Anonymous ID: d32701 Jan. 25, 2022, 7:16 a.m. No.15457580   🗄️.is 🔗kun   >>7597 >>7822 >>7839 >>7885 >>8039

https://www.state.gov/biographies/kari-johnstone/

Kari Johnstone serves as Senior Official and Principal Deputy Director of the Office to Monitor and Combat Trafficking in Persons (J/TIP), where she has been Principal Deputy Director since 2014.  In this role, she advises senior officials on U.S. Government policy and programming strategies to fight human trafficking around the world and oversees the production of the Department’s annual Trafficking in Persons Report.

In 2013 and 2014, Dr. Johnstone served as Acting Deputy Assistant Secretary for South and Central Asia and International Religious Freedom in the Bureau of Democracy, Human Rights, and Labor (DRL).  She was the Director and Deputy Director of the Office for International Religious Freedom between 2010 and 2014. In spring 2012, she served as Director for Russia and Central Asia at the National Security Staff of the White House.  She previously worked as the Acting Office Director and Deputy Director of DRL’s Office for the Near East and South and Central Asian Affairs.  Kari served as the election officer at the U.S. Embassy in Kabul in 2004 and as the human rights officer at the U.S. Embassy in Tashkent in 2003.

In 2001-2002, she was a Research Scholar at the Kennan Institute of the Woodrow Wilson International Center for Scholars.

Dr. Johnstone is a career member of the Senior Executive Service and received a B.A. from the University of Michigan and an M.A. and Ph.D. from the University of California at Berkeley, all in political science.  She speaks Ukrainian and Russian, some Czech and Slovak, and a little Hungarian.

Anonymous ID: d32701 Jan. 25, 2022, 7:19 a.m. No.15457597   🗄️.is 🔗kun   >>7604 >>7607

>>15457580

>Senior Official and Principal Deputy Director of the Office to Monitor and Combat Trafficking in Persons (J/TIP), where she has been Principal Deputy Director since 2014

https://www.state.gov/bureaus-offices/under-secretary-for-civilian-security-democracy-and-human-rights/office-to-monitor-and-combat-trafficking-in-persons/

https://twitter.com/JTIP_State/status/1485993853370998785

Will you be watching? Today at 2 p.m. EST is the Biden-Harris Administration’s first meeting of the President’s Interagency Task Force to Monitor and Combat Trafficking in Persons.

#EndHumanTrafficking

https://www.state.gov/humantrafficking-interagency-task-force/#pitf

Anonymous ID: d32701 Jan. 25, 2022, 7:20 a.m. No.15457604   🗄️.is 🔗kun

>>15457597

>Will you be watching? Today at 2 p.m. EST is the Biden-Harris Administration’s first meeting of the President’s Interagency Task Force to Monitor and Combat Trafficking in Persons.

https://www.youtube.com/watch?v=jQLNeXaeZLo

Anonymous ID: d32701 Jan. 25, 2022, 7:23 a.m. No.15457628   🗄️.is 🔗kun   >>7642 >>7653 >>7695 >>7702 >>7726 >>7745 >>7781 >>7807 >>7817 >>8165 >>8316

>>15457599

>https://hbg100.com/2022/01/24/witness-at-scene-of-cdc-lab-monkeys-crash-has-developed-symptoms

Michelle Fallon is living a nightmare. And, she’s ready to put that nightmare on record.

The Danville woman is now experiencing symptoms, believed to be related to her close encounter with wild monkeys, when the trailer they were riding in collided with a dump truck and unloaded their cages all over Route 54, close to I-80, on Friday afternoon. (The monkeys were destined for an unidentified Centers for Disease Control lab, in the Midwest.)

The following day, Fallon developed a cough and something that resembled “pink-eye.” And, by Sunday, she was visiting the Geisinger Medical Center emergency room, where infectious disease doctors were consulted. Fallon has since received her first (of 4) preventative rabies shots; as well as a prescription for a 14-day course of Valacyclovir.

The stay-at-home mom, who shared that she was fully vaccinated and received her booster, was also tested for Covid, but the results at the ER were negative.

