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White House Blocks New Coronavirus Vaccine Guidelines

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Source: The New York Times
The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

Sharon LaFraniere
Noah Weiland

By Sharon LaFraniere and Noah Weiland

WASHINGTON — Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.

The struggle over the guidelines is part of a monthslong tug of war between the White House and federal agencies on the front lines of the pandemic response. White House officials have repeatedly intervened to shape decisions and public announcements in ways that paint the administration’s response to the pandemic in a positive light.

That pattern has dismayed a growing number of career officials and political appointees involved in the administration’s fight against a virus that has claimed more than 209,000 lives in the United States.

The vaccine guidelines carry special significance: By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.

“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” the biotech industry’s trade association pleaded on Thursday, in a letter to President Trump’s health secretary, Alex M. Azar II, asking for release of the guidelines.

The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely.

A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.

The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.

That Wednesday, Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency’s career scientists. The White House on Monday did not respond to a request for comment.

Speaking to reporters on Sept. 23, Mr. Trump publicly cast doubt on whether the guidance would be approved. “We may or may not approve it,” he said, suggesting that the regulatory action “was a political move more than anything else.”

F.D.A. officials later provided additional justification to the White House, explaining that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, was not short-lived. But they have been unable to break the stalemate.

The White House has the authority to intervene in such nonbinding guidance documents — a step below enforceable regulations — at least partly because of an October 2019 executive order that tightened restrictions over the issuance of such documents. That order asserted that “agencies have sometimes used this authority inappropriately in attempts to regulate the public.” White House officials have cited it to force the Food and Drug Administration and other agencies to submit pandemic-related guidelines to the White House budget office for review before public release.

Staff members at the budget office scrutinize the documents for statements that could undercut the president’s public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.

The testing and release of a vaccine is an issue that has gained wide national attention. Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month. No clinical trial in the United States has yet advanced far enough to prove that any vaccine is safe and effective, although Pfizer, one vaccine developer, is hoping for interim results soon from its trial.

The Food and Drug Administration’s new guidelines were intended to assure companies developing vaccines that they were being held to a common standard and to reassure the public. Polls suggest that Americans are increasingly wary about taking a coronavirus vaccine: A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.

Dr. Peter Marks, the F.D.A.’s top regulator for vaccines, said last week in an event organized by Friends of Cancer Research that the government had to be transparent about the standards it was using to evaluate experimental vaccines in order to build public trust. He and other health officials have stressed that the companies developing vaccines are already fully aware of the agency’s expectations for products seeking authorization for emergency use.

Mr. Azar on Friday played down the conflict with the White House, telling a House panel that those concerned about its involvement in the guidelines were making “a mountain out of a molehill.”

“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Mr. Azar said. “The F.D.A. has already told the manufacturers what they’re going to look for.”

Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.

At a recent meeting with F.D.A. staff members, Dr. Marks said the agency “may hear more noise in the press” about trouble with the guidance but added that the “goal isn’t to get into fights,” according to people familiar with his comments. He said at the Friends of Cancer Research event that there was no reason “to get all excited” because “we are going to have a transparent advisory committee meeting for each and every emergency use authorization that comes through.”

Privately, Dr. Marks has told colleagues that an angry tweet from Mr. Trump attacking F.D.A. scientists over the guidelines could damage public confidence in a coronavirus vaccine.

The guidance laid out more specific criteria for clinical trial data and recommended that it be reviewed by the advisory committee of independent experts. It is expected to be included in the briefing papers for the committee’s next meeting, scheduled for Oct. 22.

Food and Drug Administration officials hope the committee will consider those standards before giving its blessing to any emergency use authorization for a vaccine. The most likely recipients of any vaccine that wins that authorization will be high-risk populations such as health care workers.

In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.

The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.

Katie Thomas contributed reporting from Chicago. Kitty Bennett contributed research.

How do you feel about a coronavirus vaccine? What do you think the guidelines will be? Will you take a coronavirus vaccine?

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Trump contracts COVID

After Biden and Trump’s debate at the end of September 2020, it was reported that Trump contracted COVID 19 along with many others in his camp such as Mrs. Trump and Kellyanne Conway. He soon was admitted to Walter Reed and days later returned to the White house to complete his recovery. COVID 19 is indeed the most profound and controversial disease of our lifetime. While some countries have managed the disease fairly well (Japan), others (U.S.) have not. Like most diseases, COVID 19 is no respecter of persons infecting anyone in its path and drawing mixed emotions from across the globe. Some NPR c(National Public Radio) callers are skeptical of the vaccine and believe that such things should be tested on the country’s administrators first and after 2 years the rest of us can follow our hearts. In this instance, this caller just may have gotten her wish.

