Government seeks authorisation of coronavirus (COVID-19) vaccine supply

Government seeks authorisation of coronavirus (COVID-19) vaccine supply

The Department of Health and Social Care has announced that the government has now formally requested that the Medicines and Healthcare products Regulatory Agency (MHRA) consider whether the supply of the Oxford/AstraZeneca coronavirus (COVID-19) vaccine can now be authorised. The UK has secured access to 100 million doses of the vaccine, with four million proposed to be ready by the end of 2020 and a further 40 million by the end of March 2021. Once the Oxford/AstraZeneca vaccine’s safety, quality and efficacy data has been submitted to the MHRA, the regulator can begin assessing the suitability of it for temporary supply under regulation 174 of the Human Medicines Regulations 2012 (HMR 2012), SI 2012/1916.

The government has previously requested the MHRA to review suitability of the Pfizer/BioNTech vaccine under HMR 2012, SI 2012/1916, reg 174.

Source: Government asks regulator to approve supply of Oxford/AstraZeneca vaccine

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