How 172 countries raised $18 billion for COVID-19 vaccine, and the role of Indian biotech firms

DUBAI: FACT 1: Vaccines cure numerous infectious diseases. FACT 2: Rich countries have roped in the first 2 billion doses of yet-to-be-produced (still non-existent) coronavirus vaccines. How? By signing up billions of dollars worth of advanced purchase deals with Oxford/AstraZeneca, Pfizer/BioNTech, Moderna/NIH, CureVac — and other pharma giants whose candidate vaccines are in advanced human trials, and have the best chances of getting approved soon.

Question: Given the expected supply crunch (in the initial stages immediately after approval of a vaccine — or vaccines), how can poor countries have access to them? How do you make vaccine access more equitable? Quick answer: It's not known. But there's also FACT 3: Developing nations have raised $18 billion in a "solidarity" move to deploy a COVID-19 vaccine to their citizens. The initial goal of the campaign, called COVAX, is to have 2 billion vaccine doses available by the end of 2021. China was not among the countries that made a commitment, according to a statement released Monday, though more agreements will be announced later. The program is led by the World Health Organisation (WHO); Gavi, the Vaccine Alliance; and the Coalition for Epidemic Preparedness Innovations (CEPI). The US has said it's not joining.

It's all part of the prevailing atmosphere of "vaccine nationalism". COVAX is a counter-point strategy that aims to give governments in developing countries an opportunity to hedge the risk of backing unsuccessful vaccine candidates. The upside: by forming a sort of buyers' mega-coalition, less developed countries can bump up their purchasing power. This, it's also hoped, would eventually make per-unit prices of COVID-19 shots more affordable for all (like polio vaccine is priced at $0.50 per shot. The hoped-for result is that developing nations can have access to an approved vaccine that would be otherwise unaffordable.

What is COVAX, how many vaccines and countries are under it?

COVAX is a mutilateral, multinational initiative to boost access by developing nations to vaccines. It's the main pillar of the Access to COVID-19 Tools (ACT) Accelerator, a global collaboration to speed up the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. Moreover, COVAX aims is to boost the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.

COVAX currently has nine vaccines in development and nine under evaluation in its portfolio. COVAX's goal is to secure 2 billion doses by 2021. At least 172 countries have joined the COVAX initiative, which is co-led by CEPI and Gavi, the Vaccine Alliance. The US has not contributed to the initiative, but has signed bilateral deals with various vaccine makers, including non-US pharmaceutical companies.

How do less-developed countries benefit from COVAX?

Self-financing countries can pay up front for vaccine doses that would cover as much as 50% of their populations, according to COVAX literature. In an ideal world, the shots would be proportionally distributed among poor and rich countries alike as they become available. COVAX has stated that it does not prevent coalition members (governments) from signing up deals with vaccine makers. Governments that sign up are free to reach bilateral deals to secure supplies separately. Following are the stated COVAX benefits:

What if developing countries don't act now?

Experts point to a previous pandemic: the 2009 swine flu pandemic. At that time, a few countries cornered the vaccine market, leaving the vast majority of the global population with no vaccine at all until the outbreak was effectively over. This scenario must be avoided "at all costs" during the current crisis, said WHO chief scientist Dr. Soumya Swaminathan.

How many countries are involved in COVAX?

According to a Reuters report in August, there were 172 countries engaged with the COVAX plan. The report, however, pointed out that more funding is urgently needed. The World Health Organisation also urged countries to now make binding commitments. "Initially, when there will be limited supply (of COVID-19 vaccines), it's important to provide the vaccine to those at highest risk around the globe," the WHO's director general Tedros Adhanom Ghebreyesus told a media briefing in August. He added that the terms of agreement have been sent to countries that would potentially self-finance as part of the plan.

What are advanced purchase agreements (APAs)?

The Lancet published an article this September pointing out that APAs erode collaboration between countries. Importantly, such bilateral legal agreements are likely to contribute to inequities and potentially extend the pandemic's time frame. "By contrast, multilateral legal agreements could be the path back to global health security and justice by re-establishing norms of international solidarity, committing to global equitable vaccine access initiatives, and laying a foundation for a post-pandemic era built on multilateralism and cooperation.”

