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Monday, June 21, 2021

‘At-risk’ policy change: Govt puts money on new-platform Covid-19 vaccine

It is significant that the government has put its money on a novel platform for a Covid-19 vaccine that is yet to receive regulatory approval.

Written by Prabha Raghavan | New Delhi |
Updated: June 8, 2021 10:00:46 am
A woman is vaccinated against Covid-19 in rural Maharashtra (Express Photo: Narendra Vaskar)

The decision to book 30 crore doses of Biological E’s Covid-19 vaccine before it has launched marks a major shift in the government’s stance on procurement for mass immunisation against the coronavirus.

The advance order, which includes Rs 1,500 crore in monetary assistance to help the company stockpile doses, is the government’s first at-risk investment on vaccines so far.

It is significant that the government has put its money on a novel platform for a Covid-19 vaccine that is yet to receive regulatory approval.

Bio E’s two-dose vaccine, known as Corbevax, is likely to be among the cheapest Covid-19 vaccines that will be available in India; it is also expected that it will be easy to scale up production.

Corbevax uses a recombinant protein platform, which is not used by any other vaccine in India currently.

The recombinant protein vaccine is expected to target the specific part of the SARS-CoV-2 virus that can help the body trigger an immune response, in this case, the spike protein on its surface.

While other vaccines also target the spike protein by giving cells the instructions to make them, Corbevax does so by injecting a certain dose of cloned spike proteins grown in a lab setting. The body is expected to view the spike protein as a threat and develop an immune response, thereby bringing down the ability of the real virus to penetrate cells and cause severe disease or death.

Such a platform has long been used for developing immunity against other viruses like Hepatitis B.

Early on in the pandemic, researchers at Baylor College of Medicine in Houston, Texas, had pulled out the sequence for the gene for the spike protein to use as their target. They had then worked on cloning and engineering the candidate in their lab in a “quick” turnaround time, Dr Maria Elena Bottazzi, Associate Dean, BCM National School of Tropical Medicine, had told The Indian Express earlier.

The gene for the spike protein was grown in yeast and then purified, according to Dr Peter Hotez, Professor and Dean at BCM National School of Tropical Medicine.

In August 2020, BCM and Bio E entered into an agreement to take this vaccine candidate through clinical trials in India, and to scale up production of the vaccine for the world.

Several countries including the United States and the United Kingdom had made at-risk investments in vaccines such as the ones being developed by Pfizer and AstraZeneca last year, and had placed orders while their candidates were still under development.

India had, however, waited to place its first orders until the national regulator had granted restricted use permissions to Bharat Biotech’s Covaxin and Serum Institute of India’s (SII’s) Covishield on January 3. Procurement from these companies continued in this format until the end of April, when it had become apparent that they were struggling to ramp up production to meet the demand.

SII CEO Adar Poonawalla had told a television news channel at the time that his company was seeking funding of Rs 3,000 crore to expand its “very stressed” capacity so that it could meet India’s demand, which he had earlier said was higher than had been anticipated initially.

On April 19, the Finance Ministry relaxed rules to enable the Health Ministry to make “advance payment” of Rs 3,000 crore to SII and Rs 1,500 crore to Bharat Biotech in order to speed up the procurement process. However, later that month, Poonawalla said in another TV interview that a large portion of this payment was used to account for the government’s previous orders for Covid-19 vaccines, leaving SII with less advance money to scale up production of Covishield.

The government has been struggling to procure other vaccines available in international markets, including the mRNA shots developed by Pfizer-BioNTech and Moderna-NIAID. On May 24, Health Ministry Joint Secretary Lav Agarwal said Pfizer and Moderna had told the government that their order books were “already full”. This was likely the result of the decision to wait until April 2021 to seek out these vaccines, when other countries had made at-risk investments and placed advance orders months previously.

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