NEW DELHI: With thousands of Indian nationals, largely blue collar workers, now stuck in the Gulf region and seeking repatriation amid the Covid-19 pandemic, New Delhi finds itself caught between a rock and a hard place.

When should it begin the evacuation? Where and how will it house hundreds of persons who might require quarantining or testing?

Adding to Delhi’s worries, many of the Gulf states want to see the migrant workers return home at the earliest given the need to prevent Coronavirus infections on their soil. They are also an economic drain at a time when work has dried up due to the pandemic. On Monday, news agency reports said the UAE had warned it would review work quotas issued to countries that were refusing to take back their workers.

But sources in the Ministry of External Affairs said no such warning had been received although the UAE had offered to facilitate the return of these workers to India.

“India has close relations with the UAE and it won’t do anything unilaterally,” said Navdeep Suri, India’s former ambassador to the UAE. He pointed out that nine million of the UAE’s 10 million population comprises expatriates and nearly 3.4 million of this 9 million are Indians, 70 per cent of whom are blue collar workers.

He noted that blue collar workers are on work visas for specific projects and if a project stalls, their visas expire which means they need to return to India. But Delhi’s advice to Indians stranded abroad since the lockdown is to ‘Stay where you are’, which probably also includes the workers in the Gulf.

But their patience appears to be wearing thin as they have no jobs and their money is running out. A senior Indian diplomat conceded that at some point Indians stranded abroad will have to be allowed to return, a lot of planning will be required to work out the logistics especially when the world is dealing with a highly virulent contagion.

There is also increasing pressure on the Centre from the Kerala government of Chief Minister Pinarayi Vijayan, to bring the workers home. Congress MP M.K. Raghavan has filed a petition in Supreme Court seeking the evacuation of workers from the six Gulf Cooperation Council (GCC) countries.

Lawyer A. Karthik who filed the petition told StratNews Global on Monday, that the court has asked the Solicitor General of India to look at the petition as a representation and submit a report in four weeks. The petition, among other things, has said the process of identifying those who need to return should begin. Workers from Kerala number a staggering 1.3 million of the eight million strong Indian diaspora in the Gulf region.

In recent days, India has reached out to the six member states of the GCC—Saudi Arabia, UAE, Kuwait, Bahrain, Oman and Qatar—with Prime Minister Narendra Modi speaking to each of their leaders on the welfare of the Indian workers. India has leverage: it recently dispatched a team of 15 doctors and healthcare professionals to Kuwait to help its government tackle the pandemic.

NEW DELHI: In the first part of an exclusive interview, Dr Niteen Wairagkar, global pandemic and new viral diseases expert speaks to Opinion Editor Ashwin Ahmad and explains the processes that need to be gone through before a vaccine for the COVID-19 virus can be made available in the market     

 Q: What are the main questions that scientists and researchers have to consider when developing a vaccine for the COVID-19 virus?  

A:  In the case of   COVID-19, scientists and researchers must define what type of vaccine would be needed, what is known as Target Product Profile of the vaccine needed. Then they will need to decide whether to use new technology or use the old and time-tested technology for vaccine development. There are a variety of vaccine platform technologies that you could use. (Editor’s note: A vaccine platform technology is a system that uses certain basic components which can be adapted quickly — by inserting new genetic or protein sequences—so that it can be used against different pathogens. This is faster, more efficient and cheaper than developing a single-use vaccine which is more expensive and harder to scale up.) The new technologies could be fast and effective but since they are not proven, you need to tease out safety issues and explore whether the risk-benefit equation is in favor.

Q: What are the stages that the vaccine has to go through before this happens?    

A:  Once the vaccine is developed in the laboratory, it needs to be tested in an appropriate animal model for its safety, toxicity and evaluation of immunogenicity and effectiveness, first usually in small animal model and then it will be taken up to a higher model which is usually a non-human primate or the monkey model. With all the data that is generated from these tests, vaccine regulators will then look at the safety of these vaccine constructs, the toxicity of these vaccine constructs and its immunogenicity and effectiveness i.e. whether it protects and to what extent could it protect humans. Once this is done, then permission is granted for human vaccine trials.

Q: Does it then go into human trials?    

A:  Yes. This data is studied and then goes to human trials where in Phase-I safety study, you normally begin by testing on healthy adult humans usually in the 18-55 age group. This data will look further at determining the safety and immunogenicity but also at how long does this vaccine take to develop anti-bodies and how long would these anti-bodies last?

Once the safety of the vaccine is indicated in the Phase-I study,  you can go to Phase-II where you decide the dose or the dosing schedule as to what would be is the right amount to develop enough antibodies to fight the virus. Then you go to Phase-III which is what we call clinical efficacy where you prove that this vaccine actually protects a human being against clinical disease caused by the virus. These studies are done sequentially during normal vaccine development but sometimes two studies could be combined with a bigger sample size to save some time.

Q: How long do you think it would take to create a vaccine for COVID-19?    

