Hello and welcome to another edition of the CBB.
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).