Fallon is still processing the sequence of events that unfolded on Friday. She pulled over to check on the condition of the accident victims, but she said they were more concerned about press coverage of the incident.

The driver of the truck hauling the monkeys, identified in a press release from PA State Police, as Cody M. Brooks, 31, of Keystone Heights, FL even went so far as to put his hand in the camera of a local Press-Enterprise reporter. “He was very, very upset,” said Fallon. “He was in a panic.” Brooks passenger, Daniel G. Adkins, 59, of Florahome, FL required transport to Geisinger Medical Center for an injury.

Many questions remain unanswered for Fallon, like what are these monkeys possibly infected with? Why wasn’t the vehicle marked indicating it was carrying potentially bio-hazardous contents? Why were the three monkeys that fled instantly euthanized and not captured? What did the CDC tell her doctor to test for?

Nothing forewarned Fallon that she was putting her health at risk. It was only after her risky encounter, when a CDC representative who appeared on the scene, advised her to watch for symptoms and to alert her primary care doctor. She also said the CDC and Pennsylvania Department of Health would be in touch (see letters).

“This has been a nightmare,” she said. “I had no idea doing a good deed like this could get me a rabies shot and put me in this situation.”

Fallon was simply showing compassion; she told the trailer driver that he’s “in Danville, we take care of people.” Now, she’s the one needing care.

Fallon said there were other motorists who stopped at the scene. Fallon could not identify those people but suspected some might also have been put at risk. The email from PA DOH indicated that efforts would be made to track them down with the assistance of police.

Those who believe they may have had contact with the monkeys are asked, per the CDC letter, to seek medical attention and contact PA DOH at (717) 787-3350.

The three monkeys who fled from the scene were euthanized. People for the Ethical Treatment of Animals (PETA) has since issued a statement on this incident, indicating that the organization has filed a complaint with the US Department of Agriculture’s Director of Animal Welfare Operations, asking him to investigate the treatment of these monkeys. They report that the “USDA has now confirmed that it’s investigating.”

Anonymous ID: d32701 Jan. 25, 2022, 7:26 a.m. No.15457642   🗄️.is 🔗kun   >>7698 >>7759

>>15457628

https://twitter.com/MKeelyNews/status/1484938826921484294

SHE SAW THE MONKEYS: One monkey is still on the loose in the Danville area after four escaped from a truck carrying lab monkeys. Michele Fallon saw the wreck unfold. She says people first thought the truck was full of cats! @WNEP

Anonymous ID: d32701 Jan. 25, 2022, 7:29 a.m. No.15457661   🗄️.is 🔗kun   >>7667

https://nypost.com/2022/01/24/emails-reveal-suspected-covid-leaked-from-a-wuhan-lab-then-censored-themselves/

Emails reveal scientists suspected COVID leaked from Wuhan lab – then quickly censored themselves

From almost the moment the COVID-19 pandemic broke out in the Chinese city of Wuhan, the medical-research establishment in Washington and London insisted that the virus had emerged naturally. Only conspiracy theorists, they said, would give credence to the idea that the virus had escaped from the Wuhan Institute of Virology.

Now, a string of unearthed emails — the most recent being a batch viewed by the House Oversight and Reform Committee and referred to in its Jan. 11 letter — is making it seem increasingly likely that there was, in fact, a conspiracy, its aim being to suppress the notion that the virus had emerged from research funded by the National Institute of Allergy and Infectious Diseases (NIAID), headed by Anthony Fauci.

The latest emails don’t prove such a conspiracy, but they make it more plausible for two reasons: because the expert virologists therein present such a strong case for thinking that the virus had lab-made features, and because of the wholly political reaction to this bombshell on the part of Francis Collins, then-director of the National Institutes of Health.

Anonymous ID: d32701 Jan. 25, 2022, 7:30 a.m. No.15457667   🗄️.is 🔗kun   >>7668

>>15457661

They agreed, until they didn’t

The story begins with a Jan. 31, 2020, email to Fauci from a group of four virologists led by Kristian G. Andersen of the Scripps Research Institute. The genome sequence of SARS-CoV-2 had been published three weeks before, giving virologists their first look at the virus’ structure and possible origin.

