One ‘Operation Warp Speed’ Contract Released, Riddled With Redactions
HHS made public the federal government's $1.5-billion deal with Moderna to secure access to its COVID-19 vaccine candidate. But information on 39 pages of the 53-page document is obscured by redactions, NPR reports. Other developments on the vaccine race were also in the weekend's news.
NPR:
A Federal Coronavirus Vaccine Contract Released At Last, But Redactions Obscure Terms
Late Friday, the Department of Health and Human Services released its August contract with Moderna. ... While the publicly posted Moderna contract includes previously unknown details, extensive redactions leave the public in the dark about some of the company's obligations as well as the extent of protections for taxpayers. It's 53 pages long, but only 14 of them are free of redactions. (Lupkin, 10/24)
Stat:
FDA Shows Concern Over Emergency Authorization Of Covid-19 Vaccines
There are serious signs the Food and Drug Administration is getting cold feet over the notion of issuing emergency use authorizations to allow for the widespread early deployment of Covid-19 vaccines. Instead, it appears the agency may be exploring the idea of using expanded access — a more limited program that is typically used for investigational drugs — in the early days of Covid vaccine rollouts. (Branswell, 10/23)
CNN:
Fauci Says Findings On A Potential Coronavirus Vaccine Are Expected By Early December
Experts will know by early December whether a potential coronavirus vaccine is safe and effective, but widespread availability will probably not happen until next year, Dr. Anthony Fauci said Sunday. (Bashir, 10/25)
In related COVID vaccine news —
CNBC:
AstraZeneca: Our Coronavirus Vaccine Triggers Adult Immune Response
British pharmaceutical giant AstraZeneca on Monday said its potential Covid-19 vaccine has produced a similar immune response in older and younger adults. AstraZeneca, which is developing its potential Covid-19 vaccine in collaboration with the University of Oxford, said adverse responses to the vaccine among the elderly were also found to be lower. (Meredith, 10/26)
Stat:
Covid-19 Vaccine Trials From AstraZeneca, Johnson & Johnson To Restart
Two major studies of vaccines against Covid-19, both paused because of potential safety concerns, are set to restart, the companies running them said Friday. “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” Pascal Soriot, AstraZeneca’s CEO, said in a statement. “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.” (Herper, 10/23)
The Wall Street Journal:
Covid-19 Vaccine Rollout Calls For Supply-Chain Collaboration, Logistics Chief Says
Capacity-strained shipping networks should be able to manage the rush to distribute Covid-19 vaccines if governments, logistics providers and pharmaceutical companies coordinate their efforts, the head of a top global logistics operator says. (Smith, 10/26)
Also —
Atlanta Journal-Constitution:
CDC To Launch Cell Phone-Based After-Vaccine Tracker For COVID-19
The COVID-19 vaccine is not yet available, but once it arrives in the U.S., the Centers for Disease Control and Prevention plans to follow up on the health of those who receive it with a new program called V-SAFE. According to a September CDC presentation, V-SAFE, or vaccine safety assessment for essential workers, is “a smartphone-based text-to-web survey, and email-to-web survey active surveillance program for early vaccine recipients.” (Willis, 10/23)
Stat:
Why Approval Of Remdesivir To Treat Covid-19 Obscures Scientific Failures
Late Thursday, the Food and Drug Administration gave full approval to remdesivir, Gilead Sciences’ treatment for Covid-19. The news came just a week after a large study conducted by the World Health Organization failed to show that the drug had any benefit on mortality. The approval was largely based on an earlier study, conducted by National Institutes of Health, which showed the drug helps patients recover more quickly, as well as two other studies conducted by Gilead. (Herper and Feuerstein, 10/23)
