Coronavirus

By Henry Miller, M.S., M.D. and Kathleen Hefferon There is ongoing disagreement between the popularly elected European Parliament and the executives in the European Commission over approvals of “genetically modified” (GM) crops, which are made with modern molecular genetic engineering techniques. In December, members of the European Parliament objected to authorizations of no fewer than five new GM crops — one soybean and four corn (maize) varieties — developed for food and animal feedstock. These objections follow dozens of others that have been...

This week, the U.S. Centers for Disease Control and Prevention released alarming data on COVID-19 vaccine uptake among some healthcare workers. Fewer than 40% of staffers across 11,400 skilled nursing facilities chose to get the vaccine in December and January. That's a big problem. Front-line workers are among those at highest risk of contracting the coronavirus. By holding off on getting the vaccine, they're risking the health of the people they serve. And because they're often first in line, their hesitancy could sow unwarranted doubt about...

By Sarah Downey, Northern California Record With California now predicting it could take months longer than anticipated to vaccinate people ages 65 and older, a health policy expert said a wider distribution network could improve efficacy and help the state advance further in its economic recovery. California has received nearly 5 million COVID-19 vaccine doses but only 2.2 million have been administered, according to the latest data from the CDC. . . . . . “They need to get with the program and get the vaccines out there...

Last week, former FDA commissioner Dr. Scott Gottlieb suggested that we "hit the reset" button on Covid-19 vaccine distribution. That reset should include taking the government out of the equation. The government has largely failed to get life-saving vaccines into the arms of Americans. And the consequences are deadly. The government's botched rollout of the coronavirus vaccine stands out as Exhibit A in the argument against more government control over our health care. Amazingly, inventing a safe and effective Covid-19 vaccine may turn out to...

By Monday afternoon, of 25.5 million COVID-19 vaccine doses distributed across the United States, just 9 million had actually been administered to patients. That's well short of the government's goal of inoculating 20 million people by the end of 2020. Perhaps we shouldn't be surprised. Government-controlled markets are notoriously inefficient and subject to waste, fraud, and abuse. In this case, tragically, the consequences are deadly. Inexplicably, the government is moving with no real sense of urgency. In December in New York City, vaccinations effectively weren't...

Dr. Henry Miller, M.S., M.D., joints the nationally-syndicated Lars Larson Show based out of Portland, Oregon, to discuss the latest issues with the production and distribution of the COVID-19 vaccine. Dr. Miller's interview begins at the 47:00 minute mark. Miller talks about his disappointment with the vaccine distribution, but also says that it wasn't entirely unexpected. When you put distribution on the states and farther down the chain, your going to have issues. Miller also says that the timing of the...

By Henry I. Miller, M.S., M.D. and John J. Cohrssen Few could have imagined a year ago that by now our world would be so profoundly changed by a pandemic that has killed more than 300,000 Americans; been confirmed in over 16 million; gone undiagnosed in scores of millions more; and caused debilitating, persisting symptoms in many who have “recovered.” Certainly, no credible drug manufacturer would have claimed that a new vaccine for this emerging infectious disease could go through all...

To the editor of the Wall Street Journal: Your editorial contains the statement: "There's no evidence that a three-week review is needed." You know this how, exactly? Has anyone at the Journal seen the data (which run to hundreds of thousands of pages)? Has anyone at the Journal ever seen, let alone touched, an application for approval of a drug or vaccine? I have. As an FDA reviewer, I found extraordinary complexity, and sometimes shortcomings or inconsistencies, in many submissions ....

Public Health And Economic Growth Are Two Sides Of The Same Coin Vaccination of high-risk groups against SARS-CoV-2, the virus that causes COVID-19, has begun in earnest – and not a moment too soon because the trends in the United States are moving in the wrong direction. On December 13, records were set for 7-day averages of daily cases ((211,494), the number of people hospitalized (106,656), and daily deaths (2,427); and with the Christmas and New Year’s holidays approaching, we can expect worsening...

Dr. Henry Miller joins the John Batchelor Show for his weekly conversation about the coronavirus and COVID-19 vaccine. Miller and Batchelor discuss the Pfizer declaration for an emergency track and approval with the FDA to begin distributing a vaccine for treatment against the novel coronavirus. Miller shares his 15 years of experience at the FDA including the precedent that all applications and decisions are made with incomplete data when it comes to vaccines and that an approval by the FDA...

