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COVID 19 Vaccine Trails and Ethics

Ethics and a COVID 19 Vaccine
Shidonna Raven Garden and Cook

What if you were given a vaccine very soon but it was ineffective? What are your thoughts about a corona virus vaccine? What would you like to see happen? What ethics should be implemented in the vaccine you receive? Would you like to receive a vaccine? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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Rage

Rage – Bob Woodward
Source: CBS Sunday Morning
Shidonna Raven Garden and Cook

How have you been impacted by COVID 19? Who do you know that has been impacted by COVID 19? What solutions would you like to see? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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Signs of an ‘October vaccine surprise’ alarm scientists

Such a move could further erode public trust in a vaccine and foist an unsafe shot on Americans.

Image: Donald Trump

President Donald Trump speaks at a campaign rally in Fayetteville, N.C., on Sept. 19, 2020.Evan Vucci / APSept. 21, 2020, 1:53 PM EDT / Updated Sept. 21, 2020, 3:35 PM EDTBy Liz Szabo and JoNel Aleccia | Kaiser Health News

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of expertsofficials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcastspublic forumssocial media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. The fear is that Trump’s pressure on the HHS could influence the speed of an authorization. HHS spokesperson Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.

An intervention in the process would signal another injection of politics into a sensitive public health decision by the norm-breaking Trump administration. Trump has repeatedly contradicted the advice of senior scientists on Covid-19 while pushing controversial treatments for the disease.

Overruling the FDA’s scientific judgment could lead to the rushed release of a vaccine of limited efficacy and, worse, unknown side effects.

Vaccines are typically approved by the FDA. But Azar — who reports directly to Trump — can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a Covid-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

‘I want to see the data’: Scientists express skepticism over Nov. 1 vaccine target

Physicians might refuse to administer a vaccine approved with inadequate data, said Dr. Preeti Malani, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54 percent of Americans would not submit to a Covid-19 vaccine authorized before Election Day.

After this story was published Monday, an HHS official said that Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop Covid-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed, according to NBC News, more than 200,000 lives in the U.S., will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

U.S. Covid-19 death toll surpasses 200,000

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

  • Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
  • Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
  • AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in The Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two Covid-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any Covid-19 vaccines.

Download the NBC News app for full coverage of the coronavirus outbreak

A senior FDA official who oversees vaccine approvals, Dr. Peter Marks, has said he will quit if his agency rubber-stamps an unproven Covid-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare — my worst nightmare — because we will so confuse the public,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Avorn and co-author Dr. Aaron Kesselheim wondered whether Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

Source: CNBC

Some are reporting that a COVID 19 vaccine will not necessarily be the end to the pandemic that one may think it will be. Some who get it may not be cured and all may not receive it. What do you think will be the benefits of a COVID 19? What do you hope a COVID 19 vaccine will do? When do you think a COVID 19 vaccine will be available? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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True to the Journey

covid 19 shidonna raven garden and cook

Moderna’s coronavirus vaccine deal with the U.S., announced last week with a $1.525 billion price tag, would be worth far more if all options are exercised—and if the mRNA biotech meets an aggressive timeline for the shot’s arrival.

The company stands to gain up to a whopping $8.125 billion, according to a Moderna securities filing that details the price for follow-up doses and the windfall for an early FDA approval.

The base agreement calls for 100 million doses of the company’s COVID-19 vaccine candidate, mRNA-1273, for $1.225 billion. But the drugmaker is eligible for a $300 million bonus if it’s able to score an FDA emergency use authorization or full approval by Jan. 31, the filing shows. 

Source: Fierce Pharma

As we get information regarding COVID 19 and on the many companies working on the vaccine, I am reminded of something my supervisor once said “the medical industry is a business like any other business”. A family friend recently shared that she tested positive for COVID 19. We prayed for her and offered her all the information we had about COVID 19. She was grateful, yet she stated that she would be seeking natural means for recovering from COVID 19. In the midst of a global pandemic it is easy to seek out the quickest solutions. She reminds us that through it all it is important to stay true to the ‘Organic Journey’. It is true in gardening and true with health. It may seem easier and quicker to grab the nearest chemical or drug for a solution. But, in our Organic Journey we have learned to first ask “what is the Organic Remedy to this problem. Who do you know that has been impacted by COVID 19? How has your family been impacted? How has your ability to work been impacted? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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COVID 19, The Cure

covid 19 shidonna raven garden and cook
  • The US government’s Operation Warp Speed anticipates it will take until March to deliver 300 million doses of a coronavirus vaccine.
  • The ambitious vaccine initiative has often suggested the goal is to deliver the vaccine doses by January.
  • Business Insider confirmed that OWS expects to have initial doses available by January, but it will take several more months to produce and deliver 300 million doses.

