Adar Poonwalla, Chief Executive Officer of Serum Institute of India (SII), on November 28 said the vaccine maker is in the process of applying for emergency use licensure for its COVID-19 vaccine candidate Covishield in next two weeks.
Poonwalla said the ongoing clinical trials are more than enough to prove the vaccine's efficacy.
"There was a bit of confusion in the communication. That's not going to affect the emergency use licensure in the UK, and it should not affect India at all," told Poonwalla at a virtual press conference.
"The stockpiling and manufacturing are continuing," he said.
Poonawalla said he doesn't see any need for additional trials in India other than a trial for under 18 age group, after four months following the licensure. "That's the same thing for all vaccine candidates be it US or Europe," Poonawalla said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
SII's partner AstraZeneca has indicated that it may be doing an additional global trial to confirm the efficacy and clear confusion over the lower dose regimen of its potential COVID-19 vaccine that appeared to be 90 percent effective in a preliminary analysis.
Poonawalla said SII is manufacturing 50-60 million doses per month, and from January it would increase the production to 100 million doses per month. Poonwalla added that the priority for the distribution of the vaccine would be India and Covax countries.
On November 28, Prime Minister Narendra Modi visited SII facilities in Pune to review the status of COVID-19 vaccine development process. Poonawalla said there was a discussion with the Prime Minister regarding the implementation plan of vaccine rollout.
"What we discussed is the implementation plan which will happen only after the emergency use licensure based on the data that will have to be submitted," Poonawalla said.
"We don't want any short cuts," he added.
Modi also visited Bharat Biotech and Zydus Cadila Covid vaccine facilities to get a first-hand understanding about their preparedness for a rollout, if they get the licence.
Poonawalla said at the moment they don't have anything in writing in terms of purchase committments from the Government of India, but he said as per the statements made by government officials in past, the government plan is to acquire 300-400 million doses by July.
On Novavax COVID-19 vaccine, which SII will be manufacturing and distributing in India and other markets, Poonawalla said the vaccine is 2-3 months behind Covishield. Once they also announce their efficacy results, we will do a short bridge study in India.Poonawalla said its other COVID-19 vaccine candidate Codagenix will be starting phase-1 trial in the UK in December, and would take a year to reach the stage of licensure.