The heads of nine biopharmaceutical companies issued a letter early Tuesday pledging to fully vet their COVID-19 candidate vaccines before asking for federal approval to market them.
“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the statement said.
The statement comes amid increasing concern among public health officials, scientists and doctors that the White House might bring significant political pressure to bear on the Food and Drug Administration to get a vaccine before the Nov. 3 presidential election.
All nine companies are individually or jointly developing a candidate COVID-19 vaccine supported at least in part with federal dollars, which so far amounts to more than $10 billion. They are: AstraZeneca, Johnson & Johnson, Moderna Inc., Novavax Inc., Merck, Sanofi and GlaxoSmithKline, and Pfizer Inc, which is developing a vaccine with BioNTech, another signatory.
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A widely-used vaccine will be essential for bringing the COVID-19 pandemic under control. Industry officials are worried that the current political climate is tarnishing the process and will make people more hesitant to get a vaccine when there is one.
The leadership of the industry group Biotechnology Innovation Organization, or BIO, issued a similar statement late last week, calling for a testing process “conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.” The BIO statement also called on the U.S. Food and Drug Administration to “maintain its historic independence as the gold-standard international regulatory body, free from external influence.”
The industry promise to stick to scientific principles and keep politics out of the approval process comes after a few weeks in which President Donald Trump repeatedly emphasized that a vaccine would likely be ready for public use before the Nov. 3 election.
At a White House news conference Monday, Trump said a vaccine “will be very safe and very effective, and it will be delivered very soon.” He added, “could even have it during the month of October.”
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Trump has also said that if a vaccine was not ready by then it was because of a “deep state” conspiracy against him.
The fastest vaccine ever developed took four years, although work on a COVID-19 vaccine has been happening at a much faster pace, thanks to advances in technology, research done on similar but much smaller coronavirus outbreaks, a concerted effort by the companies, and federal support.
Three of the candidate vaccines are currently being tested in Phase 3 trials involving 30,000 people each, half of whom will get the active vaccine and half a placebo.
Dr. Stephen Hahn, head of the U.S. Food and Drug Administration, has repeatedly said he would not approve a vaccine until it has been shown to be safe and effective. But he has also said there might be an intermediate endpoint — short of the completion of a 30,000-person trial — that could meet his standards for a so-called emergency use authorization.
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The statement from the vaccine developers did not address whether they would consider such an endpoint acceptable, but did say that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
None of the companies would comment Monday beyond what was in the statement.
Such a statement from industry is unprecedented, said Dr. William Schaffner, an expert in infectious diseases and immunization policy at Vanderbilt University in Nashville.
“I’ve only been doing vaccines for 40 years and I’ve never heard of anything like this before,” he said. “Having the companies themselves issue this statement I think will offer some reassurance. Not completely, but some reassurance to the medical profession.”
Schaffner said he has heard repeated concerns from medical colleagues across the country about Trump and Hahn’s comments, which he said have created “an enormous amount of unease in the very professional people who would be expected to provide strong endorsement of the vaccine, promote it and often give it in their own offices and public health departments.”
Doctors and other medical professionals must be convinced that the vaccine is worthwhile, he said. “If they hold back, that could be an enormous impediment to widespread use of the vaccine.”
More: Discipline against bad doctors plummets amid COVID-19 – and more medical errors may slip through cracks
Tuesday’s Debate: A Milestone in the History of Climate Politics – POLITICO
In Tuesday night’s demolition derby of a debate, President Donald Trump did not even pretend to confront white supremacists. He didn’t pretend to respect the legitimacy of the election, either. So it was telling that after moderator Chris Wallace asked him the first-ever question about climate change in a general election presidential debate, Trump did pretend to support electric vehicles.
“I’m all for electric cars,” he said. “I’ve given big incentives to electric cars.”
In fact, Trump is not all for electric cars; he’s mocked them, and his policies have penalized them. He certainly hasn’t given big incentives to electric cars; he actually tried to eliminate the existing incentives. But while Trump’s 90-minute tornado of unfiltered insults and right-wing red meat suggested that he’s happy to run as an enemy of cities, the news media and racial sensitivity, he clearly would prefer not to be seen as an enemy of the climate.
That is a milestone in the history of climate politics. Global warming has been dismissed for years as a niche concern for the tree-hugging fringe, but not only has it become the kind of mainstream issue that even a moderator from Fox News deemed worthy of prime time, it has become the kind of hot-button issue that even a Republican president who used to call it a hoax manufactured in China feels the need to dissemble about. If hypocrisy is the tribute that vice pays to virtue, political lies are the tribute that unpopularity pays to popularity—and 2020 polling has found that climate science and climate action are both popular.
