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First, to examine the US timeline. Important figures to remember are the US population of 330 million people, the needed vaccination rate of 70-90%, and thus the rough herd immunity threshold of 264 million, or 80 percent.

• Q4 2020: Americans received just over 3 million initial doses of the Moderna and Pfizer-BioNTech coronavirus vaccines by the end of 2020, far below the White House’s goal of administering 20 million doses by the end of 2020, in part due to delays of administering the 14 million vaccine doses that were administered to states. (Axios, Bloomberg, CDC, NY Times)

• Q1 2021: Authorized vaccines were injected into 3 priority groups: healthcare workers, frontline workers, and elderly Americans. Roughly 30 percent of eligible Americans, or about 100 million, had received at least one dose of the vaccine by the end of Q1 March 31. Over 30 million had been infected with the virus. (Business Insider, NY Times)

• Q2 2021: Joe Biden, who previously promised to use the Defense Production Act to administer 100 million vaccine shots by May 1, has since said he hopes for 200 million doses to be administered and all eligibility restrictions lifted by his 100th day, a goal that the nation is already on pace to meet (about 167 million doses had been given as of April 4). The US needs roughly 500M vaccine doses to reach herd immunity among adults. (Axios, NY Times, USA Today)

• Q3 2021: Joe Biden has soft-pedaled a July 4 “Independence Day” from the virus, by which time herd immunity is on pace to be met, barring any unforeseen issues. (White House, USA Today)

• Q4 2021: If COVID-19 variants turn out to be a minor factor (they only reduce vaccine efficacy modestly, or they don’t spread widely), then herd immunity is more likely in the third quarter than the fourth. However, if the impact of these variants is significant, we could see timelines significantly prolonging into late 2021 or beyond. (McKinsey)

Next, what about China?

• Q4 2020: China approves its first COVID-19 vaccine for the general public. Developed by Sinopharm, interim data shows it has a 79% efficacy rate, slightly lower than US-developed vaccines by Pfizer and Moderna. (Caixin, BBC)

• Q1 2021: China administered about 53 million vaccines to its citizens by February 28, barely meeting its goal to vaccinate 50 million by mid-February. This number, however, only covers around 3.6% of China’s 1.3 billion citizens. China also approved 3 more vaccines, from Sinovac, CanSino Biologics, and by Sinopharm’s affiliate Wuhan Institute of Biological Product. Only about 61% of the Chinese public said they wanted to get the shots, lagging behind the UK and Denmark, which saw 73% and 70% of their population saying yes to the idea, respectively. However, with life in cities like Wuhan having largely returned to normal, there is not a similar sense of urgency yet in China. (Quartz, NY Times, Caixin, NPR)

• Q2 2021: Having upped its vaccination doses to 100 million by the end of March, China has set a target of covering about 40 percent of the population (or 520 million) by June, “which means that the daily inoculation number will have to increase to about 10 million doses. Data shows that China is now just 30 million doses behind the US, ranking second in the world in terms of vaccines administered. As of press time, the US had administered a total of 130 million doses.” In April, Sinovac announced a manufacturing capacity of 2 billion doses per year, but it did not say when it will actually produce the amount. (Global Times, Politico)

• Q3 2021: China aims to vaccinate 40% of its population by June, but even at the rate of vaccinating 10 million people a day, experts said it would take roughly seven months to get to herd immunity and vaccinate 70% of its population. China has indicated that it will streamline entry into the country for those who have received Chinese vaccines, but that it will mutually recognize other countries’ vaccines. (Caixin, Bloomberg, Associated Press).

• Q3 2022: Quartz: “Gao Fu, director of China’s health authority, said last week [in the Global Times] that 70% to 80% of the Chinese population needs to be inoculated for it to have herd immunity, estimating this could be achieved by the middle or the end of 2022. That’s a key deadline for China—when Beijing will host the Winter Olympics, another occasion to showcase its soft power just as it did with the 2008 Beijing Summer Olympics.”

BONUS: map of countries that China has conducted trials for, promised access to vaccines to, or provided vaccines to, countries the US has provided vaccines to, and countries that both have helped.

Map Sources: CGTN, Nikkei Asia, Yahoo News, VOA, Gavi

As the US begins a slow rollout of vaccines with high effectiveness rates, China has adopted a defensive posture and has even issued statements questioning the efficacy of Western-developed vaccines, even as it begins to import one of these vaccines into Hong Kong. Read more below.

To lead off: a great summary of the current situation from the NY Times.

China’s coronavirus vaccines were supposed to deliver a geopolitical win that showcased the country’s scientific prowess and generosity. Instead, in some places, they have set off a backlash.

Officials in Brazil and Turkey have complained that Chinese companies have been slow to ship the doses and ingredients. Disclosures about the Chinese vaccines have been slow and spotty. The few announcements that have trickled out suggest that China’s vaccines, while considered effective, cannot stop the virus as well as those developed by Pfizer and Moderna, the American drugmakers.

Beijing officials who had hoped the vaccines would burnish China’s global reputation are now on the defensive. State media has started a misinformation campaign against the American vaccines, questioning the safety of the Pfizer and Moderna shots and promoting the Chinese vaccines as a better alternative. It has also distributed online videos that have been shared by the anti-vaccine movement in the United States.

