Merck spent $425 million to buy out OncoImmune in November, presumably under the belief that they could scale up their drug for severe Covid-19 and get it through the FDA on the strength of a Phase III trial the smaller biotech completed in September.
The FDA threw a wrench in those plans. The agency told Merck last week that the 203-person study wasn’t sufficient to show the drug was effective. Now, Bloomberg reports, Merck is preparing an additional Phase III study, one that will push results — and any chance of approval — back to the end of the year.
It’s another Covid-19 setback for Merck, a Big Pharma long known for elite research, particularly in infectious disease; two years ago, they developed the first vaccine for Ebola. The company joined the pandemic fight late, and the various technologies they’ve developed have since stumbled. They axed their two vaccine programs after dispiriting early results, and they’ve said little about an Emory-developed oral antiviral they licensed and put in Phase III.
The FDA’s decision is particularly surprising given how the Merck-OncoImmune buyout came about. Bloomberg reported that Operation Warp Speed chief Moncef Slaoui brokered the deal after the small biotech said their drug reduced the risk of respiratory failure or death in a Phase III trial. HHS then gave Merck a contract for $356 million to supply 100,000 doses by June.
“It’s not that the agency wasn’t impressed by the data, because they were,” Nicholas Kartsonis, Merck’s clinical infectious disease chief told Bloomberg. “They just want more of it, and more comfort that if we’re indeed going to bring this forward, that the data gets replicated.”
COVAX begins rollout but huge disparities still loom
COVAX, the WHO and Gates-backed vaccine-sharing program, has had a rocky start, edged out in the hunt for vaccines by the wealthiest countries in the world. As shots rolled out in the US, the UK, and Europe, COVAX largely stood on the sidelines: At the end of February, more than 100 of the world’s poorest countries had yet to receive a single dose.
The program, though, is beginning to set benchmarks. They posted their first round of global vaccine allocations on Tuesday, scheduling 237 million doses of the AstraZeneca-Oxford vaccine to ship to 142 nations by the end of May. The first ones began on Monday, after 600,000 doses landed in Ghana and 500,000 doses in Côte d’Ivoire.
The allocations still amount to drops in the bucket compared to the rollout in the US alone, where more than 500 million doses have been secured in the same time period. President Biden said Tuesday that the US would have enough vaccines for its entire eligible adult population by May — a benchmark most of the world may not hit for years.
In addition to shots from AstraZeneca, a company that prioritized global scale and access, COVAX will soon begin to see shots from other major developers. Just over 1 million Pfizer-BioNTech vaccines are included in the first allocation and Novavax, which has yet to be authorized anywhere but recently showed its vaccine was highly effective in the UK and moderately effective in South Africa, has pledged 1.1 billion doses.
NIH pulls plug on convalescent plasma in patients
The NIH is singing last rites on convalescent plasma.
More than a year after doctors around the country began banding together to get convalescent plasma off the ground as an emergency, stopgap treatment for a new, emergency virus — and six months after former President Trump pushed the FDA authorize it — the NIH has halted its trial in convalescent plasma for moderate patients after a data safety and monitoring board found it had little effect.
The study, called C3PO and launched in August, was one of the best hopes for proving convalescent plasma could be an effective treatment for Covid-19. Although other studies, including the Mayo Clinic’s controversial expanded access program, focused on severe patients, researchers believed it should work better the earlier it was administered. Smaller studies from other countries bolstered that belief.
The study had enrolled 511 out of a planned 900 patients. It showed the therapy was safe but unlikely to help the group studied.
The FDA already began to roll back its controversial EUA for convalescent plasma last month, in the face of new evidence pointing to its ineffectiveness in hospitalized patients. They said it would only be used in hospitalized patients with early-stage disease or an impaired ability to make their own antibodies.
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