India’s largest vaccine maker has a bandaid fix for students travelling abroad till the time its vaccine has universal acceptance. Adar Poonawalla, CEO of Serum Institute of India that manufactures the local variant of the AstraZeneca vaccine, has set aside Rs 10 crore for Indian students struggling with quarantine restrictions abroad.
Poonawalla’s tweet comes in the context that several countries that recognise AstraZeneca’s Covid-19 vaccine Vaxzevria have not given an automatic approval to Covishield, the SII-manufactured brand of the same shot.
In countries like the United Kingdom, where Vaxzevria is approved and Covishield is not, travellers despite being fully vaccinated may have to quarantine for 10 days. Covishield is also currently excluded from the European Union’s green pass, though 16 European countries have said they will accept the vaccine. This is despite the fact that it is on the list of the World Health Organization’s approved Covid-19 vaccines.
While Poonawalla’s initiative is meant for Indian students, there are millions of travellers in the 18 countries where Covishield is approved and in use, who are currently impacted by the lack of blanket approval.
Both the Indian government and Poonawalla have said that they will work with the authorities of countries where Covishield is not recognised to get it approved. But it’s not as simple as that.
Vaccine approvals are complex and involve several applications. For one, drug regulators do not consider different brands of the same vaccine as identical.
“Covishield being ‘essentially the same’ is not a term that has any meaning to drug regulators, as the European Medicines Agency and UK’s Medicines and Healthcare products Regulatory Agency have clarified,” Murali Neelakantan, principal lawyer at law firm amicus, who has extensive experience in the pharmaceutical sector, told Quartz. Neither the European Medicines Agency nor the Medicines and Healthcare products Regulatory Agency has approved Covishield, and only the latter has approved Vaxzevria version manufactured by SII.
Even when products are considered identical, regulators need to evaluate the product and the manufacturing facility for safety.
Drug regulators in the world like the Medicines and Healthcare products Regulatory Agency or the US’s Food & Drug Administration “do not have any procedure for automatic approval of drugs”, Murali said. “India does not either. No such system exists anywhere in the developed world.” That means that Serum Institute of India would need to seek approval with each regulator separately.
Before even considering that Serum Institute of India would need to seek a licence from AstraZeneca to sell in the EU, the US, and other developed countries. And since it does not have this license, it may not have considered seeking regulatory approvals.
“If SII was manufacturing Vaxzevria for the EU market, AstraZeneca could add the Serum Institute of India facility to the list of other facilities manufacturing Vaxzevria and seek approval from EMA,” Murali explained. “Similarly, AZ could apply to other national drug regulators to add the SII facility in its authorisations. That would enable SII to sell Vaxzevria in those markets but wouldn’t help Indians overcome travel restrictions since Indians have had Covishield and not Vaxzevria.”
Ideally, the onus of easing international travel for students lies on the foreign ministry. “One cannot fault SII for this unprecedented situation,” Murali said. “The government of India was aware of the EU Green Pass programme and possible restrictions since January but doesn’t seem to have addressed it.”
But the EU vaccine pass doesn’t really concern Indian travellers. The EU Green Pass is restricted only to EU citizens and as such would make no difference to Indian travellers. Yet, India’s external affairs minister S Jaishankar said on June 30 that he took up the matter of travellers who got Covishield doses with a high representative of the EU. Since the announcement of the Green Pass and Covishield’s exclusion from it, 16 countries have been able to allow those who have taken two doses of the India-made vaccine to travel with fewer restrictions.
Covishield’s approval is more to do with issues of public health than marketing rights, Murali said. “The decision to allow vaccinated Indians will be based on a risk profile which takes into account the extent of Covid in India, levels of infection and vaccination rates,” Murali said.
Add to this the issue of the credibility of vaccine certificates issued in India. Widespread fraud has been reported both in cases of RT-PCR test results and fake vaccination certificates, which is likely why countries are still circumspect about removing all restrictions for Indian travellers.
“Given the frauds that we have seen with both RT-PCR certificates and vaccination certificates, can you really blame other countries for being circumspect about Indian travellers?” Murali said.
This article first appeared on Quartz.
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