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Why Indonesia became a testing ground for a Chinese Covid-19 vaccine

Bloomberg News - September 15, 2020

On a scorching August day in Bandung, the capital of West Java province, two dozen volunteers arrive at a small community clinic inside a narrow alley to take part in the last stage of one of the world's fastest-moving trials for a coronavirus vaccine.

There, surrounded by cramped homes and kids playing outdoors without masks, they prepare to take an experimental shot developed by China's Sinovac Biotech Ltd., which many in Indonesia hope will bring an end to the destruction wreaked by the virus. With about a quarter-million infections, Indonesia's outbreak is the second-worst in Southeast Asia after the Philippines, its daily case count hitting records every week since the end of August.

"I'm tired of seeing how we are dealing with this disease. I just want to help in any way that I can," says 27-year-old microbiologist Abinubli Tariswafi Mawarid, one of the volunteers. "I believe the vaccine is the magic bullet to solve this pandemic. This is the most appropriate solution."

Few countries have embraced the possibility of a vaccine more fervently than Indonesia, where the government projects the pandemic will push an additional 4.9 million people into poverty, weighing heavily on its population of about 270 million. The country offers a look at the outsize expectations driving the speedy development of Covid-19 inoculations globally – as well as the potential pitfalls – as entire nations look for a quick fix.

In Bandung, a resort area of more than 2 million, the clinical trials, run by state-owned pharmaceutical company PT Bio Farma, have been accompanied by much fanfare. Many of the 1,620 people from Bandung and nearby towns who've enrolled in the Sinovac trial have been interviewed on local media. The region's police chief received a shot (which could have been the trial vaccine or a placebo), as did its governor, who promoted the experience on Instagram. Bio Farma has been working with regulators for expedited approval of the Sinovac vaccine. It says it will manufacture from 10 million to 20 million doses even before it gets a green light so the shot will be immediately available.

Iin Susanti, head of planning and business strategy for Bio Farma, says broader distribution will begin only after Indonesian regulators give emergency approval. President Joko Widodo has said his government is aiming for such authorization for CoronaVac, as the shot is called, by January. The first batches will go to health workers.

Yet despite all the local hoopla that help is at hand to finally tame the virus, which has infected 29 million globally, it's uncertain how soon a successful shot will be available. Health experts warn of safety risks if speed isn't balanced with caution, and little is known about how effective any inoculation will be. The risk of unexpected delays became apparent after Britain's AstraZeneca Plc paused testing of its experimental vaccine – seen as one of the world's most promising – amid concerns about a participant who became sick. The company has since restarted trials in the U.K. after regulators said it was safe to do so.

Global delays in finding a working vaccine would be devastating to nations that have bet heavily on one. Indonesia, for instance, has a large informal workforce that risks starvation during lockdowns. Its economy contracted 5.32% in the second quarter from a year earlier, the most since the aftermath of the Asian financial crisis in the late 1990s. The government briefly loosened social distancing rules, but infections surged. Concerns have risen that Jakarta, the capital, is running out of hospital beds. The city has limited the use of public transport and has required nonessential industries to have people work from home.

"The physical distancing protocol will continue. But at the end of the day, vaccine is the answer to end this pandemic," Jokowi, as the president is popularly called, told a group of foreign journalists at his palace on Sept. 1. "There's no other way that I know of." But even he acknowledged the uncertainties, pointing out that it remains unclear how long the protective effects of any vaccine will last.

CoronaVac is also in Phase III trials in Brazil and other parts of the world. (Late-stage trials require large numbers of participants in a place with an active outbreak. Those aren't possible inside China, which has largely stamped out local transmission.) Manufactured using an inactivated version of the virus, CoronaVac is neck and neck with other global brands, including the vaccine of U.S.-based Moderna Inc., in its pace of development.

Jokowi's administration has also tasked local research institutes and universities with developing the country's own vaccine, dubbed "the red-white vaccine" after the colors of Indonesia's flag, by the middle of 2021. Indonesia's biggest pharmaceutical company, PT Kalbe Farma, has teamed with South Korean biotech Genexine Co. and in November will begin Phase II clinical trials, which measure a drug's effectiveness and short-term risks.

Balancing safety with speed remains a challenge. The rate at which companies worldwide are rushing through clinical studies to deliver a coronavirus shot is unprecedented. Vaccine development that normally can take as long as a decade to complete is compressed to less than a year by drugmakers, leaving some researchers concerned there may not be enough time to fully understand the potential risks any shot might present.

Russia, for instance, has approved its coronavirus vaccine, dubbed Sputnik V, before the final stage of human testing is completed, raising safety concerns. And President Trump has pushed for a vaccine by October under his administration's Operation Warp Speed program. Meanwhile, vaccine developers from AstraZeneca to Moderna have pledged to avoid shortcuts on science, and the U.S. Food and Drug Administration has instituted safeguards to ensure that safety and efficacy criteria aren't missed amid a rush to the finish line.

Data from late-stage trials like the one Bio Farma is running in Indonesia are seen as the ultimate test of a shot's ability to protect people against the virus. Sinovac has said the vaccine had no safety issues in Phase I and II trials, and Bio Farma says it won't cut any corners.

Ensuring coronavirus vaccine safety will be key because a single adverse event found in a study with tens of thousands of people could translate into hundreds of thousands falling sick or dying when regulators give the go-ahead for billions to get the jabs, says William Haseltine, a pioneering AIDS researcher who chairs Access Health International Inc., a New York-based think tank.

The timeline suggested by vaccine developers globally means "you cannot do a yearlong safety trial, so you are not going – under any circumstances – to know the long-term effect of these vaccines," Haseltine says.

Sinovac says it has safety protocols in place. "Any clinical trials involving the use of a vaccine on large numbers of healthy people will have plans to deal with safety problems," a spokesperson said.

Jeremy Lim, an adjunct professor at Singapore's Saw Swee Hock School of Public Health, says it's likely that any vaccine will produce only partial immunity in some groups of people, and shots could be contraindicated for some because of unacceptable side effects.

Distribution also is a challenge. For Indonesia, which occupies the world's largest archipelago and spans a distance of roughly that between New York and Alaska, another obstacle is transporting any vaccine safely across its 6,000 inhabited islands – especially since the Sinovac vaccine must be stored at 2C to 8C (35.6F-46.4F) to work effectively.

So even if a vaccine ticks all the boxes on safety and effectiveness, it's still not a good idea to put all your bets on it, according to Takeshi Kasai, regional director for the Western Pacific at the World Health Organization. "Even if they can manage to develop safe and effective vaccines, the production capacity would not really meet the demand coming from the entire world," Kasai said at a briefing last month. It's important to keep improving existing containment measures such as mask-wearing and social distancing, he says, and "not just hope for the vaccine."

Bottom line – With a large informal workforce that can't be homebound, Indonesia is eager to get a coronavirus vaccine. But with 6,000 inhabited islands, distributing one will be tough.

Source: https://www.bloomberg.com/news/articles/2020-09-15/covid-pandemic-why-indonesia-became-testing-ground-for-china-s-covid-19-vaccine