covid-19 Archives - Medical Design Sourcing

Pfizer to close Durham and Morrisville, North Carolina facilities amid major restructuring effort

In a strategic initiative to streamline operations, Pfizer said it would close facilities in Durham and Morrisville, North Carolina. The company aims to cut at least $3.5 billion in costs.

The company now employs more than 80,000 people worldwide, with roughly 4,000 based in North Carolina.

The closures will not affect Pfizer’s two largest facilities in North Carolina — Sanford and Rocky Mount. The Rocky Mount facility, which specializes in producing injectable medicines for hospitals, employs approximately 3,200 people and has recently resumed operations after a tornado damaged it in July. The Durham Clinical Manufacturing Facility, on the other hand, opened in December 2021. The company initially planned for the facility to create 50 jobs and relocate 40 employees from Chapel Hill. The exact number of people employed at the facility at the time of the announcement remains unclear.

The company has lowered its full-year revenue guidance to $58.0 to $61.…

Five insights on COVID-19 vaccine side effects

[weyo/Adobe Stock]

To date, there have been more than 770 million confirmed COVID-19 cases and nearly 7 million deaths from the virus, according to the World Health Organization (WHO). Vaccines remain one of the most potent tools in blunting the severity of SARS-CoV-2 infection, and vaccine developers have distributed more than 13.5 billion vaccine doses to date.

As the global fight against COVID-19 continues, the emphasis on vaccine safety remains a priority. While COVID-19 vaccines from Moderna, Pfizer and J&J vaccines show higher reactogenicity than other commonly administered vaccines, SARS-CoV-2 remains a dangerous virus. Beyond the immediate threat of infection, the prolonged impact of ‘long COVID‘ is considerable. The National Center for Health Statistics (NCHS) reveals that more than 40% of U.S. adults have had a COVID-19 infection, with nearly 19% of these individuals still grappling wit…

3D-printed COVID-19 breath test takes two breaths and one minute

Researchers have developed this 3D-printed breath test for COVID-19. [Photo courtesy of Washington University in St. Louis]

A 3D-printed COVID-19 breath test delivers results within 60 seconds from just one or two breaths, according to Washington University in St. Louis researchers.

It’s the same team that recently developed an air monitor that can detect the COVID-19-causing SARS-CoV-2 virus in the air within minutes.

Researchers from the McKelvey School of Engineering and the School of Medicine used the same ultrasensitive biosensing technique for the breath test.

The small, portable and adaptable device could help fight the airborne virus as at-home rapid tests increasingly report false negatives for new SARS-CoV-2 variants. Most COVID-19 transmission is still pre-symptomatic and asymptomatic.

The researchers envision their device being used for rapid diagnosis by doctors or to scr…

How COVID vaccine options stack up for fall 2023

[weyo/Adobe Stock]

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is backing a significant shift in the current COVID-19 vaccine strategy: a move from multivalent to monovalent vaccines focusing on the XBB lineage strains. The advisory committee has set its sights on protecting against XBB.1.5 and has jettisoned is support for vaccines with a Wuhan component, which was included as a component of the bivalent vaccine boosters that debuted in fall 2022. “Continuing to include the original Wuhan strain was unnecessary since early strains are no longer in circulation,” said Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases.

While supporting monovalent vaccines, VRBPAC members acknowledged that the predominant SARS-CoV-2 sublineages could continue to evolve. “We may well find that XBB.1.16 or XBB.2.3 become more dominant than XBB.1…

Researchers develop device that detects airborne COVID-19 virus — llamas and ‘wet cyclone’ tech helped

Washington University researchers (from left) John Cirrito, Rajan Chakrabarty, Joseph Puthussery and Carla Yuede stand with the SARS-CoV-2 wet cyclone aerosol sampler they developed. (Photo by Shubham Sharma/Washington University)

Researchers at Washington University in St. Louis have developed a device that can detect the COVID-19-causing SARS-CoV-2 virus in the air within minutes.

The proof-of-concept device is possible thanks to recent advances in aerosol sampling technology and an ultrasensitive biosensing technique, said researchers at the McKelvey School of Engineering and the School of Medicine.

“There is nothing at the moment that tells us how safe a room is,” neurology professor John Cirrito said in a news release. “If you are in a room with 100 people, you don’t want to find out five days later whether you could be sick or not. The idea with this device is that you can know essentially in r…

‘Long vax’ phenomenon gets closer look in recent studies

[Photo from Pexels]

In 2020, researchers witnessed the emergence of post-acute sequelae of SARS-CoV-2 (PASC) — more commonly referred to as “long COVID.” Now, the notion of “long vax,” persistent and varying symptoms following COVID-19 vaccination, has come into focus, as Science has noted. This phenomenon, while not as widespread as long COVID, has concerned some in the medical community, potentially fueling vaccine hesitancy.

