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COVID-19 vaccine developer in Vietnam willing to share data

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Nanogen Pharmaceutical Biotechnology, based in Vietnam’s Ho Chi Minh City, is willing to share know-how and technology for developing its COVID-19 vaccine candidate. But the challenge for the company is finding manufacturers with the capacity to produce it in low-income countries.

“We are willing to transfer our techniques. The problem is [whether] they can produce it or not,” Do Minh Si, director of research and development at the company, told Devex.

Nanogen used recombinant protein technology to develop its COVID-19 vaccine candidate, called Nanocovax. It started phase 2 clinical trials in February, with two trial sites in Ho Chi Minh City and Hanoi, and is currently awaiting administration of a second shot to 560 healthy volunteers, expected to take place between the end of March and early April.

The company says its vaccine is safe, stimulates immune response, and is effective against the COVID-19 variant first found in the United Kingdom, but data on early results has yet to be published.

However, the company is already in discussions with the Vietnamese Health Ministry about whether to simply proceed with phase 3 clinical trials or — if phase 2 goes well and emergency use authorization is granted — to instead conduct them while also using the vaccine as part of the country’s COVID-19 inoculation campaign.

“Not only are vaccines far too expensive, [but] poor countries are being forced to the back of the queue by rich nations.”— Max Lawson, head of inequality policy, Oxfam

Vietnam has largely been successful in keeping COVID-19 cases low, although it has experienced another wave of infections in late January 2021. The country has reported 35 total deaths from COVID-19.

Vietnam’s efforts to develop its own vaccine come amid challenges in securing vaccine supplies during the pandemic, with many high-income countries pursuing deals that leave few doses for low- and middle-income countries.

It’s one of the few, however, that has some capacity to produce its own vaccines. Many low- and middle-income countries are reliant on the global vaccine distribution facility COVAX or donations, or they are directly pursuing deals with pharmaceutical companies — sometimes paying more than high-income countries.

The need for domestic vaccines

Last week, Vietnam began providing COVID-19 inoculations, starting with health workers, using doses of the vaccine developed by the University of Oxford and AstraZeneca that were secured through a bilateral deal. The country is expecting more doses to come from COVAX and continues to negotiate with other vaccine manufacturers as it awaits results for homegrown vaccine candidates.

In addition to Nanocovax, a vaccine developed by Vietnam’s Institute of Vaccines and Medical Biologicals started clinical trials this week.

Vietnam is not the only country pursuing its own COVID-19 vaccine. Thailand is developing two domestic vaccines, both of which are expected to enter clinical trials in the coming months. Meanwhile, millions of doses of China’s Sinopharm and Sinovac vaccines have been donated to nations across the globe.

The Serum Institute of India has a license to produce the Oxford-AstraZeneca vaccine, but India also has a homegrown vaccine developed by Bharat Biotech, which recently released interim efficacy data from a phase 3 clinical trial. Russia has three COVID-19 vaccines, with Sputnik V being the most high-profile.

Like most governments, Vietnam wants to ensure a diverse supply of vaccines to meet its needs while avoiding overreliance on any one producer or country, said Gregory B. Poling, a senior fellow for Southeast Asia and director of the Asia Maritime Transparency Initiative at the Center for Strategic and International Studies.

“This is especially the case vis-à-vis Chinese vaccines because Vietnam’s government is deeply skeptical of Beijing and what it might demand should it gain too much leverage of Vietnam’s vaccine supply,” he said.

But countries such as China and Russia have not shared their vaccine technologies — and, in some instances, are selling their vaccines at potentially unaffordable prices for lower-income countries, said Max Lawson, head of inequality policy at Oxfam, who is among those advocating for a “people’s vaccine.”

Lawson and other experts have welcomed Nanogen’s willingness to share information around its COVID-19 vaccine — a contrast to the reluctance expressed by some Western vaccine developers.

“Great news that the vaccine developer is offering to share the know-how of a potential Vietnamese COVID-19 vaccine with other producers,” said Ellen ‘t Hoen, a lawyer and director at research group Medicines Law & Policy. “This should ideally be done through C-TAP,” she added, referring to the World Health Organization’s COVID-19 Technology Access Pool, which has struggled to gain traction.

Amid waves of vaccine nationalism, “one long-lasting impact of the crisis is that no one wants to leave the safety of their populations to the market,” Lawson said.

“Whilst rich nations are vaccinating one person a second, the majority of poor countries have yet to give a single shot. Not only are vaccines far too expensive, [but] poor countries are being forced to the back of the queue by rich nations, and patents and monopolies of pharmaceutical corporations are artificially rationing supply,” he added.

Lawson said it will be a “game changer” if new vaccines produced by low-income countries are more affordable than the vaccines currently in use.

Other experts, while recognizing the value of local vaccines, are more cautious about the potential for wider use.

“If nothing else, there is a considerable amount of scientific and technical expertise to be gained from the development and production of local vaccines. Now whether Vietnam can efficiently produce and distribute vaccines abroad in a way that makes them competitive, or even necessary, is unclear,” Polling said.

Efforts to keep pricing low

Nanogen became involved in COVID-19 vaccine development following a call by the Vietnamese government to develop a locally made option. Si, the director of research and development, said the government first asked the company to work on monoclonal antibody therapy for COVID-19 in 2020.

However, the low number of patients in Vietnam made it difficult for Nanogen to conduct clinical trials. That’s when the government asked if the company wanted to develop a COVID-19 vaccine instead.

The company is currently testing the efficacy of a two-dose vaccine, with a four-week interval between the two shots

Si said Nanogen received investment offers for developing the vaccine, both in Vietnam and from Asian neighbors, but it has been wary of accepting any that may affect pricing. The company hopes to sell its vaccine for $5 to $6 per dose.

“We have to serve the Vietnamese people within the community. So we have to keep our vaccine prices as low as possible. … And we don’t want to raise the price more than that,” Si said.

The company has so far spent 400 billion to 500 billion Vietnamese dong and has received some financial support from the government, Si said. But it will need more financing as it scales up manufacturing to produce up to 50 million doses annually. At the moment, the company only has capacity to produce up to 10 million doses per year, Si said — not enough to cover the entire Vietnamese population of nearly 100 million people.

The company will also require more financing for its plans to hold large-scale phase 3 clinical trials involving at least 10,000 volunteers. But several countries, such as Bangladesh, Myanmar, and Mozambique, have expressed interest in conducting clinical trials of Nanocovax, Si said.

By Jenny Lei Ravelo – Devex – March 18, 2021

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