In wake of scathing criticism with respect to export of vaccines despite shortages in India, Serum Institute of India (SII) that is manufacturing the Oxford-AstraZeneca Covishield vaccine in India, has offered an explanation.

In a press statement issued on Tuesday night, SII CEO Adar Poonawala said, “In the past few days, there has been intense discussion on the decision of our Government and Indian vaccine manufacturers including SII to export vaccines.” SII goes on to explain the current vaccine shortage by taking one through the timeline since January when the nationwide vaccination campaign was kickstarted, saying that at that time “we had a large stockpile of vaccine doses” and that “most people including health experts believed that India was turning the tide on the pandemic.”

Explaining that international cooperation leading to technology access was the reason behind vaccine exports, SII says, “Cooperation between countries also forms the basis for us getting access to technology and aid for healthcare.”

It is noteworthy that India was part of the World Health Organization (WHO)-led international alliance called COVAX, where in exchange for the technology to manufacture the Oxford-AstraZeneca vaccine, it was obligated to contribute a certain number of doses to the international community so that they could be distributed among other developing nations. However, vaccine exports as a part of this obligation were temporarily halted when the second surge of Covid-19 infections proved to be deadlier and spreading faster than the original outbreak. Vaccines were then prioritized for use in India to control the spread of the more lethal domestic variant that was spreading fast.

SII reiterated, “We have never exported vaccines at the cost of the people of India.”

The entire press statement may be viewed here:

Important Information pic.twitter.com/M1R1P6rqUp

— SerumInstituteIndia (@SerumInstIndia) May 18, 2021

At present, Covaxin developed by Bharat Biotech is the only indigenously developed vaccine against Covid that is being administered to people in India. SII has been manufacturing Covishield, a vaccine developed jointly by the Oxford University and AstraZeneca. But there are certain obligations that come with this exchange of technology including contributing to COVAX’s pool from where vaccines are supplied to member nations of the developing world.

However, this brings us to two important subjects:

•       India’s obligations under COVAX vis-à-vis moral obligations of wealthier nations
•       sharing of technology and waiver of Intellectual Property Rights (IPR) related to manufacture of vaccines developed        by international pharmaceutical companies

Obligations under COVAX and role of wealthy nations

COVAX is an alliance that attempts to bridge vaccine equity gaps between the developed and the developing world. But as India is a part of it, it has to contribute to the COVAX pool despite the suffering of its own people. While India has manufacturing capacity, it also has a large population, and limited resources given how India is still a developing country. Meanwhile, it is alleged that countries like Canada, US and UK ordered an excess number of vaccines.

According to data from Duke Global Health Innovation Center, quoted by the BBC in a report, Canada has reportedly ordered vaccines five times that of its population! Meanwhile, the UK has ordered 3.6 times the number of vaccines required, EU 2.7 times and the US twice as much. In fact, the US has finished vaccinating frontline workers, elderly people, persons with comorbidities and adults. It is now turning to vaccinating children and teenagers.

Thus, it appears that wealthier nations bought up more than enough vaccines to inoculate their populations earlier in the game, leaving developing nations at the mercy of vaccine manufacturers and humanitarian organisations.

WHO recognises this unfair advantage enjoyed by wealthier countries and recently urged them to donate vaccines to developing nations. In a bid to bring about greater vaccine equity, Dr. Tedros Adhanom Ghebreyesus, Director General of the WHO recently appealed, “In a handful of rich countries, which bought up the majority of the vaccine supply, lower risk groups are now being vaccinated. I understand why some countries want to vaccinate their children and adolescents. But right now, I urge them to reconsider and to instead donate vaccines to COVAX. Because in low and lower-middle income countries, vaccine supply has not been enough to even immunise health and care workers, and hospitals are being inundated with people that need lifesaving care urgently.”