What exactly are Chinese authorities saying? See below for recent rhetoric, then compare with past statements from previous editions of the CBB.

1. Foreign Ministry’s Spokeswoman Hua Chunying’s Press Conference, Jan. 20, 2021

   • why cannot Chinese media report on something already covered by western media? Even when Chinese media report facts objectively, they are rejected as propaganda or even disinformation. This very idea reveals the deep-seated ideological bias and appalling injustice against China. Why cannot Chinese media report facts when those in the west can say whatever they like? Where is the freedom of press and freedom of speech? Aren't Chinese media and netizens entitled to the freedom of speech?

     You should have noticed this interesting phenomenon: whenever there is any negative news about Chinese vaccines, western media always rush to report on it. For example, when a volunteer taking part in Chinese vaccine trails in Brazil passed away, before the reasons were found, western media wrote headlines about the incident, which later proved to be unrelated to the vaccine. Do I remember correctly? But later not one of the western media agencies apologized to China for the mistake in their reports.

     It is the urgent task at hand for all of us to fight the virus. Vaccines themselves are a serious scientific issue. Against the grave situation, more vaccines being applied, especially in developing countries, would be of great help to our joint defence against the virus. At stake here is the fundamental interests of all humanity. But we are observing an abnormal phenomenon now. A handful of US and UK media have been taking the lead in pinning invisible geopolitical labels to vaccines and projecting political positions to their reporting. They want to promote Pfizer's vaccine and trash Chinese vaccines. But China is not affected by such narrow geopolitical bias. We are ready to contribute to vaccine accessibility and affordability and would be glad to see developed countries sharing their vaccines with developing ones. That's what we hope to see, not a zero-sum game. The double standard that has been exposed on the issue of vaccines reflect a thought-provoking and profound phenomenon that is not conducive to international anti-epidemic cooperation.

2. Global Times, Jan. 19, 2021

   • Countries like Australia, which is expected to soon give the green light to Pfizer-BioNTech's COVID-19 vaccine for use in elderly people, need to suspend their approval procedures to wait for the World Health Organization (WHO) and Norway to investigate deaths in Norway, Chinese health experts said.

   • They said that for mass vaccination programs, Australia should broaden its choices of COVID-19 vaccines, such as purchasing Chinese-produced inactivated vaccines.

   • For Australia's mass vaccination program, which is expected to kick off next month, Chinese experts advised Australia to broaden its choice of vaccines, including purchasing Chinese-developed inactivated vaccines, which are relatively safer due to their mature technology.

3. Global Times, Jan. 15, 2020

   • Twenty-three elderly Norwegian people died after receiving Pfizer vaccines. Thirteen of them have been assessed and common side effects may have contributed to severe reactions in them, according to the Norwegian Medicines Agency.

     Norway is a small Northern European country and only about 25,000 people have been vaccinated with Pfizer vaccines. Twenty-three deaths are a large number. But surprisingly, mainstream English-language media did not report the incident immediately, as if they had already reached a consensus. Major US and UK media were obviously downplaying their deaths.

     In contrast, those major Western media will immediately hype any unfavorable information about Chinese vaccines and try to amplify their impact on public psychology. For example, the data of China's Sinovac vaccine was lower than expected in Brazil, and it was reported everywhere in Western media. The death of a Brazilian volunteer who participated in the trials also became a major event in Western media. But it was later proven that the death had nothing to do with the vaccination, and Western media lost their interest.

4. Global Times, Jan. 13, 2020

   • Could the Pfizer vaccine's real efficacy be as low as 19 percent, instead of 95 percent as it claims?
     
     Questions raised by Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, have triggered heated discussion on Chinese social media.
     
     Doshi's opinion was disputed among Chinese vaccine experts interviewed by the Global Times. Many experts agreed that Pfizer should provide more raw data for peer review but said Doshi's methodology may be flawed. 

5. Xinhua, Jan. 7, 2020

   • Nearly 4,400 adverse events were reported after receipt of Pfizer-BioNTech COVID-19 vaccine as of Dec. 23, with 21 cases determined to be anaphylaxis, according to a reported released by the U.S. Centers for Disease Control and Prevention (CDC) on Wednesday.

     The U.S. Food and Drug Administration issued an Emergency Use Authorization for Pfizer-BioNTech COVID-19 vaccine on Dec. 11, administered as 2 doses separated by 21 days.

A problem with many of these reports is that they undermine the credibility of China’s own efforts for international collaboration and cooperation.

1. At the high level, China has called for global cooperation, with the State Council Information Office unveiling a white paper in June saying that the international community should resist finger-pointing and politicising the virus. (Reuters)

   • “A vaccine is still the fundamental strategy in our effort to overcome the new coronavirus,” Science and Technology Minister Wang Zhigang told a news conference in Beijing.

2. Concretely, China has had state TV hosts cast doubt via Twitter on the BioNTech/Pfizer vaccine, even as Hong Kong prepares to import it via the Chinese distributor Fosun, one of the rare examples of international vaccine cooperation.

   • On Saturday night, the government clarified that the shots to be supplied to Hong Kong will be manufactured in Europe and that the first batch of one million doses is expected to be delivered in the first quarter at the earliest. (The Standard)

     While Fosun Pharma is responsible for clinical trials, regulatory applications, sales and marketing of the jabs in China, the injections will be provided by BioNTech.

