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A M E R I C A N B I O D E F E N S E I N S T I T U T E

C O N G R E S S I O N A LC L I M A T E R E P O R T

A U G U S T 2 0 2 0

COVID 19

Scientific developments| p. 18

US CONGRESS

Pandemic and Biodefenselegislation| p. 27

CONGRESSIONALBRIEFING

Novel G4 H1N1 Influenza|p. 31

F R O M O U R

E X E C U T I V E

D I R E C T O R

The past four months have taught us how

unprepared we were for a novel threat

like COVID-19. ABI exists to collaborate

with researchers, policymakers, and

industry experts to ensure we never find

ourselves this unprepared again.

Our Congressional Climate report is

designed to give an overview of the

current policy landscape. While we have

begun to see discussion in Congress

around developing more rapid responses,

such as the recent work by Congressman

Gosar of Arizona, there is much work yet

to be done. We are calling for a four-

prong model approach to health during

pandemics going forward.

Specifically:

1. Self-care

Natural resistance to infection through

physical barriers and the innate immune

response is the first line of defense for all

people. These systems prevent infection

by most disease-causing organisms when

you are exposed to small amounts of

contagion. Clinical study has

demonstrated that the function of each

individual's innate infection resistance

can be improved by following some

simple principles.

American BioDefense Institute's

Executive Director

Ravi Starzl PhD

2. Rapid 'Preventive Firebreak' Response: Protection for New Bio Threats &

Conditions

There is a large gap between self-care and vaccination that novel threats, such

as the COVID-19 pandemic, can exploit to wreak havoc with lives and

economies. A safe, effective, and rapid means of responding to these

outbreaks is by creating passive immunity firebreaks that can be developed

and deployed quickly to intercept and suppress infectious disease threats.

This type of intervention is already well established in nature in the form of

breastfeeding. A mother transfers her immune system to her child through her

milk to help protect the child during the time when the child does not yet

have an effective immune system of their own. A mother transfers her

immune system to her child through her milk to help protect the child during

the time when the child does not yet have an effective immune system of their

own.

By 'borrowing' the 'mother's immune system, the child is able to avoid more infections than it would experience

without the benefit of passive immunity. If this could be replicated by utilizing antibodies in a way that can be

scaled, it could produce a rapid response to established or emerging infectious disease threats alike—hence

providing large-scale, inexpensive protection within 2-3 months of a novel threat.

3. Rescue response: Treatments for New Bio Threats & Conditions

When someone becomes seriously ill, a curative treatment to improve the prognosis of the disease is important.

Antibodies are the primary means of intervening in an active case of infection because they facilitate the reduction of

virus levels and speed up the recovery. Other examples of rescue medication can also be found in the form of

steroids or other small molecule formulations. All of these are important options for a patient that is already critically

ill and requires a means of improving their prognosis. While the utility of improving the prognosis of a critically ill

patient is undeniable, the direct and indirect costs of illness, as well as the cost of the rescue medication, are very

high. Thus, making avoiding illness in the first place, a far more desirable path to retaining health.

4. Development of Vaccines Fostering Natural and Herd Immunity

The long-standing utility of vaccines in public health cannot be overstated. Although many vaccines are of varying

effectiveness and can be difficult to produce, the benefits far outweigh the costs. By reducing the number, length,

and severity of cases an infectious disease creates, it reduces the impact on the overall community significantly.

Long-term use of vaccines in conjunction with passive immunity firebreak treatments offers the most comprehensive

protection for both individuals and communities.

There are significant challenges still ahead. While we as a civilization have been fortunate to avoid a serious

pandemic for decades, the COVID-19 pandemic has proven that this is a luxury we can no longer afford. Going

forward, we have to accept that the next pandemic is inevitable, just as this one was – it is only a question of when it

is going to occur and how severe it is going to be. The sacrifices made during this pandemic make it our duty to

create a system that will be able to respond effectively in the future and protect what we have been unable to

protect today.

