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The Oxford-AstraZeneca vaccine to fight Covid-19 has been taken by several million people around the world.
Although the vaccine has been shown to be effective and safe in clinical trials, where it is manufactured can influence whether a country considers it valid for entry.
There is no indication that the AstraZeneca vaccine made in India does not work as well as the one made in Europe
Prof. Paul Hunter, University of East Anglia
The vaccine is known as Vaxzevria when made in Europe, but the doses produced by the Serum Institute of India carry the Covishield trademark.
The European Medicines Agency has not yet approved Covishield. This has created obstacles for travelers wishing to visit many EU member states.
What is Covishield?
Covishield is the same vaccine produced in Europe, except that it is made by IBS, the world’s largest vaccine manufacturer.
Like the European version of the Oxford-AstraZeneca vaccine, it is a harmless version of a type of virus called adenovirus that normally infects chimpanzees.
This adenovirus received genetic material from the added coronavirus. When the vaccine enters the human body, the recipient’s cells produce spike proteins like those of the coronavirus. This teaches the immune system to recognize them and to react if the individual is subsequently exposed to the virus.
Which organizations have approved Covishield?
India’s Central Drugs Standard Control Organization approved the emergency use of Covishield in January.
The following month, the World Health Organization granted emergency use authorization for the Oxford-AstraZeneca vaccine, whether made in Europe or India. This includes doses manufactured by SII.
The UK Medicines and Health Products Regulatory Agency (MHRA) has also approved the use of doses made in India.
But the EMA – the EU regulator – has not done so, so some countries in the bloc do not accept vaccination with vaccines made in India for entry.
Last month, it was reported that a British couple had been barred by their airline from traveling to Malta because they received the Covishield vaccine rather than Vaxzevria.
The British Secretary for Transport, Grant shapps, then tweeted that the Maltese had changed their travel advice to avoid similar incidents.
Why did the EMA not approve the doses made in India?
The EMA’s failure to approve IBS as an alternative manufacturer of the Oxford-AstraZeneca vaccine appears to be simply a “licensing / bureaucratic issue,” said Professor David Taylor, professor emeritus of drug policy and public health at University College London.
He said obstacles had arisen due to the speed at which Covid-19 vaccines were developed and approved, and that there was no indication of safety concerns with the Indian vaccine.
“It all depends on whether it is an emergency situation. I wouldn’t blame anyone, ”he said. “It is absolutely true that we care about security and want things to be allowed by the [appropriate] licensing authority. “
Professor Paul Hunter, an infectious disease specialist at the University of East Anglia in the UK, said there were “no public health concerns” with the doses made in India.
“As far as I know, there is no indication that the AstraZeneca vaccine made in India does not work as well as the one made in Europe,” he said.
He said drugs from some countries might not be approved if a counterfeit was suspected, but that was not a problem with the vaccine made in India.
What is the current situation with travel to and within Europe?
The EU has a Covid digital certificate for travel to the 27 EU countries and six other locations – Iceland, Liechtenstein, Norway, San Marino, Switzerland and Vatican City.
The European Commission says: “Member States will have to accept vaccination certificates for vaccines that have received marketing authorization from the EU. “
This means that they are not required to accept snapshots made in India, and participating nations apply the same rules for visitors from outside Europe.
But the EC also says member states “may decide” to accept other vaccines. About half of the countries that are part of the EU’s Covid digital certificate have approved Oxford-AstraZeneca snapshots made in India.
Covishield is now accepted by, among others, Austria, Bulgaria, France, Germany, Iceland, Spain, Sweden and Switzerland.
But a dozen European countries are awaiting the green light from the EMA, so visitors vaccinated by Covishield in Portugal, for example, may need to be quarantined upon arrival.
Update: Aug 9, 2021, 4:37 a.m.