Category Archives: Vaccine

What do Pfizer’s and Moderna’s COVID-19 vaccine announcements mean for you?

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https://www.politifact.com/article/2020/nov/12/what-does-pfizers-covid-19-announcement-mean-you/

COVID vaccine: What the second shot in the Moderna trial was like

IF YOUR TIME IS SHORT

  • If all goes according to plan, health care workers and individuals at high risk for severe illness from COVID-19 could be vaccinated as early as December.
  • Experts predict that the broader public could start being vaccinated in April.
  • The distribution of the vaccine could present some challenges for state and federal governments. That or any other unexpected events could delay the vaccine’s distribution.

When drugmaker Pfizer announced that its new vaccine was highly effective at preventing COVID-19, it raised hopes that the coronavirus pandemic could be nearing its end. 

In a Nov. 9 press release, the company and its partner BioNTech claimed that an early analysis of clinical trial data found that inoculated individuals experienced 90% fewer cases of symptomatic COVID-19 than those who had received a placebo. 

These results surpassed expectations. For months, experts have warned that a new vaccine might only be 60% effective. If Pfizer’s analysis is accurate — and it has yet to produce official scientific documentation —  the new vaccine would offer a level of protection equal to that of highly effective vaccines for diseases such as measles. 

Experts told us that Pfizer’s announcement is cause for optimism. However, the country, and the world, still have a way to go before coronavirus vaccines become available to ordinary Americans. 

Here’s what we know about when the vaccine might be distributed and what that process could look like. What’s next for Pfizer’s vaccine?

If the information in the press release is accurate, Pfizer will likely be the first company to come up with a vaccine that meets the Food and Drug Administration’s requirements for distribution. 

To get approval from the FDA, Pfizer has to gather two months of safety data on clinical trial participants to gauge whether the treatment has any negative side effects. The company will reach the two-month benchmark in the third week of November. Barring any unexpected developments, it will then submit its vaccine to the FDA for emergency use authorization, a special provision allowing the use of an unapproved product during a state of emergency.  

After Pfizer submits its data to the FDA, the agency will analyze it to see if it’s sufficient to begin distribution. After approval from the FDA, the vaccine would be assessed by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The Advisory Committee will then issue a recommendation to the CDC, which will make the final ruling about whether to distribute the vaccine.  

This might sound intricate, but James Blumenstock, the chief program officer for health security at the Association of State and Territorial Health Officials, said that the vaccine could probably be approved by the FDA and the CDC in a matter of days rather than weeks. 

“Both agencies are standing ready and will give these requests and this assessment the highest level of priority just for expediency’s sake,” he said. 

What this means is that high-priority Americans, such as health care workers, could be vaccinated as early as December. What a vaccine rollout might look like.

Pfizer predicts that it will be able to manufacture only 50 million doses for global consumption by the end of the year, enough to vaccinate 25 million people. (The world’s population is about 7.8 billion.)

With a limited number of doses available, the eventual rollout of a vaccine would likely consist of two phases. During the first phase, U.S. health care workers, emergency responders and individuals at higher risk of severe illness would be eligible for vaccination. If all goes according to plan, the first phase will commence sometime in December. 

During the second phase, the vaccine would become available to the broader public. Most experts told us that they expect the second phase to start sometime in April, although the date would vary depending on Pfizer’s vaccine production rates and whether other companies get their vaccines greenlit by the FDA and CDC. The state of other vaccines

As of early July, there were roughly 160 vaccine projects under way worldwide, according to the World Health Organization. 

Pfizer’s announcement bodes well for other vaccine candidates, said Matthew B. Laurens, an associate professor of pediatrics at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health. 

Pfizer’s vaccine uses genetic material, known as mRNA, that provides the instructions for a body to produce coronavirus proteins, known as antigens, in the hope that these could prime the human immune system to fight the virus. The biotechnology company Moderna is also manufacturing a vaccine that uses mRNA and is set to receive trial data by the end of November. 

Other companies in the United States and Europe producing a vaccine include Novavax, which plans to start clinical trials in the U.S. and Mexico by the end of November; Johnson & Johnson, which recently resumed testing its vaccine candidate after a brief pause; and AstraZeneca, which expects to have clinical trial data by the end of the year. 

The more companies there are that are able to produce a vaccine, the quicker the vaccine will become widely available, experts say.

Vaccine presents potential distribution hurdles

The CDC will be in charge of the distribution process, with involvement from the U.S. Defense Department, said Dr. Litjen Tan, chief strategy officer for the Immunization Action Coalition, which distributes information about vaccines to try to increase vaccination rates. 

Vaccines would be manufactured and then transported to states, which will then pass the vaccine on to providers, such as hospitals. The McKesson Corp., which has received a federal contract to distribute the treatment, will assist pharmaceutical companies and the government with the shipping process. 

Shipping the doses will present some challenges. Pfizer’s vaccine has complex and ultra-cold storage requirements that many hospitals, particularly those in hard-to-reach areas, won’t be able to meet. 

The cold chain requirement “is an issue for Pfizer, but manufacturing and distribution are issues for all vaccines,” said Robert Finberg, a physician and infectious disease specialist at the University of Massachusetts Medical Center.

To surmount this hurdle, Pfizer plans to transport the vaccine in thermal shippers that can keep the vaccine at the necessary temperature of minus 70 degrees Celsius for about two weeks. However, the shippers themselves present additional problems for distribution, Tan said. Each shipment consists of five trays containing 975 doses of vaccine, and reducing the size of the shipment could dramatically raise the cost of distribution. 

As a result, the states might initially prioritize shipping the vaccine to major hospitals rather than rural hospitals that service fewer patients in order to avoid waste. 

Blumenstock told us that state and federal governments are working hard to make sure that all regions of the U.S. receive proportionate amounts of vaccine. However, he acknowledged that hospitals in remote areas that don’t service many patients could initially take longer to get the vaccine than a well-trafficked hospital in a heavily populated area.

