Biotech Insider – A new report from National Geographic has shone a light on topic only months ago was seen as too taboo to speak about on social media—serious vaccine side effects. As the US FDA continues to evaluate bringing in shots for children under 5, it looks to be a competition between the offerings of Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), and Moderna Inc. (NASDAQ:MRNA). However, with stories like those found in the National Geographic piece, and lingering public concerns over mRNA technology could open the door for up-and-coming entries being developed by innovators such as BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF), and Novavax, Inc. (NASDAQ:NVAX).
Due to the 2005 the Public Readiness and Emergency Preparedness Act, sufferers can’t sue vaccine manufacturers, including the lead example in the National Geographic story whose life was allegedly impacted by Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX). New preventative therapies are in development that are built upon safer mechanisms.
One example of an alternative vaccine in development is BVX-0320, a haptenized SARS-CoV-2 s-protein vaccine from BioVaxys Technology Corp. (CSE:BIOV) (OTCQB:BVAXF).
BioVaxys has demonstrated that their vaccine doesn’t bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor. In layman’s terms, these findings suggest that this vaccine may not lead to the unusual but serious myocarditis observed with mRNA vaccines.
Previous studies in mice showed that BVX-0320 not only stimulates a robust antibody and T cell response, but was also safe and well tolerated.
“This is the first peer-reviewed presentation of our work on BVX-0320 in mice,” said David Berd, MD, Chief Medical Officer of BioVaxys. “We expect it to be well received by the scientific community because it is novel and the data convincing.”
BioVaxys’ vaccine platform is based on the concept of haptenization, which is an idea with a long history, beginning with 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.
The recently completed study on ACE2 binding inhibition by Millipore-Sigma was part of a bioproduction run of BVX-0320 contracted by BioVaxys last September, with the new batch is being used in ongoing pan-sarbecovirus vaccine collaboration with Ohio State University.
There have been several local and systemic adverse events associated with mRNA COVID-19 vaccines, with pericarditis, myocarditis and myocardial infarction as examples of cardiac complications related to these vaccines.
A study published in the Journal of Hematological Oncology concludes that the Receptor Binding Domain (RBD) 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 cardiac issues.
Currently available vaccines, whether comprised of either recombinant full-length or partial spike protein can result in rare, but life-threatening side effects, such as abnormal blood clotting or myocarditis.
These toxicities may be caused by unwanted binding of the vaccine spike protein to ACE2 receptors in the heart or platelet factor 4. BioVaxys’ vaccine for Covid-19, BVX-0320, comprises a portion of the SARS-CoV-2 spike protein that is modified by the hapten, dinitrophenyl (DNP); hapten modification prevents ACE2 binding while retaining immunogenicity.
US biotech developers Novavax, Inc. (NASDAQ:NVAX) are betting that fears over the mRNA technology will give its Covid-19 vaccine an edge over the competition. The company already began shipping its vaccine to the EU earlier this year. Now Novavax is challenging US regulators to not only authorize their offering to Americans, but also promoting it as well.
“I would love to hear more public support from the US government and I don’t know whether they’ve been too involved in some of the other vaccines or they’ve been too busy,” said Stan Erck, CEO of Novavax, stating back in February he believed US authorisation could happen “within weeks”.
Novavax plans to ship 2 billion doses in 2022, which analysts’ forecast could generate $5 billion in revenues.
Both Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) submitted another application for US Emergency Use Authorization for another booster dose of their Covid-19 vaccine for adults, aged 65 and older. Currently the Pfizer-BioNTech COVID-19 Vaccine is currently authorized as a single booster dose administered at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older.
The claims of Pfizer and BioNTech in the release highlight what the drug companies say is increased effectiveness, based on data from two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating.
However, lower in the release there is an acknowledgement under the heading IMPORTANT SAFETY INFORMATION, that individuals shouldn’t get the vaccine if they’ve had a severe allergic reaction to a previous dose, as well as an acknowledgement of concern if individuals have had myocarditis or pericarditis.
Meanwhile, competitors Moderna Inc. (NASDAQ:MRNA) are working towards goals with global implications, including plans for vaccines against 15 pathogens with future pandemic potential.
The company will begin testing new vaccines targeting 15 of the world’s most worrisome pathogens by 2025, and will permanently wave its Covid-19 vaccine patents for shots intended for certain low- and middle-income countries.
“Too many lives were lost in the last few years,” said Moderna CEO Stephane Bancel.
So far only Pfizer-BioNTech’s vaccine is authorized for children. But Moderna is awaiting the results of an FDA evaluation for its vaccine’s use in children 6 to 11.
The CDC has stated that waiting longer between doses for both Pfizer and Moderna’s offerings may reduce risk of myocarditis for males 12-39 years old—based on data from Canada that found the risk of myocarditis is lower for younger men when they wait eight weeks.
The risk of myocarditis among men ages 18 to 39 is about 1.5x higher after a second Moderna dose than with Pfizer’s vaccine.
Article Source: https://biotech-insider.com/the-small-biotech-company-that-all-the-majors-aspire-to-be/
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