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Foreign-Approved Vaccines To Be Cleared In India, But It's No Immediate Solution For Shortage

Faced with an increase in demand for COVID-19 vaccines from across the country, the Prime Minister Narendra Modi-led government has fast-tracked emergency use approval for eligible foreign-produced shots.
Bobins Abraham Updated on Apr 14, 2021, 16:27 IST

Faced with an increase in demand for COVID-19 vaccines from across the country, the Prime Minister Narendra Modi-led government has fast-tracked emergency use approval for eligible foreign-produced shots.

This means that the pre-condition for foreign manufacturers to undertake phase 2 and phase 3 clinical trials in India for those vaccines that have already been granted approvals by relevant regulatory bodies in the US, the European Union, the United Kingdom and Japan as well as by the World Health Organisation will be waived off.

BCCL

Such vaccines will be granted emergency use approval in India, without having to go through the phase 2 and phase 3 clinical trials here.

However, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country.

This in theory will lead to import of bulk or import of finished vaccines in vials or import leading to fill and finish in the country, widening its basket of vaccines from Covaxin by Bharat Biotech, Covishield by Serum Institute of India and the Russian made Sputnik V, which is yet to be rolled out, even though it has been cleared for use.

BCCL

Given the ongoing situation with China, and the relatively low efficacy shown by them it is unlikely that the five vaccines that were developed and are being used there will make it to India.

AP

This leaves the country with just four more options, including the one by Novavax, for which the Serum Institute of India has already bagged a deal.

The other potential candidates are the Pfizer-BioNTech vaccine, Moderna¡¯s vaccines, which have both shown to be about 95% in protecting against COVID-19.

The single-dose COVID-19 vaccine of Johnson & Johnson could also make its way into India.

But here is the tricky part: the Pfizer-BioNTech vaccine has to be stored between -90C and -60C, making its transportation and administration a challenge.

Pfizer, BioNTech Vaccine Found Effective Against UK Coronavirus Strain In New Research

So if India is to approve the Pfizer-BioNTech vaccine, the infrastructure to store them has to be readied first.

Indecently, in February, Pfizer had withdrawn its application for clearance in India due to regulatory issues.

Another challenge the potential candidates are going to face is their existing commitments to the US, UK, South Korea, Japan, EU and the WHO.

All these companies have been paid upfront for their research by these wealthy countries, in exchange for millions of doses of the vaccines.

afp

So they will have to fulfill their commitments before eying a huge market like India, which in the best-case scenario could take at least a few months.

As far as Johnson & Johnson is concerned, it is currently on the back foot after several countries suspended the use of its vaccine over blood clot feares.

This could soon be cleared and the vaccine could eventually make its way to India, but it is still unclear, when.

Reuters

Earlier, as part of the Quad agreement, it was reported that the Johnson & Johnson vaccine will be manufactured in India.

But there is still a silver lining - if these foreign companies can enter into deals with Indian drug companies like what AstraZeneca and Sputnik did, they can be manufactured domestically and made available in good numbers.

Bobins Abraham

Bobins Abraham is the Assistant News Editor at Indiatimes. He has more than twelve years of experience in TV and digital journalism. An avid student of history and geopolitics, he is a conservationist and environmentalist at heart. He writes on environment, sustainability, human-animal conflict and more.

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