Andersen reported to Fauci that “after discussions earlier today, Eddie, Bob, Mike and myself all find the genome inconsistent with expectations from evolutionary theory.” Eddie is Edward C. Holmes of the University of Sydney; Bob is Robert F. Garry of Tulane University; Mike is Michael Farzan at Scripps Research. In their unanimous view, the virus didn’t come from nature and may instead have escaped from a lab.

We knew this much already from emails obtained in June 2021 by a Freedom of Information Act request, as well as from the fact that a teleconference took place the following day (Feb. 1, 2020) to discuss the virologists’ conclusion.

But something remarkable happened at the conference, because within three days, Andersen was singing a different tune. In a Feb. 4, 2020, email, he derided ideas about a lab leak as “crackpot theories” that “relate to this virus being somehow engineered with intent and that is demonstrably not the case.”

Andersen and his colleagues then prepared an article, published on March 17, 2020, in the journal Nature Medicine, that declared flatly, “Our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus.” The article was highly influential, persuading the mainstream press not to investigate lab-leak theories.

That paper, along with an earlier letter in the British medical journal The Lancet, froze into silence any dissenting voices from the scientific community. The Lancet letter was signed by Jeremy Farrar, a powerful research administrator in London who convened the Feb. 1, 2020, teleconference.

What happened at the Feb. 1 teleconference to make the virologists change their minds so radically? It was impossible to tell from the emails released in June 2021 because almost every word in them was redacted. The House Oversight and Reform Committee was allowed to view the emails only in camera, meaning members weren’t given copies, but staffers are allowed to transcribe them by hand while viewing them.

A striking feature of the excerpts released in the committee’s Jan. 11, 2022, letter is that the virologists had little doubt that the virus bore the fingerprints of manipulation. The focus of their attention was a genetic element called a furin cleavage site.

This short snippet of genetic material is what makes the virus so infectious for human cells. Scientists sometimes add this element to laboratory viruses to make them more virulent, but in nature, viruses usually acquire runs of genetic material like this by swapping them with other members of their family.

Anonymous ID: d32701 Jan. 25, 2022, 7:30 a.m. No.15457668   🗄️.is 🔗kun   >>7681

>>15457667

The furin cleavage site in the COVID virus sticks out like a sore thumb because no other known member of its family — a group called Sarbecoviruses — possesses a furin cleavage site. So how did the virus acquire it?

A member of the Andersen group, Garry of Tulane University, remarks in the latest emails on the fact that the inserted furin cleavage site, a string of 12 units of RNA, the virus’ genetic material, was exactly the required length, a precision unusual in nature: “I just can’t figure out how this gets accomplished in nature … it’s stunning. Of course, in the lab it would be easy to generate the perfect 12 base insert that you wanted.”

Another member of the Andersen group, Farzan of Scripps Research, apparently felt much the same way. “He is bothered by the furin cleavage site and has a hard time explain[ing] that as an event outside the lab (though, there are possible ways in nature, but highly unlikely),” the House committee’s letter says of his remarks.

Farzan noted that viruses can acquire elements like furin cleavage sites when grown in cultures of human cells, so “instead of directed engineering … acquisition of the furin site would be highly compatible with the continued passage of virus in tissue culture.”

Both routes — direct insertion of the cleavage site or tissue culture — would mean that the virus came from a lab.

The conferees were clearly aware of the possibility that the virus had originated in the Wuhan lab. “So I think it becomes a question of how do you put all this together,” Farzan wrote, “whether you believe in this series of coincidences, what you know of the lab in Wuhan, how much could be in nature — accidental release or natural event?

“I am 70:30 or 60:40,” he said, meaning he thought lab origin considerably more likely than not.

You might think that the senior administrators present at the conference would have rushed to investigate the startling inference that their expert advisers had drawn. But just one day after the teleconference at which his experts explained why they thought the virus seemed manipulated, Collins complained about the damage such an idea might cause.