The Trump administration has laid out an extraordinarily ambitious timeline for a coronavirus vaccine.

Operation Warp Speed, the government’s initiative to speed up vaccine work, says it’s aiming to deliver 300 million doses of a safe and effective shot by January 1. Creating a vaccine in less than a year would be an unprecedented feat — under normal circumstances, it can take a decade to develop a new vaccine and bring it to market.

But even if Warp Speed accomplishes this goal, most of us won’t be getting coronavirus vaccines in January. When administration officials talk about Warp Speed, they usually don’t mention that it will take months to distribute the shots across the nation.

The US Department of Health and Human Services, for example, says Warp Speed “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.”

But Operation Warp Speed won’t really deliver those 300 million doses to people until roughly March, administration officials acknowledged.

An unclear timeline for Operation Warp Speed

The confusion is evident in a timeline published on Thursday on the Defense Department’s Operation Warp Speed website. (OWS is a collaboration between the Department of Defense and the Department of Health and Human Services.)

The document, which Business Insider annotated below, says Warp Speed’s mission is to “deliver 300 million doses of safe and effective vaccine by 1 January 2021.” But it also shows how it will take 14 months to test, manufacture, and distribute a vaccine — a timeline that would stretch into March.

Operation Warp Speed coronavirus vaccine timeline
A one-page graphic outlines Operation Warp Speed’s plan to quickly develop, manufacture, and distribute a coronavirus vaccine. 

To be clear, distributing hundreds of millions of doses of a coronavirus vaccine by next March would be an unprecedented feat. Achieving that goal depends on a lot going right, including seeing success in clinical studies, ramping up manufacturing, and logistically executing the distribution of the shots across the nation.

It’s important to be realistic about when we’ll have a vaccine

As it stands, none of the coronavirus vaccine candidates that drugmakers are working on has shown that it can actually prevent infection or disease. Large-scale trials of vaccines from Moderna, Pfizer-BioNTech, and AstraZeneca have begun in recent weeks, with results likely to come later this fall or winter.

Stephane Bancel, the CEO of Moderna, recently estimated that in a best-case scenario — in which several of these leading vaccine candidates work — young and healthy people would likely receive their shots in spring 2021. If any of the leading shots fail in clinical trials, the timeline could be pushed into the second half of next year, Bancel said.

It’s important to be realistic about the timeline for a coronavirus vaccine, particularly as the US’s public-health response has become increasingly dependent on a vaccine to curb the pandemic. Shortcomings in testing, mask-wearing, and social distancing have laid bare the need for a vaccine, as more than 1,000 people in the US have died each day from the coronavirus in recent weeks.

Drug-industry CEOs have said we need to be cautious about the vaccine timeline

Some top drug-industry CEOs have also emphasized the need for caution on the most aggressive timelines.

Roche CEO Severin Schwan said in April that a vaccine would “most likely” not be ready before the end of 2021. Novartis CEO Vas Narasimhan said on Thursday at a Bloomberg News event that he had “reasonable confidence” that a vaccine could be broadly used by the end of next year.

Roche isn’t working on a coronavirus vaccine, while Novartis is involved in an early-stage vaccine project. Kenneth Frazier, the CEO of Merck, a drugmaker with a long track record of creating vaccines, has also urged people to be realistic about the timeline.

“I think when people tell the public that there’s going to be a vaccine by the end of 2020, for example, I think they do a grave disservice,” Frazier said in a recent interview with the Harvard professor Tsedal Neeley. “We don’t have a great history of introducing vaccines quickly in the middle of a pandemic. We want to keep that in mind.”