With the world’s history rife with the experimentation of disease and drugs on unknowing populations, one can see why some might be skeptical and want to weigh all the facts as they bare out. The Tuskegee Airman are a prime example of involuntary medical experimentation, which not only impacted them, it impacted those in their families as well. Disease can be both murky and deadly. Regardless of your thoughts on COVID 19 we encourage our readers to be well informed about the decisions they make regarding their health and to take every precaution to protect yourselves and others from COVID 19.How do you protect yourself and others from COVID 19? What should a national plan look like? How has your area been impacted by COVID 19?

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!

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COVID deaths update

COVID 19 Shidonna Raven Garden and Cook

The coronavirus pandemic has now killed at least 1 million people worldwide. That’s according to a tally maintained by Johns Hopkins University. This sobering milestone was reached just nine months after the first reported fatality in China last January. And public health experts believe the actual toll – the recorded deaths plus the unrecorded deaths – is much higher. What’s more, in the five worst-off countries, the trend line remains worrisome.

1. United States

Take the United States, which currently leads the world in terms of both total number of dead and total number of infected over the course of the pandemic. While several Northeastern states that were clobbered by the virus early on managed to use social distancing and masking to push down their new cases by early spring, states in other regions then quickly moved to re-open. This fueled an even bigger wave of deaths across wide swaths of the U.S. throughout the summer. Since then many states have managed to bring down their numbers — as well as the overall U.S. daily death count. Yet it remains far higher than it was in July. Also, most recently, daily deaths have actually begun rising again — largely driven by increasing transmission in various states in the Great Plains and the South.

2. Brazil

Brazil, the second-biggest driver of the worldwide death toll, is also once again trouble. Led by a president who repeatedly downplayed the threat from the coronavirus, Brazil’s initial response was chaotic at best, enabling a surge in deaths all through July and August. About a month ago, the daily death count began dropping. But more recently that progress seems to have stalled.

Source: NPR

Where do you live? How has COVID 19 impacted your state? Are your states numbers declining? 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!

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Gardening during a Pandemic

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During World War II food rationing was introduced in the United States, prompting Americans to grow their own fruits and vegetables in order to sustain themselves during tough times. It’s estimated that by 1944, roughly 20 million victory gardens were grown, resulting in 8 million tons of food. That’s was about 40 percent of the country’s supply of fresh produce at the time!

Though we are currently not experiencing a food shortage crisis, being self sufficient and resourceful at a time when essentials (honestly, where is the garlic?) are frequently sold out at grocery stories, isn’t a bad thing. Plus, are we all looking for a new hobby during quarantine?

We used this book when starting our own garden.

During uncertain times being proactive and not waiting for the next crisis to hit is a good idea. Indeed staff at garden centers and nurseries have reported an increase in those purchasing garden supplies. People have several of their own reasons for starting a garden and the pandemic seems to be chief among them. What do you need to get your own garden started? What is your reason for starting your own garden? What do you do differently now since 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.

Source: Forbes

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Zoning

When you purchase a packet of seeds, typically you will see a color coded map with a key to help you identify your growing zone. The USDA divides the United States into 11 separate planting zones. Each growing zone is 10 degrees (fahrenheit) warmer or cooler than the adjacent growing zone during an average winter. Near the color coded map there should also be a key with months in it. These months tell you the months in which it is best to begin planting or sowing seeds based on your growing zone.

While these maps do not tell you what is ideal to grow in your zone, it is important to know which plants will succeed in your growing zone and which will not. Where the map does come in handy is informing you of when to grow a particular plant. Some plants will grow into late fall just fine while other plants will not make it into the late fall months. Some plants can be started in doors before the traditional planting season and some cannot simply because they do not grow in containers well or they do not transplant well. Typically, plants cannot be started until the inside location (greenhouse) you have them in can remain above frost temperatures when temperatures dip.

Be careful to keep an eye out for cool summer nights when the last frost is already thought to have past. April is the big month to start sowing seeds in Norfolk, VA where we are (growing zone). Nonetheless, I have gotten more than my fair share of calls warning me about an ensuing frosty night. If you would like to learn more about protecting plants from frost, read our article “What do bed Sheets have to do with it?” dated May 2, 2020. To learn more about reading seed packets and the valuable information you can find on them read our article “Sow” dated May 12, 2020.

It amazes us how far we have come in such a short time in our journey. We have learned a lot together and in many ways our journey is just beginning. Our pest problems seem to be disappearing and the garden seems to be getting the start it needs. What has been the best part of the journey so far? How has your health changed? They say you need at least 30 days of consistency to see a change. What would you like to see in this journey? We have been getting a lot of comments, questions and positive feedback from everyone. And we would like you all to see what each other is saying, so feel at ease to leave your comments and questions here so the whole community can benefit. 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.