Meanwhile, according to the Ministry of External Affairs, India has given as many as 663.698 lakh doses of vaccines to 95 countries including Bangladesh, Myanmar, Nepal, Bhutan, Sri Lanka, Morocco, Afghanistan, Mongolia, Ghana, Angola, Gambia and Syria. This also includes 1 lakh vaccines to UN Health Workers.

Meanwhile, pressure is still mounting on SII to honour its obligations to COVAX, even as the domestic market remains under-served and in urgent need amidst a raging pandemic.

Manufacturing vaccines domestically

There are two elements that need to be viewed here:

•         IPR related issues that are preventing manufacturing of vaccines developed by international pharma companies and other nations
•         Absence of R&D to develop vaccines from the scratch domestically

International pharma companies say that they spend millions of dollars, as well as time developing a vaccine. Sharing the formulation freely so that developing countries can manufacture it, disincentivises the large investments they make into Research and Development (R&D).

But recently, the Biden-Harris administration expressed support for waiving Trade Related aspects of Intellectual Property Rights (TRIPS) for Covid-19 vaccines. US Trade Representative Katherine Tai shared her country’s stand amidst World Trade Organisation (WTO) discussions on easing global trade rules to enable vaccine access to the developing world, saying, “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.”

India and South Africa had originally proposed the IPR waiver in October 2020. If the waiver was granted, it would allow countries who are WTO members to choose to neither grant nor enforce patents and other IP related to all Covid-19 drugs, vaccines, diagnostics, and other technologies, including masks and ventilators, for the duration of the pandemic. This would provide countries with the policy space needed to collaborate in R&D, manufacturing, scaling up, and supplying Covid-19 tools. The proposed waiver would be applicable only to Covid-19. It does not suggest a waiver from all TRIPS obligations, nor does it suggest a waiver beyond what is needed for COVID-19 prevention, containment and treatment.

In November 2020, Eswatini, Kenya, Mozambique and Pakistan also backed this landmark proposal. But Australia, Brazil, Canada, EU, Japan, Norway, Switzerland, UK and US were opposed to it at that time.

When it comes to developing the vaccine from the scratch in India, investments need to be made by the government in creating R&D facilities. This has to be done on a large scale in the public sector, as that is the only way to make such vaccines affordable to common people. While private players should also be encouraged to participate in the process via public-private partnerships in R&D projects, the entire process should not be left to just the private sector as they have their own concerns with respect to costs and profits. Instead, such facilities should be developed in government run medical colleges and proper funding should be allocated to it in the annual budget. This is the only way to achieve vaccine self-sufficiency. At present the total allocation to healthcare stands at Rs 2.23 lakh crore, but only Rs 2,663 crore out of this goes towards health research.

Related:

Covid-19: Shortage of vaccines begins to pinch
Adar Poonawalla is in Britain ‘on business’, but is that the only reason?
SII provides 3 lakh doses, vaccination for 18-44 age group to begin in Maharashtra

The post Never exported vaccines at the cost of Indians: SII appeared first on SabrangIndia.

Adar Poonawalla, chief executive officer, Serum Institute of India (SII) has flown to Britain. He made it to London just before the UK banned all travellers coming from India. Poonawalla, whose SII is the biggest manufacturer of vaccines in the world told The Times, London, that he has been getting phone calls that are “incessant and very menacing”.

The Serum Institute is producing a bulk of India’s Covid-19 vaccines in Pune. However, Poonawalla has also hinted that he may produce the vaccine overseas, he posted, “Had an excellent meeting with all our partners & stakeholders in the U.K. Meanwhile, pleased to state that COVISHIELD’s production is in full swing in Pune. I look forward to reviewing operations upon my return in a few days.” 

Had an excellent meeting with all our partners & stakeholders in the U.K. Meanwhile, pleased to state that COVISHIELD’s production is in full swing in Pune. I look forward to reviewing operations upon my return in a few days.