Green cars are especially popular; a survey by the Yale Program on Climate Change Communication found that 82 percent of Americans support tax rebates for energy-efficient vehicles or solar panels. That helps explain why Trump claimed to be one of them, even though his 2020 budget would have eliminated a tax credit for electric vehicles that was enacted during the George W. Bush administration and expanded during the Barack Obama administration. Trump made fun of electric vehicles during a 2019 rally in Michigan—“Darling, where do I get a charge?”—and scoffed that “all-electric isn’t going to work” in a Fox Business interview. And his rollback of Obama’s tough fuel-efficiency standards, along with his efforts to relax clean air regulations, could be devastating blows to zero-emissions electric vehicles.
Wallace’s original question was whether Trump believes the scientific consensus about climate change in light of the fires burning in California; the president dodged it rather than repeat his recent assertions that the science can’t be trusted and the earth is about to start cooling. When Wallace pressed him to clarify whether he accepted that greenhouse gases contribute to global warming, he grudgingly conceded: “I think a lot of things do, but I think to an extent, yes.” That made political sense, too, since the Yale survey found 72 percent of Americans believe global warming is happening, while only 12 percent don’t.
The survey found the public also agreed by a 61-29 margin that global warming will harm Americans, by a 56-44 margin that it’s already harming Americans, and by a 60-11 margin that the president should do more to address it—all of which helps explain why the president tried to tack towards the climate majority on the debate stage.
“We now have the lowest carbon,” Trump said. “If you look at our numbers now, we are doing phenomenally.”
America’s emissions are indeed lower in 2020, but that’s because of the coronavirus lockdowns, not because of Trump’s energy or environmental policies, which have had the consistent objectives of relaxing restrictions on polluting industries and promoting the mining and drilling of fossil fuels. Trump scrapped Obama’s Clean Power Plan that would have regulated carbon emissions—which, incidentally, had 75-24 support in the Yale poll—as well as rules limiting mercury, soot and other pollution from coal-fired power plants. As Biden tried rather inarticulately to point out, Trump’s administration has also ditched rules limiting methane emissions by oil and gas companies, accelerated permits for drilling, mining and logging on public lands, rolled back protections for wetlands, and made the United States the only nation to announce its withdrawal from the Paris climate accords.
Nevertheless, Trump tried to portray himself as a champion of clean air and water—or, as he put it, “immaculate air, immaculate water”—another nod to the power of environmental issues, especially among the suburban women who have been such a problem for his reelection campaign. The only specific environmental policy Trump brought up, aside from his nonexistent electric vehicle incentives, was his support for a global initiative to plant a trillion trees, which he misidentified as the Billion Tree Project. “It’s very exciting for a lot of people,” he said, although he didn’t really make it sound like he was one of those people.
Trump’s message was that he’s an environmentalist, but Biden is a radical environmentalist who would destroy the American economy with left-wing nonsense. Again, though, he had to resort to wild falsehoods to make that case. He attacked the Obama-Biden administration’s Clean Power Plan for somehow “driving energy prices through the sky,” even though it never went into effect. He accused Biden of wanting to spend $100 trillion on the climate, using a sketchy right-wing analysis of the Green New Deal that Biden doesn’t even support, and also of wanting to ban cows and air travel, another misleading reference to the Green New Deal, or at least to a list of talking points about the Green New Deal that Rep. Alexandra Ocasio-Cortez’s office released and then hastily retracted.
Biden, on the other hand, seemed delighted to discuss the substance of issues he sees as politically advantageous as well as globally consequential. When Wallace said he’d like to discuss climate change, Biden blurted out: “So would I!” He talked with a lot of passion, though not a lot of focus, about his role overseeing the Obama stimulus that helped bring down the cost of wind, solar and other renewable energy sources; about “weatherization” programs that could put unemployed Americans to work caulking windows and otherwise upgrading the energy efficiency of homes and businesses; and about his idea to pay the Brazilian government to crack down on the destruction of the carbon-rich Amazon. He also called for electrifying the federal government’s fleet of vehicles and installing 500,000 charging stations on America’s roads—a solution for the Darling-where-do-I-get-a-charge problem.
Wallace also challenged Biden about the fiscal and economic cost of his climate plan, which irritated many climate activists, but it’s a legitimate question that led to one of Biden’s strongest moments in the chaotic debate. He argued not only that his $2 trillion plan will provide millions of jobs in green industries and green infrastructure projects, a common Democratic argument, but that the cost of inaction would be far greater, since America is already spending more than ever on climate-driven floods, hurricanes, fires and droughts.
“We’re in real trouble,” Biden said. “Look what happened in the Midwest with these storms that come through and wipe out entire sections and counties in Iowa. They didn’t happen before. They’re because of global warming.”