Ravi Starzl PhD

Executive Director

American BioDefense Institute

PAGE 3 AUGUST 2020

CONGRESSIONAL CLIMATE REPORT AUGUST 2020

TABLE OF CONTENTS

Visit

Biodefense 06

Biosecurity 10

COVID-19 Pandemic 12

Military 15

Darpa 15

White House 16

COVID-19 Vaccine News 18

Vaccine Development Progress

Vaccine Funding Support 19

Operation Warp Speed 19

Around the World 19

Promising Vaccine Candidates

AMERICANBIODEFENSEINSTITUTE .ORG

18

Federal Agencies

Research of Importance

Hydroxychloroquine benefits againstCOVID-19

Treatments for COVID-19

Antibody profile of COVID-19 patients

Strategic Implications of COVID-19 Pandemic

Food and Drug Administration

ReOpen America with AmericanBioDefense Institute

17

20

22

22

23

23

24

25

Letter of Endorsement

Congress in Focus 27

29

17

Congressional Briefing: H1N1

Passive Immunity

31

32

https://americanbiodefenseinstitute.org/

INTRODUCTION

This report presents brief summaries of various

bills and acts which have been introduced in the

House and Senate over the last few months. It

highlights the amendments made in already

existing bills and introduction of entirely new

acts by different government departments and

agencies in response to COVID-19 pandemic. In

addition, the latest news about COVID-19

vaccine, its development and progress are also

mentioned in this report. The later section of

this report focuses on notable research

including benefits of Hydroxychloroquine

against COVID-19, treatment and antibody

profile of COVID-19 patients and the strategic

implications of this pandemic. The final section

of the report suggests how to ReOpen America

based on the recommendations by American

BioDefense Institute.

BIODEFENSEH.R.6610 - Director of Pandemic and

Biodefense Preparedness and Response Act

Sponsors: Rep. Rose, Max; Rep. Scanlon, Mary

Gay; Rep. Norton, Eleanor Holmes; Rep. Jackson

Lee, Sheila; Rep. Foster, Bill.

This bill establishes the position of the Director

of Pandemic and Biodefense Preparedness and

Response in the executive branch with the

following responsibilities:

- Advise the President, relevant councils, and

experts with respect to pandemics and

other health threats.

- Oversee the development of a National

Pandemic and Biodefense Preparedness and

Response Strategy and, in consultation with the

Office of Management and Budget, submit

biennial reports to Congress on the

implementation of the strategy.

- Plan for and coordinate specified

preparedness and response activities.

Current status: Introduced in House

(04/23/2020)

More at: https://www.congress.gov/bill/116th-

congress/house-bill/6610

H.R.6607 - Strategic National Stockpile

Enhancement and Transparency Act

Sponsors: Rep. Lynch, Stephen F.; Rep. Soto,

Darren; Rep. Jackson Lee, Sheila; Rep. San

Nicolas, Michael F. Q.; Rep. Hayes, Jahana.

This bill requires the Department of Health and

Human Services (HHS) to establish and award

grants to states for the implementation of the

National Emergency Biodefense Network. The

network consists of state entities responsible for

tracking and maintaining adequate supplies of

drugs, medical devices, and other items

necessary for the emergency health security of

the United States.

Current status: Introduced in House

(04/23/2020)


congress/house-bill/6607

PAGE 6 AUGUST 2020

H.R.6966 - RASPP Act of 2020

Sponsors: Rep. Crow, Jason; Rep. Stefanik, Elise M.; Rep. Jackson Lee, Sheila; Rep. San Nicolas, Michael F.

Q.; Rep. Sherrill, Mikie; Rep. Carson, Andre.

The Secretary of Health and Human Services, in cooperation with the Biodefense Steering Committee,

shall clarify the national biodefense strategy and associated implementation plan developed under section

1086 of the National Defense Authorization Act for the Fiscal Year 2017 (6 U.S.C 104) to clearly document

agreed-upon processes, roles, and responsibilities for making and enforcing enterprise-wide decisions.

Current status: Introduced in House (05/22/2020)

More at: https://www.congress.gov/bill/116th-congress/house-bill/6966

H.R.5730 - National Strategy for Pandemic Influenza Update Act

Sponsors: Rep. Larsen, Rick; Rep. Langevin, James; Rep. Carson, Andre

This bill requires the White House Homeland Security Council (HSC) and the National Security Council

(NSC) to update the National Strategy for Pandemic Influenza issued by the HSC in November 2005 within

90 days of this bill's enactment. The implementation plan associated with the strategy shall be updated no

later than 180 days after such an update.



