France now accepts Covishield vaccine: What will this change?

The government previously said it was not accepting the Indian-made vaccine, which is produced using the same methods as the AstraZeneca vaccine, as it does not have European Medicines Authority approval

17 July 2021
Vials of the Covishield vaccine

France is now accepting the Covishield vaccine as part of its health pass system Pic: Paparazzza / Shutterstock

By Thomas Brent

France now accepts the Indian-made equivalent to the AstraZeneca Covid-19 vaccine, Covishield, as part of its ‘health pass’, it was officially announced today July 17.

This marks a U-turn as the French health ministry previously stated that France would not accept the vaccine based on the fact that the European Medicines Agency (EMA) has not authorised it.

Covishield is produced by the Serum Institute of India (SII) using the same methods as the EU-approved Oxford-AstraZeneca vaccine, known as Vaxzevria, and in an agreement with AstraZeneca. Its efficiency as a Covid vaccine matches that of Vaxzevria and there is no additional doubt cast on its safety. 

However no application has been made for EMA marketing authorisation for Covishield, nor has EMA approved the Indian factory site so as to add its vaccine to the authorisation for AstraZeneca, although the latter has recently been requested by AstraZeneca.

Today in a statement from the prime minister’s office France said it is now accepting the vaccine, meaning people who have been vaccinated with it are considered fully vaccinated under its travel and other rules.

The change was formalised today in a decree which said in article 1, section 2, that whereas before France only accepted vaccines authorised by the EMA, it now also accepts ones recognised by French medicines regulator ANSM to have a similar composition and manufacturing process. 

What will approval change in France?

Covishield will be accepted for France’s pass sanitaire (health pass). This refers to one of the approved ways of proving Covid-19 status.

This can be done by presenting one of the following certificates:

  • A Covid-19 test (rapid antigen or PCR) showing a negative result and taken within the past 48 hours
  • A Covid-19 vaccination certificate showing full vaccination
  • A Covid-19 test (rapid antigen or PCR) showing a positive Covid-19 result, taken between 11 days and six months prior

If Covishield is accepted as part of the health pass system, then it means people who have received it will be able to enter France without additional travel restrictions as they are considered ‘fully vaccinated’ and will also be able to use their vaccination proof to enter public places in France restricted to people with health passes. 

Read more: 12 questions on how to use the French health pass from July 21

Read more: How will foreign visitors to France use health pass to go to a cafe?

This affects Canadians, among others, whose government recognises Covishield as an accepted vaccine.

Five million doses of the vaccine were also delivered to the UK from the Serum Institute of India earlier this year – although the UK’s Department of Health and Social Care (DHSC) says they were not branded as Covishield and its Indian-made vaccines have not been identified as such on certificates and the NHS APP, only as AstraZeneca vaccine or its brand name Vaxzevria. 

The Serum Institute, however, only makes one vaccine, which it usually markets as Covishield. The vaccines sent to the UK are recognisable by the batch numbers 4120Z001, 4120Z002 and 4120Z003. 

France's change over Covishield will also remove uncertainty as to whether the country could have explicitly started refusing to accept these batches as valid, as Malta does

You can read more about Covishield use in the UK here. 

Proof of Covid status will be required in France to enter public places with over 50 people from July 21, subject to parliamentary approval.

France also plans to make the health pass a requirement to enter cafes, restaurants, bars, cinemas and long-distance transport services from the beginning of August.

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