FEELING GREAT!

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The FINANCIAL — Feeling really good! Don’t be afraid of Covid. Don’t let it dominate your life. We have developed, under the Trump Administration, some really great drugs & knowledge. I feel better than I did 20 years ago!

On Friday—the same day that Trump said he tested positive—the President received an experimental combination of two monoclonal antibodies to help his immune system fight the coronavirus infection, according to his physician, Sean Conley, TIME reported.
“The next day—after he was hospitalized at Walter Reed National Military Medical Center—he received the drug remdesivir, which blocks the coronavirus’s ability to make more copies of itself. Remdesivir is not approved by the U.S. Food and Drug Administration, but has received emergency use authorization for treating COVID-19. On Sunday—day three—Trump’s doctors revealed he’s also taking dexamethasone, a corticosteroid typically administered to control the inflammatory response common in more advanced stages of the disease.
While the monoclonal antibodies are designed to be used in non-hospitalized patients early in their infection—as the President apparently was when he received them—remdesivir was originally only authorized for hospitalized patients who are moderately to severely ill and in intensive care. That authorization has only recently been expanded, on Aug. 28, to include any hospitalized patient. Still, even hospitalized patients who may not need intensive care and receive remdesivir are generally further along in their disease than the President appears to be”.

How Trump’s Covid-19 treatment is far different from what most American patients get, CNN said.

While many Americans have struggled to get Covid-19 tests or test results without massive delays, Trump has been “the most tested man in America,” White House press secretary Kayleigh McEnany said.
“He’s tested more than anyone — multiple times a day,” McEnany said in July. (Later that same day, Trump contradicted his press secretary, saying, “I do take, probably on average, a test every two days, three days. And I don’t know of any time I’ve taken two tests in one day. But I could see that happening.”)

Are there any data showing the cocktail works and is safe?
Experiments in both golden hamsters and rhesus macaques that were intentionally infected with SARS-CoV-2 showed the cocktail could reduce viral levels and disease pathology.

Regeneron, the maker of the cocktail, earlier last week presented preliminary data from its ongoing clinical trial in people who tested positive for SARS-CoV-2 but were asymptomatic or, in the most extreme cases, had moderate disease—a group that would appear to mirror Trump’s current condition, SCIENCEMAG reported. No serious safety concerns surfaced, and the treatment reduced viral load and shortened symptomatic disease in patients who did not have SARS-CoV-2 antibodies at the trial’s start. It’s unclear whether the treatment can prevent severe disease, but there were hints that it might: Participants who received a placebo had more medical visits.

What was the regulatory mechanism that allowed the president to receive the experimental Regeneron antibodies?
The antibodies are typically only available to people who participate in clinical trials. Trump theoretically could have enrolled in the ongoing treatment study that reported preliminary data last week, but that trial randomly assigns half the participants to receive the antibodies; the other half serves as a control group and receives infusions of an inactive placebo. A U.S. Food and Drug Administration (FDA) regulation called “expanded access”—technically known as 21 CFR 312.310—allows physicians to request “compassionate use” of experimental treatments through an “investigational new drug” pathway used for individual patients or for emergencies. “These are designed to be used in these rare and special circumstances,” Yancopoulos says. “This is not the first time we’ve done compassionate use for these monoclonal antibodies. This is not a mechanism for widespread distribution.”

Could Regeneron’s monoclonal antibody treatment become more widely available through FDA’s emergency use authorization (EUA) pathway?
Yes. Both Regeneron and Eli Lilly, which similarly reported encouraging preliminary clinical trial data last month from a single SARS-CoV-2 monoclonal antibody, are discussing the possibility of an EUA with FDA. Lilly reported signs that its antibody reduced the need for hospitalization, but as with Regeneron, too few participants have so far become seriously ill to reach a convincing conclusion to this critical question.

What’s the evidence for using remdesivir in COVID-19 patients?

Remdesivir is an antiviral drug developed by Gilead Sciences, originally to treat the hepatitis C virus. It did not perform well against that pathogen but has been tried against Ebola and other viruses, after showing some activity in cells and animal models. The drug inhibits a viral enzyme used for replication of the pathogen. Earlier this year, it demonstrated a modest clinical benefit in a trial with hospitalized COVID-19 patients, leading FDA to grant Gilead an EUA for the drug. That EUA has since been expanded for use in patients with mild disease although its benefit in them is not clear. The drug has become widely used for COVID-19 patients despite continuing skepticism that it has a major clinical benefit. Because it and the monoclonal antibodies target different parts of the virus, administering them together may have a synergistic effect. One COVID-19 clinical trial is testing remdesivir and Lilly’s antibody, for example.

A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) begun enrolling adult volunteers week ago. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.

The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine (also known as Ad.26.COV2.S) and is leading the clinical trial as regulatory sponsor. Janssen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are funding the trial.

U.S. and international trial sites part of the NIAID-supported COVID-19 Prevention Network(link is external) (CoVPN) will participate in the trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.

“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” said NIAID Director Anthony S. Fauci, M.D. “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”

The Janssen vaccine candidate is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells. Adenoviruses are a group of viruses that cause the common cold. However, the adenovirus vector used in the vaccine candidate has been modified so that it can no longer replicate in humans and cause disease. Janssen uses the same vector in the first dose of its prime-boost vaccine regimen against Ebola virus disease (Ad26.ZEBOV and MVA-BN-Filo) that was recently granted marketing authorization by the European Commission.

Preclinical findings published in Nature(link is external) show that the investigational Janssen COVID-19 vaccine induced neutralizing antibody responses in rhesus macaques and provided complete or near-complete protection against virus infection in the lungs and nose following SARS-CoV-2 challenge. The safety, reactogenicity and immunogenicity of the investigational vaccine are being evaluated in a Phase 1/2a trial in the United States and Belgium enrolling adult volunteers. Positive interim results from the Phase 1/2a clinical study demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development.

“Scientific partners from government, industry and academia are working hand-in-hand to develop safe, effective vaccines to put this pandemic in our rear-view mirror,” said NIH Director Francis S. Collins, M.D., Ph.D. “While administrative steps are being streamlined to speed the process, safety and effectiveness measures are just as rigorous than ever.”

The Phase 3 trial is being conducted in collaboration with Operation Warp Speed(link is external) (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. OWS and CoVPN also are assisting with additional COVID-19 preventive candidate vaccines, including mRNA-1273, an investigational vaccine co-developed by NIAID and the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and AZD1222, a vaccine candidate being developed by United Kingdom-based biopharmaceutical company AstraZeneca.

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