H.R.1589 - CBRN Intelligence and Information Sharing Act of 2019

Sponsors: Rep. Walker, Mark; Rep. King, Peter T.

This bill expands the functions of the Office of Intelligence and Analysis of the Department of Homeland

Security, including sharing of information and providing tailored analytical support on these threats to the

state, local, tribal, and territorial authorities and to relevant national biosecurity and biodefense

stakeholders and other federal agencies.

Current status: Passed House (04/01/2020)


PAGE 7 AUGUST 2020

H.R.6334 - Securing America From Epidemics Act

Sponsors: Rep. Bera, Ami; Rep. Yoho, Ted S.; Rep. Wright, Ron; Rep. Schrier, Kim; Rep. Raskin, Jamie; Rep.

Cisneros, Gilbert Ray, Jr.; Rep. Norton, Eleanor Holmes; Rep. Costa, Jim; Rep. Sherman, Brad; Rep. Foster,

Bill; Rep. Malinowski, Tom; Rep. Meeks, Gregory W.; Rep. Allred, Colin Z.; Rep. Lieu, Ted; Rep. Smith,

Adam; Rep. Gonzalez, Vicente; Rep. Trone, David J.; Rep. Houlahan, Chrissy; Rep. Phillips, Dean; Rep.

Blunt Rochester, Lisa; Rep. Spanberger, Abigail Davis.

This bill authorizes the United States to participate in the Coalition for Epidemic Preparedness Innovations

(CEPI), an alliance of countries and private partners whose mission is to finance and coordinate the

development of vaccines for high-priority, epidemic-potential threats. The President must submit a report

outlining (1) planned US contributions to, and participation in CEPI, (2) the manner and extent to which the

United States shall participate in the governance of CEPI; and (3) how participation in CEPI supports US

government strategies and programs in health security and biodefense.



S.2695 - National Bio and Agro-Defense Facility Act of 2019

Sponsors: Sen. Roberts, Pat; Sen. Stabenow, Debbie; Sen. Grassley, Chuck; Sen. Moran, Jerry; Sen. Smith,

Tina; Sen. Blunt, Roy; Sen. Ernst, Joni; Sen. Hyde-Smith,Cindy; Sen. Boozman, John; Sen. Gardner, Cory;

Sen. Thune, John; Sen. Shelby, Richard C.; Sen. Fischer, Deb; Sen. Braun, Mike; Sen. McConnell, Mitch;

Sen. Hoeven, John; Sen. Leahy, Patrick J.; Sen. Tester, Jon; Sen. Crapo, Mike; Sen.Casey, Robert P., Jr.; Sen.

Perdue, David; Sen. Rounds, Mike; Sen. Durbin,Richard J.; Sen. Johnson, Ron; Sen. Peters, Gary C.; Sen.

Loeffler, Kelly

This bill provides statutory authority for the Department of Agriculture (USDA) to act through the National

Bio and Agro-Defense Facility to provide integrated research and development to defend US agriculture

and food against bio and agro-terrorism threats. The bill requires USDA to use the facility to implement

research and development objectives to (1) develop veterinary countermeasures for emerging foreign

animal diseases and animal transboundary diseases; and (2) provide advanced testing, diagnostic, and

evaluation capability for threat detection, vulnerability assessment, and veterinary countermeasure

assessment for animal and zoonotic diseases.

Current status: Introduced in Senate 10/24/2019

More at: https://www.congress.gov/bill/116th-congress/senate-bill/2695

PAGE 8 AUGUST 2020

S.3302 - Global Health Security Act of 2020

Sponsors: Sen. King, Angus S., Jr.; Sen. Van Hollen, Chris

This bill establishes a permanent presidentially appointed position to manage outbreak response efforts.

