September 11, 2020
JOHNS HOPKINS SUPPLIED:
1. Clinical Outcomes in Young US Adults Hospitalized With COVID-19 (JAMA) Young adults age 18 to 34 years hospitalized with COVID-19 experienced substantial rates of adverse outcomes: 21% required intensive care, 10% required mechanical ventilation, and 2.7% died. This in-hospital mortality rate is lower than that reported for older adults with COVID-19, but approximately double that of young adults with acute myocardial infarction.4 Morbid obesity, hypertension, and diabetes were common and associated with greater risks of adverse events. Young adults with more than 1 of these conditions faced risks comparable with those observed in middle-aged adults without them. More than half of these patients requiring hospitalization were Black or Hispanic, consistent with prior findings of disproportionate illness severity in these demographic groups.
(J. Harris: If you’re thinking that getting it over with now and catching COVID and then getting back to work wouldn’t be too bad, read the above. Even young adults have a 2.7% chance of dying as well as a 21% chance of requiring ICU care as well as the potential for multiorgan permanent damage and lots of debt. Wear your mask and space out. We’re getting there. Be patient.)
2. Adverse Outcomes and Mortality in Users of Non-steroidal Anti-inflammatory Drugs Who Tested Positive for SARS-CoV-2: A Danish Nationwide Cohort Study (PLOS Medicine) Concerns over the safety of non-steroidal anti-inflammatory drug (NSAID) use during severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have been raised. We studied whether the use of NSAIDs was associated with adverse outcomes and mortality during SARS-CoV-2 infection. Use of NSAIDs was not associated with 30-day mortality, hospitalization, ICU admission, mechanical ventilation, or renal replacement therapy in Danish individuals who tested positive for SARS-CoV-(J. Harris: Aspirin, Motrin, Aleve, and other non-steroidal anti-inflammatory drugs (NSAIDs) do not seem to cause any adverse effects with COVID infection.
Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine
On September 8 the CEOs of 9 pharmaceutical companies released a joint pledge that they are committed to “developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”…..
Important safeguards should be established to reassure the clinical community and the public about any vaccine approval. The FDA should explain the role of the data and safety monitoring boards (DSMBs) for the vaccine trials, the first “independent” group that reviews the data, and any correspondence between the DSMB and the project investigators should be shared with the public. Two additional groups have an important consultant responsibility to the government and the public: the FDA Vaccines and Related Biological Products Advisory Committee11,12 and the Advisory Committee on Immunization Practices (ACIP).13 These advisory groups are composed of medical, scientific, health policy, and public health experts who review data and develop recommendations for the use of vaccines…
The FDA should share all allowable and available data about a vaccine candidate with the FDA vaccine advisory committee and ACIP prior to making any decision about an Emergency Use Authorization (EUA) or approval. Typically, the FDA’s vaccine committee makes recommendations prior to agency action, and ACIP soon afterward. In this challenging situation, the FDA should seek the input of both committees prior to making a decision. An FDA decision consistent with the advice of these independent experts will then reassure the public. However, if the FDA goes in a different direction, the agency will need to explain the reasons well to avoid confusion and vaccine hesitancy. If either panel is excluded from reviewing data, the FDA may struggle to convince the public and clinical community about the strength of the evidence, and vaccine uptake may be adversely affected.
Important safeguards should be established to reassure the clinical community and the public about any vaccine approval. The FDA should explain the role of the data and safety monitoring boards (DSMBs) for the vaccine trials, the first “independent” group that reviews the data, and any correspondence between the DSMB and the project investigators should be shared with the public. Two additional groups have an important consultant responsibility to the government and the public: the FDA Vaccines and Related Biological Products Advisory Committee11,12 and the Advisory Committee on Immunization Practices (ACIP).13 These advisory groups are composed of medical, scientific, health policy, and public health experts who review data and develop recommendations for the use of vaccines.
(J. Harris: The public as well as civilian health care providers must have confidence that the Vaccines that are being developed are safe and effective. Civilian physicians, which is to say, working doctors who are not on the government payroll, must be satisfied that the Vaccine(s) selected are safe and worthwhile. If civilian physicians are unable to reassure their patients and convince them to take the Vaccine, then the people, understandably, won’t take them.
Some of us remember the Swine Flu fiasco when President Gerald Ford was ill-advised by his medical experts as well as by revered historical vaccination doctors in 1976, an election year. In those days, private physicians like myself FIRMLY believed in and trusted The Centers for Disease Control and Prevention (CDC), The National Institutes of Health (NIH), and The Food and Drug Administration. We knew many of the doctors who ran those agencies, and we trusted them. Everyone involved well knew the horrors of “Spanish Flu;” that knowledge was still fresh and familiar to practicing physicians and to most American citizens in those 1976 days.
That fall, I administered many, many Swine Flu shots and fortunately had no mishaps — and no flu. I was lucky, but retrospectively, I made a mistake in giving the vaccinations. I wasn’t alone, and until recently, I have not reconsidered my decision then to try and prevent another H1N1 flu epidemic. But my revered experts were wrong in’76 as was Washington.
WE will get it right this time. The world’s need for an effective and safe vaccine is acute and desperate. This Pandemic is real — and dreadful. A good vaccine is mandatory and will be forthcoming. It should be possible to share it worldwide.
What do you call a belt made of watches? A waist of time!
What do sprinters eat before a race? Nothing. They fast.
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