US export curbs on COVID-19 vaccine ingredients limiting efforts to scale up production: Adar Poonawalla

The US has invoked the Defense Act, which has a sub- clause that prevents the export of critical raw materials required for local vaccine manufacturers.

March 06, 2021 / 12:06 AM IST

Adar Poonawalla, Chief Executive Officer of Serum Institute of India (SII), the world's largest vaccine maker by volume, on March 5 said the manufacturers of COVID-19 vaccines were facing a global shortage of raw materials because a US law is blocking the export of certain key items.

"There are a lot of bags, filters and other critical items that manufacturers need. For example, the Novavax vaccine. We're a major manufacturer, and for it, we need these items from the US. Now the US has chosen to invoke the Defense Act, in which there is a sub-clause which prevents the export of critical raw materials required for the local vaccine manufacturers," Poonwalla said at a World Bank panel discussion.

"Now this really needs to be looked at because if we're talking about building capacity all over the world, 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," Poonwalla said.

SII is manufacturing and distributing Novavax COVID-19 vaccine under a licensing agreement.

Poonwalla said the export ban on certain critical ingredients would need some discussion with the (US President Joe) Biden administration to explain to them that there's enough to go around and have free global access.


COVID-19 Vaccine

Frequently Asked Questions

View more
How does a vaccine work?

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.

How many types of vaccines are there?

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.

What does it take to develop a vaccine of this kind?

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.

View more
In November last year, Pfizer said it will cut short its COVID-19 vaccine production target by half, citing raw material crunch. The company had earlier planned to roll out over 1.2 billion doses of coronavirus vaccines in 2021 and 100 million doses by 2020-end. Both these targets were later reduced to half due to raw material shortage in the US and Europe.

Concerned over the shortages, the Biden administration invoked the use of the Defense Production Act to boost supplies needed to make Pfizer-BioNTech COVID-19 vaccines. Biden has promised to administer 100 million vaccination shots in his first 100 days in office and laid out plans to buy 600 million doses, enough to vaccinate much of the US population.

Vaccines contain ingredients such as antiseptic liquids, antiviral agents, sterile water and some elements of virus DNA that are important to create antibodies.

Poonawalla said that despite the constraints, SII had distributed 90 million doses of AstraZeneca’s vaccine to 51 countries in the past two months, a record for the company. It was granted emergency authorisation by Indian regulators in early January.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Mar 5, 2021 04:11 pm