3. Carrie Lam, the Chief Executive of Hong Kong, seems to be walking a fine line. She said in a statement that “There have been all sorts of things happening in the European Union and this vaccine is manufactured in Germany, so we have to watch the situation very carefully. But since we have a contract to buy, I hope that all the other organisations will respect this contractual relationship and allow the Fosun Pharma/BioNTech vaccine to come to Hong Kong by the end of this month and the vaccination programme will be able to start almost immediately.”

4. Back in November, the same Chinese media that is denouncing the Pfizer vaccine now was citing Chinese CEO Guo Guangchang, the billionaire chairman of majority shareholder Fosun International, who described the partnership as “a victory for science, a victory for global cooperation … it is a landmark moment marking the light at the end of the tunnel in our fight against the novel coronavirus.” (Global Times, SCMP)

Will China pull back on its rhetoric on vaccines? Next time I’m going to look at a timeline and examine what the next phase of Chinese and US vaccination efforts could look like.

China’s Covid-19 Vaccine Rollout Update 

I. Approval Status for the main 2 vaccines (NY Times): 

• Sinopharm approved in: 

  • China, U.A.E., Bahrain 

  • Egypt (emergency-use) 

• Sinovac has limited use in China 

II. List of countries which ordered Chinese vaccines (SupChina)

- Pakistan, Hungary, Ukraine, UAE, Bahrain, Egypt, Morocco, Indonesia, Thailand, Philippines, Brazil, Peru 

- Thailand imports 2 million Sinovac doses (Fortune)

- Indonesia: imports 3 million Sinovac doses, received supplies to locally produce more (Fortune)

- Pakistan: buys 1.2 million doses (Yahoo News)

- Peru: buys 38 million doses (VoA)

Released Sinopharm Phase 3 Efficacy: roughly 79%, as per NY Times. Brazil has claimed results put it closer to 50%, however, according to BBC. Compare to Moderna, Pfizer, and Sputnik’s claimed efficacy rates of over 90%.

II. Vaccine Pricing: 

- Based on prior individual accounts, two-dose vaccine costs roughly $60-$150 - SinoVac charging $30/dose (NY Times)

- Sinopharm charging less than $75/dose 

- Zheng YiXin, deputy minister of National Health Commission states that the vaccine would be provided to the Chinese public for free.

III. Vaccine Production: 

- 18 vaccine makers in China are ramping production (SCMP)

- Health officials say that China manufactured 610 million doses by 2020, and can reach 1 billion doses in 2021. (AP)

- SinoVac raises $515 million to double vaccine production (ChinaBioToday)

- China aims to vaccinate 50 million by mid-February (NY Times)

A.    COVAX:

1.     October 9, 2020: China joined COVAX, the international collaborative Coronavirus vaccine efforts

a)    Thoughts: China is confident in its vaccines and is ready to use it for leverage, leaving the US as the only major country missing from the group (Bulletin #11)

B.    Vaccines for emergency use

1.     China in talks with WHO about assessing its vaccines for emergency use

2.     UAE, 1st country outside China, to approve the Sinopharm vaccine foremergency use for frontline workers

3.     China’s emergency use of its vaccine

a)    Zheng Zhongwei, an official in China’s National Health Commission: “The goal is to first establish an immune barrier among special populations, so that the operations of the entire cities will have a stable guarantee.”

Thought bubble: What is the cost of waiting for Phase III trials? Should a “spirit of self-testing” raise confidence for a vaccine? When is a vaccine deemed safe enough for the benefit of society?

C.    Clinical Trials

1.     SCMP: More countries host final trials of Chinese-made vaccines.

a)    Includes Peru, Argentina, Brazil, Bahrain, UAE, Egypt, Pakistan, Turkey,

Morocco, Saudi Arabia, Bangladesh, Indonesia, and Russia.

b)    Officials from Mexico, Bangladesh, Pakistan were quoted saying that local trials are a “means to gain future access to approved vaccines.”

Thought bubble: China’s vaccines are yielding strategic results in diplomacy. Access to vaccines is likely to become a strong bargaining tool.

D.    Vaccine Specifics

1.     Vaccine may be ready in November (Taiwan News)

2.     Costs

a)    Sinopharm spokesman Liu Jingzhen told state media vaccine would cost no more than 1000 yuan (~$144) for 2 shots. China’s National Health Commission official Zheng Zhongwei said that the price will be lower than what Liu said. (Nikkei).

3.     Thoughts: The Chinese government will likely control the cost and flow of the vaccines. Affordability and accessibility of the vaccines will be vital in stabilizing Chinese society and international influence, so the government is incentivized to limit corporate greed and maintain a good image.

E. China Biotech Industry

1.     Chinese search engine Baidu is in discussions to raise $2 billion for new biotech company with a focus on using AI. Earlier this year Baidu gave away algorithm “LinerFold” to gene-testing agencies, epidemic control centers, and research institutions. (CNBC)

Thought bubble: Success and momentum in coronavirus vaccines may be encouraging the government and investors to develop China’s biotech alongside 5G, AI, etc.

• Russia became the first country to approve a vaccine for COVID-19 last week. According to the New York Times, Vladimir Putin, told a cabinet meeting that the vaccine “works effectively enough,” and said that his own daughter had taken it. What does this mean for Russia and the rest of the world?

