SARS-CoV-2 Archives - Medical Design Sourcing

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…

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…

Two new SARS-CoV-2 antibodies could neutralize COVID-19 strains with high efficacy

This scanning electron microscope image shows SARS-CoV-2 in yellow. [Image courtesy of NIAID RML]

Researchers at Tel Aviv University have identified two monoclonal antibodies that are broadly effective against SARS-CoV-2 variants.

The researchers investigated the activity of nine anti-SARS-CoV-2 monoclonal antibodies (mAbs) against several variants of concern, including alpha, beta, gamma, delta and omicron.

The scientists at the Tel Aviv University’s Sackler Faculty of Medicine suspect that the antibodies may reduce the future need for regular boosters.

The research was published in Communications Biology.

Natalia Freund and doctoral students Michael Mor and Ruofan Lee at Tel Aviv University led the research in collaboration with Ben Croker of the University of California at San Diego. Other research partners included Ye Xiang, a professor at Tsinghua University in Beijing and professors Me…

FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

[Photo from Pexels]The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

Get the full story from our sister site, Drug Discovery & Development.

VRBPAC backs adding omicron-component to COVID-19 boosters

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted today to recommend the use of variant-specific boosters.

Out of 21 voting members, 19 supported the use of a SARS-CoV-2 omicron component for COVID-19 booster vaccines.

“I want to be clear that this doesn’t mean that we are saying that there will be boosters recommended for everyone in the fall, but my belief is that this gives us the right vaccine in preparation for the potential need for boosters in the fall,” said VRBPAC member Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases at CDC.

“Over the coming months, I think we’ll get a sense, and there’ll be plenty of time for debate over who is most appropriate for boosters,” said CBER director Dr. Peter Marks.

Omicron and its subvariants such as BA.2, BA.4 and BA.4 continue to drive the bulk of COVID-19 infections.

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Sanofi-GSK COVID-19 vaccine effective against omicron

GSK plc (LSE/NYSE:GSK) and Sanofi (NYSE:GSK) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study.

For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron.

The vaccine is based on the original D614 virus and the beta (B.1.351) strain.

Across variants, the vaccine was 64.7% efficacious against symptomatic infection in adults. For those previously infected with COVID-19, the vaccine was 75.1% efficacious overall.

GSK and Sanofi noted that the vaccine candidate appeared to be well-tolerated.

Moderna (Nasdaq:MRNA) is developing a bivalent omicron booster vaccine candidate known as mRNA-1273.214.

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) have released minimal data to date on their next-generation COVID-19 vaccine.

Sanofi’s and GSK’s Phase 3 COVID-19 clinical trial, dubbed VAT08, enrolled more …

Pfizer’s COVID-19 antiviral disappoints as post-exposure prophylactic

Pfizer (NYSE:PFE) announced that its COVID-19 antiviral Paxlovid failed to reach statistical significance in reducing risk after patients were exposed to the SARS-CoV-2 virus.

The primary endpoint of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study was to reduce the risk of confirmed and symptomatic COVID-19 in adults after exposure to a household contact.

Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) led to risk reductions of 32% at day five of therapy. That figure climbed to 37% at day ten of treatment.

The study was completed during the omicron wave.

The emergency use authorization for the drug calls for the drug to be administered twice daily for five days.

Paxlovid appeared to be well tolerated across the EPIC-PEP study and the related EPIC-HR and EPIC-SR trials. In addition, Pfizer noted that the post-market safety data were also encouraging.

The st…

Moderna says bivalent COVID-19 boosters could offer more robust protection against variants

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine.

A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.

Get the full story from our sister site, Drug Discovery & Development.

UK regulators approve Valneva’s COVID-19 vaccine

A COVID-19 vaccine from the French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has become the sixth to win regulatory approval in the United Kingdom.

Valneva also anticipated that it would receive the regulatory nod from the European Medicines Agency (EMA) for its COVID-19 vaccine in April.

Officials at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have already approved COVID-19 vaccines from Moderna, AstraZeneca, Janssen and Novavax vaccines. The latter two are, however, not currently in use in the UK.

Valneva vaccine vials

MHRA is the first regulatory agency to approve the Valneva vaccine, an inactivated whole-virus vaccine.

MHRA indicated that the vaccine design may spur a more comprehensive immune response than vaccines solely targeting the SARS-CoV-2 spike protein.

The Valneva vaccine is also stable when stored at standard refrige…

People who don’t get COVID-19 could provide clues for next-gen vaccines

SARS-CoV-2 image courtesy of Wikimedia Commons

A controversial SARS-CoV-2 challenge study involving 36 volunteers found that 47% of individuals did not develop COVID-19. The volunteers were unvaccinated and had no evidence of prior infection with SARS-CoV-2.

The study, whose results were recently published in a pre-print, could potentially point to new vaccine targets or inspire future COVID-19 drug research.

“This study has already generated intriguing insights into the timeline of infection, particularly in the early phase,” said Dr. Doug Brown, chief executive of the British Society for Immunology, in a statement. “In the longer term, the hope is that these findings will now open up a new research avenue to develop a platform that will allow us to speed up the development of new vaccines, antivirals and diagnostics against COVID-19.”

There are a variety of potential explanations why the volu…

Pardes Biosciences shares interim Phase 1 data on oral COVID-19 antiviral

Pardes Biosciences (NSDQ:PRDS) said its PBI-0451 twice-daily COVID-19 pill candidate had favorable tolerability and good oral bioavailability, based on interim data from an ongoing Phase 1 trial.

The company also said the drug candidate lacked clinically significant drug-drug interactions.

PRDS shares ticked down 8.70% to $10.29 today.

“We’re very encouraged by the safety profile and bioavailability profile we’re seeing to date,” said Brian Kearney, chief development officer at Pardes Bio, in an investor call.

Pardes Biosciences also noted that, in the interim results, PBI-0451 administered twice-daily maintained pharmacokinetics exposures anticipated to deliver strong antiviral activity against SARS-CoV-2.

The company plans on launching a Phase 2/3 study in the middle of 2022.

At present, two oral antivirals have won emergency use authorization (EUA) in the U.S.

FDA authorized Paxlovid from Pfizer (NYS…