The Food and Drug Administration (FDA) has released updated safety guidelines for coronavirus vaccine makers that would make it impossible for a vaccine to be ready by election day. The FDA now says that vaccine manufacturers need to follow vaccine trial participants for two months to monitor side effects before seeking emergency approval.

Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect.

Emergency Use Authorization for Vaccines to Prevent COVID-19

President Trump has continued to insist that a vaccine will be ready before elections on November 3rd, and the administration had tried to block the FDA from formally publishing these safety guidelines. The FDA has been communicating these guidelines to the public and vaccine manufacturers informally.

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Seven former FDA commissioners released an op-ed in the Washington Post that criticized President Trump’s handling of the COVID-19 vaccine process.

But a safe and effective vaccine will not be enough; people will also have to choose to take it. This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”

7 former FDA commissioners: The Trump administration is undermining the credibility of the FDA

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Two of the commissioners responsible for this statement, Scott Gottlieb and Mark McClellan, are on the boards of two of the companies with a coronavirus vaccine in development, Pfizer and Johnson & Johnson respectively.

President Trump said late Thursday on Twitter that he and the first lady, Melania Trump, would start the “quarantine process” as they awaited results of coronavirus tests they took after a senior adviser who is often with the couple tested positive.

Melania Trump wrote on Twitter at 1:27 AM on Oct 2, 2020, that she and Trump “…are quarantining at home after testing positive for COVID-19. We are feeling good & I have postponed all upcoming engagements.”

It was not immediately clear what Mr. Trump meant by the “quarantine process,” and White House officials declined to immediately provide any guidance. As of 11:30 p.m., the president still had a full day of events planned for Friday, including a private fund-raiser at the Trump International Hotel in Washington and a campaign rally in Florida. He was also scheduled to hold a call with “vulnerable seniors” about the coronavirus.

NY Times – …Hope Hicks Tests Positive

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Mr. Trump’s positive test result posed immediate challenges for the future of his campaign against former Vice President Joseph R. Biden Jr., the Democratic nominee, with barely a month until Election Day. Even if Mr. Trump, 74, remains asymptomatic, he will lose much of his remaining time on the campaign trail. If he becomes sick, it could raise questions about whether he should remain on the ballot at all.

The White House did not say how long Mr. Trump would have to remain isolated, but it canceled his plans to fly to Florida for a campaign rally on Friday, stripping his public schedule for the day of everything except a midday telephone call “on Covid-19 support to vulnerable seniors.” Appearances at rallies in Wisconsin on Saturday and in Arizona on Monday also appear sure to be scrapped, and the next debate, scheduled for Oct. 15 in Miami, was left up in the air.

NY Times – Trump Tests Positive…

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Some have questioned whether Trump is really asymptomatic or not while Michael Moore has accused the president of pretending to have coronavirus to postpone the election.

Update 10/3/20

Trump was admitted to Walter Reed Hospital for overnight care.

Trump himself was said to be spooked after he announced he tested positive early Friday, and has become increasingly alarmed by his diagnosis as he developed symptoms like a fever overnight, according to a person familiar with his reaction. Several people in Trump’s close orbit have tested now positive for coronavirus, including campaign manager Bill Stepien, former White House counselor Kellyanne Conway and adviser Hope Hicks.

A Trump adviser said there is reason for concern about the President’s health. “This is serious,” the adviser said. The adviser went on to describe Trump as very tired, very fatigued and having some trouble breathing.A source familiar with the situation said White House officials have serious concerns about Trump’s health and a top administration official told CNN that Trump is “OK for now, but our fear is that things can change quick. “A third source said the President’s condition is worse than first lady Melania Trump’s.

CNN

Update

Trump returned from the hospital, and his first public act after walking up the South Portico steps was to remove his mask. CNN points out that he remains infected with coronavirus and could potentially infect people nearby, though outdoor transmission is not necessarily happening.

“We’re going back. We’re going back to work. We’re gonna be out front,” Trump said in a videotaped upon his return. “As your leader, I had to do that. I knew there’s danger to it, but I had to do it.

“Though four hours earlier his doctors conceded he was not yet “out of the woods” in his fight against Covid-19, Trump framed the disease as in the past: “Now I’m better and maybe I’m immune? I don’t know. But don’t let it dominate your lives.”

Trump’s reckless return met with a dramatically changed White House – CNN

The city of Berkeley, California continues its quest to make its residents healthier, becoming the first city in the United States to ban sugary candy, sodas, and other junk foods from the checkout aisle. The banned food items are those with 5 grams of added sugars and 200 milligrams of sodium, chewing gum and mints with added sugars, and beverages with added sugars or artificial sweeteners.

Placement of unhealthy snacks near a register increases the likelihood that customers will purchase these foods and drinks when willpower is weak at the end of a long shopping trip…It’s not a ban, it’s a nudge. Stores can still sell candy and soda, just not at your child’s eye level in the checkout.”

