The United Kingdom’s medicines regulator has shared applicable 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 Road said on Friday.
British Prime Minister Boris Johnson also said that he’s ‘very self-assured’ 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 trip.
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 self-assured that there will not prove to be a problem,” Prime Minister Johnson told reporters at a press convention with German Chancellor Angela Merkel at Downing Road when asked approximately the issue.
Five million Covishield-branded doses were shipped from India as a part of the United Kingdom’s 100-million-dose AstraZeneca order with SII earlier this year. On being asked approximately travel-related concerns, Johnson reiterated that he saw “no reason at all” why MHRA-approved vaccines must not be used for vaccine passports.
“They are the same product which has been authorised and checked for safety and quality by our MHRA,” a Downing Road 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 one at a time already approved the India-made vaccine, including Austria, Germany, Slovenia, Greece, the Republic of Ireland, Spain, Iceland and Switzerland.
According to ‘The Day by day Telegraph’, people who have received doses from batches manufactured in India could face being blocked from taking European holidays because of the Covishield vaccine not being authorised by Europe’s regulator, and due to this fact not recognised by the EU.
“I realise that a large number of Indians who have taken Covishield are facing issues with trip to the EU; I assure everyone, I have taken this up at the highest levels and hope to unravel 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 used to be just a matter of time.
“The EMA is right 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 self-assured the EMA will approve Covishield. There is not any reason not to as it is based on AstraZeneca data and our product is the same to AstraZeneca, kind of,” he said.
UK Vaccines Minister Nadhim Zahawi also expressed his confidence in the jabs right through his session at the forum on Thursday.
“They (SII) are backed by the world’s most highly regarded regulator, the United Kingdom’s MHRA, which makes them one of the most safest, best and largest vaccine manufacturers on the planet,” 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 trip and it is in touch with member states of the bloc over this issue.
Ministry of Outside Matters Spokesperson Arindam Bagchi said in New Delhi that the European Union has now instituted what is known as 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 also 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 plenty 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 trip to their countries.
Austria, Germany, Slovenia, Greece, Iceland, Ireland and Spain are some of the countries allowing trip by people who have taken Covishield vaccines, the sources said.
They said Switzerland may be accepting Covishield as a Schengen state.
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