The production of coronavirus vaccines and scaling up global availability could be seriously limited due to ban on exports of critical raw materials by the US, according to Serum Institute of India (SII) CEO Adar Poonawalla.

He also called for regulatory harmonisation between organisations such as WHO and authorities of vaccine manufacturing countries such as India, US, Europe, and the UK during this pandemic and come on to some common platform in order to “shave off months” and give “parallel approvals” for the vaccines.

Speaking at an event organised by the World Bank, Poonawalla said one of the constraints that need to be addressed, but nobody is able to address so far is the availability of critical items from the US.

“There are a lot of bags and filters and critical items that manufacturers need. I will give you an example. The Novavax vaccine that we are a major manufacturer of, need these items from the US. Now the US has chosen to invoke the Defence Act, in which there is a sub-clause that prevents the export of critical raw materials required for their local vaccine manufacturers,” he said.

Stressing that this really needs to be looked at, Poonawalla said, “Because if we are talking about building capacity all over the world, the sharing of these critical raw materials, which just can’t be replaced in a matter of six months or a year, is going to become a critical limiting factor.”

Stating that the issue needs some discussion with the Biden administration, he asserted, “We are talking about having free global access to vaccines but if we can’t get the raw materials out of the US, which a lot of manufacturers, not just Novovax that needs, that’s going to be a serious limiting factor for other manufacturers to scale up.”

Calling for regulatory harmonisation, Poonawalla said, “We will have to come during only this pandemic on to some common platform whereby we can shave off months, where parallel approvals can come when you have countries with manufacturers whose NRAs are approved etc.”

He further said it would further enhance the speed of uptake and deliveries of these vaccines from the main manufacturing hubs, including Russia, India, US and Europe, which are making the vaccines.

SII, the world’s largest vaccines manufacturer, has the licence to manufacture AstraZaneca/Oxford’s Covishield vaccine which has been approved by the Indian government. The company is also in partnership with Novavax for the latter’s COVID-19 vaccine.