  • The vaccine could be a geopolitical boon for Russia, as the Soviet Union’s mass exports of cheap vaccines to the developing world was during the Cold War.

  • Russia has received orders for 1 billion doses from 20 countries and plans to manufacture the vaccine in Brazil, India, South Korea, Saudi Arabia and Cuba.

  • At least 20 countries and some US companies have expressed interest in the vaccine, according to Russian officials. (NYT, CNN)

  • However, there are a number of caveats.

    • For instance, it’s unclear whether the vaccine will actually work, since Russia hasn’t yet conducted Phase III trials for the vaccine, dubbed Sputnik V, and also hasn’t released any proof that the vaccine works. (The Guardian)

    • Russia has been accused of stealing vaccine research, and the US has refused to accept Russian help with its official vaccination effort, Operation Warp Speed. (NYT, CNN)

    • The US isn’t the only country with skeptics, Anthony Fauci among them. The director of Russia’s sovereign wealth fund bewailed what he called an international “information war” against the vaccine. (ABC, Newsweek, Bloomberg)

    • Notably, China has been more bullish on Russia’s efforts, even though ostensibly they have been lapped by Moscow in the vaccine race. The state-sponsored Global Times quoted Tao Lina, “a Shanghai-based vaccine researcher,” who “estimated a 90 percent chance of success for the Russian candidate [and said] that it is unnecessary to be overly concerned as it must have passed proper tests.”

• In other news, China and the US are lining up partnerships to distribute a vaccine once it passes all trials:

  • China and Chinese makers of vaccines have prioritized partnering with developing countries such as Brazil, Indonesia, Pakistan, Russia, Bangladesh, Bahrain, and the Philippines, as well as makers of advanced vaccine candidates like Britain-based AstraZeneca, while the US has courted some strategically-located countries such as Malaysia as well as traditional allies like Mexico for vaccine cooperation. (WSJ, Reuters, VOA)

  • Goldman Sachs released forecasts last week that predicted “at least one vaccine will gain FDA approval this fall,” and be widely distributed by the second quarter of 2021. (Forbes)

• Outside of COVID-19, China continues to prioritize its biotech investment efforts.

  • “There were 95 biotech-related deals [in China by] June of this year, drawing $12 billion in total investment, an unprecedented volume of deals, according to Biomedtracker and Chinabio. Two thirds of the deals involved financing, 21 were business development or licensing deals and there were 11 IPOs or follow-on public offerings.” (BioWorld)

  • US-based company Denali partnered with the Chinese Biogen to co-develop a treatment for Parkinson’s, to the tune of $2B. (The Pharma Letter)

  • Dig deeper: a report from BusinessWire on the current state of China’s biotech landscape.

Status on Covid-19 vaccine phase III trials:

• By the end of July, the WHO’s draft of Covid-19 vaccines shows that only 6 developers/manufacturers have reached Phase 3. (out of 167 candidates)

  • University of Oxford/AstraZeneca

  • Sinovac

  • Sinopharm (Wuhan Institute of Biological Products)

  • Sinopharm (Beijing Institute of Biological Products)

  • Moderna/NIAID

  • BioNTech/Fosun Pharma/Pfizer

Leading Chinese candidates are from Sinovac, Sinopharm (Wuhan and Beijing branch), and CanSino.

More speculation about China Covid-19 vaccine development:

• TIME: “According to Benjamin N. Gedan, a former regional director on the White House’s National Security Council now with the Wilson Center, “If China produces the first coronavirus vaccine at scale, it would be an extraordinary diplomatic tool anywhere in the world.”

• Nature: Jerome Kim, director-general of the International Vaccine Institute in Seoul. “The race is on,” he says, “and it’s really about who can set up in a high-risk area most quickly.” Many Chinese companies are at a disadvantage because they don’t have established networks of hospitals around the globe, Kim said.

• China has made a $1bn loan to Latin American and Caribbean countries for access to coronavirus vaccine (The Independent).

Following Chinese Covid-19 vaccine development:

§  Sinovac: traditional inactivated vaccine called “CoronaVac”

o   The phase 2 study shows that 2 doses of CoronaVac induced neutralizing antibodies 14 days after vaccination, over 90% of 600 healthy volunteers showed an immune response (FiercePharma).

o   Phase 3:

o  cooperating with Butantan Institute of Brazil, Sinovac plans to test on ~9000 medical professionals, who have greater exposure to the virus (Sinovac, Nature).

§  Sinopharm: traditional inactivated vaccine

o   Phase 3:

o  Cooperating with G42 Healthcare, an Adu Dhabi-based artificial intelligence and cloud computing company, and with Abu Dhabi Health Services (SEHA), Sinopharm plans to test 15000 participants with 2 vaccine strains and a placebo (Reuters).

o  G42 Healthcare explains that the United Arab Emirates was selected to host trials because of its diversity of more than 200 nationalities, allowing for research across various ethnicities (Pharmaceutical Business Review).

o   Sinopharm has also injected the vaccine into its chairman and other senior officials, along with testing at a state-owned oil company PetroChina (NY Times).