Back in 2012, CNN’s Candy Crowley explained after a presidential debate that she considered including a question for “you climate change people” but changed her mind because “we knew the economy was still the main thing.” Eight years later, there’s increasing recognition from politicians as well as media bigwigs that all people are climate change people, and that there’s no way to isolate the economy from the energy that fuels and powers it or the climate disasters that increasingly threaten it. It’s hard to imagine that there will ever be another year of presidential debates without a climate question, and the worse the problem gets, the more pressure candidates will face to embrace the science and call for action.
That doesn’t mean that every candidate will make climate warriors happy with every answer. Trump never did acknowledge that climate change is contributing to California’s fires, arguing that the more pressing issue was bad forest management, which was a reasonable case to make. Biden made a point of distancing himself from the Green New Deal, prompting Trump, in a weird moment of off-message punditry, to declare: “You just lost the radical left.”
But Biden isn’t tailoring his message to the radical left. He’s aiming for the 63 percent of Americans who are worried about climate change, the 86 percent who support research into renewable energy, the 56 percent who say it’s important to their presidential vote. And while it’s obvious from his rhetoric as well as his record that Trump doesn’t truly care about the climate, it’s a reflection of the changing political climate that he felt the need to pretend he does.
Coinbase CEO discourages politics at work, offers generous severance to employees who want to quit – CNBC
Coinbase is offering to pay employees who decide to quit the cryptocurrency company after it discouraged employee activism and discussing of political and social issues at work.
CEO Brian Armstrong told Coinbase staff in an email that the company would offer severance packages for anyone “who doesn’t feel comfortable with this new direction.” The pay packages range from four to six months, depending on how long an employee had been with the company.
“Life is too short to work at a company that you aren’t excited about,” Armstrong said in the email, which was previously reported by The Block. “Hopefully this package helps create a win-win outcome for those who choose to opt out.”
The message came days after Armstrong published a blog post clarifying the company’s stance of non-engagement on social and political issues.
Specifically, Armstrong said that the company “won’t debate causes or political candidates internally,” and will not engage when the issues are “unrelated to our core mission, because we believe impact only comes with focus.” The cryptocurrency company is “laser focused” on the use of digital currencies, and on profits, Armstrong said.
“While I think these efforts are well intentioned, they have the potential to destroy a lot of value at most companies, both by being a distraction, and by creating internal division,” Armstrong said. “I believe most employees don’t want to work in these divisive environments.”
The approach stands apart from many Silicon Valley companies, which have embraced social justice causes in the wake of widespread protests over racial injustice this year.
For instance, Google this week announced an extensive $310 million program to bolster diversity and inclusion at the company as part of a lawsuit settlement with shareholders who alleged the company did not take complaints of sexual harassment and discrimination seriously enough. Facebook’s Mark Zuckerberg, meanwhile, recently tightened restrictions on discussing political and social issues on the company’s internal message boards, but stopped short of discouraging or banning them entirely.
Armstrong himself was outspoken in the wake of George Floyd’s death, and tweeted his support for the Black Lives Matter movement.
“I’ve decided to speak up. It’s a shame that this even needs to be said in this day and age, but racism, police brutality, and unequal justice are unequivocally wrong, and we need to all work to eliminate them from society,” he said in series of tweets.
Coinbase’s new policy immediately sparked debate on Twitter. Some, such as investor Paul Graham, applauded the position and predicted “most successful companies will follow Coinbase’s lead.”
Others suggested it would drive away tech talent and customers.
The San Francisco-based company is the largest U.S. cryptocurrency trading platform. It has raised more than $500 million in private funding from Andreessen Horowitz, Union Square Ventures and Tiger Global, among others, at an $8 billion valuation, according to PitchBook.
Essential Politics: Chaos and consequences at the first debate – Los Angeles Times
This week began with heightened stakes for President Trump and Democratic rival Joe Biden. After their raucous first presidential debate Tuesday, who knows how it will shake out.
In what’s been a remarkably stable race despite tumultuous times, Trump has been stuck for months on a losing trajectory, amid mounting COVID-19 deaths and new, bombshell revelations about his taxes and the extent of his debt. And while Biden has enjoyed the lead in polls both nationally and in swing states, it’s not a solid one, as reporter Brian Contreras wrote this week. The Trump campaign has spent months sowing doubts about Biden’s mental fitness.
Then they finally met, at the first of the three debates of 2020 — the stage for all that brewing electoral drama to play out. It got loud. It got ugly. At times, it devolved into chaos — provoked, not surprisingly, by the disrupter president.
Political strategists often say debates are overrated and rarely change a race, David Lauter and Janet Hook wrote this week. But this time? An unconventional debate in an unconventional year could yield unconventional results.
The Times’ staff, of course, was watching. Here are the big takeaways.
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All the world’s a debate stage
Maskless but socially distant, the candidates met onstage for the first time this year. There were no handshakes, no large audience — mostly just a few family members and guests of each candidate — and so no partisan cheering for the applause lines.