Kate Harrison, Berkeley city council member and ordinance sponsor

The unanimously passed ordinance will go into effect in March of 2021. Grocery stores affected will include Safeway, Monterey Market, Whole Foods, and Berkeley Bowl.

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This is not the first time that Berkeley has taken a stand against sugary products. Last time it was sodas and sugary beverages, as Berkeley became the first city in the U.S. to implement a soda tax in 2014. That tax proved to be successful, as residents in affected areas reported drinking 52% fewer servings of sugary drinks. The city of Berkeley clearly wants to continue to offer its residents healthier options.

The secretary of California Health and Human Services, Dr. Mark Ghaly, announced on Friday that the state of California will be forming an independent review board to evaluate COVID-19 vaccine data.

We think it is an appropriate approach to take, especially because things are moving so quickly. We want to make sure — despite the urge and interest in having a useful vaccine — that we do it with the utmost safety of Californians in mind.”

Dr. Mark Ghaly, secretary of CA Health and Human Services

Related: Natural Coronavirus Prevention

California is not the only state or jurisdiction saying they will independently analyze coronavirus vaccines. Others include Colorado, the District of Columbia, Michigan, New York, Oregon, and West Virginia. Montana and Wyoming have said they would only administer vaccines if they had completed clinical trials and had been reviewed by an outside committee.

Confidence in the coronavirus vaccine has been steadily waning as government timelines continue to waver. President Trump has consistently promised that the vaccine will be ready before the election and all Americans will be vaccinated by April, while the director of the CDC, Dr. Robert Redfield, maintains that widespread vaccination will not be achieved until the third quarter of 2021. According to a new survey from the Pew Research Center, only 51% of Americans would probably get the vaccine as opposed to the 72% that would give the same answer in May.

The drama surrounding COVID-19 vaccines continues as President Trump suggested that the executive branch would not support stricter guidelines for evaluating a COVID-19 vaccine. If approved, the new guidelines from the Food and Drug Administration (FDA) would include additional specifications for clinical trial data and a committee of independent experts to review that data before any vaccine is approved. President Trump continues to promise a vaccine before the end of the year, despite experts saying that is unlikely. Trump asserted that the plan to introduce more guidelines was political in nature.

Related: Natural Coronavirus Prevention

That has to be approved by the White House. We may or may not approve it. That sounds like a political move. I think that was a political move more than anything else…”

President Trump

This announcement will add fuel to the growing anti-Trump-vaxxer movement taking place in the Democratic party. Vice presidential nominee Kamala Harris cast doubt on the efficacy and safety of a COVID-19 vaccine implemented during a Trump presidency earlier in September.

I will say that I would not trust Donald Trump, and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he’s talking about….I will not take his word for it.”

Senator Kamala Harris

Related: How To Detoxify and Heal From Vaccinations – For Adults and Children

The Trump Administration has rolled back a regulation requiring oil and gas companies to detect and fix methane gas leaks from pipelines, storage facilities, and wells. The director of the Environmental Protection Agency (EPA) cited the economic benefits of relieving the burden of reducing air pollution on small-medium sized energy companies.

E.P.A. has been working hard to fulfill President Trump’s promise to cut burdensome and ineffective regulations for our domestic energy industry. Regulatory burdens put into place by the Obama-Biden administration fell heavily on small and medium-sized energy businesses.”

Andrew Wheeler, the head of the Environmental Protection Agency

This decision could have serious effects on climate. Methane makes up 10% of greenhouse gas emissions, but according to the EPA, methane is 28 to 36 times more potent than carbon dioxide. Methane gas emissions are at an all-time high globally, and fossil fuel leaks in the U.S. play a significant role in that.

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Over the past few years there has been an explosion of new research on this, and the literature has coalesced — 80 percent of papers show that methane from oil and gas leaks is two to three times higher than the E.P.A.’s estimates…” 

Robert Howarth, an earth systems scientist at Cornell University

Historically speaking, the United States government has proven it is more than happy to put business and profits before protecting the environment while paying lip service to climate concerns. The current administration clearly follows in those footsteps.

Prime Minister Justin Trudeau announced that Canada will ban “harmful” single-use plastics by the year 2021. The precise list of products that will be banned will be available after scientific evaluation.

As parents we’re at a point when we take our kids to the beach and we have to search out a patch of sand that isn’t littered with straws, Styrofoam or bottles…That’s a problem, one that we have to do something about.”

Justin Trudeau

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This new legislation is based on bans passed in the European Union and other nations last year. During a G7 summit in Quebec in 2019, Canada, France, Germany, United Kingdom, and Italy, and the European Union signed a new letter against plastic pollution in the oceans. Those countries and the EU have committed to making 100% of plastics recyclable, recoverable, or reusable by 2030.