The adverse events that led to a pause in trials evaluating AstraZeneca Plc’s COVID-19 vaccine candidate may not have been associated with the vaccine itself, according to a document outlining participant information that was posted here online by the Oxford University.
Wednesday, September 16, 2020
U.S. plans to distribute Covid vaccine immediately after regulators authorize it
The U.S. government on Wednesday said it will start distributing a COVID-19 vaccine within one day of regulatory authorization as it plans for the possibility that a limited number of vaccine doses may be available at the end of the year.
Officials from the Department of Health and Human Services and the Department of Defense on Wednesday held a call with reporters and then released documents on the distribution plans that it is sending to the states and local public health officials.
“Our goal at Operation Warp Speed, is that 24 hours after (regulatory authorization) is issued, we have vaccine moving to administration sites,” one of the officials said.
The federal government will allocate vaccines for each state based on the critical populations recommended first for vaccination by the U.S. Centers for Disease Control and Prevention.
The guidelines suggest that the government is likely to broadly follow guidelines generated by an independent expert panel tapped by U.S. health officials to lay out which Americans to prioritize while vaccine supplies are limited.
The document, called the COVID-19 Vaccination Program Interim Playbook, said limited COVID-19 vaccine doses may be available by early November 2020 if one is authorized by then, but that supply may increase substantially in 2021.
Officials also said they were working to make sure there was no cost to patients for the vaccine.
Pharmacies and hospitals are the primary vaccination points, and the CDC document said the agency is working directly with pharmacies to develop on-site vaccination in long-term care facilities.
During a press call, officials said they were also looking to reach other groups of people in close contact, such as those that work in meatpacking plants or are in homeless shelters.
Officials said they were working with states on how to track vaccination through state immunization databases and pharmacy records.
Biogen loses Tecfidera patent infringement case in Delaware
Posts on social media say that Biogen (BIIB +1.2%) has lost its patent infringement lawsuit in Delaware related to top seller Tecfidera (dimethyl fumarate) which accounted almost a third of its Q2 revenues. The company filed its complaint in June 2017 against Amneal Pharmaceuticals (AMRX +3.5%) in an attempt to block its generic version of the multiple sclerosis med. The judge stated that she was bound by the earlier patent invalidity ruling in West Virginia.
The FDA approved Mylan’s (MYL -2.0%) generic version a month ago after a federal judge in West Virginia invalided a key Biogen patent (U.S. Patent No. 8,399,514), a decision it is appealing.
Illumina near deal to acquire liquid biopsy test developer Grail
Bloomberg reports that Illumina (ILMN -4.2%) is in advanced talks to acquire Grail (GRAL), a spinout that it formed in 2015 to develop and commercialize liquid biopsy testing for cancer.
According to informed sources, a deal could be announced as soon as this week. Grail could fetch more than $6B based on its valuation from the last financing round.
A week ago, Grail filed a preliminary prospectus for an IPO.
Myomo rallies on Medicare provider status
Thinly traded nano cap Myomo (NYSEMKT:MYO) jumps 51% premarket on increased volume on the heels of its authorization to be a Medicare provider by the Centers for Medicare & Medicaid Services (CMS), allowing it to bill Medicare directly for its devices.
The company is now included in the Medicare Supplier Directory when it delivers its MyoPro powered orthosis in 39 states and the District of Columbia. It is working to complete the requirements in the remaining states.
https://seekingalpha.com/news/3614462-myomo-rallies-on-medicare-provider-status
Twitter suspends Chinese virologist who says COVID-19 was made in Wuhan lab
Twitter has suspended the account of a Chinese virologist who has claimed that COVID-19 was manufactured in a laboratory.
Dr. Li-Meng Yan, a former researcher at the Hong Kong School of Public Health, went dark on the platform after she accused China of covering up evidence that the deadly virus came from a lab in Wuhan.
“They don’t want the people to know this truth. Also, that’s why I got suspended, I got suppression [and] I am the target that China Communist Part wants to [sic] disappear,” she told Fox News host Tucker Carlson on Tuesday.
Carlson responded, “I’m giving you the benefit of the doubt so I’m going to assume you’re not an anti-Chinese racist so it’s not clear why Twitter would shut you down or why you’re being ignored by the rest of the US media.”
Twitter declined to comment to The Post on Wednesday.
The whistleblower released a paper Monday on the open-access repository website Zenote that she says backs up her claims and shows how the virus could be “conveniently created” in a lab setting in six months.
The paper, which was co-authored with two others, claims to note how “SARS-CoV-2 shows biological characteristics that are inconsistent with a naturally occurring, zoonotic virus.”
https://nypost.com/2020/09/16/twitter-suspends-virologist-who-claims-covid-19-was-made-in-lab/
NanoViricides picks COVID-19 drug candidate, shares up
NanoViricides (NYSEMKT:NNVC) perks up 7% premarket on light volume in reaction to its announcement that it has selected a drug candidate, dubbed NV-CoV-1-R, for the treatment of COVID-19.
The company says NV-CoV-1-R consists of a nanoviricide, NV-CoV-1 with Gilead Sciences’ (NASDAQ:GILD) remdesivir encapsulated inside its core, adding that NV-CoV-1 is designed to attack the virus particles themselves and “possibly” would also attack infected cells that express a coronavirus antigen called S-protein. Normal cells, which would not display the S-protein, would be unaffected. The encapsulation of remdesivir, it claims, may protect it from rapid metabolism, increasing its stability and effectiveness.
Clinical trials are planned.
https://seekingalpha.com/news/3614465-nanoviricides-picks-covidminus-19-drug-candidate-shares-up-7
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