Shortly after Prime Minister Narendra Modi made a visit to its facility in Pune, Serum Institute of India (SII) said on Saturday that it was hoping to seek an emergency-use licence within the next two weeks for the Covid-19 vaccine that it has been testing on Indian volunteers.
Apart from SII, Modi also visited the vaccine development facilities of Zydus Cadila in Ahmedabad and Bharat Biotech in Hyderabad. Both these companies are testing a vaccine they have indigenously developed.
SII, on the other hand, has been testing a vaccine developed by Oxford University and pharmaceutical company AstraZeneca. Serum has the rights to manufacture and distribute this vaccine in India and other middle- and low-income countries. This vaccine is being tested in other countries as well.
Earlier this week, the results from one of its trials had come under a cloud over ‘errors’ in reporting the correct dosage of the vaccine, but SII CEO Adar Poonawalla said the “confusion” was unlikely to affect the fate of the vaccine in India, or even in other countries. Poonawalla ruled out additional testing of the vaccine in light of this ‘error’.
“There was a bit of confusion in the communication, which will be explained in the coming days. But that is not going to affect the emergency-use licence for the vaccine in the UK, and should not affect that in India at all,” he said, adding, “We are in the process of applying for an emergency-use licence in India in the next two weeks.”
SII is still to announce results from its combined Phase-2 and Phase-3 testing of the vaccine. It had earlier said that this could be expected sometime in December.
A licence for emergency use can be granted by India’s drug regulator if it is satisfied, even from preliminary results, that the vaccine is effective in preventing the disease. A full authorisation can be given only after the completion of the trials and assessment of the data generated from it.
A statement issued by the Prime Minister’s Office said Modi, during his visit to the vaccine facilities, stressed that India considered these vaccines “as not only vital to good health but also as global good” and that it was “India’s duty to assist other countries, including the nations in our neighbourhood, in the collective fight against the virus”.
“The Prime Minister expressed pride in the fact that India’s indigenous vaccine development has progressed at such a rapid pace so far. He spoke on how India is following sound principles of science in the entire journey of vaccine development, while also asking for suggestions to make the vaccine distribution process better,” the statement said.
SII’s Adar Poonawalla, speaking at a virtual press conference after Modi’s visit, said it was important that all the necessary information about vaccine development is put out in a transparent manner, so that people have confidence in the vaccines.
“In these times of vaccine hesitancy, we need to send out the right messages and not create doubts in the minds of the people,” he said. He stressed that the Oxford University vaccine was “a good one” and effective against the disease.
“There were zero hospitalisations amongst those who took the vaccine (during trials)… The vaccine can be transported at normal refrigerator temperatures, unlike some of the other candidates that require extreme cold storage,” he said.
Poonawalla said he expected the Indian government to procure about 300-400 million doses of this vaccine in the next six months. “At present, we do not have anything in writing from the government on how many doses will be purchased, but there are indications from the Health Ministry that it would be in the range of 300 to 400 million doses by July 2021,” he said.
With inputs from Avinash Nair in Ahmedabad, and Sreenivas Janyala in Hyderabad
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