Coronavirus

Several European countries just instituted another round of lockdowns amid a new wave of Covid-19 cases. This turn of events is sobering but puzzling. Europe seemed to have Covid-19 under control a few months ago, at least compared to the United States. What happened? The countries' vaccination rates offer an explanation. Europe has inoculated far fewer people than the United States. So while Americans may enjoy some semblance of normalcy by summer, Europeans may face dark days ahead. Unfortunately, European countries can only blame themselves for their...

Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, recently expressed a sense of "impending doom" regarding the pandemic. Her fear is that, unless Americans keep abiding by strict Covid-19 protocols like mask-wearing, social distancing, and forgoing travel, a new surge in cases and deaths could be on the horizon. "I so badly want to be done," Walensky said. "So I'm asking you to just hold on a little longer." Dr. Scott Gottlieb, the former commissioner of the Food and...

President Joe Biden recently toured a Pfizer plant in Kalamazoo, Mich., where workers are churning out millions of lifesaving COVID-19 vaccine doses. During his remarks, he mentioned that in mid-February he had “toured the Vaccine Research Center at the National Institutes of Health . . . [where] I met world-class doctors, scientists, and researchers who were critical for discovering the vaccines in record time.” Frankly, the president is giving the government too much credit. While federal grants and purchase agreements certainly helped...

Dr. Henry Miller, PRI's senior fellow, joins the nationally-syndicated Lars Larson Show to talk about the difference in COVID-19 vaccine efficacy or intended result between the Pfizer, Moderna, and Johnson & Johnson vaccines, with the vaccines ranging from 60 to 90 percent. Miller explains that there is more context to the vaccine efficacy explanation, which depends on when they were tested, approved for emergency use, and available testing at the time of the clinical trials. Miller also talks about the roles...

By Henry Miller, M.S., M.D. and John Cohrssen Over the weekend, the FDA issued an emergency-use authorization for Johnson & Johnson's Covid-19 vaccine, clearing the path to market for the third coronavirus vaccine. The FDA had previously approved the Pfizer-BioNTech and Moderna Covid vaccines in record time—mere weeks after their makers submitted results of the clinical studies demonstrating safety and efficacy. When the FDA wants to, it can get desperately needed products expeditiously to those who need them. But for some other...

Dr. Henry Miller joins the Dan Proft Show to discuss the latest re-openings of states like Texas and how they may pose challenges to stopping the spread of COVID-19. Miller and Proft discuss the different lockdown measures in other states and how that impacts lockdown policies throughout the United States. ...

Why AstraZeneca and J&J’s Vaccines, In Use Elsewhere, Are Still on Hold in America By Sarah Jane Tribble The World Health Organization greenlighted emergency use of AstraZeneca and Oxford’s covid-19 vaccine this month, following in the steps of the United Kingdom, the European Union and others, who are already injecting it as quickly as possible into the masses. But the United States is still waiting. . . . . . This moment — as Americans question why more tested vaccines like AstraZeneca and J&J’s vaccines...

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,...