Ineffectiveness Against Omicron Driving Development of Universal and Variant-Proof Vaccines

Ineffectiveness Against Omicron Driving Development of Universal and Variant-Proof Vaccines

Biotech Insider – Despite early reports of a ‘significant increase’ in protection from mRNA against Omicron, calls for an Omicron-specific are ramping up, while there’s even more demand for a universal vaccine that’s variant proof. Beyond the currently authorized vaccines available, there’s been plenty of development in new vaccines that could make a difference in the time ahead when the next variant emerges, including from BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF), GlaxoSmithKline plc (NYSE:GSK), Sanofi (NASDAQ:SNY), Novavax, Inc. (NASDAQ:NVAX), and AstraZeneca PLC (NASDAQ:AZN).

A collaboration between The Ohio State University and clinical stage biotech company BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF) has begun bioproduction of the newly developed vaccine BVX-1021.

The vaccine has been designed for the strain of coronavirus that causes Severe Acute Respiratory Syndrome ("SARS1"), the respiratory illness responsible for the deadly 2002–2004 pandemic. It’s all part of BioVaxys’ novel approach for a universal vaccine that can treat a broad range of sarbecoviruses—aka a pan-sarbecovirus vaccine. There are no vaccines currently approved for SARS1.

"Scientists have observed that people who survived the 2002-03 SARS pandemic and then were administered a Covid-19 vaccine developed antibodies that cross-reacted with all of the sarbecoviruses that they tested,” said Dr. David Berd, Chief Medical Officer of Biovaxys. “That observation suggested to us that a similar pan-sarbecovirus immune response could be generated by immunizing with haptenized spike protein from SARS1 and SARS-Cov-2, i.e., our BVX-0320 and BVX-1021 products."

BVX-1021 is a hapten-modified recombinant S-protein from SARS-CoV-1. Another BioVaxys vaccine candidate is BVX-0320, a Covid-19 vaccine that’s made with a hapten-modified recombinant S-spike protein from SARS-CoV-2, the virus which causes Covid-19.

A hapten is a small molecule that stimulates an immune response when conjugated with a protein such as a virus surface antigen, but lacks antigenicity of its own.

The concept of haptenization comes from the work of immunologist and Nobel laureate Dr. Karl Landsteiner. Today, BioVaxys uses this process which “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, to stimulate a more intense immune response. Previous studies conducted by BioVaxys in mice showed how haptenized SARS-CoV-2 spike protein elicits both, robust T cell and antibody response.

"The Covid-19 market is shifting to vaccines that will not only protect against emerging variants of SARS-CoV-2, but also for any related coronaviruses that likely may arise in the future,” said Kenneth Kovan, President & COO of BioVaxys. “BVX-1021 demonstrates that we can leverage our technology platform to create novel hapten-viral antigen vaccines to target additional markets."

BioVaxys intends to develop BVX-1021 as a standalone "booster" targeting anyone who has been immunized with a World Health Organization-recognized Covid-19 vaccine or convalesced from a Covid-19 infection.

To date, more than 410 million people worldwide have recovered from Covid-19, and 65.7% of the global population have received at least one dose of SARS-CoV-2 vaccine, or more than 5.04 billion people.

Both GlaxoSmithKline plc (NYSE:GSK) and Sanofi (NASDAQ:SNY) have sought regulatory authorization for their COVID-19 vaccine.

In late February 2022, Sanofi/GSK posted 58% efficacy in Omicron-affected COVID-19 vaccine trials, while early sequencing data indicate the vaccine provided 77% protection against symptomatic delta infection.

“No other global phase 3 efficacy study has been undertaken during this period with so many variants of concern, including omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines,” said Thomas Triomphe, Executive VP at Sanofi Vaccines. Both Sanofi and GSK also have plans to send regulators their data on the potential use of their vaccine as a booster.

Because two doses achieved 100% efficacy against severe COVID-19 and hospitalization and 75% efficacy against moderate to severe disease, Sanofi and GSK plan to use the data as the basis for approval filings. Talks with U.S. and European regulatory agencies are underway.

In the 18-55 years adult category, the GSK/SANOFI booster increased neutralizing antibodies by between 9x in recipients of Moderna’s vaccine to 84x in recipients of the Sanofi-GSK vaccine. The range of antibody increases in older adults spanned from 11-153x.

Meanwhile, GlaxoSmithKline with other partners Medicago, also provided some strong efficacy numbers in December against the Delta strain. The joint effort recently received its first global approval, in Canada. It’s proven itself to have a solid 71% efficacy against COVID-19, but not yet for Omicron, because that wasn’t present at the time of the study.

Developing another protein-based shot is Novavax, Inc. (NASDAQ:NVAX), which in December 2021 announced it would start making an Omicron-specific vaccine.

By late February 2022, the company was already projecting it would be seeking full approval of its COVID-19 vaccine in the second half of 2022, with a forecasting of total revenue of between $4-5 billion for 2022.

"We expect to gain additional authorizations where we have already filed, including in the U.S.,” said Novavax CEO Stanley Erck. “We will pursue full approval of our vaccine including filing our BLA (biologics license application), in the second half of 2022."

With data observed between May and September 2021 when the Delta variant was dominant, Novavax released a study in February, claiming its vaccine was 82% effective against infection among teenagers.

So far, 36 countries have authorized the use of Novavax’s vaccine, including India becoming the first country to approve it for teens.

While its vaccine was one of the first to gain authorizations around the globe, AstraZeneca PLC (NASDAQ:AZN) is now making progress with its new antibody-based shot, Evushield, to prevent and treat COVID-19.

An independent lab study has shown its ability to retain neutralizing activity against Omicron coronavirus variant, including the highly contagious BA.2 subvariant.

The results of the drug’s success come after Britain approved the therapy for preventing infections in adults with poor immune response.

Evusheld fills an urgent gap in the UK’s fight against COVID-19, providing protection for people for whom vaccination may not be effective and who are often amongst the most clinically vulnerable in society,” said Tom Keith Roach, President, AstraZeneca UK. “We hope to see this critical medicine made available to UK patients as quickly as possible, in line with other countries.”

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