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SARS-CoV-2

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

June 30, 2022 By Brian Buntz

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 […]

Filed Under: Blog, Pharmaceutical Tagged With: COVID-19 boosters, COVID-19 vaccines, Omicron, SARS-CoV-2

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

April 19, 2022 By Brian Buntz

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. […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, Moderna, mRNA-1273.211, SARS-CoV-2, variants of concern

WHO concludes that updated COVID-19 vaccines may be needed

January 11, 2022 By Brian Buntz

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary. Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron […]

Filed Under: Featured, Pharmaceutical Tagged With: coronavirus, Moderna, Pfizer, SARS-CoV-2

Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir

November 30, 2021 By Brian Buntz

Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir. If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting. […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: COVID-19, Merck, molnupiravir, SARS-CoV-2

Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant

November 29, 2021 By Brian Buntz

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I […]

Filed Under: Featured, News Well, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, Moderna, Omicron, Pfizer, SARS-CoV-2

Antivirals could be a vital weapon in the COVID-19 pandemic endgame

October 6, 2021 By Brian Buntz

Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could […]

Filed Under: Featured, Pharmaceutical Tagged With: antivirals, coronavirus, COVID-19, SARS-CoV-2

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

March 23, 2021 By Sean Whooley

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 in a  small number of sequential test strips in certain […]

Filed Under: Diagnostics, Featured, Genomics/Molecular Diagnostics, Recalls, Regulatory/Compliance Tagged With: coronavirus, COVID-19, LumiraDX, SARS-CoV-2

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

March 19, 2021 By Brian Buntz

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 […]

Filed Under: Pharmaceutical Tagged With: coronavirus, COVID-19, SARS-CoV-2

COVID-19’s origins remain murky one year later

March 10, 2021 By Brian Buntz

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 […]

Filed Under: Business/Financial News, Featured, Research & Development Tagged With: COVID-19, SARS-CoV-2

Ivermectin not supported for mild COVID-19, study says

March 4, 2021 By Brian Buntz

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 […]

Filed Under: Blog Tagged With: coronavirus, COVID-19, ivermectin, SARS-CoV-2

South Africa pauses rollout of AstraZeneca COVID-19 vaccine

February 8, 2021 By Brian Buntz

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 […]

Filed Under: Pharmaceutical Tagged With: AstraZeneca plc, B.1.351, coronavirus, COVID-19, COVID-19 vaccine, Johnson & Johnson, Oxford University, SARS-CoV-2, South Africa

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