Still, serious adverse events stemming from COVID-19 vaccination are rare, typically occurring within six weeks of vaccination, as CDC notes. In addition, the majority of side effects following vaccination disappear within a few days. While such side effects are generally minor, a number of patients have had acute spells of dizziness post-vaccination, chronic hives and heart palpitations.

For those with long COVID and post-vaccination malaise, symptoms can include postural orthosta…

PharmaJet Tropis becomes exclusive intradermal delivery system for 2 COVID-19 vaccines

The Tropis needle-free injection system. [Image from PharmaJet]PharmaJet announced that its Tropis system is now the exclusive intradermal delivery system for two novel COVID-19 vaccines.

Golden, Colorado-based PharmaJet engineers precision delivery systems that overcome the challenges of nucleic acid vaccine delivery. Its Tropis system now offers the delivery of the world’s first plasmid DNA COVID-19 vaccine from Zydus Lifesciences. Exclusively delivered with Tropis, the vaccine demonstrated increased immune response translating into clinical effectiveness, PharmaJet says.

Additionally, Tropis delivers Gennova Biopharmaceutical’s mRNA-based Omicron-specific COVID-19 booster vaccine. The self-amplifying therapeutic enables a low dose of a room temperature, stable mRNA vaccine.

Get the full story at our sister site, Drug Delivery Business News.

Adhesive bandage with nanoparticles tests for COVID-19

[Photo by Martin Sanchez on Unsplash]

NYU Abu Dhabi researchers say they have a new rapid COVID-19 testing method using an adhesive bandage.

This bandage uses gold nanoparticles to quickly detect the immune antibodies in the bloodstream. SARS-CoV-2 infection naturally produces these antibodies, known as IgM and IgG. They serve as valuable biomarkers to identify infected individuals and monitor the spread of pandemics.

Associate Professor of Mechanical Engineering and Bioengineering Mohammad Qasaimeh led the NYU Abu Dhabi research team. They had their work published in a paper in the journal Microsystems and Nanoengineering.

“Our goal is to contribute to improved diagnostics and help individuals with their health management, ultimately enhancing our ability to combat and control infectious diseases on a global scale,” said Imen Boumar, one of the first authors of the study and a former research ass…

The top IVD innovation news stories of 2023 — so far

[Image courtesy of the National Cancer Institute via Unsplash]This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space.

According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.

Here are five IVD innovation stories that have caught our attention so far this year:

5. Hologic wins FDA clearance for COVID-flu-RSV assay

Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Read the full story a…

Cue Health wins FDA de novo authorization for home COVID-19 test

The Cue Reader for the company’s COVID-19 test. [Image courtesy of Cue Health]Cue Health (Nasdaq:HLTH) announced that it received FDA de novo authorization for its Cue COVID-19 molecular test.

San Diego-based Cue Health designed the test for both home and point-of-care use. Its authorization marks the first such nod for a home-use COVID-19 test, the company said. It also represents the first de novo authorization for any home-use respiratory test, according to a news release.

Cue Health originally made its COVID-19 test available to consumers without a prescription in 2021. That availability came under the FDA’s emergency use authorization (EUA), a widely used pathway for COVID-19-related products.

The molecular test delivers results in just 20 minutes to connected mobile smart devices. It demonstrated overall accuracy of 98%, detecting all known COVID-19 variants of concern. The test also integrates into Cue Care, the company’s state-of-t…

Hologic wins FDA clearance for COVID-flu-RSV assay

Tge Panther Fusion SARS-CoV-2/Flu A/B/RSV assay [Image courtesy of Hologic]Hologic (Nasdaq: HOLX) + today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.

The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV.

“This past winter, we saw several respiratory illnesses — COVID, flu and RSV — spreading simultaneously throughout communities and often presenting with similar symptoms, making diagnoses difficult,” Hologic Diagnostic Solutions President Jennifer Schneiders said in a news release.

“While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the upcoming respiratory season, and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion system. This test will be a critical tool to help determine…

FDA’s mandatory medical device shortage reporting ends

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

Reporting of medical device shortages to the FDA is no longer mandatory with last week’s expiration of the COVID-19 public health emergency.

Manufacturers can still voluntarily report device production interruptions or permanent discontinuations to the FDA. Patients, healthcare providers, healthcare systems and other stakeholders can also notify the FDA of any supply chain disruptions they’re experiencing by emailing patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify the FDA by emailing [email protected].

“The FDA encourages device…