Beware of Biden’s New Virus Task Force

As the news breaks from Operation Warp Speed (Trump Administration) on the news of Pfizer’s vaccine. As announced by StatNews:

Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.

The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.

The Phase 3 study is ongoing and additional data could affect results.

In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November. More here.

Exactly what is presumptive president elect Biden’s plan and will he take full credit for the remarkable work of the Trump White House?

 

Well, let’s look at that shall we?

Source in part with additional context: The experts include Rick Bright, the former director of the Biomedical Advanced Research and Development Authority (BARDA) who said he was forced out his position earlier this year after opposing promoting unproven treatments.(Bright was fired from HHS and became a whistle-blower for fully disagreeing with hydroxychloroquine.

Dr. Zeke Emanuel on concerns surrounding politicization of ...

Bioethicist and oncologist Zeke Emanuel, who served as former adviser to the Obama administration on the Affordable Care Act and is brother of former White House chief of staff Rahm Emanuel, and Atul Gawande, a surgeon who served as advisor to the Clinton and Obama administrations, will also serve on the panel. (Emanuel was the cat that believes people — particularly the aged — who aren’t contributing materially to society should get out of the way for the benefit of the strong. And, Emanuel was a prime architect of the Affordable Care Act, or Obamacare, and remains one of the law’s most enthusiastic apologists. Readers may also recall his infamous 2014 article in The Atlantic, where he wrote that he wants to die at age 75 — implying that we should too — because people after that age become “feeble, ineffectual, even pathetic.”

Dr. Ezekiel J. Emanuel is the vice provost for global initiatives and a professor at the University of Pennsylvania.

He’s also a special adviser to the director-general of the World Health Organization (WHO) as well as a senior fellow at the Center for American Progress. If asked to put a chip on the betting calendar as to when we return to at least a “new normal,” where are you willing to place yours?

I’ve been saying this for months and I’ll continue to say it: November 2021. Even if we get a vaccine and have to play out getting it out there, it’s November 2021. I’m sticking with it. Source

Other experts who will serve as co-chairs include Vivek Murthy, a former surgeon general who served under the Obama administration; David Kessler, former commissioner of the Food and Drug Administration; and Marcella Nunez-Smith, an associate professor of internal medicine, public health and management and the founding director of the Equity Research and Innovation Center. (Marcella Nunez-Smith is at the core of blaming discrimination of healthcare and the pandemic on race.

The three also served as advisers on Biden’s campaign.

“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,” the president-elect said in a statement.

Biden had announced plans shorty after being projected winner of the presidential election on Saturday to name “a group of leading scientists and experts as transition advisers to help take the Biden-Harris COVID plan and convert it into an action blueprint” that will start in January, when he is inaugurated.

“That plan will be built on bedrock science,” he said.

Meanwhile….the Biden operation is also drafting nominees for cabinet posts:

The Biden transition team, which has been working behind-the-scenes since Labor Day, also has preferred candidates in mind for major Cabinet posts that require Senate confirmation and positions inside the West Wing that do not. The Cabinet announcements are not expected for a few weeks, aides said, and some are likely to be delayed even longer until it’s known who will control the Senate following the January run-offs in Georgia.
Ron Klain, a longtime adviser to Biden and his chief of staff during the early years of the Obama administration, is a leading contender to be White House chief of staff, people close to the process tell CNN.
The Biden transition is a robust effort with two Biden advisers, Jeff Zients and Ted Kaufman, taking the primary lead in overseeing these ongoing efforts. Anita Dunn, a senior adviser to the Biden campaign and former White House communications director, is another one of the co-chairs, along with New Mexico Gov. Michelle Lujan Grisham, and Louisiana Rep. Cedric Richmond.

China to Sanction U.S. Defense Contractors over Taiwan

The One China Policy supported by previous administrations has been earnestly challenged by the Trump administration and rightly so. China has forcefully held dominion over Taiwan, an independent nation and since the Trump administration has approved arm sales to Taiwan, the tensions have increased substantially.