Specifically, the bill establishes the role of Special Advisor for Global Health Security who shall (1) serve as

the President's principal advisor on global health security and global health emergencies (2) coordinate US

efforts to carry out global health security activities, and (3) convene the Global Health Security Interagency

Review Council. The bill establishes such a council to provide policy guidance to participating agencies on

global health security matters and to facilitate the implementation of the existing Global Health Security

Agenda. The Special Advisor must also develop a strategy to advance global health security and other

specified policy objectives and coordinate a whole-of-government approach to the implementation of such

a strategy. In addition, the Department of State must coordinate and facilitate interagency, multi-sectoral

activities outside of the United States in response to a declared global health emergency.

Current status: Introduced in Senate (02/13/2020)


S.3656 - Global Health Security Act of 2020

Sponsors: Sen. Murphy, Christopher; Sen. Romney, Mitt.

This bill is intended to authorize a comprehensive, strategic approach for United States foreign assistance to

developing countries to strengthen global health security, and for other purposes.



PAGE 9 AUGUST 2020

https://americanbiodefenseinstitute.org/sponsorship-opportunities/

BIOSECURITY

S.3734 - Bioeconomy Research and

Development Act of 2020

Sponsors:Sen. Gillibrand, Kirsten E.; Sen.

Markey, Edward J.; Sen. Rubio, Marco; Sen.

Gardner, Cory.

This bill intends to provide for a coordinated

Federal research initiative to ensure continued

United States leadership in engineering biology.

National Engineering Biology Research and

Development Initiative will be formulated to

advance societal well-being, national security,

sustainability, and economic productivity and

competitiveness.

Current status: Introduced in Senate

(05/14/2020)


congress/senate-bill/3734

S.3436 - Border Health Security Act of 2020

Sponsors: Sen. Udall, Tom; Sen. Heinrich, Martin; Sen. Gillibrand, Kirsten E.; Sen.McSally, Martha; Sen.

Sinema, Kyrsten; Sen. Cornyn, John.

This bill intends to establish grant programs to improve the health of border arearesidents and for all-

hazards preparedness in the border area, includingbioterrorism, infectious disease, and noncommunicable

emerging threats, and forother purposes.

Currentstatus: Introduced in Senate (03/11/2020)


H.R.6070 - Border Health SecurityAct of 2020

Sponsors:Rep. Torres Small, Xochitl; Rep. Kirkpatrick, Ann; Rep. Grijalva, Raul M.; Rep.Gonzalez, Vicente;

Rep. Vela, Filemon; Rep. Jackson Lee, Sheila; Rep. Escobar, Veronica; Rep. Haaland, Debra A.; Rep. Davis,

Susan A.; Rep. Vargas, Juan; Rep.Lujan, Ben Ray; Rep. Cuellar, Henry; Rep. Hurd, Will.

This bill intends to establish grant programs to improve the health of border area residents and for all-

hazards preparedness in the border area, including bioterrorism, infectious disease, and noncommunicable

emerging threats, and for other purposes.



H.Amdt.289 to H.R.2740 Labor, Health and Human Services, Education, Defense, State, Foreign

Operations, and Energy and Water Development Appropriations Act, 2020

Sponsors: Rep. Foster, Bill

Amendment increases the Biomedical Advanced Research and Development Authority account by

$1,000,000 to support increased R&D for biosecurity.

Current Status: 06/12/2019 Agreed to by recorded vote: 358 - 66 (Roll no. 273).

More at: https://www.congress.gov/amendment/116th-congress/house-amendment/289

PAGE 11 AUGUST 2020

COVID-19PANDEMIC

S.3669 - COVID-19 International Response and

Recovery Act of 2020

Sponsors: Sen. Menendez, Robert; Sen. Cardin,

Benjamin L.; Sen. Shaheen, Jeanne; Sen. Coons,

Christopher A.; Sen. Udall, Tom; Sen. Murphy,

Christopher; Sen. Kaine, Tim; Sen. Markey,

Edward J.; Sen. Merkley, Jeff; Sen. Booker, Cory

A.; Sen. Wyden, Ron.

