As R&D explodes in an aggressive quest to develop vaccines and treatments against the still-raging Covid-19 pandemic, there is still no clear roadmap to ensure that the products eventually produced, distributed equally, with vulnerable populations prioritized, says Marie-Paule Kieny, a former high-level WHO official and board chair for the Geneva-based Drugs for Neglected Diseases Initiative (DNDi).
“Planning for future access to new technologies while they are still being developed is really critical...We need to do things differently...this requires significant collaboration across many stakeholders,” said Kieny.
“Business as usual may not be sufficient. We need interventions to be on a different scale than what we’ve seen before.”
Why this matters? Viruses know no borders - As long as a virus is spreading somewhere, it has potential to spread everywhere. The virus can only be stopped if everyone has access to vaccines and treatments.
Here are the two key challenges - and potential solutions - that were discussed by Kieny and other panelists from academia and civil society in a webinar Tuesday sponsored by the Geneva Graduate Institute’s Global Health Centre.
Challenge 1: Worldwide manufacturing capacity
The sticking point - When a vaccine becomes available, no single company will be able to produce enough of the drug on its own. Even the biggest vaccine producers in the world, like the Paris-based Sanofi, would fall short of the mark. Sanofi can produce vaccines to reach a meagre 2.5% of the global population at best, some 200 million doses a year, said Kieny.
Solutions: prepare now for a big expansion - Countries and companies need to work together to prepare manufacturing capacity even before a vaccine or treatment is developed. This may be the only way to produce enough doses for the whole world. Here’s how to make this happen:
We need to take advantage of existing organizations with a proven track record like GAVI instead of wasting precious time and money by creating new structures, Kieny said. Over the past 20 years, GAVI has vaccinated half of the world and introduced some 500 vaccines.
Still, not everything has to pass through global health entities such as GAVI or WHO, either. Some countries in the global South may find ways to directly cooperate with each other, said Carlos Correa, Executive Director of the Geneva-based South Centre.
Challenge 2: Guaranteeing access to Covid-19 vaccines and treatments
The sticking point - In the absence of international agreement, “it is likely that once a country develops a vaccine, exports will be blocked to ensure that the country” serves itself first, said Suerie Moon, co-director of the Graduate Institute’s Global Health Centre, who moderated Tuesday’s webinar. Such “me first” policies have already become a problem for ensuring access to masks, gloves and other personal protective equipment (PPE), desperately needed by health workers worldwide, but often in short supply unless countries had local production capacity. Note: There has also been hoarding of the anaesthetic propofol, essential to the treatment of COVID-19 patients on respirators, according to the Bureau of Investigative Journalism
Solutions: reaching international agreement on access - Pharma innovators can agree to allow other companies to produce generic versions of their product through “voluntary licensing”, explained Marcela Vieira, coordinator of the Knowledge Network for Innovation and Access to Medicines at the Global Health Centre. The most immediate opportunity to build consensus around this approach is the upcoming World Health Assembly (WHA), 18 April. As of Wednesday evening, WHA member states were closing in on an agreement on a European Union-sponsored resolution, supporting a voluntary patent pool and other medicines access measures. White smoke may emerge over the next 24 hours - although the United States and its allies were still reportedly locked in negotiations with the resolution’s EU sponsors over the sensitive access issue.
Open-licensing agreements, like a voluntary patent pool, could be managed by entities like the WHO or the Medicines Patent Pool (MPP) to share rights for COVID-19 related technologies, Vieira added. While this idea has worked to some extent to reduce HIV drug prices, it relies on the ‘goodwill’ of innovators.
The WHA resolution also could earmark specific quantities of a vaccine for those who need it most - including countries without local manufacturing capacity as well as vulnerable populations like healthcare workers. For instance in 2009, during the H1N1 flu pandemic, WHO obtained an agreement from pharma manufacturers to distribute 10% of global output to developing countries, said Kieny. The pandemic warrants a similar approach, although in the case of H1N1, the 10% of total vaccine output allocated left ‘little for developing countries”, warned Correa.
International treaties like the Trade-Related Aspects of Intellectual Property Rights (TRIPS) also affirm the right of WTO Member States to lawfully break patent rights during emergencies like a pandemic, to produce life-saving innovations. There is emerging consensus that the draft EU resolution to go before the WHA next week, would specifically refer to these TRIPS flexibilities to put more teeth into the forthcoming agreement. But some countries are opposed to placing too much emphasis on this harder-line approach to “compulsory” licensing. Industry voices have also warned this could scare off much-needed private sector investments. Stay tuned as a hoped-for final draft emerges soon.
The national approach - If the international community doesn’t come through with explicit mechanisms ensuring access, countries are likely to take matters into their own hands. More and more member states may resort to national legislation allowing for the use of lawful TRIPS ‘flexibilities’ like compulsory licenses. Some countries have already begun that process, said Vieira:
Last week, 6 pharmaceutical companies in Bangladesh started producing copycat versions of Gilead Science’s experimental Covid-19 treatment Remdesivir, the only one so far shown to reduce the recovery time of seriously ill patients, after the government gave them a TRIPS waiver.
Other countries like Canada, Germany, Ecuador, Colombia, Chile and Israel have reformed national legislation to ease the process of compulsory licensing, just in case international agreements or voluntary patent pools fall through.
The bottom line International collaboration lies at the heart of an organized plan for manufacture and distribution of new vaccines and treatments. But if the WHA fails to pave the way for a strong international consensus, countries will have no choice but to adopt their own measures, helter-skelter.
Some quick numbers - the R&D process
Although research and development has multiplied exponentially over the past few months, most R&D is localized to just two countries - China and the USA. Getting a pharmaceutical product approved in the market takes 5-10 years, and most initiatives fail - In the case of vaccines, 80% of candidates fail.
Treatments - 721 clinical trials are ongoing for some 200 treatments
Vaccines 10 candidates are in phase I-II, and 90 candidates are in preclinical development
$US 5.5 billion - That’s how much the public sector and philanthropy has committed to the COVID-19 response
Of that, almost $US 2.5 billion has been directly channeled into vaccines R&D, said Temmy Sunyoto, post-doctoral researcher at the Global Health Centre. However that money has been spread between over a dozen vaccine candidates. To bring just one single vaccine to license, a minimum of $US 2.8 billion would be needed.