Context:

Jamestown: Events throughout 2020 have seen a measured but steady increase in tensions surrounding Taiwan. The government of the People’s Republic of China (PRC) continues to deny any legitimacy to the democratically-elected government of the Republic of China (ROC) in Taiwan. The PRC also continues to make menacing insistence upon unification on Beijing’s terms, in language that has grown more strident throughout the tenure of Chinese Communist Party (CCP) General Secretary Xi Jinping (China Brief, February 15, 2019; China Brief, November 1, 2019).

Against this background, the PRC has reacted with both harsh rhetoric and saber rattling to enhanced U.S.-Taiwan diplomatic contacts in August and September, as well as a reported further round of impending U.S.-Taiwan arms sales (see discussion further below). One PRC English-language outlet opined in late September that “The U.S. has been releasing all kinds of supportive signals to Taiwan this year, with the level and frequency of their so-called interactions flagrantly enhanced… While [some in Taiwan] jump at such signals, they’d better think long and hard whether the signals are sweet poisons from the U.S. for Taiwan” (PLA Daily, September 25).

U.S. Diplomatic Visits to Taiwan

Recent years have seen a noteworthy increase in official and semi-official U.S.-Taiwan diplomatic exchanges. In March 2018 the Taiwan Travel Act (TTA) was signed into U.S. law, providing a statement of support for increased travel by high-level Taiwan officials to the United States. This was followed by unofficial “transit stop” visits in the United States by ROC President Tsai Ying-Wen (蔡英文) in 2018 and 2019, and a May 2019 meeting between U.S. National Security Advisor John Bolton and his ROC counterpart David Lee (李大維) (China Brief, July 31, 2019). In early February this year ROC Vice President-elect Lai Ching-te (賴清德) traveled to the United States, where he met with senior U.S. political figures and attended the annual National Prayer Breakfast in Washington D.C. (Taiwan News, February 4). Although Lai had not yet assumed office at the time, and therefore visited in an unofficial role, the trip produced harsh condemnations in PRC state press (Xinhua, February 6). All of these visits by Taiwan officials have drawn similarly negative reactions from the PRC Foreign Ministry and state media, as with the “stern representations” presented over President Tsai’s stop in Hawaii in March 2019 (Xinhua, March 21, 2019).

These visits were reciprocated in summer and autumn this year by two visits made by U.S. officials to Taiwan. U.S. Secretary of Health and Human Services Alex Azar conducted a visit to Taiwan from August 9-12, described by his department as “the highest-level visit by a U.S. Cabinet official since 1979,” and “part of America’s policy of sending high-level U.S. officials to Taiwan to reaffirm the U.S.-Taiwan friendship” (HHS, August 4). Secretary Azar’s activities included a meeting with President Tsai; a visit to Taiwan’s Central Epidemic Command Center; and a speech at National Taiwan University (HHS, August 10; August 11; August 12). This trip was followed in mid-September by a visit from U.S. Under Secretary of State for Economic Growth, Energy, and the Environment Keith Krach, who traveled to Taiwan to attend a memorial service for former ROC President Lee Teng-hui (U.S. State Department, September 16).

***  Pentagon Approves $500 Million Taiwan F-16 Support Program ...

Bloomberg:

China will impose unspecified sanctions on the defense unit of Boeing Co., Lockheed Martin Corp., and Raytheon Technologies Corp. after the U.S. approved $1.8 billion in arms sales to Taiwan last week.

The sanctions will be imposed “in order to uphold national interests,” Chinese Foreign Ministry spokesman Zhao Lijian told reporters Monday in Beijing. “Boeing Defense” would be among those sanctioned, he said.