This bill intends to respond to the global

COVID–19 pandemic by enhancing protection

of American citizens abroad during a pandemic,

preventing the spread of COVID–19 at the

United States-Mexico border, and providing

international assistance and leadership for the

International Economic Pandemic Response

and humanitarian assistance to countries

affected by the COVID–19 pandemic.

Current status: Introduced in Senate

(05/07/2020)


congress/senate-bill/3669

H.R.6599 - COVID Research Act of 2020

Sponsors: Rep. Lucas, Frank D.; Rep. Weber, Randy K., Sr.; Rep. Babin, Brian; Rep. Marshall, Roger W.; Rep.

Posey, Bill; Rep. Olson, Pete; Rep. Gonzalez, Anthony; Rep. Rooney, Francis; Rep. Murphy, Gregory; Rep.

Jackson Lee, Sheila.

The OSTP, acting through the National Science and Technology Council, must establish an interagency

working group to coordinate federal activities concerning infectious disease prediction and forecasting.

Among other tasks, the working group must identify challenges in predicting outbreaks and develop a

strategic plan to address them. In coordination with specified entities, DOE shall carry out, and report to

Congress on, a competitive research program for the National Laboratories and others to leverage

analytical tools and computational and networking capabilities to prevent and respond to emerging

infectious diseases, including COVID-19 (i.e., coronavirus disease 2019).



S.3905 - Intelligence Authorization Act for Fiscal Year 2021

Sponsors: Sen. Rubio, Marco

Among other things, this bill requires a report on biosecurity risk and disinformation by the Chinese

Communist Party and the Government of the People's Republic of China. Not later than 90 days after the

date of the enactment of this Act, the Director of National Intelligence shall submit to the appropriate

committees of Congress a report identifying whether and how officials of the Chinese Communist Party

and the Government of the People's Republic of China may have sought:

(1) to suppress information about

(a) the outbreak of the novel coronavirus in Wuhan.

(b) the spread of the virus through China; and

(c) the transmission of the virus to other countries.

(2) to spread disinformation relating to the pandemic

(3) to exploit the pandemic to advance their national security interests.



PAGE 13 AUGUST 2020

H.R.6455 - COVID-19 Commission Act

Sponsors: Rep. Thompson, Bennie G.; Rep. Jackson Lee, Sheila; Rep. Langevin, James R.; Rep. Richmond,

Cedric L.; Rep. Payne, Donald M., Jr.; Rep. Rice, Kathleen M.; Rep. Correa, J. Luis; Rep. Slotkin, Elissa; Rep.

Cleaver, Emanuel; Rep. Green, Al; Rep. Clarke, Yvette D.; Rep. Titus, Dina; Rep. Watson Coleman, Bonnie;

Rep. Barragan, Nanette Diaz; Rep. Demings, Val Butler; Rep. Khanna, Ro; Rep. Cicilline, David N.; Rep.

Sherman, Brad; Rep. Clay, Wm. Lacy; Rep. Wild, Susan; Rep. Haaland, Debra A.; Rep. Cohen, Steve; Rep.

Wilson, Frederica S.; Rep. Trone, David J.; Rep. Fudge, Marcia L.; Rep. Cooper, Jim; Rep. Case, Ed; Rep.

Lawrence, Brenda L.; Rep. Phillips, Dean; Rep. San Nicolas, Michael F. Q.; Rep. Vela, Filemon

This bill seeks to establish the National Commission Regarding the 2019 Novel Coronavirus COVID–19

Pandemic, and for other purposes.

Current

status: Introduced in House (04/03/2020)


H.R.6800 – The HEROES Act

Sponsors:Rep. Lowey, Nita M.; Rep. Engel, Eliot L.; Rep. Maloney, Carolyn B.; Rep. Nadler, Jerrold; Rep.

Neal, Richard E.; Rep. Pallone, Frank, Jr.; Rep. Scott, Robert C. "Bobby"; Rep. Takano, Mark; Rep. Velazquez,

Nydia M.; Rep. Waters, Maxine; Rep. Grijalva, Raul M.; Rep. Lofgren, Zoe

This bill responds to the COVID-19 (i.e., coronavirus disease 2019) outbreak and itsimpact on the economy,

public health, state, local governments, individuals, and businesses. The bill also modifies or expands a wide

range of other programs and policies.