“Outskirt hospitals won’t be ignored or marginalized, even if it takes more time and effort to get them the vaccine,” he said. “One of the primary principles will be equitable distribution, even when that means you need to take extraordinary measures for logistics, transportation, and handling.” 

Overall, experts said that Pfizer’s announcement is a significant step forward. “I’m optimistic that we have a vaccine that’s safe and effective,” said Tan. “And I’m glad that what we’re dealing with now is the problem of how to get it to the public.”

Moderna’s coronavirus vaccine found to be nearly 95 percent effective in a preliminary analysis

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https://www.washingtonpost.com/health/2020/11/16/covid-moderna-vaccine/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR2C1xT32w2cq_7iAuorzUlDpPUdNPyoaYS_6cA4X-vF-gp91-j1g1xS2g0
Moderna says its COVID-19 vaccine is 94.5 percent effective | US & Canada | Al Jazeera

Biotechnology firm Moderna announced Monday that a preliminary analysis shows its experimental coronavirus vaccine is nearly 95 percent effective at preventing illness, including severe cases — a striking initial result that leaves the United States with the prospect that two coronavirus vaccines could be available on a limited basis by the end of the year.

The news comes a week after pharmaceutical giant Pfizer and its German partner BioNTech lifted the stock market and people’s hopes with the news that their coronavirus vaccine was more than 90 percent effective. The announcement sent stocks up again, with the Dow Jones industrial average and S&P 500 up about 1 percent in midmorning trading. Moderna’s share price rose more than 6 percent.

At a briefing Monday, government officials predicted that if the two vaccines receive a regulatory greenlight, the first shots could be given in December, with enough to vaccinate 20 million people that month — and more becoming available into 2021 as production ramps up and other vaccine candidates may be successful.

“It’s extremely good news. If you look at the data, the numbers speak for themselves,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, who was one of three people briefed on the data by an independent committee Sunday morning. “I describe myself as a realist, but I’m fundamentally a cautious optimist. I felt we’d likely get something less than this. … I said certainly a 90-plus-percent effective vaccine is possible, but I wasn’t counting on it.”

Moderna’s vaccine, co-developed with Fauci’s institute, is being tested in 30,000 people. Half received two doses of the vaccine, and half received a placebo. To test how well the vaccine works, physicians closely monitored cases of covid-19 to see whether they predominantly occurred in people who received the placebo.

Of the 95 cases of covid-19, the disease caused by the virus, 90 were in the group that received the placebo. There were 11 severe cases reported — all in people who received the placebo. With cases of covid-19 confined almost exclusively to trial participants receiving a placebo, that sends a strong signal that the vaccine is effective at thwarting the virus.

The data have not yet been published or peer reviewed, and the overall effectiveness of the vaccine may change as the study continues. But Fauci said the data on severe cases was “quite impressive” and effectively answers a question that has lingered: whether a vaccine measured by its success in preventing any case of covid-19 can prevent the most urgent cases, too.

An independent data committee, convened by the National Institutes of Health, analyzed the results Sunday morning. Stéphane Bancel, chief executive of Moderna, said in an interview that he spent the morning trying to distract himself from wondering about the results by working at his home in Boston, but instead he found himself constantly checking his phone and email. When he learned the results later in the morning, the evidence that the vaccine prevented severe disease stood out as most consequential.

“In this pandemic, what has been awful from a public health standpoint, an economic standpoint, is the worry people have to get so sick they have to go to the hospital — so sick they have to get to the ICU and have a high risk of dying,” Bancel said. “If a [vaccine] could prevent 95 percent of people to not get disease, but to not get severe disease, that would be a game-changer: the impact on hospitals, the impact on people’s psyche and the impact on deaths.”

Many questions about details remain. How long will the protection last? Will results be similar across all subgroups? Does the vaccine decrease the infectiousness of the virus in people without symptoms?

But the early successes show the power and speed of a new vaccine technology never before used in an approved medical product that delivers a strip of genetic material called messenger RNA to teach the body to defend against the virus. The messenger RNA carries the blueprint for the distinctive spike protein that dots the outside of the coronavirus, instructions that the body’s cells follow to build the spike protein.

“It is extremely encouraging,” said Stanley Plotkin, inventor of the rubella vaccine. “This and the earlier result shows that the platform really works, and this bodes very well for other diseases, where this platform could be used — and considering the speed with which the platform was put into operation. It’s an excellent result.”

Moderna has committed to completing its trial before applying for emergency-use authorization — which means waiting until there are 151 cases of covid-19 in the study. A previous projection showed that the trial might end sometime early next year, but it is instead expected to reach its endpoint in seven to 10 days, Bancel said, because of surging coronavirus cases in the United States. The explosion of virus cases translates into an expedited ability to ascertain whether a vaccine works.

The company will have enough safety data to support an application shortly before Thanksgiving. Bancel anticipates a vaccine might begin to become available to those at high risk in the second half of December.

Unlike Pfizer, which invested $2 billion of its own money in researching and developing a vaccine, Moderna is part of Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing upfront funding to companies and helping coordinate the trials. Moderna received nearly $1 billion from the U.S. government to support research and development. The companies both have contracts to sell 100 million doses to the U.S. government.

Moderna projects it can produce 20 million doses by the end of the year — enough for 10 million people to get both shots. The company aims to produce at least 500 million doses next year, with the possibility of scaling up to 1 billion doses depending on the availability of raw materials.

The side effects of the two-dose vaccine were mostly mild or moderate, including pain at the injection site, fatigue, headache and muscle pain, according to the company’s news release.

Regulators at the Food and Drug Administration must review the evidence for the Moderna and Pfizer vaccines, but the robust early indication of success suggests both vaccines might become available to high-risk populations before the end of this year.

Fauci predicted that people such as health-care workers or people with conditions that raise their risk of developing severe disease could begin receiving doses before the end of the year. It could take about four months to vaccinate people in high-risk groups, and in April, the vaccine could expand to the rest of the population.