The State Department last week approved $1.8 billion in new weapons for Taiwan and submitted the package to Congress for a final review. The submission comes two months after the U.S. and Taiwan completed the sale of 66 new model F-16 Block 70 aircraft from Lockheed, and as tensions between the two superpowers continue to escalate ahead of the American election.

Boeing Defense is one of the broader company’s three business units, according to its website. Shares in Boeing, down almost 50% this year, dropped as much as 2.2% in U.S. pre-market trading.

A spokesperson for Boeing emphasized the firm’s relationship with China in the aviation space. Boeing has “worked together successfully with the aviation community in China for almost 50 years to support Chinese efforts to ensure a safe, efficient and profitable aviation system to keep pace with the country’s rapid economic growth.”

“It’s been a partnership with long-term benefits and one that Boeing remains committed to,” the spokesperson said in the emailed statement.

One China Principle

Representatives from Raytheon weren’t immediately available for comment outside of normal U.S. business hours.

Zhao condemned Lockheed’s F-16 Block 70 sale at the time, saying it violates the One China principle, interferes in China’s internal affairs and will have a “major impact” on U.S.-China relations. Taiwan’s presidential office thanked the U.S for the sale. In July, China — which considers Taiwan part of its territory and resists any recognition of its de facto independence — had announced sanctions on Lockheed Martin for a previous arms sale to the island.

U.S. arms manufacturers face strict limitations on what kind of business they can do with countries deemed by Washington to be strategic rivals, such as China. Lockheed generated 9.7% of its revenue in the Asia-Pacific region last year, according to data compiled by Bloomberg, though that’s not broken down by individual countries.

China has previously threatened to sanction U.S. companies, including General Dynamics Corp. and Honeywell International Inc., on numerous occasions over arms sales to Taiwan. It also warned it could blacklist FedEx Corp., while Ford Motor Co.’s main joint venture partner in China was fined 162.8 million yuan ($24.3 million) last year, days after the U.S. put a ban on doing business with Huawei Technologies Co.

While China has often invoked the threat of putting U.S. companies on a blacklist — or list of “unreliable entities” — in response to various actions by U.S. President Donald Trump’s administration over the past year, it has yet to name any, at least publicly.

Delicate Time

For Boeing, China’s action comes at a delicate time. The company, reeling from the hit to air travel from the coronavirus pandemic, is trying to get its besieged 737 Max plane back into the air after two fatal crashes saw it grounded around the world. China was the first place to ground the plane, and also has the world’s biggest 737 Max fleet.

Europe’s top aviation regulator said earlier this month the plane will be safe enough to fly again before the end of this year, while U.S. Federal Aviation Administration chief Steve Dickson flew the Max in September and said the controls were “very comfortable.” More detail here.

Trump’s Re-Election Could Bring Several New Cabinet Secretaries

Axios reports:
If President Trump wins re-election, he’ll move to immediately fire FBI Director Christopher Wray and also expects to replace CIA Director Gina Haspel and Defense Secretary Mark Esper, two people who’ve discussed these officials’ fates with the president tell Axios.

The big picture: The list of planned replacements is much longer, but these are Trump’s priorities, starting with Wray.

Wray and Haspel are despised and distrusted almost universally in Trump’s inner circle. He would have fired both already, one official said, if not for the political headaches of acting before Nov. 3.

Why it matters: A win, no matter the margin, will embolden Trump to ax anyone he sees as constraining him from enacting desired policies or going after perceived enemies.

Federal Agencies Struggle To Quantify Data Consolidation ...

Trump last week signed an executive order that set off alarm bells as a means to politicize the civil service. An administration official said the order “is a really big deal” that would make it easier for presidents to get rid of career government officials.
There could be shake-ups across other departments. The president has never been impressed with Education Secretary Betsy DeVos, for example. But that doesn’t carry the urgency of replacing Wray or Haspel.
The nature of top intelligence and law enforcement posts has traditionally carried an expectation for a higher degree of independence and separation from politics.

