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Sinovac Launches Phase 3 Trial for COVID-19 Vaccine in Indonesia, Reports Phase 2 Details

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China’s Sinovac Biotech Ltd launched a late-stage human trial on Tuesday that will involve as many as 1,620 patients in Indonesia for a COVID-19 vaccine candidate that it is developing with Indonesian state-owned peer Bio Farma.

Sinovac is testing its vaccine abroad because there are too few new infection cases in China, making it no longer a satisfactory site for late-stage trials.

Separately, Sinovac released details on Monday from a mid-stage, or Phase 2, study in which it said the vaccine candidate appeared to be safe and induced detectable antibody-based immune responses in subjects.

The candidate, known as CoronaVac, is among a few potential vaccines that have entered late-stage trials for a large-scale study to gather proof of efficacy for regulatory approval.

CoronaVac is already undergoing a late-stage trial in Brazil and Sinovac expects to also test it in Bangladesh.

Sinovac’s Indonesia trial comes as Southeast Asia’s most populous country grapples with spiking infection numbers, with over 127,000 cases recorded as of Tuesday. The trial has so far recruited 1,215 people and will last six months.

“The threat of COVID-19 will not subside until a vaccine is given to all the people,” said Indonesian President Joko Widodo at a ceremony to launch the trial in Bandung, West Java. “Hopefully in January, we can produce and vaccinate everyone in the country.”

In addition to Bio Farma and Sinovac, private Indonesian firm Kalbe Farma and South Korea’s Genexine are cooperating to produce a separate vaccine. It is yet unclear how many doses these partnerships will produce and by when.

In Sinovac’s mid-stage trial involving 600 participants in China, the rate of fever in patients was relatively lower than other COVID-19 candidates including one from AstraZeneca, the study showed ahead of peer review.

Mid-stage trials usually test a candidate’s safety and ability to trigger an immune response in a relatively small number of people before it enters late-stage tests.

The study noted that the process to make the vaccines used in the Phase 2 trial was more optimized than in Phase 1, which produced more immunogens and triggered better immune responses.

Vaccines used in the late-stage trials will be made using the optimized process, a Sinovac spokesman said.

The Phase 2 results only included antibody-based immunity, the researchers said, adding that the candidate was being evaluated for other important components of the immune system.

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Key Quotes From Xi Jinping’s Speech at UNGA’s General Debate

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The General Debate of the 75th session the United Nations General Assembly was held on Tuesday under the theme of “The future we want, the United Nations we need: Reaffirming our collective commitment to multilateralism – confronting COVID-19 through effective multilateral action.” The meeting invited world leaders to deliver statements on global issues.

Chinese President Xi Jinping addressed the meeting via video link. Here are some key quotes from his speech.

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Xi Jinping Says China Firmly Supports UN’s Central Role in Int’l Affairs

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Chinese President Xi Jinping told UN Secretary-General Antonio Guterres on Wednesday that China has no intention to upset the status quo in relation to the international system but to improve UN-led global governance.

Xi made the remarks during a video meeting with the UN chief on the sideline of the 75th session of the UN General Assembly.

Earlier at the UNGA, Xi announced a series of measures to support the UN in playing the core role in international affairs.

The Chinese president called for a global response to the virus and giving the World Health Organization a leading role, adding that China will provide additional financial support of 50 million U.S. dollars to the COVID-19 Global Humanitarian Response Plan of the UN.

China will establish a third-phase South-South Cooperation Trust Fund with the Food and Agriculture Organization totaling 50 million U.S. dollars and will offer a five-year extension to the China-UN Peace and Development Fund, which had been due to expire in 2025. China will also set up a UN Global Geospatial Knowledge and Innovation Center and an International Research Center of Big Data for Sustainable Development Goals, which will facilitate the implementation of the UN 2030 Agenda for Sustainable Development, Xi said.

Speaking to the UN chief, Xi reiterated that China is committed to defending world peace and international order and to being a contributor to global development.

The COVID-19 pandemic shows just how much the world needs the UN-centered international system, Xi pointed out, while calling on global efforts to think beyond national and ideological boundaries so as to build a better future for all mankind.

The pandemic has magnified global governance problems, and relevant parties should think about how to improve the system instead of overthrowing and rebuilding one, Xi said.

“In the world, there is only one system, namely the UN-centered international system, and only one set of rules – the basic norms of international relations based on the UN Charter.”

“China opposes ideological confrontation, decoupling and hegemony.”

Xi said what concerns Chinese leaders most is how to improve the livelihood of Chinese people.

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But he told Guterres that China will not compromise when it comes to national sovereignty, dignity and development, saying China will firmly defend its own rights as well as international fairness and justice.

Xi said all countries should strengthen connectivity and think beyond national, ethnical, cultural, and ideological boundaries so as to work together to build a community of shared future for all mankind.

Guterres echoed Xi, saying that the world needs multilateralism and cooperation now more than ever in the face of the pandemic, climate change, and other challenges.

The world needs a more effective United Nations, he said.

Guterres also thanked China’s firm support to the multilateralism and the UN.

China plays a constructive role in maintaining peace and promoting development globally, and with China’s support, the UN is able to function more effectively, Guterres said.

Guterres hailed Xi’s proposals for the UN’s role in the post-pandemic era, saying that the UN hopes to strengthen cooperation with China in different areas and looks forward to seeing China to play a leading role.

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The Frontline: China’s Fight Against COVID-19

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