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SII will seek emergency license in two weeks


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

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

“We are in the process of submitting an application to the Indian Medicines Regulator, the Controller General of Medicines of India (DCGI), in the next two weeks for an emergency license and things will continue in that order. We are in the process of submitting data to DCGI for analysis, ”Poonawalla said.

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

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

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

The Oxford-AstraZeneca candidate vaccine is among the world pioneers 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 proven efficacy so far: 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 the data with which the SII approaches the national drug regulator. “We need to be sure what data they will provide, only the Indian component of [trial]? Just 2 full dose components or also include the half full flow, ”said Dr. K Srinath Reddy, founder of the Public Health Foundation of India.

The dose references refer to the difference in efficacy in the advertisement from Oxford and AstraZeneca. The developers found that the vaccine was most effective among people who received a first half-potency dose, a regimen that was not originally planned, leading many experts to question the scientific inviolability of the trials.

Poonawalla said the controversy will not affect the trials in India. “For now, the trials are sufficient to establish efficacy. In the future, if we have to conduct new trials, it will be for the under-18 age group after safety in adults is established, “he added.

The lower efficacy with two full doses, while not as good as the 95% reported by Moderna and Pfizer, could be sufficient for a regulatory approval as they have set the bar at 50%. The chief executive of the British pharmaceutical company told Bloomberg on Thursday that the company could undertake a new trial with the medium dose.

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

The PM’s discussion with the IBS team focused primarily on the vaccine implementation plan and the pros and cons of all Covid-19 vaccine candidates in the fray, as well as estimates of the doses that will need to be available. .

“The indication is around 300-400 million doses for July 2021, which the government also previously announced on several occasions. We are trying to reach the goal. The government will have to take a balanced view considering the pros and cons of all the vaccines that exist, ”Poonawalla added on Saturday.

IBS has manufactured around 40 million doses of the vaccine and can currently produce 50 to 60 million doses a month, with capacity expected to increase to 100 million in February. “How to distribute and where to distribute – all this was discussed. We have stated a price that is affordable and accessible to everyone, but it all depends on regulatory approvals. However, warehousing and manufacturing continue as is and even if there are delays in obtaining approvals, there should be no delays in producing volumes, ”Poonawalla said.

Based on currently available results, the vaccine has shown zero hospitalization in patients and viral load has been reduced by about 60%, said the director general of IBS. “It means that even if you are hospitalized, the attack will not be severe; and those who are infected do not transmit, which is an advantage for a vaccine for a disease that is so contagious, “he said.

The SII is licensed to produce 1 billion doses of the vaccine for low- and middle-income countries, and has committed to reserve half of what it produces for India.

Officials familiar with the prime minister’s plans said the visit was aimed at motivating scientists and employees of these companies. “I visited the Zydus Biotech Park in Ahmedabad to learn more about the indigenous DNA-based vaccine that Zydus Cadila is developing. I congratulate the team behind this effort for their work. The Government of India is actively working with them to support them on this journey. At the Bharat Biotech facility in Hyderabad, they were informed about their indigenous Covid-19 vaccine. I congratulated the scientists on their progress in the tests so far … ”Modi said in two tweets after the visits, each of which lasted between 20 and 25 minutes and involved frantic flights and helicopter transports.

According to an official who asked not to be named, the prime minister met with company promoters and top scientists. In each of the facilities, the PM sought to know how the trials are being carried out, the status of the vaccine development and, in addition to the Covid vaccine research, what other activities related to medicines or diagnoses are carried out in each place.

Hindustan Times