Be smart: While Trump has also privately vented about Attorney General Bill Barr, he hasn’t made any formal plans to replace him, an official said.

Trump is furious that Barr isn’t releasing before the election what Trump hoped would be a bombshell report by U.S. Attorney John Durham on the Obama administration’s handling of the Trump-Russia investigation.
Durham’s investigation has yet to produce any high-profile indictments of Obama-era officials as Trump had hoped.
“The attorney general wants to finish the work that he’s been involved in since day one,” a senior administration official told Axios.

Behind the scenes: “The view of Haspel in the West Wing is that she still sees her job as manipulating people and outcomes, the way she must have when she was working assets in the field,” one source with direct knowledge of the internal conversations told Axios. “It’s bred a lot of suspicion of her motives.”

Trump is also increasingly frustrated with Haspel for opposing the declassification of documents that would help the Justice Department’s Durham report.
A source familiar with conversations at the CIA says, “Since the beginning of DNI’s push to declassify documents, and how strongly she feels about protecting sources connected to those materials, there have been rumblings around the agency that the director plans to depart the CIA regardless of who wins the election.”

As for Wray, whose expected firing was first reported by The Daily Beast, Trump is angry his second FBI chief didn’t launch a formal investigation into Hunter Biden’s foreign business connections — and didn’t purge more officials Trump believes abused power to investigate his 2016 campaign’s ties to Russia.

Trump also grew incensed when Wray testified in September that the FBI has not seen widespread election fraud, including with mail-in ballots.
A senior FBI official tells Axios: “Major law enforcement associations representing current and former FBI agents as well as police and sheriff’s departments across the country have consistently expressed their full support of Director Wray’s leadership of the Bureau.”

Trump soured on Esper over the summer when the Defense secretary rebuffed the idea of sending active-duty military into the streets to deal with racial justice protests and distanced himself from the clearing of Lafayette Square for a photo op at St. John’s church.

Trump indicated to Axios then that he “really wasn’t focused on” firing Esper. One senior official cautioned that others who want the Pentagon job could be driving speculation to undercut Esper. But one source, who discussed options with Trump, told Axios he urged the president to wait until post-election to replace him.
Chief Pentagon spokesman Jonathan Hoffman said in a statement that Esper “has always been and remains committed to doing what is best for the military and the Nation.”

Trump 2.0 would bring more loyalty tests

Chris Liddell, Trump’s deputy chief of staff for policy coordination, is heading the White House’s transition effort, including vetting potential new Cabinet officials, two White House officials told Axios.

He’s working closely with White House counsel Pat Cipollone and Johnny McEntee, who runs the Office of Presidential Personnel and has been conducting “loyalty tests” to weed out “Never Trumpers” from the administration.
In 2016, Trump famously blew up his own transition process. The officials said Liddell is determined to avoid a repeat. Liddell declined to comment.
Politico first reported on Trump’s transition team.

Don’t forget: The transition between first and second terms is traditionally a time when presidents who win re-election accept resignations and switch out their teams.

Former chiefs of staff to Presidents George W. Bush and Barack Obama, speaking on David Marchick’s “Transition Lab” podcast, said their administrations didn’t prepare enough for a “robust transition” between terms.
Bush’s former chief Josh Bolten said he’d advise Trump to “rethink all of your personnel and know what your priorities are.”

White House spokesman Judd Deere told Axios: “We have no personnel announcements at this time nor would it be appropriate to speculate about changes after the election or in a 2nd term.”

Operation Warp Speed Status Report Courtesy of the Military

Below is a compilation of initiatives, actions and accomplishments across Operation Warp Speed (OWS)’s primary efforts in the past week. To learn more about OWS, visit the Department of Health and Human Services (HHS) website and Department of Defense (DOD) website.

Pfizer, Merck, and Moderna among finalists for Operation ...

