SII to seek emergency licence in two weeks

The Serum Institute of India (SII) will apply for an emergency approval for the coronavirus vaccine developed by University of Oxford and AstraZeneca in two weeks, its chief executive Adar Poonawalla said on Saturday, hours after meeting Prime Minister Narendra Modi who was on a three-city tour to pharma companies working on an inoculation against the Sars-Cov-2.

The announcement comes at the end of a week when Oxford and AstraZeneca announced their vaccine had shown to be at least 62% (and up to 90%) effective in an interim analysis based on 131 infections in the clinical trials being held in the United Kingdom and Brazil.

“We are in the process of applying to India’s drugs regulator-- the drugs controller general of India (DCGI) -- in next two weeks for emergency licensure and things will follow then in that order. We are in the process of submitting data to DCGI for analysis,” said Poonawalla.

“Had a good interaction with the team at Serum Institute of India. They shared details about their progress so far on how they plan to further ramp up vaccine manufacturing. Also took a look at their manufacturing facility,” Prime Minister Modi said in a tweet after visiting the Pune facility where he met Poonawalla.

Earlier, Modi visited the vaccine manufacturing unit of Zydus Cadila in Ahmedabad and of Bharat Biotech in Hyderabad. Both the companies have developed their own vaccine candidates that are into advanced stages of clinical trials.

“The central message of this trip is to motivate the vaccine producers. Here is a PM sitting down with promoters, chief scientists to discuss the details of their work. Even though he couldn’t give more than half an hour at each facility as he had to travel between different cities, he was not short of enthusiasm. Never before has any PM gone to such facilities to discuss their work in detail,” said a government official who asked not to be named.

The Oxford-AstraZeneca vaccine candidate is among the global front-runners in terms of volumes produced and clinical trial progress, and is being closely watched because it is cheaper and easier to transport than its only rivals that have shown efficacy till now: the mRNA vaccines by Moderna and Pzifer-BioNTech. All of these vaccines have a two-dose regimen.

The Oxford-AstraZeneca vaccine is also being tested among Indian volunteers as part of global phase 3 trials in different populations.

Experts said the approval process would depend on what data SII approaches the national drugs regulator with. “We need to be sure about which data they will be providing -- only Indian component of global [trial]? Only 2 full-dose component or also include the half-full stream as well,” said Dr K Srinath Reddy, founder, Public Health Foundation of India.

The dose references relate to the difference in efficacy in the announcement by Oxford and AstraZeneca. The developers found that the vaccine was more effective among people who were given a half-strength first dose, a regimen that was not originally planned, leading many experts to question the scientific sanctity of the trials.

Poonawalla said the controversy will not affect the trials in India. “At the moment trials are enough to establish the efficacy. In future, if at all we have to conduct fresh trials it will be for under 18 age group after safety is established in adults,” he added.

The lower efficacy with two full doses, while not as good as the 95% reported by Moderna and Pfizer, could be enough for an approval by regulators since they have set the bar at 50%. The British pharma company’s CEO told Bloomberg on Thursday that the company may undertake a new trial with the half-strength dose.

Poonawalla, in his comments on the opening day of the 18th Hindustan Times Leadership Summit this month, indicated that an emergency use licence could be secured by January.

The PM’s discussion with the SII team largely centred around the vaccine implementation plan, and the pros and cons of all Covid-19 vaccine candidates in the fray, as well as estimates of doses that will need to be made available.

“The indication is for about 300-400 million doses by July 2021, which the government has earlier also announced on various occasions. We are trying to get to the target. The government will have to take a balanced view keeping in mind pros and cons of all the vaccines out there,” Poonawalla added on Saturday.

SII has manufactured about 40 million doses of the vaccine and can currently make about 50-60 million a month, with the capacity expected to be scaled up to 100 million by February. “How to distribute and where to distribute -- all this was discussed. We have indicated a price which is affordable and accessible for everybody but it all depends on regulatory approvals. However, stockpiling and manufacturing is continuing as it is and even if there is delay in getting approvals there shouldn’t be any delays in producing volumes,” said Poonawalla.

As per results available currently, the vaccine has shown zero hospitalisation in patients and the viral load reduced by about 60%, said the SII CEO. “It means that even if you get hospitalised, the attack won’t be severe; and those who are infected won’t transmit, which is bonus for a vaccine for a disease that is so infective,” he said.

SII has a licence to produce a billion doses of the vaccine for low- and middle-income countries, and has committed to reserve half of what it produces for India.

Officials aware of the PM’s plans said the visit was meant to motivate the scientists and the employees of these firms. “Visited the Zydus Biotech Park in Ahmedabad to know more about the indigenous DNA based vaccine being developed by Zydus Cadila. I compliment the team behind this effort for their work. Government of India is actively working with them to support them in this journey. At the Bharat Biotech facility in Hyderabad, was briefed about their indigenous Covid-19 vaccine. Congratulated the scientists for their progress in the trials so far...,” Modi said in two tweets after the visits, each of which lasted around 20-25 minutes and involved hectic flights and helicopter transports.

According to an official who asked not to be named, the PM met the promoters of the companies and the chief scientists. At each of the facilities, the PM sought to know how they are conducting the trials, the status of vaccine development and, apart from Covid vaccine research, what other activities related to drugs or diagnostics are undertaken at each place.