The two successes could have ripple effects that influence the ongoing trials and in future coronavirus vaccine trials. People currently in the Moderna and Pfizer trials do not know whether they received the real vaccine or placebo, and at some point, those who received a placebo may be crossed over to receive the real thing. But the decision to do that will mean a loss of follow-up and valuable data.

“Given these products will be given to potentially billions of people, you have to be careful to make sure they’re safe and effective, and there’s no easy way around that issue,” said Ira Longini, a biostatistics expert at the University of Florida, who said a year of follow-up on participants would be ideal.

The focus on vaccines will now shift to the daunting logistics of manufacturing and distribution.

The Pfizer vaccine requires ultracold storage conditions — minus 70 degrees Celsius — not widely available in typical vaccination settings. The company has been working to overcome that limitation.

Moderna announced Monday that its vaccine can be stable at refrigerator temperatures for a month and frozen for up to six months. It will not require dilution at the point of care, unlike the Pfizer vaccine.

What You Need To Know About Pfizer’s Covid-19 Vaccine

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https://www.forbes.com/sites/alexknapp/2020/11/10/what-you-need-to-know-about-pfizers-covid-19-vaccine/?utm_source=newsletter&utm_medium=email&utm_campaign=coronavirus&cdlcid=5d2c97df953109375e4d8b68&sh=59243ea54c46
Pfizer's Covid-19 Vaccine Is 90% Effective, But Has Storage & Shipping Issues | Boomers Daily

On Monday, Pfizer announced preliminary results from the phase 3 trial of the vaccine that it has developed with German company BioNTech, suggesting that it may be up to 90% effective at preventing Covid-19 with no serious safety concerns. The vaccine, which represents a new way to make a vaccine, might be ready for an Emergency Use Authorization from the FDA by the end of the year. 

BioNTech’s vaccine is an mRNA (as in “messenger RNA,” which might ring a faint bell from high school biology class) vaccine, similar to one being developed by Boston-based Moderna as well as Translate Bio, which is partnered with pharmaceutical giant Sanofi. This type of vaccine has been in the works for other diseases, including the flu, but none have been approved for use by any regulatory body yet. Success with this platform has the potential to accelerate the development of vaccines for new diseases, a process which can typically take close to a decade. 

Here’s what you need to know.  

Pfizer’s vaccine is based on a new kind of technology

Traditional vaccines are made from dead or weakened versions of an infectious virus. This new type of vaccine is different. To develop it, the genes of the SARS-CoV-2 virus, which causes Covid-19, were first analyzed to locate the part that codes its “spike” protein, which is what enables the virus to infect people. The codes for that protein are then isolated and copied as mRNA fragments, which is what cells use as instructions for making proteins. Those fragments are packaged up into special molecules, then injected into the patient’s cells.

Within the cells, the mRNA comes into the body’s protein factories, called ribosomes. The ribosomes “read” the mRNA, and follow its instructions to make copies of the spike protein. Those copies of the spike protein can’t, by themselves, cause harm. But they’ll trigger the body to make antibodies against the virus. Those antibodies, in turn, will protect patients from a Covid-19 infection. At least, that’s the idea. 

The vaccine still needs to be approved by the Food and Drug Administration

Before the vaccine can be distributed, it has to first be approved by appropriate regulatory bodies. In the United States, that’s the FDA. Pfizer has said that it intends to seek an Emergency Use Authorization from the FDA to enable distribution and administration of the vaccine in late November, at which point the company will have an average of two months’ worth of safety data for each patient. That’s because most bad reactions to vaccines happen shortly after infection. Additionally, Pfizer will continue to monitor the patients in its study for two years after the vaccine administration. 

Distributing this vaccine is more complicated than for a typical vaccine

Although one advantage of mRNA vaccines is that they’re potentially faster to develop than traditional vaccines, their administration and distribution is scads more complicated. For example, the Pfizer vaccine is currently being tested on a two-dose schedule, 21 days apart, unlike the single dose of a typical vaccine for diseases like the flu. The 21-day separation has raised some concerns about the patient compliance needed for vaccines to work.

For long-term storage, the vaccine has to be kept at very cold temperatures—around –70° Celsius (–94° Fahrenheit), which requires a specialized freezer. (Flu vaccines, by contrast, can usually be stored in a refrigerator.) The company has developed a specialty thermal shipping container, which can be kept cold with dry ice and be used to store the vaccine doses for up to 15 days. If long-term storage isn’t required, Pfizer’s vaccine can be stored in a refrigerator, but only for up to five days. 

Pfizer footed the bill for its own part of vaccine development

Several companies, such as Moderna, have received federal funding and support for the development of their vaccines and treatments through the research and development process. Pfizer opted out of that, choosing instead to spend $1 billion of its own money to move the vaccine forward. “A billion dollars is not going to break us,” CEO Albert Bourla told Forbes earlier this year. 

That said, BioNTech did receive a $442 million grant from the German government to help develop the vaccine. And in July, the two companies signed an agreement to sell at least 100 million doses to the U.S. Department of Health and Human Services (HHS) for $1.95 billion. The country of Spain has initially secured 20 million doses of the vaccine as well. 

Biden’s 7 point plan for the pandemic

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https://www.beckershospitalreview.com/hospital-management-administration/biden-s-plan-for-the-pandemic-7-things-to-know.html?utm_medium=email

Trump's And Biden's Coronavirus Plans: Vaccines, Testing : NPR

President-elect Joe Biden and Vice President-elect Kamala Harris have released a seven-point plan regarding the COVID-19 pandemic.

The Biden administration’s seven pandemic plans:

1. Ensure all Americans have access to regular, reliable and free testing by doubling the number of drive-thru testing sites, investing in next-generation testing, developing a pandemic testing board to produce and distribute tests, and establishing a U.S. Public Health Jobs Corps.

2. Provide all states, cities, tribes and territories with critical supplies. Efforts will include full use of the Defense Production Act, building American-sourced and manufactured capabilities. 

