What will we have learned; how long will we remember, and how far back from neo-Marxist extremism will the political pendulum swing before we lose the current American generations so fortunately inherited? Conditions must sometimes get very bad before we wake up to...
Novavax Presents New Hope after Failure of Genetic Vaccines
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 Apple, Android, or Alexa. Each episode goes to major podcast networks early in the week and can be heard on-demand anywhere in the world.
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