Healthcare Roundup – White House may overrule tightening of FDA vaccine rules, Novavax initiates pivotal study of COVID-19 vaccine candidate

医疗保健精选——白宫可能出手干预过于严格的FDA疫苗法规;Novavax启动COVID-19候选疫苗的关键研究
Published on: September 25, 2020
Author: Amy Liu

White House may overrule tightening of FDA vaccine rules

Reports on Tuesday suggested the FDA was considering stricter guidelines for emergency-use authorization of a coronavirus vaccine, though the White House may not approve of them.

“It sounds like a political move,” President Trump said at a press conference. “When you have Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ) and Moderna (NASDAQ:MRNA) – these great companies coming up with vaccines – and they have done testing and everything else, why would the the FDA have to add great length to the process?”

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“We want to have people not get sick, the vaccine is very important, it’s the final step. When the companies come back and say we have something that absolutely works – with numbers, statistics and tests – I don’t see any reason why it should be delayed further.”

“If they delay it a week, or two weeks, or three weeks… that’s a lot of lives you’re talking about.”

Related tickers: BioNTech (NASDAQ:BNTX), Novavax (NASDAQ:NVAX), Inovio Pharmaceuticals (NASDAQ:INO), AstraZeneca (NYSE:AZN), Dynavax (NASDAQ:DVAX), GlaxoSmithKline (NYSE:GSK), iBio (NYSEMKT:IBIO), Altimmune (NASDAQ:ALT) and VBI Vaccines (NASDAQ:VBIV).

Novavax initiates pivotal study of COVID-19 vaccine candidate; shares up 5%

Novavax (NASDAQ:NVAXlaunches a U.K.-based Phase 3 clinical trial evaluating COVID-19 vaccine candidate NVX-CoV2373 in up to 10K adult (ages 18-84) volunteers.

Enrollment in the study, being conducted in partnership with the U.K. government’s Vaccines Taskforce, should be completed over the next 4-6 weeks. Results will support marketing applications in the U.K., Europe and other countries.

NVX-CoV2373 is a stable prefusion protein based on the company’s recombinant protein nanoparticle technology that includes its proprietary Matrix adjuvant. The vaccine can be stored at 2°C to 8°C, allowing for distribution using standard vaccine channels.

On the production front, Novavax continues to scale up manufacturing capacity with an expected run rate of 2B doses per year by mid-2021.

Shares up 5% after-hours.

CloudMD to acquire Snapclarity to include Mental Wellness in telehealth offering

CloudMD Software & Services (OTCPK:DOCRF) signed an Amalgamation Agreement dated September 22, 2020 to acquire 100% of Snapclarity for C$3.35M (C$975K in cash and up to C$2.4M in shares at C$0.70/payment share).

Payment Shares will be subject to a two year release.

Based on performance conditions in 2021 and 2022, Snapclarity may earn an additional C$3.65M in equity-based consideration.

Snapclarity provides an on demand digital platform enabling assessment for mental health disorders resulting in a personalized care plan, access to online resources, a clinical health care team and the ability to match to the right therapists.

CloudMD post the acquisition will be the only telemedicine companies in North America that can provide both digital primary care solutions integrated with digital mental health care plans.

NIAID recruiting participants for U.S. COVID-19 vaccine and treatment studies

Intrepid adult Americans who desire to participate in a U.S. clinical trial evaluating an investigational COVID-19 vaccine or antibody treatment can register at the website of the COVID-19 Prevention Network which was formed by NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

Participants should remember, though, that they may be given a placebo since the trials will be randomized and blinded.

All six COVID-19 vaccines in industrial manufacturing – HHS Secretary Azar

Bloomberg reports that, according to Health and Human Services (HHS) Secretary Alex Azar, all six frontrunning COVID-19 vaccines are being produced at industrial scale.

The companies have all previously announced production ramp-ups ahead of anticipated emergency use approvals aimed at being prepared for prompt widespread distribution.

Developing….

Selected tickers: AstraZeneca (NYSE:AZN), Pfizer (NYSE:PFE), BioNTech SE (NASDAQ:BNTX), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Sanofi (NASDAQ:SNY), GlaxoSmithKline (NYSE:GSK), Moderna (NASDAQ:MRNA), Dynavax (NASDAQ:DVAX), Novavax (NASDAQ:NVAX).

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