3. Provide clear, consistent and evidence-based guidance for how communities should navigate the pandemic. Planned resources will be tailored to the needs of schools, small businesses and families.

4. Plan for effective and equitable distribution of treatments and vaccines. The administration intends to invest in a $25 billion manufacturing and distribution plan to guarantee every American can receive the vaccine for free. The administration also said it will work to ensure that politics won’t play a role in determining the safety and efficacy of vaccines.   

5. Protect older Americans and other high-risk groups. Efforts will include establishing a COVID-19 racial and ethnic disparities task force and a nationwide pandemic dashboard that can be checked in real-time to gauge local transmission.

6. Rebuild and expand defenses to prevent and mitigate pandemic threats, including the restoration of the White House National Security Council Directorate for Global Health Security and Biodefense and the nation’s membership with the World Health Organization.

7. Implement nationwide mask mandates.

President-elect Biden announces coronavirus task force made up of physicians and health experts

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https://www.washingtonpost.com/health/2020/11/09/biden-coronavirus-task-force/?utm_source=nl&utm_brand=wired&utm_mailing=WIR_Science_110920&utm_campaign=aud-dev&utm_medium=email&bxid=5db707423f92a422eaeaf234&cndid=54318659&esrc=bounceX&source=EDT_WIR_NEWSLETTER_0_SCIENCE_ZZ&mbid=mbid%3DCRMWIR012019
Joe Biden Live Updates: President-Elect Talks Mask Wearing, Pandemic - The New York Times

President-elect Joe Biden on Monday announced the members of his coronavirus task force, a group made up entirely of doctors and health experts, signaling his intent to seek a science-based approach to bring the raging pandemic under control.

Biden’s task force will have three co-chairs: Vivek H. Murthy, surgeon general during the Obama administration; David Kessler, Food and Drug Administration commissioner under Presidents George H.W. Bush and Bill Clinton; and Marcella Nunez-Smith, associate dean for health equity research at the Yale School of Medicine. Murthy and Kessler have briefed Biden for months on the pandemic.

Biden will inherit the worst crisis since the Great Depression, made more difficult by President Trump’s refusal to concede the election and commit to a peaceful transition of power. The Trump administration has not put forward national plans for testing, contact tracing and resolving shortages in personal protective equipment that hospitals and health-care facilities are experiencing again as the nation enters its third surge of the virus.

“Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts,” Biden said in a statement. “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.”

The United States is recording more than 100,000 new coronavirus cases a day and, on many days, more than 1,000 deaths, a toll expected to worsen during the crucial 10-week stretch of the transition. It remains unclear whether Trump or his top aides will oversee and lead a robust response to the pandemic during the transition, which could further exacerbate the crisis Biden and Vice President-elect Kamala D. Harris inherit.

The 13-member task force also includes former Trump administration officials, including Rick Bright, former head of the Biomedical Advanced Research and Development Authority, who, after being demoted, spoke out against the administration’s approach to the pandemic. Luciana Borio, director for medical and biodefense preparedness on Trump’s National Security Council until 2019, is also on the panel.

The group includes several other prominent doctors:

· Ezekiel Emanuel, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

· Atul Gawande, a surgeon at Brigham and Women’s Hospital and a professor at Harvard Medical School who is a prolific author.

· Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

· Eric Goosby, global AIDS coordinator under President Barack Obama and professor of medicine at the University of California at San Francisco School of Medicine.

· Celine R. Gounder, clinical assistant professor of medicine and infectious diseases at New York University’s Grossman School of Medicine.

· Julie Morita, executive vice president of the Robert Wood Johnson Foundation, a philanthropy focused on health issues.

· Loyce Pace, president and executive director of the Global Health Council, a U.S.-based nonprofit organization dedicated to global health issues.

· Robert Rodriguez, professor of emergency medicine at the UCSF School of Medicine.

Rebecca Katz, director of the Center for Global Health Science and Security at Georgetown University Medical Center, and Beth Cameron, director for global health security and biodefense on the White House National Security Council during the Obama administration, are serving as advisers to the transition task force.

Task force members will work with state and local officials to craft public health and economic policies to address the virus and racial and ethnic disparities, while also working to reopen schools and businesses, the transition team said in a news release.

While the makeup of the task force garnered widespread praise, Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine, said the group needs more geographic diversity.

“They are all from the Acela corridor or the [San Francisco] Bay Area,” he said. “Who is going to be the field marshal or the supreme allied commander who goes into middle of the country and get this done? The coasts are doing okay but the red states are being hammered and the deaths are going to be extraordinary. There needs to be a frank reckoning between leaders of the two parties, to say we cannot let this happen.”

Public health experts said Biden should use the transition to provide leadership as the pandemic continues through a deadly stretch and begin communicating a strong national message.

“Clearly from the election outcomes, half the country doesn’t believe we’re in a crisis,” said Kavita Patel, a fellow at the Brookings Institution who worked on health policy in the Obama administration. Biden and Harris “have an incredible platform that can be used for communication. The country needs clear daily briefings that we thought we’d get from the White House coronavirus task force. They have an incredible platform, if not an official platform.”

Biden plans to call Republican and Democratic governors to ask for their help in developing a consistent message from federal and state leaders, according to three Biden advisers who spoke on the condition of anonymity because they were not authorized to speak publicly about these matters. He will urge governors to adopt statewide mask mandates and to provide clear public health guidance to their constituents, including about social distancing and limiting large gatherings.

The task force will have subgroups that focus on issues related to the response, including testing, vaccine distribution and personal protective equipment, according to two people familiar with the plans who spoke on the condition of anonymity to reveal plans that were not yet public.

In his victory speech Saturday, Biden addressed challenges in bringing the pandemic under control.

