Home / News / India /  SII confident of getting EMA's approval for Covishield in a month, says Adar Poonawalla

The Covishield vaccine produced by the Serum Institute of India and developed by AstraZeneca and Oxford University will receive approval from the European Medicines Agency (EMA) in a month, SII's chief executive officer Adar Poonawalla said on Wednesday.

At India Global Forum 2021, Poonawalla said, "The EMA is absolutely correct in asking us to apply, which we have through AstraZeneca, our partners, a month ago, and that process has to take its time. An approval process even with UK MHRA, WHO took its time and we have applied to the EMA."

"We are quite confident that in a month EMA will approve Covishield. There is no reason why not to, because it is based on AstraZeneca data and our product is identical to AstraZeneca more or less and it has been approved by WHO, UK MHRA. So it's just a matter of time. It is not really going to hinder anything," the SII CEO added.

On Covid vaccine passports

On the issue of vaccine passports, the SII CEO said that it was a slightly different issue.

"The issue with vaccine passports is slightly different. What I am trying to say is that let us take a manufacturer outside of India. Let's say they have been approved by WHO and everyone in that country gets vaccinated taking that product and now when those citizens need to travel, what good is their vaccine certificate if it is not acknowledged and reciprocity is not there between the countries," Poonawalla said.

It is that level of reciprocity that is expected between all these nations, he added.

On the issue of waiving of intellectual property rights on vaccines to increase the supply, Poonawalla said waiving of IP is perhaps not going to solve the immediate shortage of vaccines. However, it is a good strategy in the long term, to be prepared for future pandemics.

Stating that it was difficult for the company to stop the export of Covishield as it had prior commitments, he however said Serum did it in the wake of the second wave of the pandemic hitting India.

Decision of stopping the exports was particularly stressful, "because it was not just our partner AstraZeneca that needed vaccines for the other parts of the world, it was COVAX, it was other countries that we had commitments with, we had taken advance funding, we had to return some of that funding, and really explain to other world leaders as well that there was really no choice at that moment ," Poonawalla said.

"We had to tell them that we really had to support our nation at that moment for a few months and that we would get back to them," he added.

It was really difficult for everyone to digest that, but slowly as they realised what was going on in India everyone was really supportive and understanding, Poonawalla said.

Covishield fights the emerging Delta Plus variant

The Union Health Ministry has said that the Covid-19 vaccines work against the Delta variant of the virus. Union health secretary Rajesh Bhushan had earlier said, "In India, the two vaccines, Covishield and Covaxin, are effective against the Delta variant. We will be sharing soon the effects of the various vaccines on the Delta variant, antibody titer."

Health experts and virologists, on the other hand, have hinted that the Delta Plus variant of Covid-19 could evade both vaccine and infection immunity.

A few days back, health expert and American scientist Eric Feigl-Ding had said that AstraZeneca's Covid-19 vaccine may have limited effectiveness against the Delta variant of SARS-CoV-2. Citing a study, Feigl-Ding said, “The efficacy of AZ [AstraZeneca vaccine] against the Delta variant is not 90% (it’s 60%), Pfizer is 88% in one non-trial study. However, 1 dose of vaccine (both types averaged) is just 33%. And many countries have given just 1 dose."

Feigl-Ding’s findings have stirred fears of the AstraZeneca's coronavirus vaccine giving little protection against the newly detected Delta Plus variants.

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