More Warp Speed contracts coming, vaccine production to begin in 4-6 weeks — officials
Operation Warp Speed has already handed out 4 of what they once said would be 3-5 major contracts to develop Covid-19 vaccines, but administration officials indicated Monday that more would be on their way.
“The slate is not closed,” a senior HHS official said on a call with reporters. “We’ve invested in four … but the slate is not closed.”
At the same time, the official indicated that Warp Speed would continue to focus on three technologies: mRNA, viral vectors and protein subunits. That leaves the door open for a wide range of platforms, notably including both of Merck’s vaccine candidates — one of which has already received BARDA funding — and one of Sanofi’s candidates. It appears to preclude, though, the potential for Inovio and Vaxart, among certain other small developers that have hyped their ties to the Trump administration, to be included.
The selected vaccines will move into large-scale manufacturing within 4-6 weeks, the official said. Right now, HHS and drugmakers are preparing for scale-up — setting up facilities, acquiring raw materials and speciality equipment and setting up project teams to visit every manufacturing site. The administration’s goal is to have 300 million doses by early 2021, with the first batches coming in the fall.
So far, Moderna, AstraZeneca, J&J and most recently Novavax have been selected for Warp Speed. Large-scale trials to prove whether the vaccines work are expected to begin within weeks for Moderna and AstraZeneca, with J&J and Novavax launching soon after. With case counts rising throughout the US, investigators could have an answer faster than if the virus was under control.
“We need to conduct a clinical trial in areas where there are outbreaks,” the official said. “So somewhat paradoxically, the current outbreaks might actually help us get a vaccine to protect people faster than if we had no outbreaks.”
On the same call, the official and longtime CDER chief Janet Woodcock gave the fullest picture yet on how the White House plans to accelerate therapeutics. Woodcock recused herself from CDER in May to lead the therapeutic initiative, but until last week, when the administration announced a $450 million contract for Regeneron’s monclonal antibodies, details on the initiative were scant.
Woodcock said the key criteria for inclusion in the program was whether a company could deliver a drug before the end of the year, a difficult hurdle. “This means repurposed drugs or drugs that have undergone rapid clinical development,” Woodcock told reporters.
The first goal was drugs that reduced viral load. That meant antivirals such as remdesivir and passive immunity — a broad term that encompasses both monoclonal antibodies that have been rushed through labs at Regeneron, Eli Lilly, Vir and other companies and convalescent sera, where someone who survives the virus donates their antibody-enriched plasma.
So far, Woodcock said, about 40,000 people have received sera through BARDA and the Mayo Clinic. There are no randomized controlled data yet, but Woodcock said there’s a “strong possibility” it helps. More than 50 different monoclonal antibody programs are now in development, she said, but the administration will focus on those that can reach market before 2021. Eli Lilly has said they could have 100,000 antibodies by the fall, and the BARDA-Regeneron deal covers the delivery of between 70,000 and 300,000 doses around the same time.
Both companies have started their own trials for their drugs, but Woodcock said this summer the NIH will start trials that follow a master protocol to quickly test antibodies and antivirals. She did not indicate which antivirals, but J&J received a $152 million BARDA contract in February to screen for new small molecules. And Merck’s EIDD-2801, now in Phase II trials for Covid-19, has received government funding in the past. According to whistleblower testimony from ousted BARDA chief Rick Bright, it is also a favorite among some officials within HHS.
The goal is to know by the fall which drugs can both treat and prevent Covid-19. But unlike with vaccines, where the FDA has set a 50% benchmark for authorization, Woodcock said there would be no pre-set bar for success. Between prevention, early-stage and late-stage treatment, she said, it would be impossible to set one.
“Unlike a vaccine, we’re talking about maybe a dozen different scenarios. We have small molecules antivirals, we have monoclonal antibodies and prophylaxis and early patient and outpatient and inpatient and so forth,” Woodcock said. “It’s pretty complicated.”
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