— Adar Poonawalla (@adarpoonawalla) May 1, 2021

His mention of “return in a few days” is crucial because now he is being trolled for leaving the country at a time when Covid-19 is infecting people faster than it can be contained, and the fragile and overloaded healthcare system, and the lack of adequate oxygen supplies is leading to hundreds of deaths each day across the country. However, he told The Times on racing London, “I’m staying here an extended time because I don’t want to go back to that situation”

Poonawala added, “Everything falls on my shoulders but I can’t do it alone . . . I don’t want to be in a situation where you are just trying to do your job, and just because you can’t supply the needs of X, Y or Z you really don’t want to guess what they are going to do.”

Poonawalla has hinted that he is on the receiving end of calls from “chief ministers of Indian states, heads of business conglomerates and others demanding instant supplies of Covishield, as the AstraZeneca vaccine is known in India.” He told The Times that to term such calls “Threats’ is an understatement”. Poonawalla said, “The level of expectation and aggression is really unprecedented. It’s overwhelming. Everyone feels they should get the vaccine. They can’t understand why anyone else should get it before them.” He and the institute have been given a tight security detail.

Poonawalla joined his wife and two children in London and made it just before Britain banned travellers from India eight days ago. He said that he is also there on business and is planning to start vaccine production in outside India as well, adding that “there’s going to be an announcement in the next few days.” According to the report, “Lord Udny-Lister, until recently one of Boris Johnson’s top aides, visited the Serum Institute in March, and that the prime minister was also due to visit it on his cancelled trip to India this week.”

When asked to comment on mass gatherings such as the Kumbh Mela which were allowed even as the pandemic escalated, and may have contributed to the spread of Covid-19 in the coming months as well, Poonawalla said, “If I give you the right answer, or any answer, my head would be chopped off . . . I can’t comment on the elections or Kumbh Mela. It’s too sensitive.”

Serum Institute of India’s Covishield vaccine was to be available to state governments at Rs. 400 per dose and private hospitals at Rs. 600 a dose. This announcement was made two days after the central government decided to open up vaccinations against Covid-19 to those above the age of 18 years. While AstraZeneca and Oxford University developed the Covishield vaccine, Serum Institute of India (Pune) has been manufacturing it under a licence from the Swedish-British drug maker. This pricing was said to be the highest amount for the vaccine in comparison to others.

Poonawala was previously quoted by the Indian Express as saying, “We have given a special price of Rs 200 for the first 100 million doses only to the Government of India… and after that, we will be selling at Rs 1,000 in private markets.” But this latest decision of Rs.600 per dose translates to about 8 dollars per shot and is more than its price in any major global market.

However, he later said that as a “philanthropic gesture” he was reducing the price to the states from Rs.400 to Rs.300 per dose.

As a philanthropic gesture on behalf of @SerumInstIndia, I hereby reduce the price to the states from Rs.400 to Rs.300 per dose, effective immediately; this will save thousands of crores of state funds going forward. This will enable more vaccinations and save countless lives.

— Adar Poonawalla (@adarpoonawalla) April 28, 2021

Back in 2020, he had asked if the government of India has “Rs 80,000 crores available, over the next one year? Because that’s what @MoHFW_INDIA needs, to buy and distribute the vaccine to everyone in India. This is the next concerning challenge we need to tackle.” No answers had been given then.

Quick question; will the government of India have 80,000 crores available, over the next one year? Because that’s what @MoHFW_INDIA needs, to buy and distribute the vaccine to everyone in India. This is the next concerning challenge we need to tackle. @PMOIndia

— Adar Poonawalla (@adarpoonawalla) September 26, 2020

Related:

SII provides 3 lakh doses, vaccination for 18-44 age group to begin in Maharashtra
Covishield vaccine the costliest in India?  
Covid-19: Scientists ask Modi gov’t to release data, increase genome sequencing

The post Adar Poonawalla is in Britain ‘on business’, but is that the only reason? appeared first on SabrangIndia.