A next-gen vaccine that could help end COVID-19 whack-a-mole 

COVID-19 is an emerging focus for EpicentRx, a private biotech focused on multiple immune-mediated disorders. The La Jolla, California–based company is developing a next-gen COVID vaccine for SARS-CoV-2 based on nucleocapsid rather than spike protein. 

The recombinant replication-competent adenoviral vaccine that expresses the SARS-CoV-2 nucleocapsid protein could be more resistant to COVID-19 variants. 

The real-world effectiveness of spike-protein-based COVID-19 vaccines has generally dipped since their integration as a wave of SARS-CoV-2 variants has emerged. 

But while the spike protein mutates frequently, nucleocapsid doesn’t.

“The RNA for the virus is wrapped around it,” said EpicentRx CEO Dr. Tony Reid. “If it mutates and alters its three-dimensional structure very much, the RNA will unwind, and the virus will be nonviable.” 

EpicentRx plans to work with partners to take a nucleocapsid-based next-gen CO…

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FDA re-authorizes Meridian Bioscience’s COVID-19 assay

Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test.

Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to delay marketing so it could modify the design to correctly detect the variant.

According to a news release, Meridian completed the development work and submitted an initial data set to the FDA to validate the performance of the redesigned assay in March, then completed additional clinical studies in order to garner re-authorization.

The company intends to begin shipping the product by the end of its fiscal fourth quarter on Sept. 30, 2022.

“There continues to be demand for fast, accurate detection of COVID-19 especially considering the high transmissibility of these …

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Fall 2022 COVID-19 vaccine candidate tracker

[Photo from Pexels]

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine. 

But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus. 

A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines. 

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

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Customizing textiles to design formfitting face masks

Image courtesy of MIT and Lavendar Tessmer

Researchers at the Massachusetts Institute of Technology have developed an active fiber and process that uses heat to activate face masks and conform to an individual’s face.

The COVID-19 pandemic has emphasized the importance of face masks that effectively seal around the nose and mouth. However, faces and their features vary and make standard one-size-fits-all face masks less effective.

Lavender Tessmer, who is a doctoral candidate in MIT’s Department of Architecture, created an active fiber and process that uses heat with specific knit textile architecture to activate a mask to conform to specific faces. It uses standard textile equipment and a new customization process that allows any manufacturer to create a customized mask.

Prior to the pandemic, Tessmer was working with associate professor Skylar Tibbits in the department of archite…

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Masimo’s SafetyNet monitoring reduced length of COVID-19 hospital stays, study says

The Masimo SafetyNet [Image from Masimo]Masimo (Nasdaq:MASI) announced that a two-part retrospective study demonstrated the impact of its SafetyNet monitoring system.

Irvine, California-based Masimo’s study, led by Dr. Hemali Patel and colleagues at the University of Colorado and UC Health (UCH) in Aurora, Colorado, evaluated the impact of remote patient monitoring of COVID-19 patients using SafetyNet on hospital length of stay. Results were published in Telemedicine and e-Health.

SafetyNet uses tetherless Masimo Radius PPG SET pulse oximetry and a smartphone app to transmit continuous, home-based patient monitoring data to hospital clinicians. According to a news release, the study demonstrated a significant association between briefer hospitalization and patients discharged with SafetyNet and without home oxygen.

The researchers concluded that “home telemonitoring after discharge for patients with COVID-19 may be a safe tool that may reduce th…

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FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines in young children 

Until recently, the Pfizer-BioNTech COVID-19 vaccine was available for all individuals 5 years of age and older, while the Moderna vaccine was authorized for individuals at least 18.

Now, the FDA has authorized the use of both vaccines in children from 6 months to four years old. In addition, the agency also agreed to allow the use of the Moderna vaccine in children aged 5 to 17.

“We know that many parents, caregivers and clinicians have been anxiously awaiting today’s authorizations,” said FDA Commissioner Dr. Robert M. Califf in a press briefing. “We’re acutely aware of the importance of having vaccines available for our youngest children. And as we’ve seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19 such as hospitalization and death.”

Califf went on to stress that robust data support the use of safety and effective…

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Pfizer to spend $120M to make COVID-19 oral treatment in U.S.

Pfizer (NYSE: PFE) announced today that it will invest $120 million into its Kalamazoo, Michigan facility to support U.S.-based production of its COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir).

The investment is expected to create more than 250 additional, high-skilled jobs at the Kalamazoo site.

The money will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir. Pfizer noted in a news release that results from its EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) study showed an 88% reduction in COVID-19-related hospitalization or death among adults treated with Paxlovid compared to placebo within five days of noticing symptoms.

“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” said Prizer CEO Dr. Albert Bo…

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Former SCWorx CEO indicted over alleged COVID-19 rapid tests scheme

The U.S. Dept. of Justice announced that Marc Schessel of SCWorx was indicted for charges related to an alleged COVID-19 test scheme.

Schessel, the former CEO of the New York-based company, was charged with two counts of securities fraud for his alleged participation in a scheme to mislead investors about SCWorx’s procurement of COVID-19 rapid test kits in the early stages of the COVID-19 pandemic.

Court documents alleged that Schessel caused SCWorx to issue multiple public statements claiming the company was buying and reselling at least 48 million COVID-19 test kits, despite knowing that such statements were false and misleading. In April 2020 — just a month after the COVID-19 pandemic took hold of the world — Schessel executed a supply agreement with an unnamed Australian company to obtain 2 million COVID-19 test kits per week for six months, starting on April 24, 2020.

The agreement was made based on an understanding that SCWorx had FDA’s…

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Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

[Photo by Eugene Chystiakov]Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data supports a third dose of their COVID-19 vaccine in young children.

Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and a favorable safety profile similar to placebo in children aged six months to under five years old.

Get the full story at our sister site, Pharmaceutical Processing World.

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FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

While “COVID-19 tends to be less severe in children than adults,” Califf noted that the omicron wave has resulted in more children getting infected and hospitalized with COVID-19 infections. “Children may also experience longer-term effects, even following initially mild disease,” he added.

The FDA has determined that vaccine effectiveness in all authorized populations wanes in the weeks and months following administration of a second dose.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID…

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FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV

The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription.

Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA.

Users can self-collect a nasal swab sample at home and send it to Labcorp for testing. It can identify and differentiate influenza A and B (the flu), respiratory syncytial virus (RSV) and SARS-CoV-2, the virus causing COVID-19. Results are delivered through an online portal, with healthcare provider follow-up for positive or invalid test results.

Samples can be self-collected by individuals 18 years and older on their own, by those 14 and older with adult supervision, or with adult assistance for individuals aged two years and older.

“While the FD…

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AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2.

“Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases,” said Hugo Fry, a former Sanofi executive who is CEO of RQ Bio.

“By combining our expertise and innovative excellence in core areas, we have created a smarter approach to antibody generation, making us uniquely positioned to deliver fast patient impact,” Fry said in a news release.

The agreement gives AstraZeneca an exclusive worldwide license to develop, manufacture and commercialize mAbs against SARS-CoV-2.

“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patien…

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