Trump immediately began the debate on a biting, disruptive note that set the tone for the next 90 minutes. His frequent interruptions and the candidates’ heated exchanges led to all three men — Biden, Trump and moderator Chris Wallace of Fox News — attempting to speak over one another for minutes at a time.
But if it wasn’t always clear what the candidates were saying, clear themes did emerge, offering a glimpse of where the race might be headed. Election reporters Mark Z. Barabak and Melanie Mason broke down the most important takeaways.
It was a vintage Trump performance. The bullying, the blustering, the lack of regard for timekeeping, rules and moderators are classic Trump, they write. But while the performance played to his supporters, it’s questionable whether he attracted much-needed new ones with his old tricks.
Joe was not so sleepy. Trump has attempted to cast Biden as “Sleepy Joe,” growing senile and unfit for office. Biden has in the past struggled on the debate stage, but he held his own on Tuesday. He had no major awkward moments, and several effective ones when he turned directly to the camera to address voters.
The pandemic isn’t going away. Wallace didn’t even have to ask before the coronavirus entered the conversation. Biden laid into Trump early and often, holding him personally responsible for the more than 200,0000 Americans who have died, Barabak and Mason write. Trump defended himself with unfounded claims that China unleashed the virus and argued Biden would have done worse in his position.
Taxes, taxes, taxes. Trump’s taxes have been a source of speculation and litigation for years, and a New York Times report this week based on leaked tax returns confirmed that he’s paid little or no income taxes in many years over the last two decades. During the debate, Trump denied the report he’d paid just $750 a year in federal income tax in two recent years, instead claiming he’d paid “millions.” Prove it, Biden challenged him: Release the returns.
Courting voters through the court. The death of Justice Ruth Bader Ginsburg opened a new political front. Trump boasted of his recently announced nominee, appeals Judge Amy Coney Barrett, and defended his right to name someone even as the voting for president has begun. The pending confirmation process is a rallying point for Republicans as well as Democrats. In opposing Barrett, Biden focused on healthcare, highlighting the threat he says she poses to abortion rights and the Affordable Care Act — an appeal likely to resonate with liberals and independents who are wary of an ultra-conservative high court, Barabak and Mason write.
Here’s what else you should know about the debate:
— Trump needed the debate to change a race he’s losing; instead, he doubled down and Biden shot back, Janet Hook writes in her analysis.
— From China to healthcare to the economy, many of Trump’s talking points and a few of Biden’s weren’t quite right. White House reporter Chris Megerian fact-checked the debate.
— Chris Wallace, the debate moderator, became a referee, breaking up tense squabbles between the candidates and chastising Trump for his frequent interruptions. Here’s what to know about the veteran Fox News anchor.
— Asked to condemn white supremacists, Trump instead told the far-right hate group Proud Boys to “stand by.”
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The latest from the campaign trail
— From Hook and Megerian: Biden’s campaign is capitalizing on the revelations that Trump has paid little or no federal income taxes for years, amplifying the Democratic nominee’s message that the 2020 election is a choice between the working class he came from and the wealthy elite the president personifies.
— Biden and his running mate, California Sen. Kamala Harris, released their latest tax returns ahead of the debate, 2020 reporters Matt Pearce and Michael Finnegan write. The Democratic candidates and their spouses paid hundreds of thousands of dollars in taxes to the federal government in 2019.
— Biden and Trump are offering Latino voters different visions of America and of each other. Melissa Gomez, Vanessa Martínez and Rahul Mukherjee looked at the Spanish-language ads the campaigns are spending millions to run in states including Arizona and Florida.
The view from Washington
— The U.S. Postal Service must prioritize election mail and immediately reverse changes that resulted in widespread delays in California and several other states, a federal judge ruled Monday.
— On the healthcare beat, Noam Levey reports that U.S. employers are increasingly open to a bigger government role in healthcare, including regulating prices and expanding Medicare to more working Americans.
— The Trump administration is strengthening U.S. military and diplomatic ties with Greece. Tracy Wilkinson writes that it’s an unsubtle warning to Turkey, which is taking on what U.S. officials see as a more combative role in the eastern Mediterranean and Middle East.
What’s happening in California
— Detainees at California’s for-profit ICE detention centers will soon be able to sue over abuse and harm after Gov. Gavin Newsom signed a bill backed by immigrant-rights advocates, writes Times immigration reporter Andrea Castillo.
— A new poll from UC Berkeley finds Newsom’s response to the pandemic has put him in the good graces of California voters, with an approval rating among the highest of any governor in the last 50 years at the same point in office. But he’s also facing intense dissatisfaction over his handling of homelessness and housing costs, Phil Willon writes.
— Newsom vetoed a bill that would have authorized California to give low-income immigrants $600 to buy groceries. He said he could not sign it because of its “significant General Fund impact.”
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