Mon, 26 Oct 2020

Experts Warn of China's Emergency Use of COVID-19 Vaccine

Voice of America
29 Sep 2020, 08:05 GMT+10

China in recent months has been injecting hundreds of thousands of people with three preliminary coronavirus vaccianes that are being tested for safety and efficacy.

While the world awaits a proven drug to fight the pandemic, at least three vaccine candidates have been given to front-line medical professionals, staff of state-owned companies, and government officials since July under an emergency use program approved by Beijing.

China National Biotec Group (CNBG), a subsidiary of state-owned Sinopharm, has administered two experimental vaccine candidates to around 350,000 people outside its clinical trials, CNBG chairman Yang Xiaoming said recently. The company also donated 200,000 doses of one of the candidate vaccines that is still undergoing clinical trials in Wuhan, where the pandemic was first reported.

Another drugmaker, Sinovac Biotech, has injected 90% of its employees and their family members, or about 3,000 people, Yin Weidong, the company's CEO, said this month.

"At present, tens of thousands of people in Beijing should have been vaccinated with Sinovac's vaccine," Yin told Chinese state media.

Separately, Beijing also gave approval in June for members of the armed forces to receive an experimental vaccine developed by CanSino Biologics, a biopharmaceutical company that is backed by the military.

Phase 3 trial important

Foreign experts have criticized using the experimental vaccines before clinical trials have been completed.

"It is reckless and dangerous to distribute a minimally tested vaccine about which nothing has been published," said Dr. Arthur Caplan, head of the division of medical ethics at New York University's Grossman School of Medicine.

"Puts too many people at risk without opportunity to study safety and efficacy in a large group," Caplan told VOA in an email.

Vaccines usually require years of research and testing before being made available to the public. In Phase 3 trials, vaccines are generally given to thousands of people and tested for safety and efficacy.

"Before the completion of Phase 3 trials, we cannot have full confidence in the safety and effectiveness of a vaccine," Lawrence Gostin, professor of Global Health Law at Georgetown University, told VOA.

Under China's law, vaccines developed for major public health emergencies can be deployed for urgent use if the National Medical Products Administration considers that the benefits of the treatment outweigh the risks.

Experts say speeding up the process introduces more risk, which could undermine the vaccination effort in the long run.

"This practice can backfire if the rushed process causes a widespread distrust of the vaccine when fewer people are willing to take the vaccine. Or it can cause severe damages when vaccine complications were warned, due to the rushed trials, "Dr. Jennifer Huang Bouey, an epidemiologist and China expert at the RAND Corporation, told VOA.

Most candidates fail

Currently, there are 42 vaccine candidates that are being tested on humans, 11 of them developed by Chinese companies.

According to the American Council on Science and Health, a research and education organization, vaccines for infectious diseases in clinical trials only have a 33.4% success rate, meaning that most of the vaccines that entered the stage of clinical trials will fail.

China claims that so far, there have been no obvious adverse reactions among the people who were inoculated.

"Tens of thousands of people vaccinated have traveled to countries and regions with high risks of COVID-19. No one has been infected so far, and this proved the effectiveness of the vaccines," said Zhou Song, chief legal adviser of CNBG.

There are 11 candidates in Phase 3 trials, four of them are developed by Chinese companies. While Phase 3 is the final stage, it does not necessarily mean that successful results are imminent.

A U.S. Food and Drug Administration study in 2017 found that vaccine candidates that had encouraging Phase 2 results could still fail. Of the 22 vaccines in Phase 3 trials that scientists studied, 14 of them did not confirm the effectiveness of the product that was indicated in Phase 2 trials. One vaccine in the study had a safety problem identified in Phase 3.

"If the vaccine is ultimately proven to be poorly protective against the virus - which it may - they will have exposed many people to unnecessary risks and perhaps given people false confidence that they are protected, which undermines public health," Dr. Charles Holmes, director of the Georgetown University Center for Innovation in Global Health, told VOA.

Beijing's global reach

It is possible that within weeks the world will see its first proven coronavirus vaccine, as some of the Phase 3 trials are expected to complete as early as November.

China now has more candidates in the final stage of trial than any other nation and has been using the prospect of a vaccine's discovery to shore up its global standing.

Chinese vaccine developers are currently working with more than 40 countries and carrying out clinical trials in at least 10.

The United Arab Emirates has recently approved a Chinese vaccine candidate for emergency use, making China the first nation to receive approval to deploy a COVID-19 candidate in a foreign country.

Through various platforms like the Belt and Road Initiative, and the Association of Southeast Asian Nations, Beijing has promised to prioritize doses for dozens of countries. Officials are also claiming the countries' vaccine makers are ramping up production.

"Next year, our annual capacity will reach more than 1 billion doses," said Zheng Zhongwei, director of the National Health Commission's Science and Technology Development Center, at a news conference last Friday.

Despite Beijing's asserted ability to develop and deliver vaccines, experts warned that China is not necessarily ahead in the global vaccine race.

"Before a Phase 3 trial is completed and a manufacturing capacity is used, any country that has a promising vaccine candidate can be equally successful," said Bouey.

Gostin, who is also the director of the World Health Organization Collaborating Center on National and Global Health Law, said China and its partner countries are exposing people to significant risk by deploying the vaccine before it has completed a large-scale placebo-controlled trial.

"China is trying to exploit other countries, gaining political or commercial advantage in return for the vaccine," Gostin said.

In Indonesia, China's Sinovac Biotech promised it would help Indonesia's state-owned drugmaker Bio Farma produce at least 40 million doses of its potential vaccine before March 2021.

Muhammad Zulfikar Rakhmat, an academic at Universitas Islam Indonesia who researches China's foreign policy in Indonesia, told VOA in an email that right now, there is little public attention on the risks of taking the experimental vaccine.

"Most concerns are about whether the vaccine would work or not and if Indonesians have only become subjects of trial," Rakhmat said.

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