The UK’s medicines regulator has shared relevant data with its counterpart in the European Union (EU) to facilitate the clearance of Covishield, the India-made version of the Oxford/AstraZeneca COVID-19 vaccines, Downing Street said on Friday. British Prime Minister Boris Johnson also said that he is ‘very confident’ of the approvals of the Oxford/AstraZeneca jabs by the EU.
The Medicines and Healthcare products Regulatory Agency (MHRA) had approved the Serum Institute of India (SII) produced vaccines, but the European Medicines Agency (EMA) is yet to give its nod for the region’s so-called vaccine passports for travel. It has led to concerns that Indians vaccinated with Covishield and thousands in Britain who received the India imported jabs may face hurdles when travelling to the EU.
“I am very confident that there will not prove to be a problem," Prime Minister Johnson told reporters at a press conference with German Chancellor Angela Merkel at Downing Street when asked about the issue. Five million Covishield-branded doses were shipped from India as part of the UK’s 100-million-dose AstraZeneca order with SII earlier this year. On being asked about travel-related concerns, Johnson reiterated that he saw “no reason at all" why MHRA-approved vaccines should not be used for vaccine passports.
“They’re the same product which has been authorised and checked for safety and quality by our MHRA," a Downing Street spokesperson had said earlier on Friday, as it confirmed that the MHRA had shared its assessment of the vaccines with the EMA to assist the approvals process. The EU is rolling out a Digital Covid Certificate so travellers can prove their vaccination status to be exempt from quarantining when crossing an international border. Several European countries have separately already approved the India-made vaccine, including Austria, Germany, Slovenia, Greece, the Republic of Ireland, Spain, Iceland and Switzerland.
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According to The Daily Telegraph’, people who have received doses from batches manufactured in India could face being blocked from taking European holidays due to the Covishield vaccine not being authorised by Europe’s regulator, and therefore not recognised by the EU. I realise that a lot of Indians who have taken Covishield are facing issues with travel to the EU; I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries, SII CEO Adar Poonawalla said on Twitter earlier this week.
Addressing the recently-concluded India Global Forum, Poonawalla had said the delay in the EMA’s approval was just a matter of time. The EMA is correct in asking us to apply, which we have through AstraZeneca a month ago, and that process has to take its time. In a month, we are confident the EMA will approve Covishield. There is no reason not to as it is based on AstraZeneca data and our product is identical to AstraZeneca, more or less," he said.
UK Vaccines Minister Nadhim Zahawi also expressed his confidence in the jabs during his session at the forum on Thursday. They (SII) are backed by the world’s most highly regarded regulator, the UK’s MHRA, which makes them one of the safest, best and largest vaccine manufacturers in the world, Zahawi said. India on Friday said it expects that its CoWIN vaccination certificate would be recognised by the European Union on a reciprocal basis for travel and it is in touch with member states of the bloc over this issue.
Ministry of External Affairs Spokesperson Arindam Bagchi said in New Delhi that the European Union has now instituted what is called an EU digital COVID certificate for exempting restrictions on the movement of vaccinated people. “Our expectation is that Indians who have been vaccinated through our domestic vaccination programme would be treated at par with those vaccinated in the EU and the CoWIN vaccination certificate would be recognized by the EU on a reciprocal basis," he said at an online media briefing.
“As you are aware, such CoWIN vaccination certificates can be authenticated on the CoWIN website itself. We are in touch with the EU member states in this regard for reciprocal acceptance," Bagchi said, noting that a number of EU countries have already taken “positive steps" in this direction. His remarks came a day after sources said nine European nations are accepting Covishield vaccines for travel to their countries.
Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain are among the countries allowing travel by people who have taken Covishield vaccines, the sources said. They said Switzerland is also accepting Covishield as a Schengen state.