A:  Normally, for any normal vaccine, by normal — I mean creating any vaccine in a non-pandemic situation — the vaccine development takes at least five to seven years to go through all these stages, collect data and pass regulatory evaluation. Since we are now in a pandemic situation, we need to generate this data much faster, we need to innovate to accelerate the timelines without compromising the ‘risk-benefit ratio.’ What this means is that we generate essential data required for the safety evaluation of vaccine and then evaluate if vaccine is efficacious. Combining Phase I/II studies with enough numbers recruited in vaccine trial might generate necessary safety, immunogenicity, efficacy data which can lead to conditional approval of COVID-19 vaccines.

Once the conditional approval is granted, the vaccine can be given to the high-risk group, most probably healthcare workers in campaign mode and generate effectiveness data. We can probably accelerate these vaccines and get them to the finish line within the next two years using some innovative trial designs and parallel track processing.

Q: How many vaccine developers are working to develop the COVID-19 vaccine?

A: Currently, there are 115 vaccine candidates that are being developed globally now. 73 of these vaccine candidates are being developed by the vaccine manufacturers and the remaining are being developed by academic and non-profit institutions. Many of these vaccine developers are using new technologies like mRNA or DNA vaccine while others are using viral vectors, recombinant proteins or subunit vaccines.

Since we don’t know which vaccine will be safe and efficacious, it would be good to have as many vaccine candidates in the field. Of these vaccine candidates, at-least 4-5 vaccines have already reached Phase-I safety clinical trials in human subjects, which is remarkable progress within three months of the emergence of this virus. This has never happened in human history before.

Q: Would not climatic conditions, body types and differing reactions to drugs play a part? Would we not need different strains of the vaccine to deal with this?

A: This virus’s genetic makeup has been analyzed and it has been seen that genetically it is pretty stable. There are no variations. So, the vaccine would offer a similar kind of immune response. It may vary geographically to some extent but I don’t think there will be major differences in the immune response though and there will be a lot of data available to look into this aspect as well when this vaccine would be conditionally approved. WHO has come up with a global trial design for multi-country vaccine trials to explore possible differences in vaccine responses.

MADRID: The scale, speed and threat of the global COVID-19 pandemic are unprecedented, as is the financial response now required. According to experts, this pandemic is unlikely to be quickly contained. It may ebb and flow over time, across seasons and between regions, underscoring the importance of a coordinated global response.

As former Presidents and Prime Ministers, we have variously led our democracies in response to governance transitions, financial crises, civil unrest and violent conflict, and to epidemics as serious as SARS, H1N1, MERS and Ebola. Given the startling velocity with which COVID-19 has spread globally, this pandemic must be addressed urgently in real-time. That will require a leadership approach based on values of solidarity, equity and cooperation which transcend a sole focus on national interests—that alone would prove insufficient to stop a global pandemic.

We welcomed the convening of the first virtual Leader’s Summit of the G20 on 26 March 2020. The message sent from the Club of Madrid beforehand aimed to encourage the G20 to establish global solidarity in the fight against the pandemic. We fully agree with the call made by the Director General of the World Health Organisation to ‘fight, unite, ignite’ against the virus that threatens to tear the world apart. We call on the G20 to provide the leadership and support needed for a globally coordinated response. The G20’s engagement is particularly important. As we saw a decade ago during the financial crisis, its convening of countries from every region of the world representing more than ninety per cent of the global economy and two-thirds of its population can be critical. The G20 must develop and deliver a comprehensive response to both the unfolding public health emergency and, increasingly, the global economic and social emergency in a way that provides confidence to people and markets. This response must go beyond platitudes and principles. It must result in concrete decisions, such as to eliminate barriers to the free movement of medical personnel and equipment, to coordinate efforts around vaccine development and testing, and to support low income countries which have poor public health infrastructure and capacity.

To date, world leaders have largely focused on the outbreaks in their own countries. The priority given by leaders to solving the problems of their own citizens is understandable. No country is safe, however, from a pandemic like COVID-19. Stand-alone national strategies will not only prove ineffective in stopping the virus but they would also mean that the international response will be weaker than needed to prove effective.

The World Health Organization has worked admirably within its capacity to coordinate a global response. Yet one multilateral agency left to act alone cannot perform miracles. The multilateral system as a whole must step up to provide the response required. The UN Security Council should resolve to address the global pandemic as a threat to global peace and security. The UN system as a whole is only as strong as its members. The COVID-19 response requires leadership at the global level to tackle not only the outbreak but also to coordinate efforts to stave off the next great economic depression. Governments should not develop stimulus packages in isolation. We know from history this will only create fiscal imbalances that will make the recovery harder. And governments must also align their efforts with the Sustainable Development Goals and the Paris Agreement to ensure we are better placed to tackle other global challenges like climate change as we emerge from this crisis.

