Fuller approval for AZ/Oxford vaccine

On 24 June, the MHRA granted a Conditional Marketing Authorisation (cMA) in respect of the COVID-19 vaccine produced by AstraZeneca in collaboration with the University of Oxford – making AstraZeneca the second company (after Janssen, whose vaccine we have previously discussed) to receive such a cMA in the UK. Before this, since December 2020, the AstraZeneca vaccine had been supplied under a temporary authorisation issued by the MHRA under section 174 of the Human Medicines Regulations 2012.

A cMA is not a full marketing authorisation, but is a route used to approve new medicines such as vaccines and other COVID-19 treatments while additional data is gathered and submitted to regulators. Unlike a full Marketing Authorisation, a cMA is granted for one year and can be renewed annually.

Under the terms of the cMA, AstraZeneca must continue to conduct studies into possible mechanisms for the side effects of the vaccine. The first of these deadlines arrives in a little over a month, on the 31st of July, when AstraZeneca must submit a final report on expression of the S protein of the vaccine, which has been posited as a possible cause of platelet activation and blood clots after vaccination. By 2024, AstraZeneca must also have conducted studies on the rare thrombosis and thrombocytopenia which have been observed in vaccinated people, and which have led the MHRA to prevent the AstraZeneca vaccine being issued to under-40s in the UK.

The investigations into the potential side effects of the AstraZeneca vaccine will be of particular importance as it makes up 96% of the doses provided by the COVAX programme to the world’s poorest countries. In addition, as part of the collaboration agreement between AstraZeneca and the University of Oxford (negotiated with the help of Matthew Warren and his team at Bristows), the vaccine will be supplied at-cost to developing nations until the pandemic is over. Following up on these studies will be crucial in maintaining global public confidence in the AstraZeneca vaccine.

The cMA also stipulates that AstraZeneca must carry out and submit 6-month immunogenicity data to provide information on antibody persistence after vaccination. It remains unclear how immunity fades after vaccination, and such data will be key in assessing the need for “booster” shots to avoid the need for further lockdowns.