New Delhi: After a worldwide demonstration of India’s superpower status in IT software, now it appears that—as demonstrated in its founding of world class corporate hospitals, in its superior doctor-patient relations, and in its production of generic medicines and sensitive vaccines product—India is emerging as a superpower in medical technology.
Two institutions have recently caught international awe and attention to this emerging reality: Bharat Biotech Limited (BBL) and Serum Institute of India (SII). SII depends on the basic “raw” material of Oxford University and AstraZeneca (AZ) for producing anti coronavirus vaccines and is patronised by Bill Gates. BBL is entirely swadeshi in the production of this vaccine.
AZ was approved in the UK after a Phase III trial. However there are “warts” that may reduce the importance of this vaccine. We shall elaborate these below.
The wording of the Government of India approvals for BBL states that it has only “restricted emergency use authorization”. It could have been better worded by stating that this is through “a purchase option”. (This is what was done in the United States in the case of the Moderna, Pfizer/BioNTech, J&J and Novaavax vaccines).
The BBL vaccine, called Covaxin, is worth the risk since it is wholly Indian and fully accountable. The Ella couple who own BBL, both obtained their PhDs from a reputed US university. Thereafter they chose to return to the pell-mell of India, and faced and overcame an obstructionist bureaucracy which is more comfortable with mediocrity [I personally know what such a sacrifice for Bharat Mata means].
Hence to enhance India’s self reliance [aatmanirbharta] and India’s emerging superpower status (i.e. its emerging as a superpower in medical technology), the government must encourage BBL to succeed.
THE SII PROJECT
The Oxford-AstraZeneca vaccine, known in India as Covishield, is being produced in India by the Serum Institute of India [SII], the world’s largest vaccine manufacturer.
Last May, the US Biomedical Advanced Research and Development Authority (BARDA) provided Astra Zeneca and Oxford University with more than $1 billion to discover or invent this Covid-19 vaccine. Astra Zeneca also agreed to supply the US with at least 400 million doses of the vaccine if it is approved.
Additionally, with the Center for Epidemic Preparedness Innovations (a global partnership between public and private entities) it has managed to scale up manufacturing by June when it reached an agreement with Europe’s Inclusive Vaccine’s Alliance [IVA] to provide 400 million vaccine doses at cost. (This is pandemic creative, not pandemic induced.)
SII’s billionaire owner, Adar Poonawalla, has pledged 50% of its production for India. It has stockpiled 40 million to 50 million doses and plans to produce 300 million doses by July.
The country’s drug regulator said that SII’s Phase 2 and 3 trials were conducted on 1,600 participants, and the data was found to be “comparable to the data from overseas studies”. According to press reports, the regulator’s approval to SII is subject to regulatory conditions, though information about this is not immediately available.
The regulator’s first announcement on 4 January morning was marked by excluding BBL’s Covaxin. Fortunately, by the same evening, authorities had changed their mind and Bharat Biotech’s Covaxin was also announced.
THE BHARAT BIOTECH LTD. PROJECT
BBL’s product, Covaxin, has not completed its third phase of human clinical trials. According to the regulator the first two phases showed that the vaccine was safe. Health Minister Harsh Vardhan clarified last Sunday night that “All Covaxin recipients to be tracked, monitored as if they’re in trial”. BBL has said in a statement that the vaccine would address “unmet medical need” and that it would provide “global access to populations that need it the most”.
The spike protein of the virus is about 1250 amino acids long. Two hundred and fifty (250) of these are considered to be the site of the current pandemic-induced mutation of SARS-CoV2. In all, a coronavirus has about 15,000 amino acids.
The Oxford AZ vaccine has focused on less than 2% of this sequence, and it has assumed that the remaining portions of the sequence do not impact the virulence of the pathogen.
In accordance with this hypothesis, British scientists modified a part of the trial. This modification has not been accepted by the US FDA which has declined to certify it.
Why should we likewise not wait for the US FDA opinion before rushing to prescribe the vaccine for Indian citizens?
The vaccine admittedly does work with 62% efficacy. This is not particularly bad or good, hence it was preferable for the Indian government to look at international data (such as from US), before rushing to prescribe the foreign vaccine for Indian citizens.
Oxford vaccine is intended to be mass produced in SII for not only India but also for other (Gates determined) foreign nations.
Though admittedly funding for its earlier projects did come from the US, Bharat Biotech presently is a Swadeshi company.
The BBL is very likely to have a decent vaccine. By using the Virion method to make an inactivated killed vaccine, and adding an adjuvant (to improve immunity), Covaxin of BBL encompasses the best possible in science.
But the criticism is that BBL has not completed the third phase trial, (which started on 16 November 2020 and is expected to conclude late next month). Anyway the full clearance granted by Government will be effective only after Phase III trials are over.
As a Swadeshi company in Aatmanirbharta Bharat it will be good if at this stage, both vaccines were approved subject to conditions. According to information provided to me, the Covaxin Phase III sample trials have already exceeded in the thousands. This incomplete testing is already much higher than some of those others who claim to have concluded Phase III trials, with fewer than 6,000 trials.
Let us not be misled by media reports of higher numbers from some competitors since for some it is a cumulative Phase I-III figure.
India must aspire to a superpower role in the supply of coronavirus vaccines for the developing world through its home-grown vaccine, since this is a region struggling to secure supplies.
India has a big advantage in its vaccine-manufacturing capacity: it produces sufficient doses of vaccine without incurring huge amounts of foreign exchange (which would be needed to pre-order the vaccines as with Covishield).
Besides, as a global leader in vaccine manufacturing, since it produces more than 60% of the world’s vaccines, India also has vast experience in managing large-scale immunization programmes in the past. Its current child immunization programme covers 27 million newborn babies annually.
We in India are still suffering from inferiority complex. Some of our westernised Indian industrialists have become conduits for Western buccaneers who are testing their own country’s untested experiments in India. The latest unauthorised intervention in India was last year’s the Chinese Wuhan University’s bat virus research in Nagaland, a supposedly restricted area for foreigners.
We must work hard and begin to protect our path to superpower status in the near future.
Dr Subramanian Swamy is an MP nominated by the President for his eminence as an economist. He is a former Union Cabinet Minister for Commerce and Law & Justice.