Current status: Passed House (05/15/2020) Yeas and Nays: 208 – 199; Placed on Senate

Legislative Calendar under General Orders (06/01/2020)


PAGE 14 AUGUST 2020

https://americanbiodefenseinstitute.org/sponsorship-opportunities/

MILITARY

Darpa

DARPA has several ongoing programs focused

of COVID-19 medical countermeasures. Several

active programs are engaged in research of

rapid detection of COVID-19 exposure or

infection in both symptomatic and

asymptomatic individuals: Epigenetic

Characterization and Observation (ECHO),

Prometheus, Friend or Foe, SIGMA+ and

PREPARE. In addition, DARPA provided some

funding support to Sherlock Biosciences, which

is developing CRISPR SARS-CoV-2 kit for rapid

detection of the virus, providing results in

approximately one hour.

More at: https://www.darpa.mil/work-with-

us/covid-19

WHITE HOUSE

White House

President Trump has unveiled Guidelines for Opening Up America Again, a three-phased approach

based on the advice of public health experts. These steps will help state and local officials when

reopening their economies, getting people back to work, and continuing to protect American lives

More at: https://www.whitehouse.gov/openingamerica/

FEDERALAGENCIES

Food and Drug Administration

FDA - information on the Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and

therapeutic medical devices that CDRH has issued related to COVID-19.

More at: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-

devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices

Full information on all Emergency Use Authorization (EUA) and the list of all current EUAs

More at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-

policy-framework/emergency-use-authorization

COVID-19 VACCINE NEWS

Vaccine Development Progress

Currently, there are 41 vaccines in pre-clinical or

clinical trials. Two have entered phase 3 of

clinical testing, while two others have finished

phase 2. Six vaccines are in phase 2 of clinical

trials.

More at: https://www.raps.org/news-and-

articles/news-articles/2020/3/covid-19-vaccine-

tracker

On June 26th, China approved the start of phase

3 clinical trials of an inactivated vaccine

candidate against COVID-19 in the United Arab

Emirates by the China National Biotech Group

Co (CNBC). The vaccine was developed by the

Wuhan Institute of Biological Products, and has

already been tested on around 2,000 volunteers

in phase 2.

More at: https://covid

19.chinadaily.com.cn/a/202006/25/WS5ef3d66a

a3108348172553ca.html

Other Chinese companies engaged in COVID-19

vaccine development are also looking to conduct

phase 3 of clinical trials abroad: Sinovac Biotech

is expected to commence its phase 3 trial in

Brazil, with about 9,000 volunteers.

More at: https://www.news-

medical.net/news/20200626/China-to-initiate-

phase-3-SARS-CoV-2-vaccine-trial-in-UAE.aspx

CanSino Biologics is in talks to conduct phase 3

of clinical trials in Russia, Brazil,Chile or Saudi

Arabia.

More at: https://www.reuters.com/article/us-

health-coronavirus-china-vaccine/chinas-

cansino-in-talks-for-covid-19-vaccine-phase-iii-

trial-overseas-idUSKCN24C0HS

U.S. biotech company Moderna started phase 3

of clinical trials on 30,000 participants in the

U.S. in collaboration with Biomedical Advanced

Research and Development Authority of the

National Institute of Allergy and Infectious

Diseases (NIAID).

More at: https://www.nih.gov/news-

events/news-releases/phase-3-clinical-trial-

investigational-vaccine-covid-19-begins

More at:

https://clinicaltrials.gov/ct2/show/NCT04470427

PAGE 18 AUGUST 2020

Vaccine Funding Support

Operation Warp Speed

All of the investments under Operation Warp Speed include investment into manufacturing capabilities.

On March 30th HHS announced $456 million in funds for Johnson & Johnson's candidate vaccine.

Moderna received $483 million in federal funding to support COVID-19 vaccine development on April

16th.

On May 21st HHS announced awarding up to $1.2 billion in support for AstraZeneca's candidate vaccine,

developed in conjunction with the University of Oxford.

More at: https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html

Novavax announced on July 7th it received $1.6 billion in federal funding from Operation Warp Speed.

