Vaxzevria (AstraZeneca) Covid-19 vaccine: Recognition of batches manufactured in India
This briefing provides an overview of the regulatory concerns associated with batches of the Vaxzevria (previously called AstraZeneca) vaccine that were manufactured in India and the associated travel issues.
In July 2021, there were reports that people travelling from the UK to EU countries (where proving Covid-19 vaccination status is needed to enter), were being refused entry because of the type of vaccine they’d had.
These people had received at least one dose of a Vaxzevria (previously called AstraZeneca) vaccine from one of three batches manufactured at the Serum Institute of India (SII) and administered in the UK.
Concerns about the regulatory status of Vaxzevria manufactured by the SII are related to another Covid-19 vaccine, Covishield, also manufactured by the SII. While Covishield has the same biochemical formulation as Vaxzevria, the licensing and proprietary arrangements differ.
What is the regulatory status of Vaxzevria in the UK and EU?The UK medicines regulator, the Medicines and Healthcare products Agency (MHRA), has issued a conditional marketing authorisation for Vaxzevria, which allows it to be marketed in the UK.
While the majority of Vaxzevria vaccines have reportedly been manufactured in the UK and EU, the MHRA authorised three batches of Vaxzevria to be manufactured by the SII and around five million of these doses were administered as part of the UK vaccination programme.
The European Commission has also issued a conditional marketing authorisation for Vaxzevria, enabling it to be marketed in all EU Member States, Iceland, Norway and Liechtenstein.
What is the regulatory status of Covishield in the UK and EU?The SII is a large-scale manufacturer of another Covid-19 vaccine called Covishield.
Vaxzevria and Covishield have the same chemical composition but are subject to different proprietary and licensing arrangements. Covishield has been granted an emergency use listing by the World Health Organization. This vaccine is mainly being used in low to middle income countries via the COVAX scheme.
Covishield is not currently licensed for use in the UK and has not been administered in the UK vaccination programme. Similarly, Covishield has not been licensed for use by the EMA. At the time of writing, neither the MHRA nor EMA have received applications for marketing authorisations for Covishield.
There has been some confusion about the regulatory status of the SII manufactured Vaxzevria vaccines, with some suggestion that they are being recognised as Covishield vaccines by some EU countries. It has been reported that recipients of the SII manufactured vaccines of Vaxzevria were being refused entry to countries where vaccination with an approved vaccine is an entry requirement.
The EMA does not appear to have published information about any regulatory concerns over SII manufactured Vaxzevria.
Whilst Covishield is not presently recognised in England for travel purposes, the UK Government has said that Covishield vaccines administered in some countries will be recognised as approved vaccines for travel purposes from 4 October 2021. Some EU countries are reportedly accepting Covishield vaccines for travel purposes.
[1] MHRA, Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca), last updated 24 Jul 2021
[2] EMA, Vaxzevria (previously Covid-19 vaccine AstraZeneca), accessed 5 Aug 2021