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Countries around the world are snatching up coronavirus vaccines even though they are still under research. An equitable vaccine distribution mechanism is crucial to ensure maximum access

By NewsChina Updated Dec.1

A scientist in protective gear works in a new lab built to produce a Covid-19 vaccine at Sinovac, a company approved to conduct clinical trials for coronavirus vaccines, Beijing, September 24

On August 11, 2020, the world was caught off guard when Russia announced that Sputnik V, the first vaccine for Covid-19, was approved for production despite not having completed Phase III trials.  

One day later, the State of Parana in Brazil signed an agreement with the Russian Direct Investment Fund for testing, manufacturing and distributing the vaccine, officially called Gam-COVID-Vac. What’s more, Russia revealed that more than 20 countries in Latin America, the Middle East and Asia have applied for over one billion doses. 

As of mid-October 2020, the novel coronavirus has infected over 40 million people worldwide, killing more than 1.1 million as of Octber 19. Seven of the 10 worst-hit countries are in Asia, Latin America and Africa.  

Developing countries have no better options than to bet on Russian vaccines. High profile vaccine candidates such as the mRNA vaccines from Moderna and adenovirus vector vaccines from Oxford University have been snapped up by developed countries. Sputnik V, a dark horse, has provided a chance for developing countries. 

Panic Buying
The US has signed pre-order contracts with several leading vaccine companies worth US$6 billion. On August 11, the US purchased 100 million doses of coronavirus vaccines from American drug company Moderna for US$1.5 billion. Weeks later, the US also pre-ordered 100 million doses from Johnson & Johnson, 100 million from French pharmaceutical company Sanofi and British firm GlaxoSmithKline (GSK), six million mRNA doses from Germany’s BioNTech and US-based Pfizer, 300 million from the British-Swedish AstraZeneca, and one million doses from American firm Novavax. 

Most agreements are not direct purchase contracts but provide R&D and manufacturing investment in exchange for the right to priority purchase. As part of the US government’s Operation Warp Speed to speed up vaccine development, it aimed to cut vaccine research time to eight months and ensure the country’s access to 300 million effective and reliable doses of one or more vaccines by January 2021. 

The UK has purchased 90 million coronavirus doses from Janssen, a Belgian pharmaceutical company. In May, it also bought 100 million doses from AstraZeneca. To date, the UK has purchased six vaccines with a potential stock of 340 million doses. On August 14, the European Union inked the first pre-order agreement for 300 million doses from AstraZeneca. 

Since February, the US government has paid US$2.1 billion to Sanofi and GSK for trials and manufacturing scale-up for the delivery of 100 million initial doses of a vaccine they are jointly developing. In May, Sanofi CEO Paul Hudson said that “the US government has the right to the largest pre-order” because of the amount that it had invested. However, Sanofi walked back the comments a day later after pushback from other countries, including the EU, and promised to make its vaccine “accessible to everyone,” Bloomberg reported.  

On July 22, shortly after the US’s decision to purchase 600 million doses from BioNTech, the EU Commission announced that it has been negotiating with several vaccine development companies including BioNTech, Sanofi and Moderna on the acquisition of vaccines. 

On July 31, the EU announced that it planned to purchase 300 million vaccines from Sanofi for EU member countries.  

Barry Bloom, a professor of public health at Harvard University, said the US government is committed to not monopolizing any vaccine, or else the country would lose respect and credibility in the world. 

“I don’t think how many dollars was put in will determine how many vaccines go outside the US and how many will stay in the US. We will have to make negotiations within a globally agreed-upon plan,” he told NewsChina.  

“So this is a complicated negotiation, not just between powerful countries with political purposes, between funders and perhaps the WHO, but the vaccine companies and their shareholders who also have to be part of these discussions.” 

A woman undergoes a nucleic acid test for Covid-19 in New Delhi, India, August 31

Vaccine Nationalism
Sangeeta Shashikant, a legal adviser at the Third World Network, an independent non-profit international research and advocacy organization involved in issues relating to development, developing countries and North-South relations, has been working to help developing countries access vaccines fairly and solve intellectual property problems involving the vaccines. 

She said developing countries have little access to Covid-19 vaccines due to a global imbalance in research and production, most of which takes place in Europe, North America, China and Japan. 

“There is almost no research and production in Latin America, Africa and most parts of Asia. Therefore, these countries, most of whom are developing countries, have no power to negotiate and buy in,” she told NewsChina. “They can only rely on international aid or one or two deals for small amounts [of vaccine].” 

Statistics from the WHO show that as of October 19, there are 198 vaccine candidates developed worldwide, with 44 of them in clinical trials, including three from China and three from the US and UK entering Phase III trials. Countries like Brazil, Argentina and Mexico have provided test subjects for Phase III trials in exchange for technology and production licences. 

For example, Brazil has signed technology transference agreements with the Jenner Institute of Oxford University, China National Biotec Group and Sinovac Biotech. Brazil is able to produce 30 million Oxford vaccines during the trial period and 70 million vaccines after the clinical trials. 

Shashikant told our reporter that the world is in a totally different scenario than before and the same rules no longer apply. The coronavirus is spreading rapidly and with high mortality, so it will not end as quickly as SARS and H1N1. The only solution is that “everyone takes a vaccine and [we] attain herd immunity.” 

“The biggest challenge is if we want to manufacture that scale of vaccines, this is almost an unprecedented scale, and we also need to do this in a very short period of time. No country has this kind of experience, [even] America, Britain or any country with a big vaccine production capacity,” she said. 

Herd immunity means that 70 to 90 percent of people are immune to the virus. There are around 7.5 billion people in the world and at least 5.25 to 6.75 billion people have to acquire immunity. It sometimes takes two shots to acquire immunity and a minimum of 10 billion coronavirus vaccines will be required. In 2018, the world had a production capacity of 3.5 billion vaccines and it is still unable to meet global needs if all vaccine manufacturing lines are producing coronavirus vaccines only. 