“The voices of conspiracy will quickly dominate, doing great potential harm to science and international harmony,” he wrote on Feb. 2, 2020, according to the new emails.

Even after the March 2020 Nature Medicine article, which made the natural-origin theory the mainstream view, Collins still fretted that the lab-leak idea had not been sufficiently suppressed. “Wondering if there is something NIH can do to help put down this very destructive conspiracy,” he emailed Fauci on April 16.

Fauci was less concerned. “I would not do anything about this right now,” he replied the next day. “It is a shiny object that will go away in times.”

For many months, it did just that. Natural emergence remained the only possibility on the table in the scientific establishment and mainstream media.

Anonymous ID: d32701 Jan. 25, 2022, 7:32 a.m. No.15457681   🗄️.is 🔗kun   >>7683

>>15457668

Truth about gain-of-function

But the lab-leak theory gained in plausibility as more facts emerged about the research NIAID was funding at the Wuhan Institute of Virology. The program followed a debate among virologists as to how far one should go in enhancing a virus’ abilities in the lab in order to study its properties.

Collins and Fauci were proponents of “gain-of-function” research, as it is blandly known. “Important information and insights can come from generating a potentially dangerous virus in the laboratory,” they wrote in the Washington Post in 2011.

Some virologists questioned whether the possible gains were worth the substantial risks. But Collins and Fauci prevailed over the doubters, and in 2014 they began supporting a program of manipulating SARS-related viruses in Wuhan. Peter Daszak, president of the EcoHealth Alliance of New York, managed the program, using NIH money to fund research by Shi Zhengli, the chief expert on coronaviruses at the Wuhan Institute of Virology.

As we know from EcoHealth’s grant applications to the NIAID, Shi collected many types of coronaviruses from wild bats and took them back to her lab. There, she manipulated the viruses, principally by taking the gene for the spike protein of one virus and inserting it into the genome of another. The stated goal of this research was to find out how close the wild viruses might be to jumping to humans. To this end, she tested the novel viruses in humanized mice — animals genetically engineered to carry in their airways the proteins that the virus targets. The process adapts the virus to be capable of attacking live humans, even though this is not the intent.

Besides adding novel spike proteins, Shi’s manipulations may well have included insertion of a furin cleavage site. EcoHealth applied for a grant in 2018 for research that proposed to “introduce appropriate human-specific cleavage sites” into SARS-like coronaviruses. Though this grant application, submitted to an agency of the Defense Department, was turned down, Shi’s research team was clearly aware of the technique and may well have conducted such experiments with other funds. It is common practice for researchers to test out experimental techniques before applying for the grant in which they will be used.

The Andersen group’s detection of the furin cleavage site on Jan. 31, 2020, was a plausible basis for suspecting that SARS-CoV2 was not a natural virus. It’s an enduring puzzle as to why they then ruled out this possibility a mere four days later. There is thus far no counterargument in the public record. Farzan, the one member among Andersen and his three colleagues who did not sign the Nature Medicine article, declined an email request to discuss the episode.

However, Garry said in an email response that his remarks about the furin cleavage site in the emails discussed in the House committee’s Jan. 11 letter were just arguing a position and were taken out of context. “I favored the natural origin and had so for weeks, but the furin cleavage site was hard to rationalize.”

The Andersen group’s change of mind, Garry said, was not precipitate and had developed over several weeks for scientific reasons, not political pressure. A principal factor was “extremely important and compelling” data posted on Jan. 23 about a coronavirus found in pangolins. The pangolin virus’ receptor-binding domain, a critical feature that recognizes a target protein on the cell surface, was almost identical to that of SARS-CoV-2. This was a “big deal,” Garry said, because “if this feature was natural then very likely the whole virus was natural including the furin cleavage site.”

The argument is a little difficult to follow. Just because one part of the virus is natural, why does that show that someone had not inserted a genetically engineered furin cleavage site in another part?

