British pharma major AstraZeneca has announced that the company is ramping up capacity to produce upto 3 bilion ( 300 crore) doses of its COVID-19 vaccine candidate in a very short time. The vaccine, developed by researchers at Oxford University, is currently in advanced Phase 3 trials in many countries.

AstraZeneca’s partner, Serum Institute of India, has started Phase 3 trials of the
vaccine, Covidshield, at Bharati Vidyapeeth Deemed University Medical College and Hospital, with two volunteers in Pune. In all, 300-350 volunteers will be administered the vaccine over the next few weeks.

The Indian Council of Medical Research (ICMR) is sponsoring Phase 2 and 3 trials of the vaccine, and plans to administer the vaccine to at least 1,600 volunteers across the country. Four more hospitals have been enrolled for the trial of Covidshield vaccine.

Serum Institute of India has an agreement with AstraZeneca to produce upto one billion doses ( 100 crore doses) of the vaccine if it gets regulatory approval.

Government regulators have so far given only conditional approval for clinical trials of the vaccine. However, companies are making the investments inproduction capacity hoping that the vaccine will get approval for large scale use in the near future.

"In that particular process you will be making millions of vaccines", said Pall Corporation's director of strategy Dr. Clive Glover told the CBS News. The challenge is how to scale-up from a small vial of vaccine to billions of doses, and quickly. Pall Corporation is a major supplier of sophisticated equipment needed to produce vaccines around the world.

"That process would generally be measured in years, and five years is not unusual", Mr Glover told CBS News. We were able to design the process, get our equipment into one of our manufacturing partners and run the initial process within eight weeks."

"So it was a sprint, to say the least", Mr Glover added. 

The process starts by making a small batch of vaccine. "We grow the cells up in
this bioreactor and use a starter version of the vaccine, put that in the  bioreactor", Mr Glover said. "It infects the cells that are growing inside here and allows the vaccine to actually make more of the vaccine itself."

The rest is a complex filtering process that screens out impurities until they are left with a bagful of vaccine ready for vials and, eventually to patients. A blueprint will be used by manufacturers of the vaccine around the world, all of whom are waiting for the go-ahead to start rolling it out, hopefully in record time.

Mr Glover himself has been a volunteer for the vaccine trials.

On Tuesday morning, the director of the Oxford vaccine program, Professor Andrew Pollard, told the BBC that it was possible his team could have enough data to present to regulators before the end of the year.

ABLE member Serum Institute of India starts Phase 3 clinical trials of the vaccine in Pune