Novavax Presents New Hope after Failure of Genetic Vaccines

by | Jun 11, 2022 |

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Novavax’s two-dose Covid-19 vaccine for adults ages 18 and older cleared a key step on the path toward Food and Drug Administration emergency use authorization this week. The FDA’s committee of independent vaccine experts voted 21 to 0 with one abstention at the end of an all-day meeting to recommend authorizing the two-dose series of 5 mcg in the U.S. after an all-day public meeting in which it weighed safety and effectiveness data.

The FDA usually follows the committee’s recommendations, though it is not obligated to do so. The agency could clear Novavax’s vaccine for distribution in the U.S. as soon as this week. The Centers for Disease Control Prevention would still need to sign off on the product before distribution, and for pharmacies and other healthcare providers can start administering them to people. 

Novavax was one of the early participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the company struggled for more than a year to get manufacturing in place, and its clinical trial data appeared much later than Pfizer and Moderna.

The Maryland biotech company’s shots are based on protein technology with purified Spike protein in a matrix 5 mcg per dose. The technology differs from Pfizer and Moderna’s shots, which were the first ones using messenger RNA technology to receive FDA approval and have resulted in catastrophic rates of injury, disability, and death. In the Novavax clinical trial experience, there were no hospitalizations or deaths due to COVID-19, and the overall number of deaths was similar between the groups.

Novavax fairly reported several cases of myocarditis and blood clots caused by the vaccine. Importantly, the briefing booklet indicated that the data are old, and they tested Novavax against extinct variants of the virus, and thus we do not know if the product will work against Omicron or its subvariants.1 Protection against “severe disease” with Omicron is purely speculative and is not expected given the failures of Pfizer, Moderna, JNJ, and AstraZeneca against Omicron.

Novavax’s vaccine would potentially appeal to unimmunized people who have not had COVID-19 and who would prefer a potentially safer product that is not based on the mRNA technology used by Pfizer and Moderna. Though Johnson & Johnson’s shot is also available, the CDC has restricted its use due to a risk of blood clots, primarily in women, and thus JNJ is infrequently utilized.

As with all the products, according to their clinical trials, they are only meant for people who have not had COVID-19 respiratory illness and should not be used in COVID-19 recovered patients since they were excluded from the clinical trials because of lack of expected benefit and the anticipation of harm.

On this week’s show, we have a Monkeypox update, music from Joseph Langham’s “Inside these Bodies,”2 and on the backside, an exploratory interview with Dr. Michael Boehmer, PharmD,3 and Dr. Salaheldin Halasa4 on methylene blue and photodynamic therapy as a local virucidal approach in the oral and nasal cavity. We will also explore extracorporal and system uses of methylene blue in a futuristic manner for COVID-19 and other illnesses. 

So let’s get real, let’s get loud; on America Out Loud Talk Radio, this is The McCullough Report!

The McCullough Report: Sat/Sun 2 PM ET Encore 7 PM – Internationally recognized Dr. Peter A. McCullough, known for his iconic views on the state of medical truth in America and around the globe, pierces through the thin veil of mainstream media stories that skirt the significant issues and provide no tractable basis for durable insight. Listen on iHeart Radio, our world-class media player, or our free apps on AppleAndroid, or AlexaEach episode goes to major podcast networks early in the week and can be heard on-demand anywhere in the world.

References:

1 https://www.fda.gov/media/158912/download
2 https://music.apple.com/us/album/some-new-sky/128672953?i=128673016
3 https://www.linkedin.com/in/mike-boehmer-15ba1817/
4 https://www.bostonbiolife.com/wp-content/uploads/2018/09/SalaheldinHalasa_Bio.pdf

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Dr. Peter McCullough

Dr. McCullough is an internist, cardiologist, and epidemiologist managing the cardiovascular complications of both the viral infection and the injuries developing after the COVID-19 vaccine in Dallas, TX, USA.

Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection,” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. He has 56 peer-reviewed publications on the infection and has extensively commented on the medical response to the COVID-19 crisis in TheHill, America Out Loud, and FOX NEWS Channel.

On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs, in 2021-2022, the Texas Senate Committee on Health and Human Services, Colorado General Assembly, New Hampshire Senate, Pennsylvania Senate, and South Carolina Senate concerning many aspects of the pandemic response. On January 24, 2022, Dr. McCullough co-moderated and testified in the US Senate Panel “COVID-19: A Second Opinion” chaired by Senator Ron Johnson. Dr. McCullough has reviewed thousands of reports, participated in scientific congresses, group discussions, and press releases, and has been considered among the world's top experts on COVID-19.

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Drew
Drew
19 days ago

“As with all the products, according to their clinical trials, they are only meant for people who have not had COVID-19 respiratory illness and should not be used in COVID-19 recovered patients since they were excluded from the clinical trials”

So will America’s health system be testing all it’s citizens for antibodies to determine previous infection of each Guinea pig prior to any injections?

Ak409
Ak409
Reply to  Drew
18 days ago

DR Mobeen Syed has closely reviewed the available data on this vaccine (the review link included below). He reported there were 3 clinical trials noted, one where Novamax had about 50K participants, another by the FDA reporting about 40K, who then again had about 29K in their “briefing documents”. (I’m already confused.) DR Mobeen reportedly thinks this vaccine should not be given to males, under 30 yrs. of age, out of fear of myocarditis and other cardiac risks. He also had concerns that the prevalence of myocarditis could be higher than anticipated and explained his reasoning for this. He was also indicated the potential for “unknown long term effects”. He thought it would be wise to review current and emerging safety data from countries already administering it to their populations, like Australia, in order to better understand its potential longer-term risks. I personally, am particularly concerned about the thousands of young active-duty military members who will become the guinea pigs for this vaccine.

https://www.youtube.com/watch?v=v5V8AjWUlRs

Ak409
Ak409
Reply to  Drew
18 days ago

Sorry, I missed replying to your specific question. From what we have seen, my opinion is “Hell No”!

I would add that Denmark, and some other countries, required “aspirated” injections to decrease risk of harm, yet many countries, like the U.S. and others, refuse to do it. Can you guess why? The word begins with an M… and rhythms with Honey, and their may be even more sinister reasons!

First of all, injecting these vaccines into a blood vessel is a “BIG No-No” due to potential risk of serious injury. While the powers “that be” say there is no significant risk. But “aspiration” will eliminate or dramatically reduce whatever risk is present, so many agree it is the the safest way to proceed.

Aspiration shows a sign of blood in the syringe if the needle penetrates a blood vessel, so the needle can be carefully removed BEFORE the vaccine is injected. But this dose of contaminated vaccine now has to be discarded, along with any others showing signs of blood contamination, and that’s the “rub” to many who are calling the shots (pun intended). However, the Hippocratic oath, written in the 5th century BC, contains language suggesting that the physician and his assistants “should not” cause physical or moral harm to a patient. This is commonly referred to as, “First, do no harm”! Well, the harm has been, and continues to be done in many ways.

https://www.youtube.com/watch?v=md8pJFbMVnk

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