Covid-19 roundup: US and Pfizer strike deal for 100M more doses; NIH and partners cut critically ill patients out of blood thinner trial
The US government has sealed a deal with Pfizer and BioNTech for 100 million additional doses of their Covid-19 vaccine, doubling the country’s dose order.
Pfizer and BioNTech say they can deliver the full 200 million doses by July 31, 2021. The deal also includes an option for the US to purchase up to 400 million more down the road. The US is paying another $1.95 billion for the additional doses, at least 70 million of which should be delivered by June 30. The remaining will be delivered by July 31, according to the companies.
“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio,” HHS Secretary Alex Azar said in a statement. “This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021
The US entered negotiations with Pfizer last week — roughly a month after the government allegedly passed up an offer to acquire more doses. The government has already doubled down on its order from Moderna, inking a deal for 100 million more doses. The additional Moderna shots will be delivered in Q2, on top of an initial 20 million doses that are expected to ship this month. The remainder of the initial dose order is due in Q1.
OWS chief Moncef Slaoui told Fox News Sunday last week that he hopes 100 million people will be vaccinated by the end of March, with about 40 million doses of vaccine distributed by the end of December.
“With these 100 million additional doses, the United States will be able to protect more individuals and hopefully end this devastating pandemic more quickly,” Pfizer CEO Albert Bourla said in a statement. “We look forward to continuing our work with the U.S. government and healthcare providers around the country.”
NIH and partners cut critically ill patients out of blood thinner trial
Another NIH trial for the treatment of Covid-19 has come up short in one subgroup of patients.
Studies conducted by the NIH’s ACTIV-4 program, the Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP), and Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC) have stopped enrolling critically ill patients in the ICU, after the drugs didn’t reduce the need for organ support.
Covid-19 is associated with inflammation and widespread blood clots. Many patients with the virus, including some who died, have formed blood clots throughout their bodies, “even in their smallest blood vessels,” which can lead to complications like lung failure, heart attack and stroke, according to the NIH.
But for critically ill patients, “a potential for harm in this sub-group could not be excluded,” the NIH said in a statement. “Increased bleeding is a known complication of full-dose anticoagulation.”
Patients who don’t require ICU care will still be enrolled, per recommendation from oversight boards. Researchers are looking to see if full-dose blood thinners are more effective than lower dose ones in non-critically ill patients.
This isn’t the first time an NIH trial for a Covid-19 treatment turned up negative results. The agency halted its clinical trial of hydroxychloroquine back in June after finding the drug provides no benefit, despite President Donald Trump touting its effects. The agency also threw cold water on Trump’s so-called “historic breakthrough” with convalescent plasma in September, saying there was no evidence of its safety or efficacy.
The agency expanded its study of convalescent plasma in September, after FDA commissioner Stephen Hahn came under fire for issuing misleading statements about its effectiveness.
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