As Additional COVID Variants Surface, Questions Arise to Effectiveness of Vaccines to Combat New Strains

Palm Beach, FL – March 1, 2021 – The epic global race to solve the COVID-19 crisis has just gotten a be a more of a puzzle with the emergence of new variants. The existing vaccines have been based on research centered on the original virus but the variants are raising questions if the approved vaccines will be effective on these new variants. In the U.S. the CDC has said that: “… mutations in the virus genome that alter the characteristics and cause the virus to act differently in ways that are significant to public health (e.g., causes more severe disease, spreads more easily between humans, requires different treatments, changes the effectiveness of current vaccines). It’s important to understand that genetic mutations are expected, and some variants can spread and become predominant while others subside… A new virus variant has one or more mutations that differentiate it from the wild-type or predominant virus variants already circulating among the general population. As expected, multiple variants of SARS-CoV-2 have been documented in the United States and globally throughout this pandemic. Several new variants that emerged in the fall of 2020 are concerning, most notably: B.1.1.7: In the United Kingdom (UK); B.1.351: In South Africa; and P.1: In Brazil. “  Active biotech companies in the market this week include Johnson & Johnson (NYSE: JNJ), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Pfizer Inc. (NYSE:PFE), Moderna, Inc. (NASDAQ: MRNA), INOVIO (NASDAQ:INO).

 

An article in the U.K. based Lancet said that: “Many variants of SARS-CoV-2 are emerging, but will they have different clinical effects? A new consortium is trying to find out… All viruses mutate. But three variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have raised particular concerns. Making sense of how the variants will influence the pandemic is the task of the newly formed G2P-UK National Virology Consortium. Its remit is to use cell cultures and animal models to examine how the mutations affect the transmissibility of the virus, the severity of the disease, and the effectiveness of the vaccines and treatments. The initiative brings together researchers at ten academic institutions in the UK, who will work alongside the COVID-19 Genomics UK Consortium.”

 

BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS:  BIOVAXYS EXPANDING TECHNOLOGY PLATFORM TO ADDRESS EMERGING SARS-COV-2 VARIANTSBVX-0320 and Covid-T to have capability to address UK, Brazilian and South African Virus Variants – BioVaxys Technology Corp. (“BioVaxys”) the world leader in haptenized protein vaccines for antiviral and cancer applications, announced today that it is assessing steps to modify BVX-0320 and Covid-T, its SARS-CoV-2 vaccine candidate and T-cell diagnostic, to address the newly emerging variants (the South African, UK, and Brazilian variants) of SARS-CoV-2 that are of high concern to worldwide governments, healthcare practitioners, and infectious disease researchers.

 

Given the flexibility in BioVaxys’ viral vaccine platform based on haptenizing viral antigens, the Company is exploring the potential for producing a multivalent vaccine, which will be a combination of the haptenized spike proteins subunits from each clinically significant variant. Once the amino acid sequences for the variants are available, BioVaxys should be able to quickly produce a multivalent vaccine.  BioVaxys is also planning a product line extension of Covid-T, its disposable diagnostic for screening for T cell response to SARS-CoV-2, that would have capability to screen for T-cell responses to SARS-CoV-2 variants.

 

In recent months, highly transmissible SARS-CoV-2 variants – United Kingdom (B.1.1.7 lineage), South Africa (B.1.351 lineage), and Brazil (P.1 lineage) – with mutations in the spike protein have been spreading globally and appear to cause major changes in the way the virus acts, including enhanced transmissibility and possibly increased clinical severity.  Most disconcerting are findings that recently approved Covid-19 vaccines may not work as well against these variants.   In a new study which was published the New England Journal of Medicine, researchers from Pfizer, BioNTech, and the University of Texas Medical Branch examined how well blood taken from people who had received the companies’ vaccine fought off a virus engineered to have the key mutations found in B.1.351. They reported that there was about a two-thirds drop in neutralization power against the variant compared to other forms of the SARS-CoV-2 (NEJM, Neutralizing Activity of BNT162b2-Elicited SerumPreliminary Report February 17, 2021).  These “mutations” have quickly emerged in different geographical regions, such as the UK, South Africa and Brazil, and in some places have outcompeted the existing variants.  Given the nature of viruses and their natural propensity to mutate, it is likely that additional clinically significant variants will emerge.

 

A multivalent vaccine based on haptenized spike proteins of the emerging variants would be expected to have the same level of effectiveness that Biovaxys has demonstrated with its monovalent BVX-0320 vaccine in a mouse model: a 96.4% spike protein-binding antibody response, activation of CD4+ helper T cells and CD8+ killer T cells, and stimulation of T cells that produce the cytokine, gamma interferon.  Helper CD4+ T-cells are memory cells that retain information about the virus, enabling them to respond rapidly after viral exposure.  CD8+ T cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells.

 

Dr. David Berd, Chief Medical Officer of Biovaxys, noted that “hapten modification induces a strong T cell response against the unmodified, native viral protein.  It is likely that T cells induced by the original viral spike protein would also react with the new variants, even though the antibody response is attenuated.” Continued…. Read this full release and more news for BioVaxys Technology at:  https://www.financialnewsmedia.com/news-biov/    

 

Other recent developments in the biotech industry include:

 

Johnson & Johnson (NYSE: JNJ) recently announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered today includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO is now complete.

 

“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. “If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries.”  The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and UN procurement agencies. The EUL process expedites access to such products in many countries around the world and is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

 

Pfizer Inc. (NYSE:PFE) recently announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) begins.

 

“The epidemiology of pneumococcal serotypes causing disease has been changing due to the success of pneumococcal conjugate vaccines targeting pediatric and adult populations. In many countries across Europe and around the world, more than half of all cases of invasive pneumococcal disease in older adults are due to the 20 serotypes covered in 20vPnC, including seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that are not included in any currently licensed pneumococcal conjugate vaccine,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research and Development, Pfizer. “20vPnC builds on the legacy of Prevenar and Prevnar 13 and our more than two decades of experience and innovation in developing pneumococcal conjugate vaccines. Today’s acceptance of the 20vPnC application in the European Union is a significant step forward in our continuing efforts to potentially provide adults with robust and meaningful protection against more pneumococcal disease-causing serotypes.”

 

Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, recently announced that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and has shipped doses to the National Institutes of Health (NIH) for a Phase 1 clinical trial that will be led and funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The Company also is providing an update on its strategy for addressing SARS-CoV-2 variants of concern.

 

While initial data confirms that the Moderna COVID-19 Vaccine (mRNA-1273) provides neutralizing activity against variants of concern, out of an abundance of caution, Moderna is pursuing two strategies against these variants, subject to U.S. Food and Drug Administration (FDA) review. First, the Company is evaluating booster doses of vaccine to increase neutralizing immunity against the variants of concern.  “We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration to combat this pandemic,” said Stéphane Bancel, Chief Executive Officer of Moderna. “As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control. We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary.”

 

INOVIO (NASDAQ:INO) recently announced the first participant was dosed in a Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, in Ghana. The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, is the first vaccine clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic. INO-4500 is also the first vaccine candidate for Lassa fever to enter human trials.

 

INOVIO is advancing INO-4500 with full funding from the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership that leverages funding from public, private, philanthropic, and civil society organizations to support research projects to develop vaccines against emerging infectious diseases. INOVIO previously received a $56 million grant from CEPI in 2018, under which the company is developing vaccine candidates for Lassa fever and Middle East Respiratory Syndrome (MERS). INOVIO and CEPI are committed to making a vaccine available as soon as possible for emergency use as a stockpile product post-Phase 2 testing.

 

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