“We cannot repair the economy, restore our vitality or relish life’s most precious moments — hugging a grandchild, birthdays, weddings, graduations, all the moments that matter most to us — until we get this virus under control,” Biden said. “That plan will be built on a bedrock of science. It will be constructed out of compassion, empathy and concern. I will spare no effort — or commitment — to turn this pandemic around.”

Yet the plans Biden laid out on the campaign trail are set to collide with political realities. That includes a deeply divided nation in which more than 71 million people voted for Trump and the possibility of having to navigate a Republican-controlled Senate disinclined to support a greater federal role in testing and contact tracing, among other responsibilities now left mostly to the states.

Biden’s most ambitious plans will require significant congressional funding. Senate Majority Leader Mitch McConnell (R-Ky.) has said he would like to pass new coronavirus relief measures during Congress’s lame-duck session, and Congress faces a Dec. 11 government funding deadline. Biden and his team are poised to begin engaging with congressional Democrats on their priorities.

Biden’s plans include dramatically expanding testing and building a U.S. public health jobs corps to have 100,000 Americans conduct contact tracing. They also include ramping up production of personal protective equipment and implementing a vaccine distribution plan.

Murthy, who served as the 19th U.S. surgeon general, is a physician whose nomination was stalled in the Senate for more than a year because of his view that gun violence is a public health issue. Three months into the Trump administration, he was replaced as “the nation’s doctor” with more than two years left on his four-year term.

In 2016, he wrote a landmark report on drug and alcohol addiction, which put that condition alongside smoking, AIDS and other public health crises that previous surgeons general addressed. The report called the addiction epidemic “a moral test for America.” Murthy’s office sent millions of letters to doctors asking for their help to combat the opioid crisis.

The son of immigrants from India, he earned medical and MBA degrees at Yale before joining the faculty at Harvard Medical School, where his research focused on vaccine development and the participation of women and minorities in clinical trials.

After leaving his post as surgeon general, he wrote a book on loneliness and social isolation, including their implications for health, that grew out of his conversations with people in clinical practice and as surgeon general.

Several public health officials celebrated Nunez-Smith’s leadership role on the task force. Her research focuses on promoting health and health-care equity in marginalized populations, according to her Yale biography. She has also studied discrimination that patients endure in the health-care system — expertise that many said was welcome in an epidemic that is disproportionately affecting people of color.

Kessler was FDA commissioner from 1990 to 1997, during the George H.W Bush and Clinton administrations. He is well-known for his attempts to regulate cigarettes — an effort that resulted in a loss in the Supreme Court, which ruled that the agency did not have the authority. That prompted Congress to pass a law, enacted in 2009, that explicitly gave the agency that power.

Kessler, a pediatrician and lawyer, worked at the FDA to accelerate AIDS treatments and on food and nutrition issues. He oversaw the FDA’s development of standardized nutrition labels and notably ordered the seizure of orange juice labeled “fresh” because it was made from concentrate. He has written several books on diet, mental illness and other topics, and has served as dean of the medical schools at Yale and UCSF.

Pfizer vaccine needs to be stored at ultra-cold temperatures that could significantly complicate distribution

Posted on by • Posted in Clinical Research, Coronavirus, Pandemic, Supply Chain, Supply Chain Cold Logistics Network, Vaccine, Vaccine Efficacy, Vaccine Ultracold Storage, World Health Organization (WHO) • Leave a comment
https://www.washingtonpost.com/nation/2020/11/09/coronavirus-covid-live-updates-us/?wpmk=1&wpisrc=al_news__alert-hse–alert-national&utm_source=alert&utm_medium=email&utm_campaign=wp_news_alert_revere&location=alert&pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJjb29raWVuYW1lIjoid3BfY3J0aWQiLCJpc3MiOiJDYXJ0YSIsImNvb2tpZXZhbHVlIjoiNWI2M2EzNDJhZGU0ZTI3Nzk1NTBjYTFiIiwidGFnIjoid3BfbmV3c19hbGVydF9yZXZlcmUiLCJ1cmwiOiJodHRwczovL3d3dy53YXNoaW5ndG9ucG9zdC5jb20vbmF0aW9uLzIwMjAvMTEvMDkvY29yb25hdmlydXMtY292aWQtbGl2ZS11cGRhdGVzLXVzLz93cG1rPTEmd3Bpc3JjPWFsX25ld3NfX2FsZXJ0LWhzZS0tYWxlcnQtbmF0aW9uYWwmdXRtX3NvdXJjZT1hbGVydCZ1dG1fbWVkaXVtPWVtYWlsJnV0bV9jYW1wYWlnbj13cF9uZXdzX2FsZXJ0X3JldmVyZSZsb2NhdGlvbj1hbGVydCJ9.InT0k3jxTJfTh5KA7asZ9LJAVADgvd0AfA6jsvscCNk
Satire: No charges for Iowa man arrested after he dressed up as Mr Freeze and shouted nonconsensual polar vortex puns in public | Boing Boing

A promising vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech would need to be stored at ultracold temperatures that experts say could make it far more difficult to distribute than other potential vaccines.

Pfizer announced Monday that an interim analysis had shown the vaccine was more than 90 percent effective, news that was greeted with near universal celebration among experts.

But the Pfizer vaccine is relatively unusual as it has to be stored and transported at an ultracold temperature of around -94 Fahrenheit (-70 Celsius), significantly complicating the process of getting the vaccine to people.

Ultracold storage is “is not necessarily routinely available in most health centers even in the U.K., let alone globally,” Michael Head, a fellow in global health at the University of Southampton said in a statement.

Vaccines often require some kind of cold storage to remain effective; some candidates for a coronavirus vaccine need to be held at cooler temperatures like 26 Fahrenheit (2 Celsius). They need to be kept this temperature not only while in storage but also while being delivering on planes and trucks.

The Pfizer vaccine would be considerably colder, requiring more than just refrigeration but something capable of producing freezing temperatures even during potential lengthy periods of transport. It has been done before, though at a smaller scale: A vaccine for the Ebola virus was notable for requiring ultracold storage. Pfizer has been preparing for the challenge by creating special containers that can last 10 days at -94 Fahrenheit, according to the Wall Street Journal.