§  CanSino (in partnership with China’s Academy of Military Medical Sciences):adenovirus called Ad5

o   CanSino and AstraZeneca both use the same method for their Covid-19 vaccine. Lancet papers analyzing released phase 2 data show that both have encouraging results.

o   However, many people have pre-exiting immunity to CanSino’s viral vector, meaning vaccine effects may be compromised; spectators say the vaccine may be useful in children instead of adults (BioPharmaDive, Stat News).

o   Phase 3:

§  CanSino is in talks with Russia, Brazil, Chile, and Saudi Arabia about conducting a Phase 3 with plans for 40,000 participants (Economic Times).

§  In the vaccine race, where does India, one of the world’s leading vaccine manufacturers, stand?

Read more about the Serum Institute of India (Observer Network via Baidu, link in Chinese).

o   India manufactures 1.5 billion doses of various vaccines annually

o   many Covid-19 vaccine manufacturers want access to their production lines

o   Covid-19 vaccines are being prepared before clinical trials are over

o Oxford/AstraZeneca closed a deal with India for 400 million doses to be manufactured by 2021

o  The Serum Institute of India is manufacturing at a risk the vaccine doesn’t work; however, they are 70-80% confident

o  They have also agreed to make 1 billion doses of Oxford/AstraZeneca’s vaccine at a break-even cost for some under-developed/developing countries

• Vaccine update:

  The Guardian reports today that 3 vaccines are in Phase III trials (Sinovac, University of Melbourne/MCRI, and Oxford/AstraZeneca), with an additional 11 in Phase II and 19 more in Phase I. (Moderna is set to start Phase III trials July 27.)

  • What is the timeline? According to the NIH’s Francis Collins (Anthony Fauci’s boss), there is “cautious optimism” that a vaccine could be available by the end of the year, according to TIME. “The Phase I data…looks really encouraging that these are vaccines that generate strong antibody responses,” Collins said.

  • Speed bumps: Medically, those most at risk for contracting COVID-19 are likely to be those who a vaccine will be hardest to protect. Politically, intelligence agencies perceive threats from countries such as Russia stealing sensitive biotech data.

    • National Geographic: “Up until very recently most of the focus of the vaccine community has been on saving lives of young children,” says Martin Friede, the World Health Organization’s coordinator for vaccine product and delivery research. “The people who need the vaccine the most may actually be the people in whom the vaccine might not work.”

    • WIRED: “The UK, US, and Canada have discovered hackers working on behalf of the Russian state launching attacks against coronavirus vaccine-development projects. Criminals working for the hacking group known as Cozy Bear have been caught attacking pharmaceutical businesses and academic institutions involved in vaccine development.”

  Distribution: China has been approving domestically-produced vaccines for “emergency use,” testing vaccines that have not been approved by regulatory bodies on its military and employees of state-owned-companies (NYT).

  • At the same time, China is seen as the leader in the international vaccine development race. Some even say that China is aiming through these efforts to become the world’s leading biotech hub (Bloomberg, Reuters, Asia Times).

    • But, as national security expert James Carafano notes, competition can be a double-edged sword. “‘If being first is the goal, and then you cheat and lie and steal and cut corners and don’t tell the truth, that actually undermines your competitiveness.’ International trust in Chinese vaccines has already eroded significantly since 2018, when a Chinese company was found to be making vaccines with expired products.” (Politico)

    • This underscores how the race for a vaccine has become a point of national pride for whichever country successfully produces it. Although Europe and China have shown willingness to share resources, the US, India, and Russia have not joined a WHO initiative to promote collaboration in the development and distribution of coronavirus vaccines and treatments.

      • Domestically, the US government has implemented more restrictions on US-China medical collaboration, even as scientists continue to do so informally.

• Parting shot: last month Yuan Peng, the head of China’s prominent CCP-affiliated think tank CICIR, published an article comparing the COVID-19 pandemic to a world war, and wrote that the existing international order is unsustainable (“国际秩序难以为继”). He goes on to write that the relationship between China and the world has passed the stage of integration and is moving into one where China can constructively read. Read more here (in Chinese).

1. COVID-19 trials have begun: Chinese companies have partnered with Brazil and the United Arab Emirates, among others, to test vaccines abroad. Notably absent: the US, which has the highest number of cases in the world and has seen a spike in the last week.

   • Reuters: “China National Biotec Group won approval to run a large-scale “Phase 3” clinical trial of its novel coronavirus vaccine candidate in the United Arab Emirates, the company said last week, joining Clover Biopharmaceuticals, whose shots have been given to participants in Australia in an early study, and Sinovac Biotech, which is expected to begin a Phase 3 trial in Brazil with 9,000 volunteers.”

   • FiercePharma: “Mexico is in talks with the Chinese government, private Chinese labs, and the University of Oxford and AstraZeneca to run COVID-19 vaccine trials in the country, a government official told Reuters.”

   • Wall Street Journal: “The Academy of Military Medical Sciences, run by the People’s Liberation Army, said this week that regulators had granted it permission to test a Covid-19 vaccine built using so-called messenger RNA on human subjects, making it the first such vaccine ever to reach the clinical-trial stage in China.”

     • “The PLA said its mRNA vaccine candidate triggered an immune response and antibodies in mice and monkeys. For this project, it is working with private companies Suzhou Abogen Biosciences Co. and Shenzhen-listed Yunnan Walvax Biotechnology Co., according to the Chinese Clinical Trial Registry.”

