“Shared expectations lead to predictability.”
- After President Trump was diagnosed with COVID-19, he was given the Regeneron antiviral cocktail along with Remdesivir and Dexamethasone
Q: What is this “Regeneron antiviral cocktail” given president Trump last Friday?
A: Regeneron Pharmaceuticals, Inc., based in Tarrytown, NY, has been conducting a seamless Phase 1/2/3 trial of its investigational antibody cocktail (REGN-COV2) with non-hospitalized patients. Two types of antibodies are derived from serum taken from recovered COVID-19 patients. Each is then processed and concentrated to increase their effectiveness. These are then mixed together, making this pharmaceutical a “cocktail.” The first antibody type attacks the spikes on the coronavirus making it more difficult for the virus to penetrate into a healthy cell where it can replicate itself. The second antibody type allows the healthy cell with a coronavirus virion inside to remain healthy. Normally, a cell with a virion replicating inside, dies once the replicated coronavirus virions exit to find new hosts. These current trials are preliminary to Regeneron later applying for authority to conduct expanded clinical trials. To date, there has been descriptive analysis of the first 275 people participating in this current trial. It has been a double-blind study where half the group is given the drug, the other a placebo. “We are extremely gratified to see that Regeneron’s REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-9 patients,” said George D. Yancopoulos, MD. PhD, president and chief scientific officer at Regeneron.
As widely publicized, president Trump was taken by helicopter last Friday to The Walter Reed National Military Medical Center in Bethesda, Maryland. After he arrived, the medical team caring for him wanted to administer REGN-COV2. But this “investigational pharmaceutical” is not authorized to be given to patients outside the clinical trials. However, the physicians at Walter Reed agreed that this drug was the most appropriate one available for Trump. On their request, the FDA granted “compassionate use” to administer this. Compassionate use, or more formally known as “extended care,” is reserved for a pharmaceutical to be used for a patient with a serious or immediate life-threatening condition to gain access to an investigational medical product for treatment. He was given a maximum dose (8 grams) of REGN-COV2 on Friday.
Later, president Trump began a five-day regimen of Remdesivir[1], an anti-viral medication authorized for use only by seriously ill patients. Even later, Dexamethasone[2] was prescribed. This is a medicine also authorized for use only on seriously ill patients. It suppresses the immune system. A patient’s overreacting immune system with too many antibodies can cause inflammation in the lungs and other organs. Dexamethasone reduces the patient’s immune system to abate this inflammation. If used on less seriously ill patients, a reduced immune system could actually increase the viral load. Based on the information available about Trump’s care, many physician experts have publicly questioned how recovered Trump really is. Sean Conley, D.O., the White House physician, repeatedly has cited that he is “doing great.” But Dr. Conley has also avoided questions about Trump’s lung scans, the date of his last negative coronavirus test, and clinical findings. This questioning of the treating physician’s judgement will only escalate after it was announced Monday, mid-afternoon, that Trump will soon be discharged!
- COVID-19 cases among young adults are rising.
Q: Is it true that an increasing number of younger people are getting COVID-19?
A: The CDC conducted a study on the impact of young adults returning to attend college. Between August 2 and September 5, weekly cases of COVID-19 rose an average of 55.1%. The Northeast region recorded a 144% increase while Midwest cases rose 123.4%. This increase was not limited to people attending college, as non-college students were also included in this study.
In a separate study published in last Tuesday’s CDC Morbidity and Mortality Report, researchers reported a rapid rise of COVID-19 cases two weeks after a North Carolina university opened its campus to students. Between August 3 and August 25, the university reported 670 laboratory-confirmed cases. Preliminary findings show that student gatherings and congregate living contributed to this spread. On August 19, classes moved online and the school began to reduce the density of on-campus housing. Results show a decrease in reported cases. No deaths were reported in this second study.
128. Moderna COVID-19 vaccine shows positive results in its clinical trials.
Q. What’s happening with the scientific findings of vaccine clinical trials?
A: Results from an early safety study of Moderna’s “MRNA.O” coronavirus candidate vaccine showed that it produced virus-neutralizing antibodies in older adults to the same level as in younger adults. It also produced side effects compatible with the current, long-term, wide-spread seasonal flu shots. The study was published in the New England Journal of Medicine. It offers an improved picture of the vaccine’s safety in older adults who have risk of severe complications of COVID-19. “The findings are reassuring because immunity tends to weaken with age,” stated Evan Anderson MD, lead researcher of the Emory University (Atlanta) study. The early study was an extension of Moderna’s Phase 1 safety trial, conducted for individuals aged 18-55. This more recent study tested two doses of Moderna’s vaccine – 25 micrograms and 100 micrograms – in 40 adults aged 56 to 70, and another group over age 70. Side effects, which included headache, fatigue, body aches, chills and injection site pain, were deemed mild to moderate. Two cases, however, resulted in more severe reactions. One developed a grade 3 fever (over 101.9 degrees Fahrenheit). The other developed a short period of severe fatigue. These appeared soon after the injections, and resolved quickly. “This is similar to what a lot of older adults are going to experience with a high dose influenza vaccine,” Dr. Anderson said. Moderna is continuing with its phase 3 clinical trial with the higher dose of this vaccine. This phase 3 study is the last step before its findings can be reviewed for emergency use authorization allowing it to be released to the public.
129. Can Vitamin D reduce the impact of COVID-19?
Q. I saw on TV that president Trump was given Vitamin D at the hospital. Does this help?
A: Recent research has shown that Vitamin D can reduce the risk of COVID-19 infection by 54%. It can also cut in half the risk of fatal consequences of this disease. This new research was led by Michael Holick, MD of Boston University School of Medicine. It claims that adequate vitamin D levels is linked to a significantly decreased level of inflammatory markers and higher levels of immune cells. “Because vitamin D deficiency and insufficiency is so widespread in children and adults in the U.S. and worldwide, especially in the winter months, it is prudent for everyone to take a vitamin supplement to reduce the risk of being infected and having complications from COVID-19,” he said.
130. China vaccination program continues.
Q: We heard that China had begun its vaccination program months ago. Is it continuing?
A: China has developed four different experimental COVID-19 vaccines. Two were developed by the state-backed China National Biotec Group (CNBG): one by Sinovac Biotech. These three are all in Phase 3 trials. A fourth trial vaccine developed by Can Sino Biologics was approved last June to be used by the Chinese Military.
Zheng Zhongwei, an official of the National Health Commission, stated China launched its emergency program in July[3] after communicating with the WHO in late June. Mariangela Sim, MD, assistant director-general of WHO stated that countries have autonomy to issue their own emergency use authorizations for any health product following their national laws and regulations. WHO chief scientist Soumya Swaminathan said earlier that emergency use authorization for coronavirus vaccine is a “temporary solution” and that a long-term solution lay in completion of Phase 3 trials.
China has been reluctant to release any information about its clinical trials. Working in isolation of other national efforts, China has avoided collaboration to share knowledge and technical information. Many have assumed China is taking a competitive stance. If China immunizes its population before any other country, this would give it an immense strategic advantage diplomatically, economically, and militarily. The assumption can be made that by stating that WHO indirectly approved this effort rather than by its own national authorization, China can avoid direct responsibility should the vaccines prove unsafe or ineffective.
[1] See FAQ #24 & #33
[2] See FAQ #52
[3] See FAQ #62 & #104
