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.

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VRBPAC backs adding omicron-component to COVID-19 boosters

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted today to recommend the use of variant-specific boosters.

Out of 21 voting members, 19 supported the use of a SARS-CoV-2 omicron component for COVID-19 booster vaccines.

“I want to be clear that this doesn’t mean that we are saying that there will be boosters recommended for everyone in the fall, but my belief is that this gives us the right vaccine in preparation for the potential need for boosters in the fall,” said VRBPAC member Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases at CDC.

“Over the coming months, I think we’ll get a sense, and there’ll be plenty of time for debate over who is most appropriate for boosters,” said CBER director Dr. Peter Marks.

Omicron and its subvariants such as BA.2, BA.4 and BA.4 continue to drive the bulk of COVID-19 infections.

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Sanofi-GSK COVID-19 vaccine effective against omicron

GSK plc (LSE/NYSE:GSK) and Sanofi (NYSE:GSK) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study.

For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron.

The vaccine is based on the original D614 virus and the beta (B.1.351) strain.

Across variants, the vaccine was 64.7% efficacious against symptomatic infection in adults. For those previously infected with COVID-19, the vaccine was 75.1% efficacious overall.

GSK and Sanofi noted that the vaccine candidate appeared to be well-tolerated.

Moderna (Nasdaq:MRNA) is developing a bivalent omicron booster vaccine candidate known as mRNA-1273.214.

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) have released minimal data to date on their next-generation COVID-19 vaccine.

Sanofi’s and GSK’s Phase 3 COVID-19 clinical trial, dubbed VAT08, enrolled more …

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Pfizer’s COVID-19 antiviral disappoints as post-exposure prophylactic 

Pfizer (NYSE:PFE) announced that its COVID-19 antiviral Paxlovid failed to reach statistical significance in reducing risk after patients were exposed to the SARS-CoV-2 virus.

The primary endpoint of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study was to reduce the risk of confirmed and symptomatic COVID-19 in adults after exposure to a household contact.

Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) led to risk reductions of 32% at day five of therapy. That figure climbed to 37% at day ten of treatment.

The study was completed during the omicron wave.

The emergency use authorization for the drug calls for the drug to be administered twice daily for five days.

Paxlovid appeared to be well tolerated across the EPIC-PEP study and the related EPIC-HR and EPIC-SR trials. In addition, Pfizer noted that the post-market safety data were also encouraging.

The st…

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

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.

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UK regulators approve Valneva’s COVID-19 vaccine

A COVID-19 vaccine from the French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has become the sixth to win regulatory approval in the United Kingdom.

Valneva also anticipated that it would receive the regulatory nod from the European Medicines Agency (EMA) for its COVID-19 vaccine in April.

Officials at the ​​Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have already approved COVID-19 vaccines from Moderna, AstraZeneca, Janssen and Novavax vaccines. The latter two are, however, not currently in use in the UK.

Valneva vaccine vials

MHRA is the first regulatory agency to approve the Valneva vaccine, an inactivated whole-virus vaccine.

MHRA indicated that the vaccine design may spur a more comprehensive immune response than vaccines solely targeting the SARS-CoV-2 spike protein.

The Valneva vaccine is also stable when stored at standard refrige…

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People who don’t get COVID-19 could provide clues for next-gen vaccines

SARS-CoV-2 image courtesy of Wikimedia Commons

A controversial SARS-CoV-2 challenge study involving 36 volunteers found that 47% of individuals did not develop COVID-19. The volunteers were unvaccinated and had no evidence of prior infection with SARS-CoV-2.

The study, whose results were recently published in a pre-print, could potentially point to new vaccine targets or inspire future COVID-19 drug research.

“This study has already generated intriguing insights into the timeline of infection, particularly in the early phase,” said Dr. Doug Brown, chief executive of the British Society for Immunology, in a statement. “In the longer term, the hope is that these findings will now open up a new research avenue to develop a platform that will allow us to speed up the development of new vaccines, antivirals and diagnostics against COVID-19.”

There are a variety of potential explanations why the volu…

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Pardes Biosciences shares interim Phase 1 data on oral COVID-19 antiviral

Pardes Biosciences (NSDQ:PRDS) said its PBI-0451 twice-daily COVID-19 pill candidate had favorable tolerability and good oral bioavailability, based on interim data from an ongoing Phase 1 trial.

The company also said the drug candidate lacked clinically significant drug-drug interactions.

PRDS shares ticked down 8.70% to $10.29 today.

“We’re very encouraged by the safety profile and bioavailability profile we’re seeing to date,” said Brian Kearney, chief development officer at Pardes Bio, in an investor call.

Pardes Biosciences also noted that, in the interim results, PBI-0451 administered twice-daily maintained pharmacokinetics exposures anticipated to deliver strong antiviral activity against SARS-CoV-2.

The company plans on launching a Phase 2/3 study in the middle of 2022.

At present, two oral antivirals have won emergency use authorization (EUA) in the U.S.

FDA authorized Paxlovid from Pfizer (NYS…

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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.

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