Founder of vaccine manufacturing company Shantha Biotechnics, K.I. Varaprasad Reddy on Wednesday cautioned against rushing through with the regulatory approval processes for COVID-19 vaccine candidates.
Speaking at the TiE Global Summit 2020 on ‘COVID-19 Vaccine: How soon is soon? Is there an alternative?’, he said vigorous scientific evaluation is important. While the pace of development of vaccines may be faster, the regulatory aspects have to be examined at every stage.
There should be enough scientific data available to give comfort to the people, he said, pointing to the significance of vigorous scientific evaluation of the vaccine candidates. He said the Influenza vaccine came after two decades – of the 1918 Spanish flu – around 1940, while Ebola vaccine took five and a half years and chickenpox vaccine took 22 years.
Scientists are under pressure, following the COVID-19 outbreak, to come out with a vaccine, he said, stressing the need for the regulators to still not to rush with the approval processes. “Earlier, we used to wait and study the medicines for a long time, going through different stages of trials and scientific evaluation. There is not enough scientific data to give us comfort. There is no publication of data on clinical trials [of COVID-19 vaccines] in scientific journals and its review. All we know is just [information] coming through news reports,” he said.
Noting that there are several questions that remain unanswered about the safety, efficacy, cold storage, distribution, handling, training of personnel who will administer the vaccine, who is going to foot the bill and who gets the vaccine first, Mr.Reddy called for a blueprint, with an emphasis on equitable distribution.
Given that almost all vaccine candidates are likely to be two-dose vaccine, India, with a population of 1.3 billion, would required 2.6 billion doses. With 15% wastage normal, this would translate into 3 billion vaccine doses. Thus, in this kind of situation, there would also be need to curb hoarding, black marketing and counterfeiting.
Hasty statements by those in authority about the date by which the vaccine would be available are a great disservice to the public, he said, adding the vaccines will come only by the middle of 2021 or the latest by April. The Shantha Sanofi vaccine – Shantha Biotechnics is a Sanofi company – will come by end of 2021, he added.
The TiE Summit, on the second day, had a number of sessions lined, including an address by Delhi Chief Minister Arvind Kejriwal. He said Delhi NCR has 7,000 active startups, the highest in the country. The valuation of startups is estimated at $50 billion and the city is adding one Unicorn every year since 2013.
In the first six months of 2020, 109 startups were founded in Delhi, he said, listing out the plans of the government for hand-holding and aiding growth of startups. Delhi government, he said, is in an advanced stage of coming out with a new startup policy.
