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Nod for emergency use authorisation expected in a few days: SII’s Adar Poonawalla
The Pune-based vaccine maker’s CEO Adar Poonawalla said separately on Monday that approvals were expected in a few days,
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) is likely to meet this week to examine Serum Institute of India (SII)’s application for emergency use authorisation (EUA) of the Oxford University-AstraZeneca Plc. vaccine candidate against the coronavirus disease (Covid-19).
The Pune-based vaccine maker’s CEO Adar Poonawalla said separately on Monday that approvals were expected in a few days,
The subject expert committee of the CDSCO is likely to be convened this week to go through SII’s application, a government official with knowledge of the matter said, requesting anonymity.
“All the data has been submitted to both the regulators. By January we should have the Oxford-Astrazeneca vaccine licensed in India,” Poonawalla, whose company is manufacturing and testing the vaccine in India, told reporters.
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The regulators he referred to were the Drugs Controller General of India (DCGI) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The DCGI is the head executive of the CDSCO.
“Eminent experts are examining it (the data) right now and nobody wants to rush through the process. We must give a few more days for the good news to come, ” Poonawalla said. “Then it will be down to the government to decide how much [of the vaccine] to take and when to take as they would be looking at at least 300 million doses by July 2021.”
He also said that he was looking at the end of December or early January for the MHRA approval to come in. “Then from India also we are hopeful to get it as currently the Drugs Controller General of India is looking at the data, and not just from India but also data from UK, South Africa and everywhere else. He is doing a great job,” Poonawalla said.
Initially, SII is looking at providing 50 million doses to India. The company has already made about 50 million doses that it will be ready to supply after receiving regulatory approvals.
Poonawalla noted that India was also a part of Covax, the global initiative to ensure rapid and equitable access to vaccines for all countries.
“...we have always said that we will keep giving 50% of everything we make to India and to Covax at the same time. So, if we are producing 60-70 million doses every month, there will be plenty of vaccines to go around both to India and to Covax countries, including some of our neighbours like Bangladesh etc. because everybody wants the vaccine, and we are trying to give as much as we can and equitably to nations including India.”
Initially, the company may give most of its production to India because to export to these countries, it would need WHO’s pre-qualification.
“… that may take another month or so after it is licensed in India. That way India will have priority, and because India is such a large country that we may end up giving a majority of those 50 million doses to India first. Every month we are churning out 40-50 million doses which will go up to about 100 million doses every month by March as by then we are going to commission a third facility that is getting ready. Eventually everyone is going to get it; of course some countries will have to wait a little longer,” said Poonawalla.
He also said the first six months of next year were going to be tight for vaccine delivery.
“… In first six months there is definitely going to be a situation where there is a shortage globally; nobody can help that. We will see that easing off by August-September because you will have other vaccine manufacturers also being able to supply,” he added.
Poonawalla spoke to reporters at the launch of SII’s pneumococcal vaccine, the first made-in-India protection against pneumococcal diseases, caused by bacterial infections.
“The subject expert committee is likely to be convened this week to go through the application. Since Pfizer had also sought fresh date to present its case on its EUA application of its anti-Covid-19 vaccine, the committee is likely to give them time on the same date,” said a government official with knowledge of the matter, requesting anonymity
Possible approval of the vaccine by the UK drug regulator will likely ease the regulatory process for the candidate in India.
Pfizer Inc. and BioNTech SE may be asked to conduct a small bridging study among the Indian population to determine the vaccine candidate’s efficacy on the local population.
“Since Pfizer has not conducted a clinical trial in India for its vaccine candidate, the company may be asked to do that first. They could also get a waiver from trials as they already have EUA from other national regulators such as in the US and UK. The ultimate call, however, will be of the experts,” the official cited above added.
