COVID-19 vaccines Archives - Medical Design Sourcing

Moderna and Pfizer ready updated COVID-19 boosters to combat BA.2.86 and other emerging variants

[Image courtesy of Production Perig/Adobe Stock]

Against the backdrop of a nearly 16% spike in COVID-19 hospitalizations in late August, according to CDC data, federal authorities are gearing up to greenlight updated boosters. Moderna announced that its latest COVID vaccine is effective against this new strain. Meanwhile, Pfizer revealed positive preclinical data for its vaccine, developed in collaboration with BioNTech.

In late August, Novavax also announced that its updated protein-based XBB COVID vaccine candidate retained neutralizing antibody responses to several emerging subvariants, including EG.5.1 and XBB.1.16.6. Unlike the mRNA-based boosters from Pfizer and Moderna, Novavax’s COVID vaccine would be the sole protein-based non-mRNA vaccine option available for the upcoming fall season.

The following visualization, based on CDC data, highlights the top SARS-CoV-2 variants for August and Sept…

Pfizer and Moderna tout preliminary data in battle against Eris SARS-CoV-2 subvariant

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COVID-19 vaccine giants Pfizer and Moderna are gearing up for a battle against the Eris SARS-CoV-2 subvariant, which has rapidly emerged as the dominant strain in the U.S. Eris now is responsible for more than one in five COVID infections, based on CDC estimates from August 6 to 19.

Pfizer has noted that its most recent COVID-19 shot, which it is testing against emerging variants, demonstrated neutralizing activity against the “Eris”in a mouse study. The company said it is keeping a close watch on the variant and is ready to produce “variant-modified vaccine templates” if needed. Pfizer intends to launch its updated vaccine commercially by the end of August, pending regulatory approval.

Moderna has also announced positive preliminary testing of its latest vaccine shot against the Eris SARS-CoV-2 subvariant. The company indicates that preliminary clinical trial data demonstra…

Codagenix taps synthetic biology and machine learning in vaccine development

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In the quest to outsmart viral foes such as SARS-CoV-2, RSV and influenza, Codagenix, a clinical-stage biotech firm based in Farmingdale, New York, has engaged a unique arsenal: the intersection of synthetic biology and machine learning. Their weapon of choice is a blend of live-attenuated virus design and codon deoptimization technology. Their process involves introducing mutations or ‘bad codons’ into the virus to slow its replication rate in the human host, thus converting it from a deadly pathogen into a live attenuated vaccine.

A machine learning-aided algorithm meticulously guides this process, ensuring the modifications are safe and effective. “We recode the DNA of a virus to slow down the rate of translation in the human host cell,” said J. Robert Coleman, the co-founder and CEO of Codagenix.

All viruses use the body to replicate t…

The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

Inhaled COVID-19 vaccines making inroads in China, India and Russia

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]

The idea of inhalable COVID-19 vaccines may not be new, but, until recently, no country had approved a COVID-19 vaccine with an alternative delivery route.

That changed on March 31, 2022, when Russia greenlit the Galaleya Institute’s Sputnik V inhaled vaccine. The country authorized a similar nasal-drop-based vaccine known as Salnavac on July 4, 2022.

To authorize those vaccines, Russian regulators weighed data from the formerly approved Sputnik V vaccine in conjunction with Phase 1/2 safety and immunogenicity data from the intranasal versions of that vaccine.

More recently, China authorized the inhalable Convidecia Air COVID-19 vaccine from CanS…

Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

Startup licenses Harvard tech to develop ultra-sensitive COVID antibody assay

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]

New startup Spear Bio plans to commercialize ultrasensitive protein-detection technology from Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Boston-based Spear Bio licensed the DNA nanotechnology-driven Successive Proximity Extension Amplification Reaction (SPEAR) in a worldwide exclusive agreement with Harvard’s Office of Technology Development.

Spear Bio will develop a reagent-based platform for ultrasensitive protein detection in small-volume samples with an initial focus on research-use-only applications, Harvard said in a news release.

RELATED: Here’s where Harvard’s engineering dean sees medtech research going Read more

U.S. government plans to stop paying for COVID-19 vaccines

[Pfizer-BioNTech vaccine image courtesy of Wikimedia Commons.]

The Biden administration is in the process of transferring responsibility for COVID-19 vaccines to the healthcare industry, according to media reports.

To date, the federal government has footed the bill for the shots, but the Trump and Biden administrations have intended to eventually cease that practice as the pandemic shifts to an endemic phase.

Confirmed COVID-19 cases are declining steadily, reaching levels not seen since mid-May.

HHS has scheduled a planning session dedicated to COVID-19 drug payments. The agency will invite representatives from pharma companies, pharmacies and state health departments to the meeting. The meeting will cover regulatory matters and treatment for uninsured patients.

The transition to shifting financial liability for COVID-19 therapies to the private sector could take months, according to …

FDA issues new COVID-19 testing guidance to avoid false negatives

New at-home COVID-19 antigen testing guidance recommends repeat testing after a negative result. [Image courtesy of Abbott]

COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers.

The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies from people likely infected by the omicron variant shows repeat testing increases the chance of an accurate result, reducing the likelihood of spreading the virus.

“At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19,” the FDA said yesterday. “At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polym…

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.

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 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.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

Will COVID-19 vaccines be updated by fall?

Photo by Frank Meriño from Pexels

FDA advisors are slated to meet to discuss the prospect of updating the first generation of COVID-19 vaccines for use as boosters this fall and winter.

But it remains unclear whether updating the COVID-19 vaccines will be necessary. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) have updated vaccines in the works.

Pfizer and Moderna have both said their next-generation vaccines appear to be more effective against the omicron BA.1 variant. But fighting the growing number of omicron lineages could prove challenging. For example, the recent emergence of BA.4 and BA.5 subvariants threatens those infected with older omicron variants.

Pfizer noted in a press release that it was developing monovalent and bivalent versions of its COVID-19 vaccine, developed jointly with BioNTech. Protection appeared to be substantially stronger against the BA.1 subvariant than the BA…