Omicron-specific mRNA vaccine elicited similar protection as original in early primate study 

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine.

In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine. 

The study involved a total of eight macaques who received two initial 100-μg doses of the mRNA-1273 vaccine. Nine months after the second dose, four primates received a dose of the existing vaccine, while the remaining four received the omicron-based version. 

The study authors performed a challenge test, exposing the non-human primates to the omicron variant to gauge their immune response. The researchers ultimately concluded that both…

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Sorrento says its oral COVID-19 main protease inhibitor candidate ‘strongly’ neutralizes omicron

Sorrento Therapeutics (NSDQ:SRNE) revealed that its late-stage preclinical main protease inhibitor STI-1558 inhibited omicron virus entry and replication in cell-based assays.

Prior research indicates that STI-1558 offers broad-spectrum activity against SARS-CoV-2.

STI-1558 is distinct from Pfizer’s SARS-CoV-2 drug Paxlovid (nirmatrelvir), which pairs the SARS-CoV-2-3CL protease inhibitor PF-07321332 with ritonavir, which works as a pharmacokinetic enhancer. Sorrento developed STI-1558 to offer optimized human liver microsomal stability to avoid the need for ritonavir.

The company anticipates that STI-1558 will thus have fewer issues with drug-drug interactions.

Sorrento also noted that STI-1558 inhibited pseudovirus entry into cells in an omicron S protein-mediated pseudovirus entry assay, whereas nirmatrelvir did not.

“With omicron becoming a globally dominant variant of SARS-CoV-2 in such a short period of time, we are focused on develop…

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Cannabinoids may protect against COVID-19 infection

Structural formula of cannabigerolic acid from Wikipedia

U.S. researchers have found that cannabinoid acids extracted from cannabis sativa prevented infection of human epithelial cells. They conclude cannabinoids may also have the potential to treat COVID-19.

Using a pseudovirus expressing the SARS-CoV-2 spike protein, the scientists found that cannabigerolic acid (CBGA) and cannabidiolic acid (CBDA) effectively blocked infection from the alpha (B.1.1.7) and beta (B.1.351) variants.

The researchers are affiliated with the Linus Pauling Institute in Corvallis, Oregon and Molecular Microbiology & Immunology in Portland, Oregon.

“These cannabinoid acids are abundant in hemp and in many hemp extracts,” Richard van Breemen, principal investigator at the Linus Pauling Institute, said. “They are not controlled substances like THC, the psychoactive ingredient in marijuana, and have a good safety pr…

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WHO concludes that updated COVID-19 vaccines may be needed

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 variant.

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

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Adagio Therapeutics’ stock slides after presenting negative Omicron data

Adagio Therapeutics (NSDQ:ADGI) saw its share price drop 82% to $6.85 in afternoon trading after releasing data reflecting a reduction in vitro neutralizing activity of ADG20 against the Omicron SARS-CoV-2 variant. 

ADG20, the company’s lead product candidate, is a neutralizing monoclonal antibody intended to potentially treat and prevent COVID-19. 

In vitro data from authentic and pseudovirus testing of the Omicron variant reflected a more than 300-fold reduction in neutralizing activity of the neutralizing antibody against Omicron.

The company is conducting further research. 

“Due to the highly conserved and immunorecessive nature of the epitope recognized by ADG20, we anticipated that ADG20 would retain neutralizing activity against Omicron, consistent with activity observed in in vitro models with all other known variants of concern,” said Tillman Gerngross, CEO of Adagio, in a press release. 

The latest data “show that the combination …

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GSK and Vir upbeat about efficacy of sotrovimab against Omicron

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant.

In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults and children.

Drawing on preclinical research, the two companies suggest that at least one dose of sotrovimab would protect against Omicron, which WHO has categorized as a variant of concern. The preclinical research involved pseudo-virus testing, including 37 mutations in the Omicron variant spike protein.

Formerly known as VIR-7831, sotrovimab is a monoclonal antibody.

The antibody is the first with “preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the sti…

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

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.

First, Carome argued that the drug appeared to have modest efficacy, offering a relative risk reduction against hospitalization or death of 30% through day 29 of the MK-4482-002 Phase 2/3 study.

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

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

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 don’t think the result would be the vaccines don’t protect,” Pfizer CEO Dr. Albert Bourla told CNBC. It is possible, however, that the vaccines could offer less protection against Omicron than other variants such as Delta.

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

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

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, which

“I don’t think the result would be the vaccines don’t protect,” Pfizer CEO Dr. Albert Bourla told CNBC. It is possible, however, that the vaccines could offer less protection against Omicron than other variants such as Delta.

“Given the large number of mutations, it is highly possible that the efficacy of the vaccine – all of them — is going down,” Stéphane Bancel, Moderna CEO, told CNBC.

If they decide it is necessary, Pfizer and its German partner BioNTech (NSDQ:BNTX) could develop a new vaccine based on Omicron in under 100 days.

Moderna has similar plans.

On November …

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Senator Markey pushes U.S. to develop universal COVID-19 vaccine

Image from www.edmarkey.com

Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine.

NIAID had awarded $36.3 million to academic institutions to conduct research that will help develop a coronavirus vaccine that protects against multiple types of coronaviruses.

Coronavirus outbreaks have resulted in three outbreaks in the past two decades. First, there was severe acute respiratory syndrome (SARS) from 2002 to 2004. Then, Middle East respiratory syndrome (MERS) appeared in 2012 and SARS-CoV-2 seven years later.

“Had a universal coronavirus vaccine existed at the onset of the pandemic, hundreds of thousands of American lives could have been saved,” wrote Senator Markey in a press release. “And we remain at risk of variants that have the pot…

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How an airway-on-a-chip model can help identify promising antivirals for COVID-19

One of the first focuses of organ-chip specialist Emulate (Boston) was to reduce the need for animal testing over time. Its technology can simulate tissue-tissue interfaces within organs using human cells.

But the potential of the organ chips to yield mechanistic insights for drug discovery and understanding toxicities has become more evident over time. 

The pandemic has underscored that promise, highlighting the potential of Emulate’s technology for drug discovery and vaccine testing. 

A spinout of the Wyss Institute for Biologically Inspired Engineering at Harvard University, Emulate’s human airway chip culture was highlighted earlier this year in Nature Biomedical Engineering. 

Created with microchip manufacturing techniques and microfluidic culture technology, Emulate’s organ chips contain living human cells that simulate organ-level functions. The organ chips can “recreate tissue-tissue interfaces, which is what defines an organ,” said Dr. D…

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VRBPAC panel votes in favor of Pfizer-BioNTech vaccine for 5- to 11-year-olds

FDA’s Vaccines and Related Biological Products Advisory Committee has endorsed the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine for children 5 to 11.

A total of 17 voted in that the vaccine’s benefits outweighed the risk in the age group.

VRBPAC member Dr. Michael Kurilla, the director of NIH’s Division of Clinical Innovation, abstained from voting.

Kurilla had advocated that children with a prior COVID-19 infection receive alternate dosing.

The committee based its conclusions on data from Pfizer, which found that two 10-µg doses of the vaccine were generally well tolerated and 90.7% effective against COVID-19. Pfizer also provided some immunobridging data.

Before the vaccine is available for children in this lower age group, FDA and CDC will need to issue formal recommendations concerning its use in children 5 to 11. There are roughly 28 million children in that age group in the U.S.

Several panelists said they were less wo…

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