We are especially concerned regarding the rapid spread of COVID-19 to countries in the Global South. Public health infrastructure and capacities have already been sorely stretched in China, South Korea, Europe and the USA. United Nations Secretary General (and Club of Madrid Member), Antonio Guterres, has rightly called on wealthier countries to focus beyond their national challenges and work towards a comprehensive response which supports poorer countries. The proposal of the Government of Norway to the G-20 to establish an international fund to help the countries of the Global South is a step in the right direction. A global response fund which envisions public-private cooperation across borders, at the disposal of international public health experts, is critical for leaving no one behind both between and within countries.

In many places, identifiable groups have not enjoyed full access to goods, opportunities and services. Public health responses must take into account the need to focus on and include those historically or otherwise marginalised from healthcare, including ethnic and religious groups, indigenous peoples, minorities, migrants, women and youth. If their exclusion is replicated in the response to the pandemic, not only will they be potentially decimated by illness but they may also become continued transmitters of the virus even as it begins to recede among other populations.

Technology is part of the solution but it also needs to be applied equitably between and within nations. We know that digital transformation has not been inclusive and equitable across societies, particularly as it affects women and minorities. We must be sure that the technological responses we develop like testing, medical care and, in time, vaccines are distributed equitably. In South Korea for example, access to continuous and rigorous testing procedures made accessible to the public through user-friendly drive-through and even walk-through sites, has maintained civil order and allowed public health managers to achieve a high recovery rate.

Efforts to support the global economy must also focus on the most marginalised and excluded populations. This means building economic recovery strategies around employment, poverty reduction and sustainable business models.

Without an effective global strategy and action, COVID-19 will continue to spread, taking a heavy toll on human health and well-being and severely damaging economies and societies. As former Presidents and Prime Ministers, we call on the G-20 and world leaders to finance and empower a reinvigorated and coordinated international response which leaves no one behind and aims to stop the COVID-19 pandemic.

(Authored by Club de Madrid members Jan Peter Balkenende, Ban Ki-moon, Kjell Magne Bondevik, Helen Clark, Benjamin Mkapa, Ricardo Lagos, Kevin Rudd, Aminata Touré, and Danilo Türk)

NEW DELHI: In the worldwide race to develop a vaccine for the Coronavirus, Indian firms are not far behind. Hyderabad-based Indian Immunologicals is collaborating with Australia’s Griffith University to develop a “lead candidate vaccine” for the virus. Company scientists said they are developing a “live attenuated” vaccine, meaning a weakened strain of the virus which will stimulate a strong response from the body’s immune system. The vaccine is envisaged as a single dose providing lifelong immunity.

The same firm is also working with Griffith University for a vaccine against the Zika virus which hit Rajasthan three years ago, infecting 157 people. That vaccine is currently at “pre-clinical toxicology testing stage”.

The Pune-based Serum Institute of India, the world’s largest vaccine manufacturer by volume, says it has reached the animal clinical stage with its Coronavirus vaccine and could have results in about two months. The institute tied up with the U.S.-based drug research company Codagenix to develop a live attentuated Coronavirus vaccine. It says it has already progressed to the pre-clinical trials phase and is hopeful of hitting the market with the vaccine in 2022.

Zydus Cadilla based in Ahmedabad is trying to develop a “DNA Plasmid Vaccine”. DNA immunization is a novel technique used to efficiently stimulate humoral and cellular immune responses to protein antigens and develop immunity.

Hyderabad-based Bharat Biotech and the U.S.-based FluGen along with scientists at the University of Wisconsin-Madison are testing a unique vaccine against the Coronavirus called CoroFlu. Company CMD Krishna Ella said: “If the govenemnt acts fast and treats it as a national emergency, it should be possible to get the vaccine out in about eight months.”

Ella believes the process will move faster in India since the CoroFlu is based on FluGen’s flu vaccine known as M2SR which is already proven in phase 2 human challenge studies. CoroFlu will be delivered nasally, which follows the path of the coronavirus infection. It is believed that intranasal delivery is more efficient since it induces multiple immune responses.

China, where both the SARS and the Coronavirus originated, is reported to be funding a major vaccine effort. The Hong Kong-based South China Morning Post quoted Zhang Xinmin, director of the China National Centre for Biotechnology Development, in February as saying: “…vaccine development is a priority and we have pulled together all the best units in the country to work towards a breakthrough and to expedite the development of a vaccine.”

Elsewhere, the Coalition for Epidemic Preparedness Innovation (CEPI), a group backed by the Bill & Melinda Gates Foundation, the Wellcome Trust and other investments from other countries, is funding Inovio Pharma, a joint venture of U.S. pharma major Moderna and the US National Institute of Allergy & Infectious Diseases. CEPI wants to see if vaccines for different viruses if developed on the same platform with some adjustments can be applied for the new Coronavirus and reduce the production time.

Experts say it takes about 12 to 18 months to bring a vaccine to trial and one out of every 10 candidate vaccines fail in the trials. Incidentally, according to the World Health Organisation, there are 60 candidate vaccines in various stages of pre-clinical studies.