Covid-19 roundup: Paul Hudson says US will have first dibs on Sanofi vaccine; Gilead selects 5 generic manufacturing partners for remdesivir
If Sanofi can successfully deliver a Covid-19 vaccine, the US will get first access to it, CEO Paul Hudson told Bloomberg News.
That’s because the US, through its biomedical defense agency BARDA, has invested in the technology, backing the company’s Protein Sciences subsidiary with a $30 million grant for its recombinant Covid-19 vaccine effort. Since its founding in 2005, BARDA has heavily funded both Sanofi — a French company — and Protein Sciences, which was an independent biotech until 2017.
“The U.S. government has the right to the largest pre-order because it’s invested in taking the risk,” Hudson told Bloomberg. The US expects “that if we’ve helped you manufacture the doses at risk, we expect to get the doses first.”
Hudson’s comments are the latest glimpse at a simmering battle over who will get a vaccine once it’s approved. That battle has particularly centered on the US and the Trump administration, which has eschewed international cooperation — including an $8 billion fund raised earlier this month — in favor of an internal and thus far vaguely defined effort to get Americans inoculated first. BARDA is funding some of the world’s leading Covid-19 vaccine efforts, backing not only Sanofi, but also putting around $1 billion behind J&J and Moderna’s efforts.
The debate began in earnest in March, when Reuters and a leading German newspaper reported that the Trump administration tried to lure German mRNA vaccine company CureVac to the United States. German scientists and officials responded with dismay and acrimony, condemning efforts for any country to secure exclusive access to a vaccine. The EU subsequently gave CureVac an $89 million grant, in part to expand manufacturing on the continent.
Since then, other countries have tried to secure early access. AstraZeneca said the UK will receive first access to the Oxford vaccine they have agreed to manufacture.
Hudson’s comments are particularly surprising because Sanofi is a French company, and it’s unclear how French officials will respond. Hudson said he has tried to encourage Europe to back vaccine efforts in the way the US and Chinese governments have, but to little avail.
“I’ve been campaigning in Europe to say the U.S. will get vaccines first,” Hudson said. “That’s how it will be because they’ve invested to try and protect their population, to restart their economy.”
Partnering with GSK, Sanofi has said they can produce 600 million doses of their experimental vaccine per year but are aiming for more. — Jason Mast
Gilead selects 5 generic manufacturers for remdesivir
Gilead has sealed deals with five generic manufacturers in India and Pakistan to produce remdesivir for 127 countries — mostly low- and lower-middle income countries but also a handful of upper middle and high-income countries where healthcare access is an issue.
Soon after the US-based company unveiled pivotal data suggesting its antiviral could help hospitalized Covid-19 patients recover faster, which prompted the FDA to issue an emergency use authorization, execs had laid out plans to ramp up mass production around the world through voluntary licenses complete with tech transfers.
The five partners initially chosen are Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan. They are free to set their own prices for the drugs in the countries where the licenses are effective.
In a statement, Gilead added:
The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.
Countries like the US, China, South Korea and Japan — where remdesivir has already been approved — are not included from the deal. Gilead is expected to team up with “leading chemical and pharmaceutical manufacturing companies” for most parts of Asia and Europe. — Amber Tong
China’s leading Covid-19 vaccine manufacturer makes move in Canada
CanSino Biologics, the Chinese biotech that’s emerged at the head of a global race for a Covid-19 vaccine, will soon be bringing its experimental inoculation to North America.
CanSino and Canada’s National Research Council have agreed to collaborate on a Phase I/II trial in the country, with the goal of ramping quickly into an accelerated Phase III study that can prove efficacy. The agency said the deal includes bioprocessing and that the NRC would help scale up production, although it was unclear to what level.
Although Moderna, working with the NIH, was the first to put their vaccine into humans, CanSino quickly emerged as the most clinically advanced effort. Working with the medical science arm of the Chinese military and with a technology that’s already yielded a Chinese-approved Ebola vaccine, they were able to gain swift authorization for a Phase II trial. Moderna and a group at Oxford have both since joined them at that intermediate efficacy stage.
CanSino’s history with the Canadian research council goes back to 2013, the NRC said, when CanSino licensed from the agency the cell lines it used to create its Ebola vaccine and is now using for Covid-19. Their approach involves using an adenovirus vector to deliver a gene for a coronavirus antigen into human cells. J&J and Oxford, along with a handful of other smaller efforts, both use a similar technology. — Jason Mast
430 vaccine and drugs aimed at Covid-19? Is that a massive response or chaos?
The latest tally and analysis by BIO, the biotech trade group, has tracked 430 unique compounds in development either to protect against or treat Covid-19. US-based companies are leading the campaign with 207 programs in various stages of human testing, they noted.
China lays claim to 31 programs in development while the UK is home to 16 potential weapons to fight the coronavirus.
Breaking down the total number into antivirals, treatments and vaccines, BIO found while more than half of the antivirals and essentially all vaccines were new for the coronavirus, as many as 63% of treatments were redirected and another 31% were repurposed. — Amber Tong
Source: BIO
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FDA looks to resume on-site inspections
As the White House ponders steps to reopen the country, the FDA said it is collaborating with the CDC to “develop a process that would govern how and where to return to on-site facility surveillance inspections.”
The agency decided in early March — one day before the WHO would declare the Covid-19 outbreak a pandemic — to postpone most foreign inspections. A week later, it stopped visiting domestic facilities too.
With the exception of “mission critical inspections,” regulators have been turning to alternative tools for surveillance.
“Although inspections are critical, they are one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA regulated products,” FDA commissioner Stephen Hahn said in a statement. “Based on decades of experience with our diverse regulated industries, we believe most FDA-regulated firms understand and appreciate their responsibility to ensure the safety of the products they manufacture or produce. We consider these firms to be our partners in public health.” — Amber Tong
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