Seth Berkley, an epidemiologist and the CEO of Gavi, the Vaccine Alliance, told NewsChina that “vaccine nationalism” further aggravates the extremely uneven distribution of vaccines around the world. In the end, he added, only a few countries have the ability to supply enough vaccines for their own people, such as the US and UK. Even within the EU, many wealthy countries cannot get sufficient vaccines, which in turn will delay the global escape from the pandemic. 

He added that for countries that are clear of the pandemic, there are still risks. No one can predict if the virus will mutate. Before all countries are protected, there is still the risk of a renewed outbreak.  

“Unlike the H1N1 outbreak in 2009, in today’s globalization, most downstream supply chains have moved to developing countries. The inevitable global economic recession brought about by the pandemic will mainly affect the United States, Europe and China. The United States will not be alone in its own way, if it practices vaccine nationalism,” he said. 

Gambling Game
COVAX, a global collaboration for speeding up the development, production and equitable distribution of new vaccines, was established to enhance global fair access to Covid-19 vaccines since April. It is operated by Gavi, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI). 

“This is a global problem that requires a global solution,” Berkley said during the first fund-raising event for COVAX in May. 

Because of the peculiarities of the coronavirus pandemic, it has taken a much shorter time than the normal five years it takes to research, produce and get approval for a new vaccine. The initial consensus on the R&D of coronavirus vaccines is 18 months, which means that the research, testing and manufacturing have to be conducted simultaneously. It thus generates unprecedented risks in terms of safety and costs. 

The possibility of successfully inventing a vaccine before clinical trials is 7 percent and it reaches 15 to 20 percent after clinical trials. It is a huge gamble for a country to pre-order vaccines because of the uncertainty. In Berkley’s opinion, by taking a purely “me-first” bilateral approach, governments risk ending up with no vaccine at all.  

“This is why buying into an international risk management system such as COVAX Facility - whereby enough doses are guaranteed to protect the most at-risk sections of the population - is the safest bet for all countries,” he told NewsChina. 

After joining COVAX, all countries are entitled to the use of vaccines invested in by the institution. COVAX pledged that if the vaccines some countries invested in fail, they could obtain a vaccine from COVAX to cover roughly 20 percent of their populations.  

COVAX aims to acquire at least two billion coronavirus doses by 2021, including 950 million for middle and high-income countries which have pre-ordered the vaccines, 950 million for middle and low-income countries and 100 million for emergencies and reserves. 

Berkley told our reporter that with nine CEPI-supported candidate vaccines, deals are underway with other manufacturers, and there is a backup portfolio of another nine candidates. Within nine CEPI-supported candidate vaccines, he added, three are from US firms: Novio, Moderna and Novavax.  

“SCB-2019 is a recombinant S-trimer subunit vaccine developed by Clover Biopharmaceuticals in China. The other one from China is RBD replicating influenza vector from the University of Hong Kong, which is still preclinical. There are also candidates from the UK, Germany and Australia,” he said. 

By late August, at least 172 countries had joined the COVAX initiative, covering over 60 percent of the global population and more than half of the G20. The US refused to join this global Covid-19 vaccine effort and Russia has not commented on the initiative. China officially joined COVAX on October 8. 

Kate Elder, a senior vaccine policy adviser at the Medecins Sans Frontieres Access Campaign, said some major countries have been reluctant to engage with COVAX and are not interested in equitable vaccine distribution. Therefore, COVAX is unlikely to play a major role. “Many parts of the program are not transparent enough,” she told NewsChina. 

China National Pharmaceutical Group conducts clinical trials for a Covid-19 vaccine in Manama, Bahrain, August 27

Intellectual Property
COVAX acquires vaccines after signing agreements with vaccine research and manufacturing companies. Shashikant said this pandemic is different from previous ones and therefore the gap between supply and demand is huge. 

“It is impossible for any vaccine company to produce amounts that could meet demand all over the world. Therefore, it is necessary to open up and share vaccine patents so that developing countries can use their own production capacity,” she told NewsChina. “This is the most critical point in solving vaccine allocation.” 

Chee Yoke Ling, director of the Third World Network, told our reporter that during the 2009 H1N1 influenza pandemic, the US had pre-purchased 600 million of the one billion vaccines in the world. The US and many European countries pledged to donate 10 percent of their vaccine stocks to developing countries, but it turns out that this happened only after their own people had enough. By that time, the pandemic was already over.  

She added that several large private pharmaceutical companies in Europe and the US have created monopolies through their use of patents. These companies claim they are assisting developing countries as much as they can, but actually are chasing profits and are not in it for the good of global public health. 

“We have to break the monopoly of several major private pharmaceutical companies in Europe and America. In other words, we should eventually break the existing intellectual property system if we don’t want these things to happen again,” she told NewsChina. 

Shashikant added that in order to construct a new intellectual property mechanism, developed countries in the US and Europe cannot be depended upon, and developing countries have to make their voices heard and actively participate in the distribution of vaccines. 

During a virtual Trade-Related Aspects of Intellectual Property Rights (TRIPS) conference on July 30, developing countries including South Africa pushed for equitable access to vaccines and said that business-as-usual scenarios are insufficient for the challenges. Bold approaches are needed, it said. South Africa insisted that it is urgent to share intellectual property rights and technologies of coronavirus vaccines to ensure the maximum global distribution with the lowest costs. Developed countries, however, persisted in the protection and implementation of intellectual property rights. 

“Nobody is safe unless everybody is safe in a pandemic,” Berkley said. “So we have designed the COVAX facility to try to provide vaccines for everybody in the world.”