   What is going to happen with distribution once a vaccine is found?

   • Axios: “All nations — including developing nations with few funds — will need access to vaccines to build herd immunity. The World Health Organization and nonprofits like the Gates Foundation and Gavi are taking steps to ensure developing nations have access to vaccines when available. Many Big Pharma companies are promising they will distribute as many vaccines as they can produce, to everyone. But some worry the world will face the same issues it did during the H1N1 epidemic a decade ago, when nationalism and big money held sway.”

   • MedScape: US distribution will likely prioritize at-risk groups, and follow a seasonal flu vaccine distribution model.

   • The Times of India: “Astrazeneca…which is currently conducting mid-scale trials in Brazil, one of the worst affected countries globally, recently said that the South American nation might be one of the first to deploy the vaccine if approvals are met. Currently, testing is going on more than 5000 frontline workers in Brazil, after plans to start phase-III trials were given the go-ahead by the experts in early June.”

   • Politico: A shake-up on White House’s Operation Warp Speed team foreshadows future political pressure to approve a COVID-19 vaccine.

     • “The current and former government health officials POLITICO spoke to saw [Director of the FDA’s Center for Biologics Evaluation and Research Peter] Marks' decision to leave Operation Warp Speed as crucial to shield FDA decisions on coronavirus vaccines from political pressure. Although President Trump has repeatedly promised that a vaccine will be available by the end of the year, it is Marks who will be the ultimate arbiter. In his current job, he will oversee FDA review — and any eventual approvals — of vaccines.”

       • Go deeper: Read Politico’s breakdown of the current vaccine landscape.

   • Politico: “There’s no guarantee that a vaccine is going to work,” said Luciana Borio, who served as the FDA’s acting top scientist and worked on White House pandemic preparedness efforts earlier in the Trump administration. “And even if it does, there’s no guarantee that it’ll be the right product for most people, or that people will want to take it, or that the virus won’t mutate.”

   Ethical considerations:

   • In an essay for Stat News, Dr. Michael Rosenblatt, former Tufts Medical School dean, argues against using challenge trials, which have not been implemented in the US, to accelerate finding a COVID-19 vaccine: “The practice of deliberately infecting people with disease, termed “human challenge trials,” has a long history…In the June 1 issue of the Journal of Infectious Diseases, Nir Eyal, Marc Lipsitch, and Peter G. Smith argue that this approach could accelerate the development and approval of a Covid-19 vaccine by many months. That may sound tempting, but human challenge studies with live virus are unlikely to save time.”

     • “Moreover, there are ethical and practical reasons for not undertaking human challenge studies with this virus. These authors, like 1DaySooner’s volunteers, are well-intentioned but wrong.”

   • Open Orphan, a UK-based biotech organization, has expressed interest in the human challenge model and has developed a model for how it might work (China Daily, Open Orphan).

• International cooperation on COVID-19 vaccine:

  • (Reuters) - China will strengthen international cooperation in future COVID-19 clinical vaccine trials, building on earlier collaboration in vaccine development, the science and technology minister said earlier this month.

    In a white paper unveiled by the State Council Information Office at the news conference, the government urges global cooperation, saying the international community should resist finger-pointing and politicising the virus. It did not name any country.

  Practically speaking, of the list of advanced COVID-19 vaccine efforts (WHO/RAPS), only one seems to have significant collaboration between US and Chinese players: BioNTech, Pfizer, and Fosun Pharma’s BNT162 candidates.

  However, Chinese companies are working with other countries such as Brazil, as Sinovac plans to do late-stage trials next month on 9,000 Brazilians (The Week).

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  Treatment updates:

  • NPR breaks down five types of COVID-19 treatments currently in development in the US.

    (Reuters) “In May, Canada’s National Research Council said it will work with CanSino to develop a coronavirus vaccine; U.S.-based Eli Lily and Shanghai Junshi Biosciences will soon start clinical trials for the latter’s Covid-19 treatment.”

    China may be poised to gain geopolitically from the attention: “China’s biotechnology sector is having a moment in the spotlight thanks to the pandemic. Little-known firms like the $5.3 billion CanSino Biologics are among front runners developing vaccines and treatments for Covid-19. They look set to go global despite rising diplomatic tensions between Beijing and the world.”

    • Meanwhile: US Senator Rick Scott has accused China of trying to sabotage Western countries’ vaccine development, underscoring the perceived geopolitical significance of getting to a vaccine first.

  Ethical questions and concerns:

  • (Axios) Chinese coronavirus test maker agreed to build a Xinjiang gene bank.

    U.S. officials are worried that widespread coronavirus testing may provide an opportunity for state-connected companies to compile massive DNA databases for research as well as genetics-based surveillance…The Chinese government, and the private Chinese companies that often work hand in glove with government ministries, have already pushed human genetics research beyond what many consider to be acceptable ethical boundaries.

    • Go deeper.

  • Abortion opponents protest COVID-19 vaccines’ use of fetal cells (Science).

  • CRISPR gene editing is being used for fighting the disease at Stanford (FierceBiotech).

