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Once parent company gets clearance from US FDA, we’ll get approval for Covavax: Cyrus Poonawalla

Covavax is a vaccine developed specially for children, but has faced hurdles at the US FDA, said Poonawalla

Updated on: Aug 14, 2021, 16:17:00 IST
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On Friday, Cyrus Poonawalla, founder of Serum institute of India (SII), which is mass producing Covishield, the anti-Covid19 vaccine, said that Covavax would be sent for approval once its parent company in the US gets approval for the same.

Cyrus Poonawalla, Managing Director of the Serum Institute of India receives Lokmanya Tilak Award 2021 by the hands of former Union Minister Sushil Kumar Shinde at Tilak Maharashtra Vidyapeeth, Gultekdi in Pune, on Friday. (HT PHOTO)
Cyrus Poonawalla, Managing Director of the Serum Institute of India receives Lokmanya Tilak Award 2021 by the hands of former Union Minister Sushil Kumar Shinde at Tilak Maharashtra Vidyapeeth, Gultekdi in Pune, on Friday. (HT PHOTO)

Covavax is a vaccine developed specially for children, but has faced hurdles at the US FDA, said Poonawalla.

Novavax which is developed by a US pharmaceutical company with the same name will be mass manufactured by SII. The current approved vaccines are only approved for adults making children a susceptible population.

Poonawalla said, “Novavax is a very good product, however, unless we get the licence to launch it we cannot do so. The American parent company has got some issues with the US FDA which should be cleared by the end of year. Once they get the licence, we will get the licence. We will also try to get it approved before the parent company if possible.”

Novavax is yet to be tried for phase 2/3 trials and efficacy for children aged 12-18 years.

Poonawalla said, “Novavax can be given to the age group of 12 years and above and the trial is underway . However, Covishield was found to not be safe for kids aged under 18 and if something happens due to this then who would bear the responsibility? Not me. Regarding reopening of schools and colleges, we will need to see the effect as they start opening each class and then we can go ahead. If students do not go to school for a year or two it is fine, they can study at home. I never went to college and today, I am the founder of Serum Institute.”

“As schools reopen,” he said, “it would be wise to wait and see how it impacts children and then we can take a call.”

Poonawalla also said that lockdown is not a good option because it will not lead to herd immunity. “Those who have lost lives in this pandemic lost it because of lack of treatment, vaccine hesitancy or delay in reaching the hospital,” he said.

Poonawalla also said that he is against mixing vaccines. He said, “It is too risky to mix two different vaccines and as a manufacturer I would not take the responsibility in case anyone develops any reactions or side effects due to the mixing. Also if one vaccine type is working then why mix?”

Poonawalla also said that a gap of two months is ideal between two doses of Covishield, however, the current gap of three months, or the earlier gap of just one month, both were wrong. He said, “Two months’ gap is ideal. Also it is true that the number of antibodies would decrease after six months, however, memory cells in the body are present. It is advised to get a third dose or a booster shot, six months after the second shot. Unless the virus is reduced nominally across the world we might need to take vaccines.”

Poonawalla was speaking during an award ceremony, where was presented with the Lokmanya Tilak National Award 2021 for his contribution in fighting the pandemic