The European Medicines Agency's exclusion of Covishield- the Oxford-AstraZeneca COVID-19 vaccine produced by Serum Institute of India- from European Union's Digital Green Pass has created problems not only for India but also for countries that received Covishield through the COVAX deal.
An AstraZeneca spokesperson told BOOM that the company is trying for Covishield to be included among the vaccines selected for EU's green pass. According to EU's Europa website, a Digital Green Pass or Certificate "will be a proof that a person has been vaccinated against COVID-19, has received a negative test result or has recovered from COVID-19 that can be used across all EU Member States."
AstraZeneca in its statement to BOOM said, "We are working closely with the EMA as they develop guidance to support opening of borders and relaxing restrictions, and this includes guidance on inclusion of COVISHIELD as a recognised vaccine for immunisation passports."
It is pertinent that Covishield be included among the list as it is the vaccine that has been distributed to several developed and low- and middle-income countries through the WHO- COVAX initiative. The African Centres of Disease Control and Prevention have opposed this move as Covishield is the only vaccine that most African nations are distributing among its citizens. Residents of many Asian, and African countries as well as Canada who have received Covishield will have to face issues in travelling on their Schengen's visa because of the exclusion of the vaccine.
The digital green pass only permits unhindered mobility for those who received Vaxzevria (AstraZeneca manufactured in Europe), Pfizer-BioNTech, Moderna, and J & J's COVID-19 vaccines. Those who have received any other vaccines will have to follow quarantine just like those who are actually unvaccinated.
The EMA, however, has specified that individual states can create their own regulations too for other vaccines. Some Twitter users in France who received Covishield in India tweeted that they will have to follow a ten-day quarantine period in the country.
Taking into consideration the issues raised by the African nations, BOOM asked both SII and AstraZeneca if SII was unaware that they had to apply separately for authorisation in the European Union. Both SII and AZ chose not to comment on this issue.
A Serum spokesperson told BOOM that they have nothing else to share apart from their CEO Adar Poonawalla's tweet in which he informed that he was interacting with regulators and the respective countries to ensure that people who received Covishield would not face issues while travelling in EU.
While the EMA has not yet replied to BOOM, in a statement to CNN, the EMA stated that Covishield is not under review and never applied to the EMA for authorisation.
BOOM spoke to Murali Neelakantan, former Global General Counsel at Cipla and Glenmark, who shared that since SII was not contractually bound to produce vaccines for Europe, it perhaps never considered applying for approval there.
"If Serum had no intention of selling these vaccines in the EU, it would not have any incentive to go and apply by itself for the approval of this drug in the EU. As far as I understand it, the license from AstraZeneca to the Serum Institute does not include Europe as a territory. So, Serum does not have a license from AstraZeneca to manufacture this vaccine to sell in the European Union. And therefore, may not have been considered as a necessity to even seek an authorisation. Why should it? So, AstraZeneca did not intend perhaps for Serum to manufacture a vaccine and be sold in the European Union. Therefore, again, AstraZeneca did not see any need to include the Serum manufacturing facility during the application for approval," Neelankantan said.
The EMA in its reply to CNN stated that in the EU, the vaccine called Covishield does not currently have a marketing authorization. "Even though it may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules. This is because vaccines are biological products and even tiny differences in the manufacturing conditions can result in differences in the final product. The EU law therefore requires the manufacturing sites and production process to be assessed and approved as part of the authorization process," the EMA said while justifying why it has excluded Covishield.