Groups like the World Health Organization and UNICEF have said that countries need to improve their “cold chain” logistical networks to make sure vaccines can be distributed safely. The Associated Press reported last month that nearly 3 billion people live in areas where temperature-controlled storage is insufficient for the task.

U.S. surpasses 10 million coronavirus cases, experts warn country is entering worst phase

Posted on by • Posted in Asymptomatic Transmission, Clinical Research, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Infection Control, Infection Control Plan, Infectious Virus, Mortality, National Strategy, Out of Control, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Vaccine, Vaccine Efficacy, Vaccine Safety • Leave a comment
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US coronavirus: The country nears 10 million Covid-19 cases - CNN

The United States surpassed 10 million coronavirus cases on Monday, just 10 days after hitting 9 million. The average number of daily new infections has exceeded 100,000, and public health experts warn the country is entering the pandemic’s worst phase yet.

The United States hit the milestone as Pfizer announced its coronavirus vaccine candidate was more than 90 percent effective, compared with a placebo. Epidemiologists and health experts were optimistic about the results, but also cautioned that more information is needed on the vaccine’s long-term efficacy and safety.

2021 Healthcare Reform

Posted on by • Posted in 2020 Election Issues, ACA, Asymptomatic Transmission, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Economic Stimulus, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Health Insurance Coverage Adequacy, Health Policy, Infection Control, Infection Control Plan, Infectious Virus, Leadership, Leadership Alignment, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Supreme Court, Vaccine, World Health Organization (WHO) • Leave a comment
https://gisthealthcare.com/gist/gist-alert-biden-elected/
Healthcare Reform in the US Should Be Left to a Panel of Healthcare MBAs - The Leader Newspaper

After an exhausting and contentious election campaign, and a vote count that was prolonged by enormous voter turnout and record-breaking use of early and mail-in voting, the major news networks have now made their calls. Joseph R. Biden, Jr. will be the 46th President of the United States, and Kamala D. Harris will be the first woman, and first person of color, to become Vice President. Securing an electoral victory by achieving razor-thin victories in a number of battleground states, President-elect Biden received the largest number of votes of any candidate in American history. Although the Trump campaign vowed to pursue legal challenges to the validity of the election, Biden’s win appeared to be secure.

The election results came in the midst of a dramatic acceleration of the coronavirus pandemic. Over the last week, the average number of new cases per day in the US surpassed 96,000, up 54 percent from just two weeks earlier. On Friday the nation recorded a pandemic-high 132,700 new cases, along with at least 1,220 COVID deaths. Hospitalizations were up in most states, hospital bed and workforce capacity are strained, and public health experts warned that the coming weeks and months will bring even worse news. Unsurprisingly, the pandemic was a top issue on the minds of voters. According to exit polls, however, the electorate was deeply divided on the issue: 82 percent of Biden voters cited the pandemic itself as one of the most important issues in determining their vote, with only 14 percent of Trump voters agreeing. Conversely, 82 percent of Trump voters said the economy was the most important issue on their minds, as opposed to Biden voters, only 17 percent of whom listed the economy as their top issue. Based on that data, it appears that at least one important split among the electorate was “lives” versus “livelihoods”—whether the pandemic response, or its impact on the economy, was of greatest concern.

In the coming weeks, attention is likely to turn in earnest to addressing both aspects of the issue during the lame duck period. Senate Majority Leader Mitch McConnell (R-KY) has signaled that he intends to resume negotiations on a stimulus package with Democrats in the House, whose majority was diminished in the election. At this writing, it appears likely that control of the Senate will come down to the results of two runoff elections in Georgia, and McConnell will undoubtedly want to make the case that Senate Republicans have taken decisive action to bolster the economic recovery. It’s also possible that, as part of the Trump administration’s Operation Warp Speed, a coronavirus vaccine will be granted approval by the end of the year. Health officials at both federal and state levels must continue to work closely together to tackle the complex logistics of distributing and administering the vaccine, and it will be critical for the incoming administration to seek ways to collaborate with the Trump team to ensure a smooth transition of this vital work.

The outcome of the Senate runoffs in Georgia will determine whether the Biden administration must work with divided Congress, or an evenly split Senate in which Vice President-elect Kamala Harris casts the deciding vote. In either case, given the political realities underscored by the electoral result, it’s very unlikely than any of the more sweeping proposals in the Biden campaign platform—lowering the eligibility age for Medicare, establishing a government-run “public option” insurance plan, extending premium subsidies to middle-income workers—will advance very far. Rather, as we’ve discussed before, we’d expect a Biden administration’s first actions to focus on an enhanced federal response to managing the pandemic, including issuing a national mask mandate, enhancing efforts to augment and coordinate personal protective equipment (PPE) supply, and rejoining the World Health Organization.

As we look to the next two years, most healthcare policy changes are likely to come in the form of regulatory reform, such as reversing waivers for Medicaid programs to establish work requirements and withdrawing flexibility for short-term plans that fail to comply with the Affordable Care Act (ACA). Other Trump-era regulatory changes might continue. There’s broad bipartisan support for efforts to make value-based Medicare payment reforms more successful, to increase price transparency, and to address the issues of surprise billing and the cost of prescription drugs. But even in if Democrats beat the odds and win back control of the Senate, we believe the Biden administration will have other legislative priorities that will supersede any attempt to dramatically overhaul healthcare coverage—voting reforms, climate change legislation, immigration reform, and long-overdue infrastructure investments.

Unless, that is, the Supreme Court throws a spanner in the works by overturning the ACA. Should the Court rule that the individual mandate is not severable from the rest of the law, and that the entire ACA is unconstitutional, the new administration would be forced to take quick action to protect coverage and insurance protections for millions of Americans. In that event, healthcare would rocket to the top of the agenda. Either the Biden team would be forced to find a compromise solution that could pass a divided Congress, or (if Harris is the tie-breaking vote) find a way to use the budget reconciliation process to address coverage. That potential drama lies months in the future, as we won’t know the outcome of the case until next spring. We’ll monitor the oral arguments in the ACA case closely, and let you know what we hear, and what we think it means for the future of the case.

