We’ve been more than six months after the SARS-Co-V2 pandemic in the United States. Patients, families, and physicians are frightened, tired, and frustrated by the lack of help from regulatory agencies: the National Institutes of Health, Food and Drug Administration, Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Disease Control and State Medical and Pharmacy Counseling: for Medical Prophylaxis and COVID-19 Remedy.
Warnings and barriers have caused thousands of patients to be treated at home with proper unlabelled use of unwanted antivirals (zinc, hydroxychloroquine, azithromycin, doxycycline), steroids (dexamethasone, prednisone, budesonide, colchicine) and antithrombotic (low molecular weight). heparin, oral anticoagulants). It is clear that the United States has followed a hospitalization style in case of overdue disease while patiently and painfully waiting for the panacea of a COVID-19 vaccine.
For months, the economic news cycle has been full of stories about the progression of the vaccine. “Operation Warp Speed” is an impressive effort with approximately $10 billion in federal dollars spent with giant pharmaceutical corporations such as Merck, Pfizer, JNJ and AstraZeneca, and small biotechnology corporations such as Moderna, Emergent Biosolutions, ApiJect and Panacea Biotec for vaccine progression and marketing. Prospective monetary provision has stimulated inventions with patents and royalty deals implemented or granted to industry and government employees.
Many countries, besides the United States, are involved, in addition to Canada, the United Kingdom, France, Israel, China and others. Financing allocated through direct grants, procurement agreements and distribution systems. On 15 May, 14 vaccine applicants were announced. Russia has provoked heavy reprisals from us vaccines when Vladimir Putin approved and used the first COVID-19 vaccine. The public dazzled through representations of viral vectors, stemming RNA derivatives, antibody responses, and mobile immunity models.
We learned a lot about COVID-19 and immunity in just a few months. The virus uses a protein on its surface to access respiratory epithelial cells and then to the body. Diagnostic laboratories can measure antibodies (IgG, IgM) in the blood targeting complex protein and viral nucleocapside. Although these antibodies targeted as opposed to the complex protein neutralize the virus in the control tube, it is another, in stiff circle of antibody relatives (IgA) produced in the mucous membranes that actually defends against the inhaled virus in other newly immunized people afterwards. COVID-19 cure.
The production of antibodies after COVID-19 takes a few weeks to increase, but decreases temporarily after several weeks or even months. Therefore, it was hoped that a vaccine could simply instill permanent reminiscence in antigen-presenting T cells that would remind plasma cells and B lymphocytes to proliferate and repair the production of antibodies more temporarily as a component of a re-inoculation. The science is unclear as to whether a vaccine can stimulate immediate IgA production for immediate coverage or whether it can permanently print the immune formula for lasting immunity. Many main points need to be resolved, adding initial management and withdrawal program, vaccination dose, management direction (intranasal, oral, injection) and defense confirmation.
These problems have created one of the biggest bets in fashion history with billions of dollars spent, thousands of lives lost and unimaginable misery, pain and human suffering by giving up the first medical remedies and waiting for the arrival of the vaccine.The ultimate solution for the giant population still at risk of infection and prospective providence for stakeholders have converged into a single inexorable force.
The headwinds for vaccine development are prodigious. The big Phase 3 clinical trials are designed to recruit previously uninfected persons; however, given large numbers of asymptomatic cases and unreliable antibody tests, the vaccine/placebo may have no differential impact on a large group of younger subjects enrolled. Patients may reject “challenge studies” because they are fearful of being exposed to the infection intentionally while getting the placebo. There may be early (injection site reactions, fever) and late (autoimmune, neurodegenerative) safety events. Lastly, and most importantly, the vaccines may simply be modestly effective — meaning there is partial immunity but no guarantee of freedom from future infection.
What are the most likely final scenarios? First, and effective vaccines will soon be marketed, giant populations are being stocked and stakeholders getting their benefits. Second, however, partial or useless vaccines are provided and there is a struggle for the benefits and dangers with lukewarm adoption and marketing. Third, despite the impressive effects on the control tube, vaccine trials cannot demonstrate statistically significant discounts on true VOCD-19 infections and none are approved for use. Fourth, any of the above scenarios, however, the result is so backward that collective immunity has grown enough, infection rates have declined or virulence has declined and there is simply no market for those products.
My prediction is that vaccines will be a reality, as in Russia, however, they will only be sent immediately to the market for them to be partially effective and adoption and benefits to the population will remain dubious given all the issues discussed.
Meanwhile, many frontline and clinical physicians continue to pressure regulators for unrestricted use of all available drugs to treat PATIENTS with COVID-19 at home. Every day of vaccine progression means more hospitalizations and deaths. Caregivers, unlike government officials and biotechnology executives, are horrible actors. They are trained to take calculated hazards and prescribe medications that they know have a basis to run early with COVID-19.
Vaccine actors, in addition to government agencies, deserve not to delay the remedy now in the bid for a long-term panacea, even if it reaches a “distortion rate.”
Peter A. McCullough, MD, MPH, is an internist, cardiologist and epidemiologist, and the editor-in-chief of “Cardiorenal Medicine” and “Reviews in Cardiovascular Medicine.” He has authored over 500 cited works in the National Library of Medicine and lectured across the world on contemporary medical issues.
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