Garry replied that engineering such a site would be a “very expensive, labor intensive, multiple month” process, and that in any case the Chinese researchers wouldn’t have used a virus so different from SARS1, the cause of a 2003 epidemic and their primary known focus of interest. But this is a hypothetical, not a clinching argument. If the Andersen group heard compelling new information about the virus’ origin between Jan. 31 and Feb. 4, Garry seems unable to say what it was.

Anonymous ID: d32701 Jan. 25, 2022, 7:32 a.m. No.15457683   🗄️.is 🔗kun

>>15457681

Congress must keep digging

So what induced these virologists to such a radical change of view? “The Feb. 1, 2020, telecon sent a clear message to participants that Fauci and Collins regarded discussion of the lab leak possibility, even though plausible on scientific data, to be politically unacceptable and something that had to be blocked,” says Richard Ebright of Rutgers University, a molecular biologist and a leading critic of gain-of-function research.

Fauci oversees a large portion of funds available for virology research in the US. It is not unreasonable to suppose that virologists keen on continuing their careers would be very attentive to his wishes. Both Garry’s and Andersen’s labs receive large sums of money from the NIAID. “Telecon participants with current and pending grants controlled by Fauci and Collins could not have missed or misunderstood the clear message,” Ebright says.

The repudiation by Andersen, Garry and Holmes of their original conclusion, expressed in the Jan. 31, 2020, email was of enormous benefit to Collins and Fauci. Though primary responsibility for any lab leak would rest with Shi at the Wuhan Institute of Virology and with Chinese regulatory authorities, Collins and Fauci could share a portion of the blame for having funded gain-of-function research despite its obvious risks and then failing to ensure that grant recipients were taking all necessary precautions.

If there really was a conspiracy surrounding the origin of SARS-CoV-2, Congress should search for it — first, in the still-closed records of the National Institutes of Health and the EcoHealth Alliance. Congress then needs to ask scientists free of outside pressures or conflicts to reassess the probable origin of a virus that has now killed some 5 million people worldwide.

Anonymous ID: d32701 Jan. 25, 2022, 8:03 a.m. No.15457839   🗄️.is 🔗kun

>>15457580

>Department’s annual Trafficking in Persons Report

Washington Foreign Press Center Briefing on the 2021 TIP Report, on July 1, 2021.

The mission of the Foreign Press Centers is to assist foreign media in their coverage of the United States by providing firsthand access to both government and non-government experts to gain a deeper understanding of U.S. politics, history, values, and culture. The views expressed by briefers not affiliated with the Department of State or U.S. government are their own and do not necessarily reflect those of the Department of State or the U.S. government. Participation in Foreign Press Center programming by briefers not affiliated with the Department of State or U.S. government does not imply endorsement, approval, or recommendation of their views.

Anonymous ID: d32701 Jan. 25, 2022, 8:52 a.m. No.15458127   🗄️.is 🔗kun   >>8130 >>8225 >>8248

https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Testimony%20-%20Fauci%20%28NIH%29%2012.04.2019.pdf

 

Most existing influenza vaccines are produced by growing the virus in eggs. This is a time-honored, but time-consuming process. Furthermore, the vaccine undergoes a process of adaptation to grow in eggs that may in itself lead to mutations that make the resulting vaccine less effective. In recognition of these limitations, the President signed the Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health on September 19, 2019. Broadly, the Executive Order directs BARDA, CDC, NIH, and FDA to accelerate the adoption of improved influenza vaccine technologies. In alignment with the goals of the Executive Order, NIAID is conducting and supporting research to develop state-of-the-art vaccine platform technologies that could be used to develop universal influenza vaccines as well as to improve the speed and agility of the influenza vaccine manufacturing process. These platform technologies include DNA, messenger RNA (mRNA), virus-like particles, vector-based, and self-assembling nanoparticle vaccines. For example, NIAID-supported scientists are investigating an mRNA vaccine candidate that would allow for a more rapid and flexible response to both seasonal and pandemic influenza than do existing vaccine production strategies.