In the coming weeks, we’ll be watching for answers to some of the big healthcare questions that lie ahead: How will the Trump administration handle the worsening pandemic situation in the 75 days between now and Inauguration Day? Will any new stimulus package include additional economic relief for healthcare providers? When and how will a COVID vaccine become widely available? And perhaps most importantly, what toll will the “third wave” of the pandemic take on a nation already exhausted by a difficult year, and a bitter political fight? Surely one reason to be optimistic is that, having turned out to vote in the largest numbers in a century, Americans are more engaged than ever in finding a way forward amid the problems that confront us. Let’s hope our political leaders from across the ideological spectrum will rise to the occasion, and meet this difficult moment with positive, constructive solutions.

Coronavirus cases exceed 100,000 in one day for the first time, even as the nation is split on the pandemic vs. the economy

Posted on by • Posted in 2020 Election Issues, Asymptomatic Transmission, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Election, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, False Hope, False Narrative, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Transparency, Trust, Truth, Vaccine • Leave a comment

https://www.washingtonpost.com/health/covid-19-cases-record-100000/2020/11/04/9733adcc-1ec8-11eb-b532-05c751cd5dc2_story.html

COVID-19 cases exceed 100,000 a day for the first time, even as the nation is split on the pandemic versus the economy | The Seattle Times

The coronavirus pandemic reached a dire milestone Wednesday when the number of new U.S. infections topped 100,000 in one day for the first time, continuing a resurgence that showed no sign of slowing.

The pandemic is roaring across the Midwest and Plains states. Seven states set records for hospitalizations for covid-19, the disease caused by the virus. And Connecticut, Iowa, Maine, Michigan, Minnesota, Nebraska and North Dakota saw jumps of more than 45 percent in their seven-day rolling average of new infections, considered the best measure of the spread of the virus.

The record, 104,004 cases, was reached a day after the deeply divided nation went to the polls to choose between President Trump and Democratic nominee Joe Biden, an election widely seen as a choice between fully reopening the economy and aggressively quelling the outbreak.

Just as they split almost down the middle on the two candidates, voters broke into almost equal camps on how to address the pandemic that has killed more than 233,000 people and infected nearly 9.5 million people in the United States.

“It’s clear we’re heading into a period where we’re going to see increasing hospitalization and deaths in the U.S. And it worries me how little we’re doing about it,” said Tom Frieden, director of the Centers for Disease Control and Prevention during the Obama administration. “We know by now how fast this virus can move. You have to get ahead of it.”

After more than nine months of restrictions, some state leaders are hesitant to risk further pandemic fatigue, Frieden said.

But if case counts continue rising at the current rate and strong action isn’t taken, viral transmission may soon reach a point in some areas where nothing will stop the virus except another shutdown, he said.

“The numbers keep going up, and we’re only getting closer and closer to Thanksgiving and Christmas,” when some families are expected to congregate indoors and risk spreading the virus further, said Eleanor Murray, an assistant professor of epidemiology at Boston University. “For so many reasons, the next few weeks are going to be bad for us and good for covid.”

With Trump and his aides fighting to hold on to the White House, the federal response to the pandemic, which already leaves major responsibilities to the states, may be even more fractured, Murray said.

“Something that deeply worries me is either way this election goes, Trump will still be in charge the next few weeks, when cases are higher than they’ve ever been,” she said. “And he’s made clear there will be no top-down, coordinated action coming from the federal government.”

Despite months of surveys that clearly indicated strong voter disapproval of the president’s response to the pandemic could weigh heavily against his reelection effort, more voters chose the economy as the primary issue in casting their ballots, exit polling showed.

Even if Biden captures the White House, the results appear to signal that, for many people, covid-19 is not as daunting as the prospect of being unable to pay their bills or send their children to school.

“I got news for you, pal. Covid-19 is over. It’s done,” said Nick Arnone, owner of HLSM, a software company for the power sports industry in Plains, Pa. “We have therapeutics, so deaths are way down. We are very close to a vaccine. We’ve got to ride it out now.

About 35 percent of voters said the economy was the most important issue for them, while about 17 percent cited the pandemic and about 2 in 10 were motivated most by racial inequality.

At the same time, however, just over half the voters said it is more important to contain the virus, even if that hurts the economy, while slightly more than 4 in 10 said rebuilding the economy is most critical, even if that impairs work to quell the virus.

In El Paso, where the pandemic is surging, James Clark said he voted for Biden because of the uncontrolled outbreak.

“Covid was the main reason . . . and the things he was saying specifically about it,” Clark said. “I mean there were some things Trump was doing well, too, but overall it was covid.”

Some analysts were surprised and concerned that voters appeared to view the decision before them as a choice between the virus and their livelihoods, rather than as intertwined problems that could be solved together.

“That was shocking to me, that Trump could convince so many people it was a choice between the economy and pandemic,” said Eric Topol, a cardiologist and head of the Scripps Research Translational Institute in San Diego. “I’m amazed the extent he pulled that off, because it’s so obviously a false dichotomy. There’s no way for the economy to thrive unless we get control of the pandemic.”

On the campaign trail, Biden warned voters of a “dark winter” and invoked empty chairs in homes where families grieved the death of a loved one. He suggested he would follow science and tighten restrictions in places where that was necessary.

Trump repeatedly declared that the country was “rounding the turn” on the pandemic and said a vaccine was almost ready to be distributed. “You know what we want? We want normal,” Trump said this past weekend in Butler, Pa.

The two political messages were consistent with the viewpoints of each candidate’s base, said Kathleen Hall Jamieson, director of the Annenberg Public Policy Center at the University of Pennsylvania.

