Covid-19 roundup: Anthony Fauci, Stephen Hahn testify in Congress; China's Sinopharm speeds into PhIII vaccine trial
In the early days of the outbreak, NIAID-chief-turned-America’s-Doctor Anthony Fauci cautioned Americans that a vaccine could come in 12-18 months. After several months of research and development and hundreds of vaccine projects around the globe, he’s sticking with the most optimistic end of that assesment.
Appearing in a black cloth mask before the House Energy and Commerce Committee, Fauci expressed confidence about the arrival of a vaccine even as he offered a sober assessment of the “disturbing surge” of infections now taking off in some parts of the country.
“You remember, I told your committee a few months ago, that a vaccine would be available from a year to 18 months,” he said in a response to a question from Diana DeGette (D-CO). “I said that in January of 2020. A year from January is December. I still think there is a reasonably good chance that by the very beginning of 2021, that — if we’re going to have a vaccine — that we will have it by then.”
For a little over 2 hours, Fauci answered questions alongside CDC director Robert Redfield, FDA director Stephen Hahn and HHS assistant secretary for health Brett Giroir. He explained adjuvants, the first large-scale trials set to begin this summer, and how the government and industry were scaling up production at-risk so they’ll be ready if one proves effective. He batted down the idea that mutations in the virus might make a vaccine ineffective — an assertion not yet borne out by data on the thousands of sequenced coronavirus genomes.
“Well, we already know it’s mutated, right?” Kurt Schrader (D-OR) said, after Fauci said the flu vaccine is often ineffective because of influenza virus changes.
“Yeah,” said Fauci. “That doesn’t make any difference. All RNA viruses mutate. That doesn’t mean they change.”
Hahn, meanwhile, faced a litany of questions on how the FDA would evaluate a vaccine. The agency has faced scrutiny for its actions during the outbreak particularly after it authorized the Trump-touted anti-malaria drug hydroxychloroquine, despite a paucity of evidence for the effectiveness.
“Let me be clear,” he said. “The data and science will dictate when we will have safe and effective treatments and vaccines for Covid-19.”
“The acceleration is really around taking financial risk round the developmental process; the acceleration is not cutting corners with respect to the assessment of safety and effectiveness,” he added when pressed by Fred Upton (R-MI). “We’ve been doing this for years, and we will rely upon the science and data when it’s available to us, to make that adjudication and decision regarding an EUA. I cannot prejudge when that will happen.” — Jason Mast
United Arab Emirates hosts PhIII trial for vaccine candidate from China’s Sinopharm
Leapfrogging both domestic and overseas rivals, China’s Sinopharm has started a Phase III trial for one of its inactivated vaccine candidates against Covid-19 in the United Arab Emirates.
That the study of a homegrown vaccine is taking place outside China highlights the bizarre problem researchers can encounter when a country brings its local outbreak (even the second waves) under control. If the disease isn’t prevalent enough in a given region, it may be near impossible to tease out the real effects of an immunization compared to placebo.
Sinopharm is working with local partners for both data analytics and manufacturing, including Abu Dhabi-based AI and cloud computing company Group 42.
The vaccine being tested is made by the Wuhan Institute of Biological Products, one of its multiple subsidiaries, and has completed Phase I/II trials in Henan province. A similar experimental vaccine developed by the Beijing Institute of Biological Products is still in the earlier phase.
A state-owned enterprise, Sinopharm enlisted its own workers to help determine the safety and efficacy of the vaccines in development, ultimately administering them to more than 1,000 employees. It’s also offered jabs to staffers of other state-owned enterprises travelling overseas.
Specialized manufacturing facilities are required to produce inactivated vaccines since the producers must first bring in the live virus in order to “kill” them, either with heat or chemicals. Sinopharm has disclosed that it has capacity to make 120 million doses in Beijing and another 100 million in Wuhan — although it’s not yet clear how many shots each person will need. — Amber Tong
AstraZeneca turns to Scotland for latest vaccine supply deal
Scotland’s Symbiosis Pharmaceutical is the latest partner on AstraZeneca’s roster for churning out 2 billion doses of the Oxford vaccine by the end of 2021.
By Reuters’ count, this marks the 10th Covid-19 vaccine supply deal from the pharma giant, which had signed on less than two months ago to scale up the global development, manufacturing and distribution of the chimpanzee adenovirus-based vaccine candidate originating from the Jenner Institute.
The new partners didn’t specify how many doses Symbiosis has committed to producing, noting only that its headquarters in Stirling is staffed with 100 professionals.
With Phase III trials underway in the UK and Brazil, AstraZeneca had mapped out plans to launch with help from Operation Warp Speed. — Amber Tong
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