Rare Adverse Effects Continue to Fuel Covid-19 Vaccine Hesitancy, Despite Safety Breakthroughs

VANCOUVER, BC, Sept. 23, 2021 /PRNewswire/ -- USA News Group  -  Despite the approval for the Comirnaty vaccine from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) by the FDA back in August, vaccine hesitancy in the USA persists and is unlikely to disappear. Now with what PFE/BNTX are calling encouraging results for their Covid-19 vaccine trial on kids in hand, it's expected that parents are going to be even more hesitant to jab their own children. Reports of heart inflammation are adding fuel to the fire, spurning closer studies into myocarditis risk taking place inIsrael and the USA, and Canada particularly with mRNA vaccines such as those from Pfizer, BioNTech and Moderna, Inc. (NASDAQ:MRNA), while earlier this year multiple European countries suspended the use of AstraZeneca PLC (NASDAQ:AZN) over worries about blood clots. While these manufacturers are standing by their safety and efficacy, a new study on the hapten-modified spike protein used in the BVX-0320 SARS-CoV-2 vaccine from BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF) is giving hope to another method that could potentially mitigate some of these abnormal life-threatening side effects.

Albeit rare, life-threatening side effects, such as abnormal blood clotting or myocarditis can be the result from either recombinant full-length or partial Spike protein—which are found in currently available vaccines. These toxicities may be caused by unwanted binding of the vaccine spike protein to ACE2 receptors in the heart or platelet factor 4.

The BVX-0320 vaccine for Covid-19 from BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF) comprises a portion of the spike protein that is modified by utilizing haptenized protein technology based on the work of the immunologist and Nobel laureate Dr. Karl Landsteiner.

James Passin, CEO of BioVaxys, stated: "Haptenization, as a method to inhibit the ACE2-binding ability of the s-spike protein, while increasing its immunogenicity, may prove to play a critical role in global Covid-19 vaccine development and deployment strategies, as public health authorities consider options for repeated seasonal vaccine boosters in the context of reported, albeit rare, adverse effects and apparent waning immunity."

Biovaxys believes that the haptenized spike protein has much diminished ability to bind to ACE2, which would result in much diminished vaccine toxicity.

The company's belief appears to be backed by the conclusions of the scientifically groundbreaking peer-reviewed research paper, published in the Journal of Hematological Oncology. The paper concluded that the Receptor Binding Domain of the SARS-CoV-2 spike protein binds to the ACE2 receptor and that this binding of SARS-CoV-2 to ACE2 prevents the enzyme from converting angiotensin II, potentiating pulmonary and cardiovascular issues.

"Biovaxys will compare the binding of haptenized spike protein with the non-haptenized," explained Chief Medical Officer of Biovaxys, David Berd, MD. "The results could provide evidence that our vaccine has lowered potential for some of the observed serious vaccine side effects."

Accompanying its commentary on the new findings from the research paper, BioVaxys also announced it has entered into an agreement with a subsidiary of one of the largest pharmaceutical companies in the world, with a market capitalization of US$102 billion Merck KGaA.

Through the deal, the subsidiary—named Millipore—will manufacture a supply of GLP-grade BVX-0320, the Company's SARS-CoV-2 vaccine candidate for the study. 

Last summer, Millipore produced similar yields of BVX-0320 last summer for the BioVaxys' animal immune response studies. This time, Millipore will be incorporating in the manufacturing the recently produced purified recombinant s-protein produced by BioVaxys' bioproduction partner, the $63-billion Chinese bio manufacturer WuXi Biologics.

BioVaxys President & Chief Operating Officer Kenneth Kovan said, "The production of the recombinant s-protein using WuXi Biologics' proprietary cell expression system is a significant milestone for Biovaxys, as we not only have a high production yield of protein, but also now have the ability and know-how to produce protein in large scale with the level of purity, consistency and protein characterization required by the FDA for our clinical studies and commercial-scale yields."

BioVaxys is currently finalizing arrangements with a major US academic research institution to collaborate on the study. The company has already previously announced research collaboration with The Ohio State University, Wexner School of Medicine for BVX-0320.

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) recently announced "positive topline results" from a pivotal trial of Covid-19 vaccine in children 5 to 11 years. The trial used a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. Antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. 

"These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

Meanwhile, safety trials are being conducted for Moderna, Inc. (NASDAQ:MRNA) both for children and for people with organ transplants.

Moderna also recently announced that Health Canada approved its vaccination, SPIKEVAX^TM for individuals 12 and older.

"Health Canada's approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank Health Canada for their hard work throughout the process," said Stéphane Bancel, Chief Executive Officer of Moderna.

Beyond its vaccine offering, AstraZeneca PLC (NASDAQ:AZN) recently released promising results from its Phase III prophylaxis trial for its AZD7442 PROVENT—the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial.

AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo.

"The PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19," said Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the trial. "With these exciting results, AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to return to their normal lives."

For more information, please visit: https://biotech-today.com/heres-why-you-want-biotech-stocks-in-your-portfolio/ 

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