SARS-CoV-2 Archives - Page 5 of 5 - Medical Design Sourcing

Johnson & Johnson to test COVID-19 vaccine in adolescents

Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in a study involving 12-to-15 year-olds. FDA has already authorized its vaccine for patients 16 or older.

Moderna (NSDQ:MRNA) announced plans to launch a Phase 2/3 study known as TeenCove that will test its COVID-19 vaccine in adolescents aged 12 to 18.

Johnson & Johnson’s recent announcement shared its plans to extend its randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to adolescents.

The study had previously intended to evaluate the reactogenicity and immunogenicity of its Ad26.COV2.S vaccine after administering it in a vari…

GSK and Vir Biotechnology seek EUA for COVID-19 monoclonal antibody

GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody.

VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells.

VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for patients 12 or older who weigh at least 40 kg who have a high risk of hospitalization or death from COVID-19.

One notable example of a monoclonal antibody that has won such an EUA from the FDA is Lilly’s bamlanivimab, which is intended to be used soon after a positive COVID-19 test result is obtained but is contraindicated for patients who are hospitalized COVID-19 infections.

Compared with bamlanivimab, VIR-7831 may offer more resistance to SARS-CoV-2 variants based on preclinical data and a preprint study published in BioRxiv.

The U.S. government recently stopped…

Forthcoming WHO report could provide multiple theories of COVID-19 pandemic’s origins

[Image courtesy of World Health Organization]

The World Health Organization has a leading theory regarding the origins of the COVID-19 pandemic but is considering three others in a forthcoming report, according to a recent AP article.

The most likely scenario is that the virus, which many scientists believe first appeared in bats, infected humans through an intermediary animal. Less likely is that bats infected humans directly.

The report also considers the possibility that the vaccine could have initially spread through contaminated frozen food products. The least likely scenario, although still possible, is that a laboratory such as the Wuhan Institute of Virology seeded the pandemic through an accident.

Shi Zhengli, who directs the Center for Emerging Infectious Diseases at the Wuhan Institute of Virology, has denied that the lab was the source of the SARS-CoV-2 pandemic. She also co-authore…

Pfizer launches trial for novel oral COVID-19 therapeutic

An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults.

Known as PF-07321332, the drug has shown promise in in vitro studies against SARS-CoV-2.

PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to a viral enzyme known as protease to stop viral replication.

Pfizer believes PF-07321332 to be the first orally-administered SARS-CoV-2-specific investigational protease inhibitor to be studied in a clinical trial.

Pfizer is also researching an intravenous protease inhibitor, PF-07304814, for hospitalized COVID-19 patients in a Phase 1b trial.

The most recent trial involving the oral antiviral candidate PF-07321332 will administer multiple ascending doses to evaluate the drug’s safety and tolerability.

Pfizer says the antiviral also has potential in battling other coronaviruses in addition…

LumiraDx warns on false-positives with SARS-CoV-2 antigen test

LumiraDx issued an urgent device recall regarding a software update for its SARS-CoV-2 antigen test.

The company received a customer complaint regarding a suspected false-positive result with the antigen test on Dec. 29, 2020. An investigation into the complaint identified a manufacturing issue that resulted ina. small number of sequential test strips in certain batches having the potential to produce false-positives.

LumiraDx determined that approximately 1% of test strips are affected within 24 lots that were distributed in Europe. No reports of patient harm were presented to the company in relation to the issue.

The company identified the root cause of the issue and immediately implemented changes to its manufacturing process and updated its QC release and test procedures to reflect such changes.

In order to continue testing with the LumiraDx SARS-CoV-2 Ag test, users must install software version 1.21 immediately, as the software identifies th…

U.S. government classifies threat levels of SARS-CoV-2 variants

Image courtesy of Wikipedia

The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them.

The criteria divide variants into three categories including the following:

Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples include mutations that could change how the virus enters cells and responds to antibodies from vaccination or infection. Such a virus could also potentially enhance transmissibility or disease severity. Variant of concern: This class includes variants with evidence of increased transmissibility, severe disease or reduction in neutralization by antibodies from infection or vaccination. Such a variant may also pose a higher risk of eluding testing. See the table below for examples. Variant of high consequence: This category poses the most significant risk. A variant…

COVID-19’s origins remain murky one year later

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]More than a year after it became a pandemic, the source of the COVID-19 pandemic remains a mystery.

The World Health Organization (WHO) is working on formulating a likely narrative of how the virus first infected humans, but some scientists are pressing for an independent investigation.

An open letter from 26 scientists published by The Wall Street Journal concluded that it is “all but impossible” for the WHO researchers to uncover the virus’s origins given their perceived lack of access to substantive data.

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

Ivermectin not supported for mild COVID-19, study says

Ivermectin image courtesy of Wikipedia.

The antiparasitic drug ivermectin does not appear to be an efficacious COVID-19 treatment for mild COVID-19 cases, based on a randomized study recently published in JAMA.

Ivermectin — which is widely used in veterinary medicine to get rid of worms and other parasites— emerged as a potential COVID-19 treatment, owing to its ability to inhibit replication of the SARS-CoV-2 drugin in vitro and animal studies.

Similar research elevated hydroxychloroquine as a potential COVID-19 therapeutic agent, but the drug also has disappointed in human studies. The World Health Organization now cautions against its use as a COVID-19 treatment.

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

EU and US take steps to battle coronavirus mutations

Electron microscopic image from the first confirmed case of SARS-CoV-2 in the U.S. Image from CDC.

The EU recently added clauses to COVID-19 vaccine contracts to prioritize vaccines that are effective against emerging SARS-CoV-2 variants.

Meanwhile, a U.S. House bill that would provide $1.75 billion for genomic sequencing of coronavirus samples is scheduled for floor debate and the Senate is considering similar legislation.

The UK variant (B.1.1.7) that is spreading across Europe and the U.S. is more infectious and possibly more dangerous than earlier strains and could become dominant in the U.S. by March, according to CDC projections. Even more potentially threatening are the South Africa (B.1.351) and Brazil (P.1) variants, which are also spreading in both regions.

The U.K. helped the world understand the threat of B.1.1.7 with its sizable genomic sequencing apparatus. The country has sequenc…

South Africa pauses rollout of AstraZeneca COVID-19 vaccine

South Africa has scrapped its plans to vaccinate a portion of its population with the COVID-19 vaccine from Oxford University and AstraZeneca (LON:AZN) after a small study showed it was ineffective against a variant widely circulating there.

In the interim, South Africa will rely on vaccines from Johnson & Johnson (NYSE:JNJ) and Pfizer (NYSE:PFE).

Researchers at Oxford University and the University of the Witwatersrand in South Africa found the AstraZeneca vaccine to offer little to no protection against mild-to-moderate disease. The research has not been peer-reviewed.

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