Merck is working on a coronavirus vaccine of its own but hasn’t provided a detailed timeline.

We asked the Trump administration to clarify Warp Speed’s goals

Business Insider asked Trump administration officials in recent days to clarify Warp Speed’s goals, because the recent timeline isn’t the only instance in which the administration has been unclear. For example:

  • Paul Mango, a senior administration official working on Operation Warp Speed and a deputy chief of staff at HHS, said on a press call on Wednesday, “I can tell you and reiterate we are on track to deliver hundreds of millions of doses by January 2021.”
  • President Donald Trump said earlier this month that a vaccine could be ready “right around” the November 3 election. “I’m rushing it. I am. I’m pushing everybody,” Trump told the radio host Geraldo Rivera, adding, “And we’re mass-producing the most promising candidates in advance so that we’re ready upon approval.”
  • HHS Secretary Alex Azar said in an interview with a local television station in August: “We now stand at a position where it is very credible that by the end of the year we will have in the high tens of millions of doses of FDA, gold-standard vaccine and, by the beginning of next year, hundreds of millions of doses of vaccines.”

Administration officials confirmed to Business Insider that it would take months after January to accomplish Warp Speed’s goals of injecting 300 million vaccine doses.

Here’s how Dr. Francis Collins, the head of the National Institutes of Health, put it in response to a question about the timeline:

“That last three months is distribution of 300 million doses,” Collins said. “That is the process of getting a dose to every American, which we didn’t expect we could do by the first of January. That’s going to take the additional three months to do so.”

Source: Business Insider

As noted above many have stated that it will be at least March 2021 before a vaccine is available and January 2021 simply is not realistic. What do you think of the current administrations handling of the pandemic? Do you think they can deliver a vaccine by January 2021? What do you think of this administration current handling of the economic crisis caused by the pandemic? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.

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How to Celebrate Memorial Day

As COVID 19 lingered on, it left many of us with more questions than answers. Finally we could see the number of deaths begin to slow. While COVID 19 seemed to sweep the world in a matter of weeks brining things to a halt in the United States, we finally began to receive reports that we were effectively slowing the spread of COVID 19. While there is neither vaccine nor cure in sight yet, we could gather some satisfaction from the fact that things were beginning to work in slowing the spread of the virus. As we entered phase one of reopening and things seem to be returning to normal, in the back of our minds we know that things will inevitable not be the same. COVID 19 has caused us to rethink many things. How we work, socialize, shop and celebrate just to name a few. Many of us are sporting hair styles and facial hair that was totally different a few months ago because barber shops and salons are closed to the public.

As things reopen, we wonder what the new normal will be. We believe healthy will be the new normal. While many communities such as the African American and elderly communities got hit the hardest because of pre existing health conditions, many are left grappling with the fact that preexisting health conditions make them susceptible to disease and illness. So, one must reconsider having preexisting conditions at all and rethink how they define healthy. Preexisting health conditions cannot simply be left to linger. If we allow illness to linger, than we are not the fittest and many of them did not survive this pandemic.

Memorial Day is a day to celebrate those who have fallen in the line out duty. It is a time to gather and often eat. Many people have cookouts during this time. With Memorial Day just around the corner many of us are wondering just how to celebrate Memorial Day. The Military is huge in a town home to the largest Naval Base in the United States (Norfolk, Virginia), so is Memorial Day. While we are still in phase one of reopening, gatherings are still limited to just 10 people and we still have to be cognizant of the fact that COVID 19 can remain on surfaces for hours to days.

While we highly recommend following all the recommended and enforced guidelines, we recently had a cook out without any issue. Our gathering was about seven people and we were highly organized and clean when we cooked out. So, we believe that you can still celebrate Memorial Day with a traditional cookout but just on a small or smaller scale. You might have to forgo any traditions of fireworks or events with large gatherings as they are still being discouraged.

COVID 19 has caused many people to rethink how they stay connected and socialize with many people making use of software such as zoom and Google hangout. What are ways that you can celebrate and acknowledge Memorial Day here with us? What is your favorite salad recipe? Submit it via a comment or email it to us. Share your recipe with the community. How can you make your favorite recipes organic recipes? Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep growing.

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today.