Anonymous ID: d32701 Jan. 25, 2022, 9:16 a.m. No.15458248   🗄️.is 🔗kun   >>8250

>>15458127

>Broadly, the Executive Order directs BARDA, CDC, NIH, and FDA to accelerate the adoption of improved influenza vaccine technologies.

https://trumpwhitehouse.archives.gov/presidential-actions/executive-order-modernizing-influenza-vaccines-united-states-promote-national-security-public-health/

Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health

Section 1. Findings. (a) Influenza viruses are constantly changing as they circulate globally in humans and animals. Relatively minor changes in these viruses cause annual seasonal influenza outbreaks, which result in millions of illnesses, hundreds of thousands of hospitalizations, and tens of thousands of deaths each year in the United States. Periodically, new influenza A viruses emerge from animals, including birds and pigs, that can spread efficiently and have sustained transmission among humans. This situation is called an influenza pandemic (pandemic). Unlike seasonal influenza, a pandemic has the potential to spread rapidly around the globe, infect higher numbers of people, and cause high rates of illness and death in populations that lack prior immunity. While it is not possible to predict when or how frequently a pandemic may occur, there have been 4 pandemics in the last 100 years. The most devastating pandemic occurred in 1918-1919 and is estimated to have killed more than 50 million people worldwide, including 675,000 Americans.

(b) Vaccination is the most effective defense against influenza. Despite recommendations by the Centers for Disease Control and Prevention (CDC) that nearly every American should receive the influenza vaccine annually, however, seasonal influenza vaccination levels in the United States have currently reached only about 45 percent of CDC goals.

(c) All influenza vaccines presently in use have been developed for circulating or anticipated influenza viruses. These vaccines must be reformulated for each influenza season as well as in the event of a pandemic. Additional research is needed to develop influenza vaccines that provide more effective and longer-lasting protection against many or all influenza viruses.

(d) The current domestic enterprise for manufacturing influenza vaccines has critical shortcomings. Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires months-long production timelines, limiting their utility for pandemic control; rely on a potentially vulnerable supply chain of eggs; require the use of vaccine viruses adapted for growth in eggs, which could introduce mutations of the influenza vaccine virus that may render the final product less effective; and are unsuitable for efficient and scalable continuous manufacturing platforms.

(e) The seasonal influenza vaccine market rewards manufacturers that deliver vaccines in time for the influenza season, without consideration of the speed or scale of these manufacturers’ production processes. This approach is insufficient to meet the response needs in the event of a pandemic, which can emerge rapidly and with little warning. Because the market does not sufficiently reward speed, and because a pandemic has the potential to overwhelm or compromise essential government functions, including defense and homeland security, the Government must take action to promote faster and more scalable manufacturing platforms.

Anonymous ID: d32701 Jan. 25, 2022, 9:16 a.m. No.15458250   🗄️.is 🔗kun   >>8254

>>15458248

>Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health

Sec. 2. Policy. It is the policy of the United States to modernize the domestic influenza vaccine enterprise to be highly responsive, flexible, scalable, and more effective at preventing the spread of influenza viruses. This is a public health and national security priority, as influenza has the potential to significantly harm the United States and our interests, including through large-scale illness and death, disruption to military operations, and damage to the economy. This order directs actions to reduce the United States’ reliance on egg-based influenza vaccine production; to expand domestic capacity of alternative methods that allow more agile and rapid responses to emerging influenza viruses; to advance the development of new, broadly protective vaccine candidates that provide more effective and longer lasting immunities; and to support the promotion of increased influenza vaccine immunization across recommended populations.

Anonymous ID: d32701 Jan. 25, 2022, 9:17 a.m. No.15458254   🗄️.is 🔗kun   >>8274

>>15458250

>Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health

Sec. 3. National Influenza Vaccine Task Force. (a) There is hereby established a National Influenza Vaccine Task Force (Task Force). The Task Force shall identify actions to achieve the objectives identified in section 2 of this order and monitor and report on the implementation and results of those actions. The Task Force shall be co-chaired by the Secretary of Defense and the Secretary of Health and Human Services, or their designees.

