Covid-19 roundup: Germany pours nearly $450M into BioNTech; AstraZeneca still hasn't resumed its vaccine trial in the US
Pfizer CEO Albert Bourla has made a point since the pandemic’s early days of rejecting US assistance for their Covid-19 vaccine, separating them from the rest of the big players and casting the old pharma giant as a dynamic company that could move better and faster alone.
The story, though, for their German biotech partner BioNTech — the company whose mRNA technology is actually behind their vaccine — is a little different. In June, the European Investment Bank gave BioNTech €100 million debt financing to support manufacturing and development.
And today, Berlin handed them a €375 million — nearly $450 million — grant to support late-stage development of the vaccine. The contract, analogous in both size and scope to some of the contracts handed out by Operation Warp Speed, will help BioNTech run the German arm of their pivotal Phase II/III trial and upscale manufacturing in Germany, although no details were disclosed on how many doses it might cover.
For Germany, the grant represents another attempt to keep some of the vaccines produced by German companies within German borders. It is an extension of a larger tussle between countries over access to the first Covid-19 vaccines and a tug-of-war over German companies in particular. The country’s sizeable biopharma sector includes multiple home-grown companies built on mRNA — a technology that has proved vital in the world’s response to Covid-19.
In June, CureVac, the other major mRNA player, received a €300 million grant from Germany in a move explicitly tied to keeping the company and supply of its vaccines within the country. Earlier reporting, confirmed by the German Health Ministry but denied by CureVac, suggested that the Trump administration had tried to lure the company to the US.
With their pivotal trial already nearing 30,000 participants, Pfizer and BioNTech are currently frontrunners to be the first vaccine to grab authorization. Bourla has repeatedly said they expect to know if the vaccine works by the end of October — a timeline that other public health officials have said is possible but unlikely. — Jason Mast
AstraZeneca still hasn’t resumed its vaccine trial in the US
Nine days after AstraZeneca’s Covid-19 vaccine trial screeched to a halt to probe a potentially serious side effect, the biotech still hasn’t gotten the FDA green light to resume dosing in the US.
Dosing won’t continue until US investigators finish reviewing the case, according to a Reuters report. The patient in Britain reportedly experienced inflammation of the spinal cord.
AstraZeneca has already restarted a trial of the Oxford vaccine in Britain, according to Reuters. CEO Pascal Soriot remains confident the vaccine will still arrive this year. The company had struck deals to supply the UK with doses as early as September.
“If the review of the safety committee allows us to restart the trial, I still think we are on track for having a set of data that we would submit before the end of the year, and then of course after this it depends on how fast the regulator will review and give approval,” Soriot told a Tortoise Media conference last week. “So we can still have a vaccine by the end of this year or maybe early next year, but by the end of this year it’s still feasible.”
This isn’t the first time the trial has been held up. AstraZeneca acknowledged that the trial hit a brief roadblock in July after a different patient reported neurological symptoms. That case, however, was tied to undiagnosed multiple sclerosis.
This time, the potentially serious adverse event occurred in a 10,000-person trial. Experts say the incidence may have been coincidental, given the large size of the study. The condition is rare, but there has been speculation tying it to other vaccines. Guillain-Barre syndrome, another inflammatory condition, was connected to the 1976 Swine Flu vaccine.
Earlier this month, AstraZeneca began dosing 30,000 subjects for its final round of US vaccine testing. The volunteers are scheduled to get 2 doses 4 weeks apart. Plus, AstraZeneca beefed up ongoing trials with another 20,000 people in the UK, Brazil and South Africa.
Soriot has said that though the company is moving fast, it will adhere to safety and efficacy standards. Experts have said the hold-up shows the system of checks and balances is working. — Nicole DeFeudis
Chinese CDC says vaccine could come as early as November
Chinese CDC chief biosafety expert Guizhen Wu said vaccines being developed in the country could be ready for general use in November or December, according to a Reuters report.
Wu didn’t specify which of China’s four vaccines in late-stage clinical trials would be ready. But she added that she hasn’t experienced any abnormal side effects since taking a vaccine in April.
Sinopharm and Sinovac are working on three vaccines under the state’s emergency use program. Sinovac’s candidate CoronaVac was authorized for emergency use in July, and offered to some medical professionals and border officers, a Chinese official said in an interview with state media.
CanSino’s candidate became the first vaccine approved for limited use in humans in June, when China’s government began allowing the military to take it. It was also China’s first vaccine to enter human testing. The biotech recently dropped plans for a Phase I/II study in Canada, after doses of the vaccine got stuck in customs. There’s been speculation that political tension caused the hold-up. — Nicole DeFeudis
Kiadis gets $9.5 million to advance potential Covid-19 treatment
Amsterdam-based Kiadis Pharma bagged $9.5 million in funding from the Advanced Regenerative Manufacturing Institute’s (ARMI) BioFabUSA program and the US DoD to develop its potential Covid-19 treatment.
The money will fund research of its candidate, K-NK-ID101, a new company-sponsored Phase I/IIa clinical trial, and the expansion of GMP manufacturing. Kiadis will work with the ARMI program to establish large-scale manufacturing capacity for K-NK cell therapy in the US.
The company believes NK (natural killer) cells can control Covid-19, which has been correlated with the shortage and exhaustion of NK cells. The cells are able to work together with antibodies, immunoglobulins and vaccines, according to the company.
“K-NK cells could potentially offer a universal pandemic preparedness platform, for COVID-19 and future pandemics. Over time, K-NK cells could be developed to protect immunocompromised and high-risk patients against multiple seasonal respiratory infections, including influenza and RSV, either alone or in combination with vaccines and antibodies,” CEO Arthur Lahr said in a statement. — Nicole DeFeudis
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