In the past, vaccine development had been a very expensive undertaking, usually beyond the reach of most underdeveloped countries. However, while APAs are a gamble for the big countries, it's a gaime that poor countries can ill afford. Given the spread of SARS-CoV-2 and urgent need for a vaccine, no gap between rich and poor nations has been more pronounced than the ability to sign APAs.

How many COVID-19 vaccines had been secured by rich nations? 

More than 2 billion doses, according to The Lancet. In the lead-up to the World Health Assembly (WHA) in May, 2020, current and former politicians and civil society leaders from around the world, including the President of Ghana, Nana Akufo-Addo, the Prime Minister of Pakistan, Imran Khan, and the President of South Africa and Chair of the African Union, Cyril Ramaphosa, called for a “bold international agreement” that guarantees global equitable access to vaccines as global public goods. The only resolution adopted during the WHA was the recognition of immunisation, rather than vaccines themselves, as a global public good. "However, since then, the global legal landscape has shifted from a rhetoric of global public goods to a reality largely based on nationalism."

How many vaccines are under development?

According to WHO, there are more than 170 COVID-19 candidate vaccines in development. As of September 7, 2020 only eight of those vaccine candidates were in Phase 3 trials. As of now, wealthy nations have secured more than 2 billion doses of potential future COVID-19 vaccines using APAs.

What is the role of China?

At the WHA, China's President Xi Jinping stated that any Chinese vaccine developed will be a “global public good”, and contribute to “ensuring accessibility and affordability in developing countries”. Having China on board would be a big deal for COVAX. The reason: providing doses to even a fraction of China's 1.4 billion people would boost critical mass, enhancing the COVAX alliance's negotiating power on bulk purchases.

For China, COVAX could act as a kind of insurance policy that allows it access to any successfully developed vaccine. While being a member doesn't necessarily mean Chinese vaccines will be included in COVAX's portfolio, it's probable that'll be the case. China could also provide manufacturing support for a successful vaccine, regardless of which country develops it. China has promised to prioritise providing doses for at least 62 countries, including governments that have received infrastructure loans under Xi's Belt and Road Initiative. Indonesia, Bangladesh, Pakistan and Morocco have formal agreements with China's major vaccine manufacturers, and Egypt is close to signing one.

Participation in COVAX could mean that Chinese vaccine manufacturers play a significant role in the global roll-out. And if a Chinese-developed vaccine were selected, their brands would benefit from WHO certification, according to Xiaoqing Lu Boynton, a consultant at Albright Stonebridge Group who focuses on health care and life sciences. Latin American and Caribbean countries have been promised a $1 billion loan to purchase a Chinese-designed vaccine. Currently, Mexico, Chile, Brazil, and Argentina have all made commitments to testing a Chinese vaccine. Latin America has been one of hardest-hit regions, with Brazil, Mexico and Peru among the world's top 10 countries by total COVID-related deaths.

What are the challenges and opportunities?

China doesn't have much experience in manufacturing and distributing a vaccine for global consumption. The industry's reputation took a hit in 2018 when two Chinese vaccine-makers were found to have cut corners in production, undermining confidence both at home and abroad. Still, China has been a front-runner in developing vaccines against the coronavirus.

Nine of China's vaccine candidates have entered clinical trials, and four of them got approval for final stage Phase III clinical trials in foreign countries. Tianjin-based CanSino was the first in the world to reach the crucial final stage of human testing for a vaccine it co-developed with the Chinese military. CanSino Biologics, Sinovac Biotech Ltd. and SinoPharm China National Biotec Group (CNBG) have kicked off or completed testing in countries including Brazil, Russia, Indonesia, the United Arab Emirates, Peru, Chile and Morocco. The UAE, which has trialled the SinoPharm CNBG vaccine in 31,000 volunteers in Abu Dhabi, has already approved it vaccine for use by frontliners and public school staff.