(b) In addition to the Co-Chairs, the Task Force shall consist of a senior official from the following executive branch departments, agencies, and offices:

(i) the Department of Defense (DOD);

(ii) the Department of Justice;

(iii) the Department of Agriculture;

(iv) the Department of Veterans Affairs (VA);

(v) the Department of Homeland Security;

(vi) the United States Food and Drug Administration;

(vii) the Centers for Disease Control and Prevention;

(viii) the National Institutes of Health (NIH);

(ix) the Centers for Medicare and Medicaid Services (CMS); and

(x) the Biomedical Advanced Research and Development Authority (BARDA).

(c) The Co-Chairs may jointly invite additional Federal Government representatives, with the consent of the applicable executive department, agency, or office head, to attend meetings of the Task Force or to become members of the Task Force, as appropriate.

(d) The staffs of the Department of State, the Office of Management and Budget (OMB), the National Security Council, the Council of Economic Advisers, the Domestic Policy Council, the National Economic Council, and the Office of Science and Technology Policy (OSTP) may attend and participate in any Task Force meetings or discussions.

(e) The Task Force may consult with State, local, tribal, and territorial government officials and private sector representatives, as appropriate and consistent with applicable law.

(f) Within 120 days of the date of this order, the Task Force shall submit a report to the President, through the Assistant to the President for National Security Affairs, the Assistant to the President for Domestic Policy, the Director of the Office of Management and Budget, and the Director of the Office of Science and Technology Policy. The report shall include:

(i) a 5-year national plan (Plan) to promote the use of more agile and scalable vaccine manufacturing technologies and to accelerate development of vaccines that protect against many or all influenza viruses;

(ii) recommendations for encouraging non-profit, academic, and private-sector influenza vaccine innovation; and

(iii) recommendations for increasing influenza vaccination among the populations recommended by the CDC and for improving public understanding of influenza risk and informed influenza vaccine decision-making.

(g) Not later than June 1 of each of the 5 years following submission of the report described in subsection (f) of this section, the Task Force shall submit an update on implementation of the Plan and, as appropriate, new recommendations for achieving the policy objectives set forth in section 2 of this order.

Anonymous ID: d32701 Jan. 25, 2022, 9:19 a.m. No.15458274   🗄️.is 🔗kun   >>8275

>>15458254

>Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health

Sec. 4. Agency Implementation. The heads of executive departments and agencies shall also implement the policy objectives defined in section 2 of this order, consistent with existing authorities and appropriations, as follows:

(a) The Secretary of HHS shall:

(i) through the Assistant Secretary for Preparedness and Response and BARDA:

(A) estimate the cost of expanding and diversifying domestic vaccine-manufacturing capacity to use innovative, faster, and more scalable technologies, including cell-based and recombinant vaccine manufacturing, through cost-sharing agreements with the private sector, which shall include an agreed-upon pricing strategy during a pandemic;

(B) estimate the cost of expanding domestic production capacity of adjuvants in order to combine such adjuvants with both seasonal and pandemic influenza vaccines;

(C) estimate the cost of expanding domestic fill-and-finish capacity to rapidly fulfill antigen and adjuvant needs for pandemic response;

(D) estimate the cost of developing, evaluating, and implementing delivery systems to augment limited supplies of needles and syringes and to enable the rapid and large-scale administration of pandemic influenza vaccines;

(E) evaluate incentives for the development and production of vaccines by private manufacturers and public-private partnerships, including, in emergency situations, the transfer of technology to public-private partnerships — such as the HHS Centers for Innovation and Advanced Development and Manufacturing or other domestic manufacturing facilities — in advance of a pandemic, in order to be able to ensure adequate domestic pandemic manufacturing capacity and capability;

(F) support, in coordination with the DOD, NIH, and VA, a suite of clinical studies featuring different adjuvants to support development of improved vaccines and further expand vaccine supply by reducing the dose of antigen required; and

(G) update, in coordination with other relevant public health agencies, the research agenda to dramatically improve the effectiveness, efficiency, and reliability of influenza vaccine production;

