This affects Canadians and others whose government recognizes Covishield as an accepted vaccine – while the EMA does not.
The French Ministry of Health said The connection it will only approve vaccines for the purposes of travel rules related to entry into France if they are approved by the EMA, an EU agency.
This is important because only fully vaccinated people (with approved vaccines) can currently enter France from non-EU countries without needing to have an essential reason (usually related to work or life here) and without a quarantine period. Essentially, this means that anyone coming for tourism and to visit a second home should be vaccinated.
There is controversy over the Indian-made doses administered in the UK (see below). These are not referred to as “Covishield” on vaccination certificates and telephone applications and are only identifiable by certain lot numbers. Despite this, the Indian manufacturer only exports one vaccine, so the substance is the same.
The lot numbers are 4120Z001, 4120Z002 and 4120Z003.
France has not confirmed whether it has tasked border officials to search for them.
What is Covishield?
Covishield is a vaccine manufactured by Serum Insitute of India (SII) in cooperation with AstraZeneca which allowed it to use its technology to make a vaccine in the same way as its own.
The Serum Institute of India currently manufactures and exports only one Covid vaccine, which is this vaccine that it typically brands as “Covishield”. but he is also working on a version of a vaccine from the American company Novavax.
IBS ‘AstraZeneca’ vaccine has been widely marketed in countries outside of Europe, including Africa, Canada, the Caribbean and South America. Vials of this vaccine have been sent to these countries with a green label bearing the name Covishield.
Does EMA recognize Covishield as the same as regular AstraZeneca vaccine?
No. The regular vaccine, previously called the COVID-19 AstraZeneca vaccine and now branded ‘Vaxzevria’, is one of the vaccines that have been granted marketing authorization in the EU by the EMA. However, the EMA said The connection: “In the EU, the vaccine called Covishield does not currently have a Marketing Authorization.
A spokesperson added that Vaxzevria is “the only” AstraZeneca vaccine currently authorized by the EMA and that for the purposes of EU authorization, vaccines manufactured by SII are not recognized as Vaxzevria.
He said: “EU law requires manufacturing sites and the production process to be assessed and approved as part of the authorization process for vaccines used in the EU. Our Product information for Vaxzevria shows in Appendix II starting on page 13 a list of currently approved manufacturing sites for this vaccine.
Serum Institute of India does not appear in this list.
The World Health Authority (WHO) has cleared Covishield and considers it a version of the AstraZeneca vaccine, and refers to both with the same technical name ChAdOx1-S [recombinant].
He indirectly criticized the EMA’s policy in a statement demanding that authorities everywhere recognize the vaccines it has approved. He said doing otherwise would worsen inequalities around the world in travel rights.
The European Commission has said that while Covishield is not accepted for its EU Covid digital certificate program, each EU country can make its own decisions about whether or not to accept visitors with vaccines listed. on the WHO list, including Covishield. Several countries, including Ireland, have done so.
Has the UK used doses of Covishield?
It is difficult to give a clear answer.
The UK Department for Health and Welfare (DHSC) said The connection: “No Covishield vaccine has been administered in the UK. All AstraZeneca vaccines administered in the UK are the same product and appear on the NHS COVID Pass as Vaxzevria. “
However, it is known that at the beginning of this year, SII sent five million doses of its vaccine to the United Kingdom.
They are identifiable by lot numbers and we know of several readers who have received confirmation of having received a dose that used one of them.
The British health regulator MHRA has evaluated the doses of the Indian vaccine and agreed to treat it as identical to the AstraZeneca vaccine. This is clarified, along with the lot numbers, in Annex 1 on this link.
According to the MHRA, however, the doses received by the UK did not bear the name “Covishield”.
A spokesperson said: “SSI manufactures both Vaxzevria and Covishield. All of the doses manufactured by SII approved by the MHRA and administered in the UK were referred to as the ‘COVID-19 AstraZeneca vaccine’, which is now known as ‘Vaxzevria’ – the MHRA has not approved the doses carrying the ‘Covishield’ brand and none were administered in the UK.
He added: ‘All vaccines authorized and deployed in the UK have undergone rigorous controls by the MHRA, including individual lot testing and site inspections, even when those sites are outside the UK. United. This data has been shared with the EMA.
We asked SII if they sometimes send lots without the name Covishield and if this is the case with doses sent to the UK but we have not received a response.
Will the IBS vaccine be approved by the EMA?
The CEO and owner of SII recently admitted that there were travel issues to the EU for those who had received his vaccine and that he was looking for a solution.
I realize that many Indians who have taken COVISHIELD are facing travel issues in the EU I assure everyone I have taken this to the highest level and hope to resolve this issue soon , both with regulators and at the diplomatic level of countries.
– Adar Poonawalla (@adarpoonawalla) June 28, 2021
AstraZeneca is now seeking EMA approval for the IBS vaccine, but as an adjunct to the authorization of Vaxzevria as opposed to a separate authorization process.
A spokesperson for AstraZeneca said: “We have requested the addition of Serum Institute of India as an alternative manufacturing site on the Vaxzevria license. A decision is expected shortly. “
Will anyone check the vaccination certificates of people entering France from the UK to look for vaccination with the IBS vaccine?
The French government has not responded to inquiries as to whether its border police will search for vaccine lot numbers, which is the only way to identify SSI doses used in the UK as such.
Travel agency policies regarding checking travelers’ vaccination certificates vary, but we have not identified any travel agencies that advise against traveling if your vaccine has a certain lot number.
Air France, for example, claims that passengers cannot travel if they do not present either a French attestation form identifying an essential reason for the trip, nor a vaccination certificate indicating a complete vaccination with one of the vaccines approved by the EU, including AstraZeneca.
Brittany Ferries said there was no need to check vaccination certificates, so it doesn’t. Eurostar said it was leaving the care to the French border police.
EasyJet says on its website that travelers to France must have a full vaccination certificate with one of the names approved by the EU, including AstraZeneca, and they must bring it, because “the certificate may be requested from different moments of the trip ”.
Questions Raised about Covishield, UK Vaccination and EU Travel