Report: U.S. should have enough COVID-19 vaccine in Q3 2021, CDC head tells Senate panel

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC.

Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to inoculate all Americans, the network reported.

“If you’re asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at third … late second quarter, third quarter 2021,” Redfield told the U.S. Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is p…

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AstraZeneca resumes COVID-19 vaccine trial

AstraZeneca (NYSE:AZN) has resumed its COVID-19 vaccine trial in the U.K. following confirmation from the Medicines Health Regulatory Authority (MHRA) that it was safe to proceed.

The news of the trial resumption, announced Sept. 12, came six days after a voluntary pause so that an independent committee could review safety data surrounding a single event of an unexplained illness. The person with the illness was part of the Phase III  trial for the AZD1222 vaccine AstraZeneca is developing in collaboration with Oxford University.

Now that the trial has resumed, AstraZeneca declined to disclose further information.

AstraZeneca is one of nine drug companies that have pledged to ensure safety with a potential COVID-19 vaccine and only submit for approval or emergency use authorization (EUA) after demonstrating safety and efficacy through a Phase 3 clinical study. The companies made the pledge amid worries that there is political pressure in the U.S. to rele…

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Pfizer touts non-human preclinical trial results for COVID-19 vaccine candidate

Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials.

The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release.

In a viral infection model, macaques received two injections with 100 µg of the vaccine candidate and macaques that received saline control injections were challenged 55 days after the second immunization with a high viral inoculum of about 1 million plaque-forming units of SARS-CoV-2. Immunization with BNT162b2 reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while the control group demonstrated evidence of viral RNA.

Among the anti-viral effects demonstrated by the vaccine were concomitant…

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AstraZeneca puts COVID-19 vaccine trial on hold

AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness.

The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine being developed in collaboration with Oxford University.

“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” an AstraZeneca spokesperson told Drug Discovery & Development in a statement. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the t…

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Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE)  and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

Get the full story at our sister site, MassDevice.
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LabCorp launches flu-COVID diagnostic combo

Laboratory Corporation of America (NYSE:LH) announced today that it launched its COVID-19, influenza A/B and RSV diagnostic combo.

The single-panel test is designed to detect multiple types of infections including the novel coronavirus, the flue and respiratory syncytial virus (RSV), helping doctors diagnose patients and inform decisions for treatment options.

Burlington, N.C.-based LabCorp’s testing method is aimed at easing the strain that could be put on the healthcare system in the U.S. if there is a significant flu/RSV season in which the symptoms are similar to COVID-19 and other respiratory viruses, according to a news release.

LabCorp is offering the test through doctors, hospitals and other authorized healthcare providers in the U.S., while the company has submitted an application to the FDA to offer the combined test through its Pixel by LabCorp collection kit to add convenience and accessibility.

The Pixel by LabCorp at-home test …

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Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the pledge states. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly dem…

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MedTech 100 roundup: Stocks top pre-pandemic high

After weeks of flirting with the heights hit before COVID-19 ravaged the markets, medtech stocks finally topped the pre-pandemic high last week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — spiked up to 93.11 points on Sep. 2, nearly a full point ahead of the pre-pandemic high of 92.32, which the market reached on Feb. 19.

Medtech stocks had hit a previous mid-pandemic high of 91 points last week, hanging around there before the sudden rise to 93.11, which was followed by a quick dip to 90.64 points 24 hours later.

The index dipped from that peak, though, sitting at 89.29 points at the end of last week (Sep. 4). Overall, medtech stocks saw a -1.6% decrease from the 90.78-point total at the same time a week prior (Aug. 28).

The most recent high mark represents a 0.9% rise from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -3.3% decrease from that pre-pande…

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How decontamination could solve the COVID-19 mask shortage problem

With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks.

(Image courtesy of Brian McGowan on Unsplash)

A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks.

Hundreds of frontline healthcare workers have died from the virus since the pandemic struck in China in 2019, bringing the need for effective face masks into sharp relief. But despite the efforts of 3M and other companies worldwide to boost production of the most effective filtering masks — N95s — there still might not be enough.

Get the full story on our sister site, Medical Design & Outsourcing.

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Roche test for both COVID-19 and influenza receives EUA

Roche (SWX: RO,  ROG) announced today that the FDA has granted an EUA for its Cobas SARS-CoV-2 and Influenza A/B Test for use on Cobas 6800 and 8800 systems.

The test is also available in nations accepting the European Union’s CE Mark.

The new Roche test can provide simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in people.

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” Roche Diagnostics CEO Thomas Schinecker said in a news release.

 

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Cummins is supplying material for millions of face masks against COVID-19

Cummins (NYSE:CMI) is making material for millions of face masks out of its Cookeville, Tenn., filtration plant — thanks to a partnership with the U.S. Department of Energy’s Oak Ridge National Laboratory nearby.

“Because of our expertise in the automotive filtration industry, we believed we could adapt to supply the filter media used in the face masks worn by healthcare providers, which are also in high demand across the nation,” Christopher Holm, director of filter media technology and IP at Cummins, said in a news release posted yesterday.

Get the full story on our sister site Medical Design & Outsourcing.

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Report: Abbott to hire 2,000 in Illinois to make rapid COVID-19 test

Abbott’s BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]

Abbott (NYSE:ABT) is reportedly set to hire 2,000 new employees to increase manufacturing for its rapid COVID-19 test.

The Chicago Sun-Times reported last week that the Abbot Park, Ill.-based company would be adding jobs at its Gurnee, Ill., facility following the FDA emergency use authorization (EUA) for its BinaxNow COVID-19 Ag Card and the subsequent announcement that the U.S. government would pay $750 million for 150 million tests.

Abbott did not offer comment on the announcement but told the Sun-Times that the added jobs will be in place “for the foreseeable future,” while many of the new positions will not require technical experience and will offer training on the job.

The company expects the Gurnee facility to be operating in a couple of weeks, according to the report, while another facility in Maine will assist…

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