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COVID-19 updates:

• Politico: “The United States will have a "better" vaccine than China — and it will have it sooner, former Food and Drug Administration Commissioner Scott Gottlieb predicted Sunday. Data on the potential vaccines in clinical development in China "didn't look overwhelmingly strong," Gottlieb told Margaret Brennan on CBS' "Face the Nation." "Those vaccines, if they do work, probably are going to provide lower levels of immunity than the platforms that the U.S. and Europeans are working with," he said. "So I think we're going to have a better vaccine, and I think we're probably going to have it sooner based on where we are in clinical development, some of the early progress that we've shown.’”

  • Nevertheless: China National Biotec Group Co. has completed phase II testing of its COVID-19 vaccine and is expected to be widely available as soon as the end of 2020, according to the official Wechat account of the State-owned Assets Supervision and Administration Commission. (Bloomberg)

  • And even if a firm in another country is first to a vaccine, mass producing it will require raw materials and chemicals, a market which China controls 80% of. (Straits Times) Will Chinese manufacturers be willing to work together with producers elsewhere?

  Want a full run-down of the top vaccine candidates in China, the US, and elsewhere? Check out this list. (The Times of India)

• Treatment updates on Russia’s Aviifavir and Gilead’s Remdesivir, which showed relative improvments in a Phase III trial announced last week. (CNBC, ChinaBioToday, FiercePharma).

  What I’m reading:

  • Stat News’ longform interview with Anthony Fauci on COVID-19 reopenings, vaccines, and moving at ‘warp speed’:

    • “You can have a significant number of doses available by the end of the year, the beginning of 2021…I think it’s aspirational, but it’s certainly doable.

      “The only thing that’s the big unknown to me is that, is it going to be effective? I think we could do it within the time frame that I’ve outlined. But there’s no guarantee that it’s going to be effective.”

  Beyond COVID-19:

  • China’s biotech landscape has been weathering a storm amid the economic slowdown in the last several months.

    • “Pharmaceutical sales fell 22% in hospitals and 6% in drugstores in the first quarter of this year compared to the same period last year. Sales in China’s pharmaceutical market will be flat at ¥1,010 billion (US$141 billion) in 2020, according to data from Iqvia.” (BioWorld)

  • Stat News recently released a report on the top 20 executives and companies in Chinese biotech (paywall).

  • I’m planning to release my own primer on biotech in China soon. If you are interested, just reply to this message.

The big news this past week has been Chinese and American biotech companies’ progress in creating a vaccine for COVID-19. Several major storylines below:

1. What’s happened:

   • (Reuters) “Sinovac Biotech Ltd said on Friday it had started mid-stage human trials of its experimental coronavirus vaccine in China earlier this month. The China-based company said it has received $15 million in funding from two investors that will help speed up development of the vaccine, dubbed CoronaVac.”

   • (NBC New York) Moderna’s Phase I trials for its coronavirus vaccine produced antibodies in all 45 participants, the Boston-based biotech company announced last week. If the vaccine passes Phase III trials this July, it could be ready for the market in early 2021.

     • Go deeper: “Scientists are exploring not just one approach to creating the vaccine, but at least four. So great is the urgency that they are combining trial phases and shortening a process that usually takes years, sometimes more than a decade.” (NYT)

   • Both a Chinese company (CanSino Biologic) and a US-Chinese joint venture (Sorrento) have had successful trials of COVID-19 treatments, with CanSino publishing its findings in the British medical journal The Lancet.

2. Why it matters:

   • In short, for China, finding a vaccine is about 1) restarting the economy and 2) gaining international credibility.

     • As Zuoyue Wang, a history professor at California State Polytechnic University, Pomona, said to NPR, “If a Chinese scientist could come up with a workable vaccine, I think it will help to defuse that kind of blaming or call for, you know, even reparation. [There is] enormous pressure, I think, for Chinese scientists to come up with an efficient or workable vaccine for the coronavirus pandemic.”

   • Great power competition also plays a role. China sees this opportunity to be the first to a vaccine as not only being an aspect of tech competition with the US, but also as an opportunity to take a leading role on the world stage.

     • Op-ed in China Daily: “It is not unlikely that one or more of the vaccines that eventually contribute to beating the virus will be developed in China. When that happens, it will help elevate China's biotechnology sector to world-class.”

     • CNBC: “Even though many countries have invested efforts to boost their domestic biotech sector, China is the “only one whose scale could potentially ... pose a threat to American pre-eminence” in biotech, said Scott Moore, director of the Penn Global China Program at the University of Pennsylvania, during the same webinar. China’s policy target is for biotech to account for roughly 4% of Chinese GDP by 2020, and in comparison, biotech makes up around 2% of the U.S.’s GDP, Moore said. 

     • Politico: “COVID-19 vaccine development and deployment in China, when available, will be made a global public good,” Xi Jinping told the World Health Assembly at its virtual gathering. “This will be China's contribution to ensuring vaccine accessibility and affordability in developing countries.”

       • One example of contributing to developing countries: (AA): “Cuba has announced that it will cooperate with China to open the first joint biotechnology park to increase the Caribbean region's competence in the pharmaceutical industry…Melangenin, Heberferon, Proctokinase and the therapeutic vaccine against Hepatitis B are among the initial drugs to be produced.”

3. Also of interest:

   • A 90-minute interview with Professor Marc Lipsitch, director of Harvard’s Center for Communicable Disease Dynamics, on whether we’re winning or losing against COVID-19 (from 80,000 Hours).

