India to have 200-300 mn Covid vaccine doses ready by December end, says SII Executive Director

India will have 200 to 300 million Covid-19 vaccine doses ready by the December-end and the final tested vaccine will be available by March 2021, Serum Institute's (SII) Executive Director Dr Suresh Jadhav said on Saturday.

"India will have 200 to 300 million Covid vaccine doses ready by the end of December. So, once the license is given by the DCGI, this product can be launched," said Dr Jadhav.

He also said that the Serum Institute is working on five different products to combat the coronavirus menace.

WHEN WILL THE VACCINE BE AVAILABLE?

To a question posed by Dr Swadeep Srivastava, the Founder of HEAL Foundation, Dr Jadhav said: "Although there were some pauses and the trial was stopped for some time and also extended by three weeks as some regulators wanted some clarity about the people who are involved in the phase three trials, so, Serum will be able to submit all of the clinical trials phase three data to the DCGI by end of December."

"If the DCGI is satisfied, then it might give us a EUL, i,e. emergency use license within one-month time or marketing authorisation can also be given by the DCGI. Then the Serum Institute will go to the WHO for prequalification. Only after the prequalification, international organisations like Gavi will buy this product," he said.

"Serum institute is trying to simultaneously proceed with the DCGI and the WHO so that the time is saved. All these will happen by the first quarter of 2021 and that's when the vaccine by the Serum Institute will be available for masses," he said.

Dr Jadhav said that by December 2020, the Serum Institute will have 200 to 300 million doses ready and once all of the permissions are given, the SII will produce 60 to 70 million doses per month thereafter.

Dr Jadhav summed up his statement by saying that everything now is going smoothly but to see how long the immunity lasts after administered with the Covid Vaccine, it will take another 2 to 3 years by monitoring these people.

Addressing at Pharma Excellence E summit 2020 organised by HEAL Foundation, Dr Suresh Jadhav referred to SII CEO Adar Poonawalla's statement that Serum can produce 700 to 800 million vaccine doses in a year.

"Serum can even increase the production but it will take some time," Dr Jadhav said.

Dr Jadhav said that India is fortunate to have three pharma companies that are into Covid vaccine manufacturing. Two of them are at stage 3 of clinical trials while one is at stage two.

He said that the results of the third phase of clinical trials will be available to Serum Institute in the second or third week of December. "Simultaneously, the Data will be unfolded and it will be presented to the Drugs Controller General of India (DCGI) for licencing," Dr Jadhav said.

The Pune-based Serum Institute of India has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine candidate, Covashield. The company is also conducting Phase 2 and 3 human clinical trials of the candidate in India

THIRD VACCINE IN INDIA

Dr Jadhav further said that generally, it takes 8 to 10 years for any vaccine to hit the market.

"This is the third time that India has needed such a vaccine as early as possible. Earlier, it was during the H1N1 outbreak. The H1N1 flu came in from Mexico sometime in June and July in the year 2009, and the vaccine from big pharma was ready, licensed and launched by December 2009. It was possible because there was a continuous update from WHO. The process was in place and the modalities were also in place so the H1N1 vaccine could be launched very fast."

The second time, it during the Ebola outbreak in Africa and other parts of the world. "The product [Ebola vaccine] was launched even as the product trials were in phase II," Dr Jadhav said.

Dr Jadhav said: "This is for the first time that the world did not know anything about the coronavirus, but fortunately, its modalities are in place -- when this virus came from Wuhan [in China] and the type of disease it is going to cause, how it affects human beings and how it spreads."

"If we go by the normal way, then the product will be available in at least 7 to 8 months of additional time," he said.

He also thanked the Centre for granting the pharmaceutical company permission to manufacture the Covid-19 vaccine in bulk even before the final trials are completed. This was decided keeping in view the quick availability of the vaccine to masses without any delay

Dr Suresh Jadhav also thanked the World Health Organisation (WHO) for its global coronavirus vaccine programme Covax.

WHO WILL GET VACCINE FIRST?

Dr Jadhav also mentioned that 50 per cent of India's population is below the age of 55 and the trials are being carried out in the age group of 18 and above.

The first people to get the vaccine in India are the health workers.

Second on line "will be people of 60 years of age and with comorbidities. Further, the vaccine will be given to people of lower age. And by that time data will also be available for those of lower age groups that are below the age of 18 years," he said.

Dr Suresh Jadhav also clarified that the vaccine by the Serum, that are contracted with Gavi, will be 50 per cent for India and 50 per cent for Gavi.

"India being part of the UN, cannot put its foot down saying that it will only take care of the Indian Population. Covid situation is not India specific but it has affected 7.5 billion people all over the world. India gets money, technology, scientific inputs from all over the world organisations. So, it becomes our moral responsibility to help them in this time of crisis," Dr Jadhav signed off.

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