved after meeting the required safety, quality and effectiveness standards.

  • News story – Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC

The National Institute for Biological Standards and Control will carry out independent testing in the UK for any potential COVID-19 vaccines.

Information for healthcare professionals and the public about the COVID-19 Vaccine Moderna

Data published from UK’s independent medicines regulator confirms approved vaccines meet strict regulatory standards for safety

Information for healthcare professionals and the public about the COVID-19 Vaccine Moderna

It has not been confirmed that the reports of blood clots were caused by the AstraZeneca COVID-19 vaccine. People should still go and get their COVID-19 vaccine when asked to do so.

  • Government response – UK regulator confirms that people should continue to receive the COVID-19 vaccine AstraZeneca

Following suspensions by some countries of the COVID-19 Vaccine AstraZeneca over suspected blood clots, the MHRA confirms that the benefits of the vaccine in preventing COVID-19 far outweigh the risks. People should still go and get their COVID-19 vaccine when asked to do so.

  • Decision – Medical devices given exceptional use authorisations during the COVID-19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

  • Press release – MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots

The benefits of vaccination continue to outweigh any risks but the MHRA advises careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition.

  • Government response – MHRA response to JCVI advice on COVID-19 Vaccine AstraZeneca for people aged under 40
  • Decision – Medical devices given exceptional use authorisations during the COVID-19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

  • Decision – Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.

  • Government response – Pfizer/BioNTech COVID-19 vaccine shelf-life extended from 5 to 31 days, says MHRA

Change approved following detailed review of additional stability data

  • Decision – Medical devices given exceptional use authorisations during the COVID-19 pandemic

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

  • Decision – Regulatory approval of COVID-19 Vaccine Janssen

Information for healthcare professionals and the public about the COVID-19 Vaccine Janssen

  • Press release – One-dose Janssen COVID-19 vaccine approved by the MHRA

The vaccine has been approved after meeting the required safety, quality and effectiveness standards.