We are in the midst of a pandemic of historic proportions. COVID-19 has killed more than a quarter of a million Americans, caused pain and suffering to many more, damaged a thriving economy, and caused great public anxiety. And it promises to get worse before it gets better. The numbers of cases, the percentage of positive test results, and hospitalizations are all trending upwards. That bodes particularly ill as the Thanksgiving and Christmas holidays approach, tempting many of us into high-risk situations. Relief...

By Andrew Fillat and Henry Miller, M.S., M.D. The announcement last week by Pfizer that its COVID-19 vaccine has been shown in large-scale clinical trials to be more than 90% effective at preventing symptomatic infection has been much in the news. [After this article was posted, biotechnology firm Moderna, Inc., announced that its vaccine was 94.5% effective.] It is especially welcome news, given the skyrocketing numbers of COVID-19 cases, percentage of positive tests, and hospitalizations in much of the nation. However, to state the obvious,...

President Trump’s COVID-19 recovery has thrust into the spotlight the possibilities of novel, experimental therapies for this potentially deadly disease.  During his stay at Walter Reed National Military Medical Center, he was treated with at least three drugs that have since received substantial attention in the media: the anti-viral remdesivir, the glucocorticoid steroid dexamethasone, and the monoclonal antibody cocktail REGN-COV2. While evidence suggests these drugs may be effective (and remdesivir just received full marketing approval from the FDA), there are other potential game-changers...

There is widespread anticipation of the availability of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal. Some four dozen vaccines, made with a variety of technology platforms, are now in clinical trials; nine are in large-scale safety/efficacy testing. Several of the more promising development programs have been accelerated by a White House crash program, “Operation Warp Speed,” which was launched in May. It was no secret that there would be intense pressure...

Dr. Henry Miller and Lars Larson talk about who could be eligible for an early vaccine and what data could tell us about how effective the vaccine will be on different age groups. Miller also talks about having insufficient data on vaccine clinical testing for seniors or those more at risk of COVID-19 due to those not involved in the study and sheltering at home. Miller and Larson also discuss concerns from health experts like Dr. Anthony Fauci about the coming...

Title: Here’s what you need to know about clinical trials as drug makers push forward with coronavirus vaccine studies By: Jaimy Lee Whether you’re new to investing in pharmaceutical or biotechnology companies or simply paying close attention to the race to develop a COVID-19 vaccine, questions may have occurred about how clinical trials work — here’s what you need to know to understand the process. The first thing is that we’ve never seen vaccines developed as quickly as what is happening right now....

Dr. Henry Miller and Lars Larson talk about the latest in progress in the search for a vaccine for the coronavirus pandemic, including the recent news that AstraZeneca has paused their third-stage clinical trial for a COVID-19 vaccine due to an illness to a participant. Miller talks about how the review process works when it comes to assessing the safety of a vaccine in the clinical trial phase. Dr. Miller's segment begins at the 47:00-minute mark. Lars Larson National Podcast · Lars...

There is widespread anticipation of the availability of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal. About four dozen, made with a variety of technology platforms, are now in clinical trials, nine in large-scale safety/efficacy testing. It was hardly a secret that there would be intense pressure on the FDA from a White House desperate for good news to provide an “October Surprise” in the form of a vaccine approval before...

There is widespread anticipation of vaccines to prevent COVID-19 infections so that Americans can get their lives back to some semblance of normal. About four dozen, made with a variety of technology platforms, are now in clinical trials, nine in large-scale safety/efficacy testing. Vaccines have also assumed unprecedented political importance. The Washington Post reported on Sunday: “President Trump is so fixated on finding a vaccine for the novel coronavirus that in meetings about the U.S. pandemic response, little else captures his attention, according to administration...

Nearly three dozen attorneys general are attempting a legal act of theft. This month, attorneys general from 31 states, American Samoa, Guam and the District of Columbia sent a letter to the heads of the U.S. Department of Health and Human Services, the National Institutes of Health and the Food and Drug Administration asking the federal government to revoke Gilead Sciences ’ patent for remdesivir, an antiviral drug shown to reduce mortality in patients with Covid-19. The attorneys general effectively assert...