   • How and where would countries export COVID-19 vaccines - if at all? NBC reports that some worry it might not happen.

   • Biotech firms continue to deliver strong IPOs as Peijia Medical Ltd., a medical device company based in Suzhou, delivers the best opening performance of 2020 on the Hong Kong stock exchange with an IPO of $50M+. (Bloomberg)

1. Chinese and US biotech firms are pursuing partnerships across borders, especially COVID-19 related research partnerships, even as government agencies express concern over IP theft.

   • Chinese company Junshi Biosciences out-licensed rights for a therapeutic antibody aimed at prevention and treatment of COVID-19 to US-based company Eli Lilly. According to ChinaBioToday, “the antibody research was developed jointly by Junshi and the Institute of Microbiology, Chinese Academy of Science. Lilly plans to file an IND and start trials in the US in Q2 of 2020. Junshi retains all China rights to the candidate.”

     • Eli Lilly had previously teamed up with Vancouver-based company AbCellara to produce antibodies, FierceBiotech reported.

   • Yin Weidong, the CEO of the Beijing-based Sinovac Biotech company, hinted at interest last week in testing a COVID-19 vaccine trial in the US. The Straits Times quoted Yin as saying that “the US has the most developed biotech industry, the most sophisticated regulatory framework and its epidemic is now the worst.” Sinovac previously developed a vaccine for SARS in 2003, but stopped development at the Phase I stage once the virus got under control.

   • Meanwhile, Xinhua reports that the U.S. biotech company Herbalmax Inc will invest $150 million in Wuxi, Jiangsu Province, for an R&D center and production site. Herbalmax produces dietary supplements.

2. The US has turned up the heat further under China this week, with government officials and agencies accusing China of stealing COVID-19-related research and IP.

   • On May 13, the FBI released a report which said it is investigating “the targeting and compromise of U.S. organizations conducting COVID-19-related research by PRC-affiliated cyber actors and non-traditional collectors.”

   • Even before the FBI report, US officials had said that Operation Warp Speed, a White House-led initiative to find a COVID-19 vaccine, would “not consider ones made in China,” according to Science Magazine. Said one unnamed official: “We can’t partner with Chinese companies. That’s just not going to happen.”

   • China responded to the allegations through Foreign Ministry spokesperson Zhao Lijian by saying that “any attempt to smear or frame China without evidence is immoral.” Other Chinese experts were cited in the Global Times as saying that the two countries have different development paths: while China focuses on developing inactivated vaccines, the US is working on DNA and RNA vaccines.

     Why it matters: “In China, the government’s instinct is to showcase the country’s growth into a technological power capable of beating the United States.” (NYT)

   • BiotechPrimer: “Last week, the FDA granted emergency-use approval for Sherlock Bioscience’s (Cambridge, MA) new coronavirus diagnostic. The test uses CRISPR genome editing to detect the presence of Sars-Cov-2, the virus that causes COVID-19. With the ability to return results in about an hour, this new diagnostic could be a game-changer in the race to accurately diagnose and track new COVID-19 cases.”

3. CRISPR is back in the news.

   • BiotechPrimer: “Last week, the FDA granted emergency-use approval for Sherlock Bioscience’s (Cambridge, MA) new coronavirus diagnostic. The test uses CRISPR genome editing to detect the presence of Sars-Cov-2, the virus that causes COVID-19. With the ability to return results in about an hour, this new diagnostic could be a game-changer in the race to accurately diagnose and track new COVID-19 cases.”

   • Dig deeper: MIT Tech Review analyzes excerpts from He Jiankui’s original research on gene-edited twins (from December 2019).

"For the first time, one of the many COVID-19 vaccines in development has protected an animal, rhesus macaques, from infection by the new coronavirus," Science Magazine reported. "The vaccine, an old-fashioned formulation consisting of a chemically inactivated version of the virus, produced no obvious side effects in the monkeys, and human trials began on 16 April."

Learn more

Reuters: Sinovac acquires land in Beijing area and loans to speed up work on coronavirus vaccine

"Sinovac, founded in 2001, has previously developed vaccines for hepatitis A, hepatitis B, H1N1 influenza and gained approval to sell them in China," Reuters reported. "Its Beijing-based unit aims to make up to 100 million shots a year if the vaccine is shown to be effective. If it isn’t successful, the buildings and equipment will be used to make other types of vaccines."

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Financial Times: Biotech stock soars on debut in Hong Kong as coronavirus fuels investor boom 

"Little-known Chinese biotechnology company...Akeso, which develops cancer drugs and immunology treatments, soared by as much as 57 per cent in Hong Kong following its initial public offering on Friday. Demand for the HK$2.4bn (US$314m) float was 639 times the number of shares offered, with much of that demand coming from Hong Kong’s army of “mom-and-pop” traders."

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Xi Jinping speech on integrating Biosecurity into the National Security System

April 15 was China's fifth national security education day, and Party organ CPC News reproduced Xi Jinping's remarks from a February speech on biosecurity, where he added a 12th plank to a platform including security areas such as homeland, military, and economic security.

Read remarks (in Chinese)

FiercePharma's Coronavirus Drug Tracker

FiercePharma has created a tracker for daily updates on biotechnology, vaccine and treatment advancements in the fight against the COVID-19 pandemic.

Visit webpage

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