VACCINE DEVELOPMENT:

The U.S. Food and Drug Administration today authorized the restart of AstraZeneca’s Phase 3 clinical trial in the U.S. As part of the standard review process for adverse events in clinical trials, a voluntary pause was triggered to allow for the examination of safety data by independent monitoring committees. This pause while the adverse event was fully investigated means the science-based, data-driven process continues to work as it should.

Moderna announced it completed enrollment on its Phase 3 clinical trial, noting 37 percent of the 30,000 participants are part of minority populations. To date, more than 25,650 participants of Moderna’s participants have received their second vaccination. According to Moderna’s announcement, the company’s decision to submit a dossier to FDA requesting Emergency Use Authorization will be based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks. The science and data behind this assessment is accruing.

The FDA’s Vaccines and Related Biological Products Advisory Committee met Thursday to discuss the ongoing development of a COVID-19 vaccine. In the interest of transparency over the process, the FDA streamed the entire committee meeting on both its own website and on YouTube. The all-day meeting explored the potential of granting Emergency Use Authorization and the standards and criteria that will be applied to vaccine candidates.

The Centers for Disease Control and Prevention launched a new page on their website dedicated to education on the COVID-19 vaccine planning efforts: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html.

In its commitment to transparency, Operation Warp Speed has posted four redacted contracts here: https://www.hhs.gov/foia/electronic-reading-room/index.html

THERAPEUTICS DEVELOPMENT:

The U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) Oct. 22 for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.

MANUFACTURING, DISTRIBUTION AND ADMINISTRATION:

Operation Warp Speed is working with the U.S. Marshals Service as part of a “whole of government” approach to ensure the security of the vaccine supply chain, including delivery to administration points. Marshals Service liaisons are embedded with the OWS team to ensure there is consistent communication and information flow in the security sector.

Synchronizing and integrating data across distribution and administration operations is a critical effort of Operation Warp Speed. To that end, OWS is using a specially designed platform to collect, correlate and visualize data across the entire operation. The “Tiberius” platform integrates the related manufacturing, supply chain, allocation, state and territory planning, delivery and administration of both vaccine products and ancillary kits. The 2020 technology provides visibility across all U.S. jurisdictions to provide decision support and ease the burden of public health officials throughout the nation. Additionally this week, HHS in support of Operation Warp Speed began signing Memorandums of Understandings with jurisdictions to provide access to information technology (IT) support to assist them with vaccine response planning and distribution at no cost.
An OpEd by HHS Secretary Alex Azar titled “Why Operation Warp Speed is a Made-in-America story,” highlighted the scaling up of manufacturing facilities across the country. He discussed DOD’s success in applying a military supply chain and logistics mentality to develop and deliver a COVID-19 vaccine to the American people.

KEY ENGAGEMENTS:

HHS Secretary Alex Azar visited Emory University Hospital in Atlanta and saw their work on clinical trials for Regeneron’s antibody cocktail and Moderna’s candidate vaccine.

Operation Warp Speed Chief Science Advisor Dr. Moncef Slaoui visited a Moderna clinical trial site at George Washington University Wednesday and spoke with ABC’s Bob Woodruff.

HHS Deputy Secretary Hargan visited the University of Kansas Medical Center for a meeting with their leadership and physicians about the Phase 3 clinical trials they have been overseeing for the AstraZeneca Vaccine. Deputy Secretary Hargan will also join Nebraska Governor Pete Ricketts on Saturday, October 24 for a tour of the University of Nebraska Medical Center where they are conducting clinical trials for COVAXX vaccine and therapeutic candidates.

Dr. Anthony Fauci joined a Univision Town Hall entitled “COVID-19 Vaccines: Myths and Facts” to discuss the importance of Hispanics being represented in clinical trials.

The Washington Post: “Unprecedented vaccine trials on track to begin delivering results.”

Operation Warp Speed Chief Operating Officer Gen. Gus Perna and Vaccine Development Lead Dr. Matt Hepburn will participate in a discussion with The Heritage Foundation on “The Fight to get a COVID-19 Vaccine” Oct. 27 at 3 p.m. The virtual event is free and open for registration.

