Biotech Sector's Response to Omicron Panic Should be Swift and Effective

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Dec 07, 2021, 09:45 ET

VANCOUVER, BC, Dec. 7, 2021 /PRNewswire/ -- USA News Group - Despite a level of panic that JP Morgan has already downplayed in its 2022 forecasts, the market's reaction to the latest COVID-19 variant scare (omicron) has been swift. A multitude of reactionary strategies have begun to swirl, including injecting more boosters from the original vaccine, or fast-tracking newly revamped vaccines. As COVID researchers rush to learn about the new variant, the biotech sector is responding in kind, with new developments already underway from companies such as BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), Moderna, Inc. (NASDAQ: MRNA), BioNTech SE (NASDAQ: BNTX), and Pfizer, Inc. (NYSE: PFE), as well as Novavax, Inc. (NASDAQ: NVAX).

In the case of clinical-stage immunotherapy developers BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), the company recently announced it has entered into a major sponsored research collaboration with Ohio State University to further develop BioVaxys' haptenized viral antigen platform to create a broadly reactive pan-sarbecovirus vaccine.

"The repeated emergence of SARS-CoV-2 variants and the potential for new coronaviruses increases the urgency for a universal vaccine," said Kenneth Kovan, President and Chief Operating Officer of BioVaxys. "Research suggests that a pan-sarbecovirus vaccine could potentially prevent additional emergent variants and help end the Covid-19 pandemic."

Sarbecoviruses are a subset of the Coronaviridae family, which includes the emerging SARS2 variants Delta and Omicron. Sarbecoviruses are responsible for at least two pandemics in the last 20 years, including SARS-CoV-1 (SARS1) in 2003 and the current Covid-19 pandemic. Additional SARS-like viruses are continuously being found in nature reservoirs.

This is the second research collaboration that leading global academic research institute OSU has made with BioVaxys in the SARS-CoV-2 field. The collaboration will leverage BioVaxys' proprietary haptenized viral antigen platform to create a broadly reactive pan-sarbecovirus vaccine composed of hapten-modified S-spike protein from SARS-CoV-2 and a hapten-modified S-protein from SARS-CoV-1.

BioVaxys recently filed a patent application for its haptenized viral antigen vaccine platform to elicit a broad cross-reactive immune response against most or all sarbecoviruses.

Beyond its work with vaccines, BioVaxys has also been developing a new test called CoviDTH that screens for a T cell-mediated immune response to SARS-CoV-2 along with WuXi Biologics—a $63-billion Chinese biomanufacturing partner.

The test is based on Delayed-Type Hypersensitivity ("DTH") technology, and is the world's first low cost, disposable, diagnostic to identify a T-cell immune response to the presence of SARS-CoV-2. So far, data suggests DTH testing may even be more accurate than current methods, by measuring the immune system's active infection response.

OSU will conduct animal studies with BVX-0320, BioVaxys' haptenized SARS-CoV-2 S1 protein vaccine and a new haptenized SARS-CoV-1 S1 protein vaccine from BioVaxys. Initial data are expected by Spring 2022.

Also in early 2022, Moderna, Inc. (NASDAQ: MRNA) is stating that its Omicron COVID-19 vaccine could be ready to go, if it is needed.

"The remarkable thing about the mRNA vaccines, Moderna platform is we can move very fast," said Moderna's Chief Medical Officer, Dr. Paul Burton, in an interview with the BBC.

According to Burton, Moderna should know whether their current COVID-19 vaccine can provide protection against Omicron in the "next couple weeks." However, he suspects that Omicron may escape that protection given the 30 mutations of the variant — nine of which are known to be "associated with immune escape."

In the meantime, Moderna recently announced a supply agreement with the UK for an additional 60 million doses of its current vaccine, with 29 million doses in 2022, and 31 million doses in 2023.

"We thank the UK government for their support in this supply agreement for our mRNA COVID-19 vaccine and booster candidates, if approved, in 2022 and 2023," said Stéphane Bancel, Moderna's Chief Executive Officer. "This agreement reflects the efforts of the UK government to address the ongoing pandemic and builds on our existing collaboration to protect people in the UK."

BioNTech SE (NASDAQ: BNTX) CEO Ugur Sahin told Reuters that his company should be able to adapt its coronavirus vaccine relatively quickly—and that over the next few weeks we'll see how urgently such an upgrade is needed.

"I believe in principle at a certain timepoint we will need a new vaccine against this new variant," said Sahin. "The question is how urgent it needs to be available. We anticipate that infected people who have been vaccinated will still be protected against severe disease."

According to Sahin, a product relaunch could be achieved within approximately 100 days, and that a redesign is currently underway. Any confirmation of protection from the existing shot could buy developers such as BioNTech SE and partners Pfizer, Inc. (NYSE: PFE) some time for a more measured approach.

Pfizer expects its vaccine to hold up to Omicron, according to Ralf Rene Reinert, Vice President of Vaccines for International Developed Markets.

"We don't expect that there will be a significant drop in effectiveness," said Reinert in an interview with Bloomberg Television. "But again, this is speculation. We will check this. We will have the data in the next couple of weeks."

Pfizer recently released follow-up data from its Phase 3 trial of its Pfizer-BioNTech COVID-19 vaccine support safety and high efficacy in adolescents 12-15 years of age.

"As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine's safety and effectiveness profile in adolescents. This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We look forward to sharing these data with the FDA and other regulators."

Perhaps ahead of the Spring or early 2022 dates put forth by other groups, Novavax, Inc. (NASDAQ: NVAX) could potentially have an Omicron-specific COVID vaccine ready by January—which unlike Pfizer/BioNTech and Moderna isn't an mRNA vaccine, but is built through a protein subunit vaccine, which involves engineering host cells (in this case cells from a moth) to produce large quantities of the SARS-CoV-2 spike protein. These proteins are then harvested and shaped into a structure that resembles a coronavirus.

"The initial steps required to manufacture an Omicron-specific spike are underway and GMP manufacturing in a commercial facility is anticipated in January 2022," said Novavax in a company statement. "Lab-based assessment of a new strain-matched nanoparticle vaccine will begin within a few weeks."

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