(ii) through the Director of NIH, provide to the Task Force estimated timelines for implementing NIH’s strategic plan and research agenda for developing influenza vaccines that can protect individuals over many years against multiple types of influenza viruses;

Anonymous ID: d32701 Jan. 25, 2022, 9:19 a.m. No.15458275   🗄️.is 🔗kun   >>8279

>>15458274

>Sec. 4. Agency Implementation. The heads of executive departments and agencies shall also implement the policy objectives defined in section 2 of this order, consistent with existing authorities and appropriations, as follows:

(iii) through the Commissioner of Food and Drugs:

(A) further implement vaccine production process improvements to reduce the time required for vaccine production (e.g., through the use of novel technologies for vaccine seed virus development and through implementation of improved potency and sterility assays);

(B) develop, in conjunction with the CDC, proposed alternatives for the timing of vaccine virus selection to account for potentially shorter timeframes associated with non egg based manufacturing and to facilitate vaccines optimally matched to the circulating strains;

(C) further support the conduct, in collaboration with the DOD, BARDA, and CDC, of applied scientific research regarding developing cell lines and expression systems that markedly increase the yield of cell-based and recombinant influenza vaccine manufacturing processes; and

(D) assess, in coordination with BARDA and relevant vaccine manufacturers, the use and potential effects of using advanced manufacturing platforms for influenza vaccines;

(iv) through the Director of the CDC:

(A) expand vaccine effectiveness studies to more rapidly evaluate the effectiveness of cell based and recombinant influenza vaccines relative to egg-based vaccines;

(B) explore options to expand the production capacity of cell-based vaccine candidates used by industry;

(C) develop a plan to expand domestic capacity for whole genome characterization of influenza viruses;

(D) increase influenza vaccine use through enhanced communication and by removing barriers to vaccination; and

(E) enhance communication to healthcare providers about the performance of influenza vaccines, in order to assist them in promoting the most effective vaccines for their patient populations; and

(v) through the Administrator of CMS, examine the current legal, regulatory, and policy framework surrounding payment for influenza vaccines and assess adoption of domestically manufactured vaccines that have positive attributes for pandemic response (such as scalability and speed of manufacturing).

(b) The Secretary of Defense shall:

(i) provide OMB with a cost estimate for transitioning DOD’s annual procurement of influenza vaccines to vaccines manufactured both domestically and through faster, more scalable, and innovative technologies;

(ii) direct, in coordination with the VA, CDC, and other components of HHS, the conduct of epidemiological studies of vaccine effectiveness to improve knowledge of the clinical effect of the currently licensed influenza vaccines;

(iii) use DOD’s network of clinical research sites to evaluate the effectiveness of licensed influenza vaccines, including methods of boosting their effectiveness;

(iv) identify opportunities to use DOD’s vaccine research and development enterprise, in collaboration with HHS, to include both early discovery and design of influenza vaccines as well as later-stage evaluation of candidate influenza vaccines;

(v) investigate, in collaboration with HHS, alternative correlates of immune protection that could facilitate development of next-generation influenza vaccines;

(vi) direct the conduct of a study to assess the feasibility of using DOD’s advanced manufacturing facility for manufacturing cell-based or recombinant influenza vaccines during a pandemic; and

(vii) accelerate, in collaboration with HHS, research regarding rapidly scalable prophylactic influenza antibody approaches to complement a universal vaccine initiative and address gaps in current vaccine coverage.

(c) The Secretary of VA shall provide OMB with a cost estimate for transitioning its annual procurement of influenza vaccines to vaccines manufactured both domestically and with faster, more scalable, and innovative technologies.

Anonymous ID: d32701 Jan. 25, 2022, 9:19 a.m. No.15458279   🗄️.is 🔗kun

>>15458275

>Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health

Sec. 5. Termination. The Task Force shall terminate upon direction from the President or, with the approval of the President, upon direction from the Task Force Co-Chairs.

Sec. 6. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

 

DONALD J. TRUMP

THE WHITE HOUSE,

September 19, 2019.