SENIOR LEADER QUOTES:

“Clinical trial volunteers are the real heroes of this pandemic. Many people are looking for a way to make an impact and serve. Volunteering is a tremendous opportunity to be helpful.” ~Dr. Matt Hepburn, OWS Vaccine Development Lead

“Advances in science are the foundation for the unprecedented progress we are seeing under Operation Warp Speed. But the broader set of requirements for ultimate success—unwavering leadership, ingenuity, determination, the commitment of enormous resources, exceptional logistical infrastructure, and public-private collaboration—can be assembled only in America.” ~HHS Secretary Alex Azar

“It’s not a certainty, but the plan – and I feel pretty confident – should make it such that by June, everybody could have been immunized in the U.S.” ~Dr. Moncef Slaoui, OWS Chief Advisor

“Trust in the science. We have executed vaccine development with rigor. The leading scientists in the world and the quality of the nation’s pharmaceutical base, with oversight of the FDA’s gold standard, lend credibility to this unprecedented effort.” ~Paul Ostrowski, OWS Director for Supply, Production and Distribution

Operation Warp Speed is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostic

US blames Iran for Spoofed Proud Boys Emails

US blames Iran for spoofed Proud Boys emails threatening Democrat voters

ZDNet: US claims Iran is behind a wave of emails purporting to be from right-wing Proud Boys group that threatened registered Democrat voters with repercussions if they didn’t vote for Trump.

iran-emails-proud-boys.png

In a short press conference held today by the US Department of Justice, high-ranking officials with the US government claimed that Iran was behind a wave of emails sent to US voters earlier this week.

Spoofing the identity of violent extremist group Proud Boys, the emails threatened registered Democrat voters with repercussions if they didn’t vote for Donald Trump in the upcoming US Presidential Election.

The senders claimed to have “gained access into the entire [US] voting infrastructure,” but appeared to use public voter registration databases to target Democrat voters in Alaska, Arizona, and Florida.

Two waves of emails were sent this week, the first on Tuesday (October 20), and the second on Wednesday (October 21), according to a report from email security firm Proofpoint, which has been tracking the spam campaigns.

The second wave of emails, besides the original message threatening Democrat voters, also included a link to a video claiming to show an individual print out a voting ballot with another person’s information (a copy of the video is embedded in the Proofpoint report). The video was debunked by several US news media publications.

Responding to intense media coverage surrounding the emails, in a short press conference earlier today, FBI Director Christopher Wray and Director of National Intelligence John Ratcliffe attributed the spam campaigns to Iran.

Addressing the video shared in the emails, Ratcliffe added that “the information in the video is not true.”

Ratcliffe also added that besides Iran, Russia has also also “taken specific actions to influence public opinion relating to our election.”

“Although we have not seen the same actions from Russia, we are aware that they have obtained some voter registration information,” Ratcliffe added.

The two officials urged the US public to remain calm and not spread any similar messages they receive in the future.

Neither of the two officials presented any evidence during the press conference but only made short statements.

Spokespersons for several cyber-security firms could not confirm the Iranian attribution, when inquired by ZDNet today. However, they didn’t dismiss it either.

“Iranian information operations date back at least eight years and they have grown beyond fake news sites and social network activity to elaborate tactics, such as impersonating journalists to solicit video interviews and placing op-eds. They have even impersonated American politicians,” John Hultquist, Senior Director of Analysis, Mandiant Threat Intelligence, told ZDNet.

“The information operations we have seen from Iran to date have been about amplifying pro-Iranian messages and pushing a desired narrative out into the world that’s anti-Saudi or ant-Israeli or pro-JCPOA,” he added.

“This is different. This is deliberate interference in our democracy and it crosses a major red line. I think the Intel community scored a win here against Iran today,” Hultquist said.