Covid-19 roundup: China's Sinovac goes to Brazil for PhIII; AstraZeneca signs Emergent on for $87M manufacturing deal
Sinovac, the first Chinese biotech to publish animal data on a Covid-19 vaccine, is teaming up with a Brazilian partner to test its candidate in the South American country.
Instituto Butantan is still awaiting clearance from local authorities to kick off the Phase III trial, which will enroll 9,000 people in July. The company will get a license for the vaccine in Brazil should it prove effective.
As new infections in China become a rare occurrence, scientists have run into the bizarre problem of not having enough exposure to really know whether the inoculations are protecting their volunteers.
CanSino Biologics, the leading developer, has turned to Canada for its Phase III. The government is reportedly going to offer two experimental candidates from state-owned pharma conglomerate Sinopharm to employees of other state-run companies travelling overseas.
Brazil is battling a serious coronavirus outbreak, topping the global charts with over 30,000 new cases recorded in a day.
— Amber Tong
AstraZeneca signs Emergent on for $87M manufacturing deal
Having negotiated left and right to secure supply of Oxford University’s Covid-19 vaccine around the world, AstraZeneca has sealed a $87 million deal with a US manufacturing partner.
Emergent BioSolutions already obtained a meaty $628 million contract from BARDA to support Operation Warp Speed, as well as a collaboration with J&J. With the new AstraZeneca pact, it now supports “two of the five leading candidates being developed with U.S. government funding,” CEO Robert Kramer said.
The company will offer up its product development facility in Gaithersburg, MD for development services, technology transfer, analytical testing, drug substance process and performance qualification. Large-scale manufacturing capacity will also be reserved at the Baltimore Bayview site through 2020.
Notably, with a capacity to produce tens to hundreds of millions of doses every year, Emergent only meets a fraction of the goal sketched out by companies — with AstraZeneca outlining a goal for 2 billion. — Amber Tong
Following Sinovac, China’s Sinopharm posts positive animal data
Sinopharm has reported animal data for one of two Covid-19 vaccine candidates its subsidiaries are testing in the clinic, spotlighting “high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits and nonhuman primates.”
Like three other Chinese candidates currently in clinical testing, BBIBP-CorV is an inactivated version of SARS-CoV-2.
All in all, the scientists reported in Cell, everything — including the genetic stability for manufacture — supported further evaluation in the clinic. And evaluated it is, with a multi-arm Phase I/II trial ongoing.
Two-dose immunizations using 2 μg/dose of BBIBP-CorV provided highly efficient protection against SARS-CoV-2 intratracheal challenge in rhesus macaques, without detectable antibody-dependent enhancement of infection. — Amber Tong
Russia to test servicemen in race to get vaccine approved by September
Russia is barreling forward on a homegrown vaccine race, with 10 candidates in the pipeline, plans to test them on military recruits, and the potentially dangerous goal of having one approved by September.
The Wall Street Journal dove into the bristling effort, as coronavirus cases surpass 500,000 in a country that once counted among the world’s top research hubs. Although Russia lacks the biotech and pharma base that have made the UK, US and China home to the world’s leading vaccine efforts, the country’s race bears passing similarities to programs, such as Operation Warp Speed, whereby governments try to secure their citizens access to the first vaccines available.
President Vladimir Putin has insisted on an approval by September, in line when AstraZeneca may begin delivering vaccines to the UK. It’s unclear, though, if the country plans on the kind of large-scale testing AstraZeneca, in partnership with the US government, has already set into motion and which is necessary to test not only a vaccine’s efficacy, but also its safety.
Russia has 10 candidates, the fourth most of any country, behind the US, China and Canada, according to the WHO. Last week, the Russian military isolated 45 men and 5 women from the military, who will then be given a vaccine developed by the ministries of defense and health. Clinical research for that vaccine is scheduled to be completed by July, according to WSJ.
Another vaccine will soon begin testing on paid volunteers at the Institute for Translational Medicine and Biotechnology at Sechenov University. A third is underway at the St. Petersburg Institute for Experimental Medicine. That one involves a coronavirus gene delivered via probiotic bacteria in yogurt. — Jason Mast
Equipped with €2.7B fund, EU eyes BARDA-style deals with vaccine developers
The European Union will be prioritizing companies with manufacturing capacity outside of the US as it gears up to ink advance purchase deals with developers of Covid-19 vaccines with a €2.7 billion emergency fund.
EU health ministers will discuss the strategy today, the Financial Times wrote, echoing a previous Reuters report. By handing over millions to multiple pharma companies — sometimes before clinical trials even start — the goal is to secure access to one or more that’s eventually proven to work.
“Every month gained in the deployment of a vaccine will save many lives, many jobs and many billions of euros,” read a document reviewed by the FT.
Sanofi CEO Paul Hudson heightened concerns about so-called “vaccine nationalism” when he said in an interview that the US will have the right to the largest pre-order of the French drugmaker’s vaccines — due to its generous financial support at-risk. Ethicists and non-governmental organizations fear that politicians will fight for coveted vaccines at the peril of poorer and more vulnerable countries.
On their part, vaccine developers have mostly vowed to strive for equitable access. AstraZeneca has struck deals to provide the Oxford vaccine to low- and middle-income countries even as it signed supply commitments with the US and the UK.
The new EU initiative will be looking for projects that are ready for mass production in 2021.
“Location is important, timing is important and the solidness of the scientific approach is important,” an official told the paper. “We need to make sure we are betting on candidates that have a good chance of being successful.” — Amber Tong
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