Trump-Xi rift: How would it affect vaccine production, distribution?

As the rift between the US President Donald Trump and Chinese President Xi Jinping remains, and it being an election year in the US, vaccine has become a central US campaign issue in the November vote. As for other countries, an incident involving CanSino and Canada highlighted concerns that China could use its vaccine as a gambit. The Chinese vaccine developer was supposed to send its vaccine candidate so that clinical trials could begin in Canada. However, Chinese customs reportedly disapproved the shipments, according to the National Research Council Canada. Malaysia is in talks with many parties, including China. "We have more questions than answers at the moment," said Noor Hisham Abdullah, the Southeast Asian nation's Director General of Health. Vietnam, which has sparred with Beijing over territorial disputes in the South China Sea, last month agreed to purchase millions of doses of Russia's vaccine, and it's developing a national one expected to be ready late next year.

For its part, the Philippines has expressed a willingness to accept a vaccine from the US, Russia, and China, rejected any notion that China may be using the vaccine to curry diplomatic favors. "No such concern about China's vaccine at all," said Teodoro Locsin, the Philippine foreign affairs secretary. "I think that it's in China's interest to join (COVAX)," said Wang Huiyao, an adviser to China's cabinet and founder of the Center for China and Globalization, referring to Covax. "If the world is still in the pandemic, China will not be in good shape either."

What about Europe? What is its role in COVAX?

On Friday, September 18, 2020, the European Commission said it will put $473 million into the COVAX programme aimed at procuring COVID-19 vaccines for lower- and middle- income countries. The commission will contribute an initial $272 million, enough to contribute 88 million doses of vaccines to eligible countries, followed by an additional $201 million. More than 170 countries have joined the COVAX initiative, which is co-led by the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance. The U.S. has not contributed to the initiative.

What about India's role?

On September 7, 2020, the Times of India reported that New Delhi officials are in talks to join the COVAX initiative. India has a number of biotech giants of its own, now testing their own COVID-19 vaccines in humans. India has some of the world top vaccine makers including Bharat Biotech, Serum Institute and Zydus Cadila. These manufacturers have also signed research and mass manufacturing deals with Western vaccine counterparts. India's vaccine makers produce  billions of vials for the UNICEF's immunisation campaigns against polio, mumps, measles, rubella, diptheria, pertussis, tetanus. Indian vaccine makers have a good safety record too.

Regulators have approved Phases II and III trials of COVID-19 shot in the subcontinent. India currently has three vaccines in different phases of human trials, according to Dr. Shriram Bhargava, director general of the Indian Council of Medical Research (ICMR). India's Department of Biotechnology has funded Zydus Cadila's candidate vaccine. On August 3, the Drugs Controller General of India (DCGI) approved the clinical trials of Pune-based Serum Institute of India (SII) for the Oxford University-Astra Zeneca COVID-19 vaccine in India.

If their vaccines get approved, India's biggest biotech could help salve for the world, potentially without blowing a big hole in the pockets of poor nations. Bharat Biotech is the biggest vaccine manufacturer in the world by volume. On August 4, 2020, Dr Krishna Ella, Bharat Biotech's managing director, vowed to supply Covaxin to the whole world, at a cost "less than a water bottle." Bharat Biotech, incorporated in 1996, has since become a global leader in vaccines. He also sits on the Scientific Advisory Committee in India's Union Cabinet.

On September 10, 2020, the Bill and Melinda Gates Foundation announced it will fork out $150 million of ‘at-risk’ funds to help Serum Institute “accelerate” the production of the COVID-19 vaccine candidates being developed by the University of Oxford-AstraZeneca and the American vaccine developer Novavax Inc.

As part of the deal, the SII will supply up to 100 million doses of the vaccines to India and low- and middle-income countries through COVAX. India is expected to get access to 50 percent of these doses. On September 7, 2020, the Times of India reported that New Delhi officials are in talks to join the COVAX initiative.

[With inputs from The Lancet, Gavi, Bloomberg, AP, AFP]