Biden has much more support among urban voters and people of color who, until recently, have been hit harder by the pandemic. Trump’s base is more White and rural, constituencies that have been slammed by the virus only in recent weeks, as the number of infections soared in the Upper Midwest and Plains states, she said.

“Who’s more likely to know someone’s who’s died? People who are already more likely to be Democrats than Republicans,” Jamieson said. “The lived experience of the two constituencies, the base vote for each side, is different.”

In Florida, which Trump carried more easily than expected, Biden’s emphasis on the pandemic hampered grass-roots campaigning, said Susan MacManus, an emerita professor of political science at the University of South Florida. With Biden emphasizing social distancing, the Democratic campaign there followed his lead.

“The Republicans never let their foot off the pedal in terms of continuing to register [voters] and going door to door, all through the covid,” she said. “The Democrats, once covid hit, they made a conscious effort, not going door to door.”

Rep. Donna Shalala (D-Fla.), who appeared to be headed toward losing her seat to television newscaster Maria Elvira Salazar (R) in Miami, campaigned heavily on Trump’s response to the virus.

Stefan Baral, a physician and epidemiologist at Johns Hopkins School of Public Health, Wednesday faulted Democrats’ pandemic messaging, saying Biden did not adequately express empathy for the economic hardships caused by the pandemic-related shutdowns.

“This is a terrible virus. But empathy for all the folks who have lost their jobs and lost their opportunities and kids who are out of school — I just never felt that message of empathy come across at all,” Baral said.

When some people heard Biden talk about the dark winter ahead, they thought, “The first thing he’s going to do is close my business,” Baral said.

Voters also had to make up their minds amid a torrent of misinformation and purposeful distortion about the pandemic, said Matthew Seeger, a risk communication expert at Wayne State University in Michigan, who helped the CDC develop its past communications plans.

“The messaging around the pandemic has been deliberately confused and strategically manipulated to downplay its significance,” Seeger said. “You combine that with the fact that this is a slow-moving crisis with risk fatigue starting to settle in, and you can see why public perception is what it is.”

In Chandler, Ariz., a suburb southeast of Phoenix last week, Al Fandick said he considers the pandemic wildly overblown and masks largely pointless. Fandick, 53, who runs a transport company, said he found it absurd that he was required to wear a mask to enter a restaurant but could remove the face covering once he sat down.

“Having a face mask on while I walk into that restaurant, but then I can take that face mask off, that’s like having a peeing section in a pool,” Fandick said.

Aside from trips to visit people in the hospital, he never wore a mask until Maricopa County began mandating it for public spaces, a policy he vehemently opposes, he said.

“Don’t need the hassle,” he said.

On the other side of the gulf are those who see the accelerating pandemic and a possibly very deadly period ahead.

“It is demoralizing to feel like: Here we are in November. A third surge is not just underway, but has already surpassed past surges. And people still don’t understand what’s happening and what’s at stake,” said Murray of Boston University.

“We are in the middle of an emergency. We have cases higher than they have ever been since this pandemic started, and yet you will have people paying less attention than ever to covid,” Murray said. “We as a country are not in a place right now where it’s safe to do that.”

The virus doesn’t care about November 3rd

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Credibility, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Election, Employer-Based Health Insurance, Essential Health Benefits, Health Insurance Coverage Adequacy, Health Policy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Mortality, National Strategy, Out of Pocket Expenses, Pandemic, Preexisting Conditions, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing, Transparency, Trust, Truth, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Vaccine • Leave a comment

https://mailchi.mp/2480e0d1f164/the-weekly-gist-october-30-2020?e=d1e747d2d8

8 Big Reasons Election Day 2020 Could Be a Disaster - POLITICO

As the “third wave” of coronavirus continued to gain steam across the US this week, the nation passed another grim milestone, with more than 9M Americans now having tested positive for the virus, and the seven-day average number of new cases hitting a pandemic record of almost 72,000 new diagnoses daily. In states that we’ll surely be discussing a lot in the next week, cases were up 33 percent in Pennsylvania, 25 percent in Michigan, 23 percent in Wisconsin, 21 percent in Florida, and 16 percent in Arizona.

In a sign that the magnitude of case growth is not just an artifact of more testing, hospitalizations for COVID have risen 46 percent since the beginning of October, and are up 12 percent just this week. Nevertheless, as part of its “closing argument” to voters, the Trump administration this week touted “ending the COVID-19 pandemic” as one of its signature first-term accomplishments, although new polling data from Axios/Ipsos show that 62 percent of Americans believe the federal government is making the recovery worse, and 46 percent say the response has gotten worse since the first surge of cases in March and April.

Dr. Anthony Fauci, the talismanic director of the National Institute of Allergy and Infectious Diseases, told CNBC this week that “if things do not change, if they continue on the course we’re on, there’s gonna be a whole lot of pain in this country with regard to additional cases, and hospitalizations, and deaths.”
 
In separate remarks, Fauci pulled back from earlier predictions for the timing of a safe and effective vaccine against the coronavirus. In comments made Thursday, he said he now expects a vaccine to be available to those in high-priority groups “by the end of December or the beginning of January.” 

The CEO of drug maker Pfizer, which is among the furthest along in vaccine development, urged patience as its Phase 3 trial nears full enrollment, and researchers prepare to review and submit safety data to the Food and Drug Administration. He again assured investors that the vaccine timeline would remain apolitical, stating “This is not going to be a Republican vaccine or a Democratic vaccine. It would be a vaccine for citizens of the world.” AstraZeneca, also ahead in development of a coronavirus vaccine, reported promising results regarding immune responses among participants in its clinical trials, being conducted jointly with Oxford University.

With the Presidential election just a few days away, it remains clear that neither the virus nor the scientific community’s efforts to combat it are conforming to the best-laid plans of political leaders.

The outcome of the looming political battle, however, will surely determine the context in which the larger fight against this pandemic takes place. Again, please vote—it’s a matter of life and death.