More at: https://ir.novavax.com/news-releases/news-release-details/novavax-announces-16-billion-

funding-operation-warp-speed

Around the World

The European Union has been negotiating deals for advance purchase of promising vaccine candidates

from Moderna, Sanofi, Johnson & Johnson, CureVac and BioNTech. On June 13th, four EU members of

Inclusive Vaccines Alliance (France, Germany, Italy, and the Netherlands) negotiated a deal with

AstraZeneca for the purchase of 400 million doses of its vaccine, which entered phase 3 of clinical trials.

The deals with all of the companies supported under Operation Warp Speed include provisions for 300

million doses of their respective vaccine for the U.S, Japan and the Bill & Melinda Gates

Foundation are in talks with Johnson & Johnson.

More at: https://www.fiercepharma.com/pharma/coronavirus-tracker-hydroxychloroquine-fails-va-study-

fda-approves-at-home-sample-collection

PAGE 19 AUGUST 2020

RELEVANT VACCINECANDIDATES

Novavax – NVX-CoV2373

Uses SARS-CoV-2 recombinant spike protein

nanoparticle with proprietary saponin-based

adjuvant Matrix-M. Currently in phase 1/2

clinical trials.

More at:


8

Moderna – mRNA-1273

Messenger-RNA based vaccine – contains

mRNA in a lipid nanoparticle dispersion.

Entering phase 3 of clinical trials.

More at:


AstraZeneca – AZD1222

Adenovirus vector. Entered phase 3 of clinical

trials in the UK.

More at:

https://www.precisionvaccinations.com/vaccines

/azd1222-sars-cov-2-vaccine

CanSino Biologics – Ad5-nCoV

Recombinant adenovirus vector. Entering phase

3 of clinical trials. Moderate side-effects

reported in over 80% of the patients.

PAGE 20 AUGUST 2020

https://americanbiodefenseinstitute.org/reopen-america-with-american-biodefense-institute/

More in: Zhu, F.C., Li, Y.H., Guan, X.H., Hou, L.H., Wang, W.J., Li, J.X., Wu, S.P., Wang, B.S., Wang, Z.,

Wang, L. and Jia, S.Y., 2020. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5

vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomized, first-in-human trial.

The Lancet. (https://doi.org/10.1016%2FS0140-6736%2820%2931208-3)

BNT162 – BioNTech, Fosun Pharma, Pfizer

mRNA vaccine. Currently, in phase 1/2 of clinical trials for four vaccine candidates.

More at: https://www.precisionvaccinations.com/vaccines/bnt162-sars-cov-2-vaccine

INO-4800 – Inovio Pharmaceuticals, CEPI, Korea National Institute of Health, International Vaccine

Institute

DNA plasmid vaccine. It is currently finishing phase 1 of clinical trials in the U.S.

with phase 1/2 underway in parallel in South Korea.

More at: https://www.precisionvaccinations.com/vaccines/ino-4800-dna-coronavirus-vaccine

Ad26 (JNJ-78436735) - Johnson and Johnson (J&J) and Janssen Pharmaceutical, in collaboration with Beth

Israel Deaconess Medical Center

Non-replicating viral vector vaccine. Entering phase 1 clinical trials on an accelerated schedule. Phase 3

planned for September 2020.

More at: https://www.precisionvaccinations.com/vaccines/ad26cov2-s-sars-cov-2-vaccine

PAGE 21 AUGUST 2020

PANDEMIC RESEARCH

Hydroxychloroquine benefits against COVID-

19

A study at the University of Minnesota claims

that hydroxychloroquine offers no benefits to

patients with COVID-19. The death rates in the

group treated with hydroxychloroquine and the

control group were identical at 0.4%, with

patients receiving hydroxychloroquine

reporting a higher incidence of mostly mild

side effects. Hospitalizations and persistent

symptoms were more common in the placebo

group, but the difference was not statistically

significant.

More at: https://triblive.com/news/health-

now/another-study-shows-no-

hydroxychloroquine-benefit-in-covid-19-fight/

On July 4th, the World Health Organization

discontinued its trials of hydroxychloroquine

and lopinavir/ritonavir treatment of COVID-19

patients, based on the recommendations of its

Solidarity Trial's International Steering

Committee.

The interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no

reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.

More at: https://www.who.int/news-room/detail/04-07-2020-who-discontinues-hydroxychloroquine-and-

lopinavir-ritonavir-treatment-arms-for-covid-19

Treatments for COVID-19

A preliminary report suggests that dexamethasone reduced 28-day mortality among those receiving

invasive mechanical ventilation or oxygen at randomization, but not among patients who did not receive

respiratory support. This paper has not been peer-reviewed.

More in: Horby, P., Lim, W.S., Emberson, J., Mafham, M., Bell, J., Linsell, L., Staplin, N., Brightling, C.,

Ustianowski, A., Elmahi, E. and Prudon, B., 2020. Effect of dexamethasone in hospitalized patients with

COVID-19: a preliminary report. MedRxiv.

There are conflicting reports on the effect of antiviral drug remdesivir on recovery times in COVID-19

patients. A study in China found no statistically significant differences in recovery times of patients on

remdesivir versus those on placebo. A study financed by Gilead, the manufacturer of remdesivir, conducted

in the U.S. found that the recovery times for remdesivir patients were shorter, 11 days versus 15 days for

placebo patients. Although the use of remdesivir will require more study, it appears that the effects on

patient recovery are not significant enough to classify it as a cure for COVID-19.

More in: Wang,Y., Zhang, D., Du, G., Du, R., Zhao, J., Jin, Y., Fu, S., Gao, L., Cheng, Z., Lu, Q. and Hu, Y.,

2020. Remdesivir in adults with severe COVID-19: a randomized, double-blind, placebo-controlled,

multicentre trial. The Lancet.

Beigel, J.H., Tomashek, K.M., Dodd, L.E., Mehta, A.K., Zingman, B.S., Kalil, A.C., Hohmann, E., Chu, H.Y.,

Luetkemeyer, A., Kline, S., and Lopez de Castilla, D., 2020. Remdesivir for the treatment of Covid-19—

preliminary report. New England Journal of Medicine.

Antibody profile of COVID-19 patients

Long, Q., Liu, B., Deng, H. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med

26, 845–848 (2020).

More at: https://doi.org/10.1038/s41591-020-0897-1

Xiang, F., Wang, X., He, X., Peng, Z., Yang, B., Zhang, J., Zhou, Q., Ye, H., Ma, Y., Li, H. and Wei, X., 2020.

Antibody detection and dynamic characteristics in patients with COVID-19. Clinical Infectious Diseases.

More at: https://doi.org/10.1093/cid/ciaa461

PAGE 23 AUGUST 2020

Iwasaki, A., Yang, Y. The potential danger of suboptimal antibody responses in COVID-19. Nat Rev

Immunol 20, 339–341 (2020).

More at: https://doi.org/10.1038/s41577-020-0321-6

Strategic Implications of COVID-19 Pandemic

Japanese Ministry of Defense released a white paper on primary security concerns for Japan: including

COVID-19 pandemic, China, Russia and North Korea.

More at: https://www.stripes.com/japan-defense-ministry-s-white-paper-warns-of-coronavirus-threat-

aggressive-competitors-1.637432

The Chinese government released a white paper, “Fighting Covid-19: China in Action.”

More at: http://english.scio.gov.cn/whitepapers/2020-06/07/content_76135269.htm

DHL released a white paper, “Post-Coronavirus Supply Chain Recovery: The Journey to the New Normal.”

More at: https://www.dhl.com/global-en/home/insights-and-innovation/thought-leadership/white-

papers/post-coronavirus-supply-chain-recovery.html

ABI released a congressional briefing “Novel G4 H1N1 Influenza.”

More at: https://americanbiodefenseinstitute.org/novel-g4-h1n1-influenza/

ABI commended Congressman Gosar on the submission of an amendment to the H.R.6395 – William

M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021

More at: https://americanbiodefenseinstitute.org/american-biodefense-institute-commends-congressman-

gosar-for-biosecurity-amendment/

PAGE 24 AUGUST 2020

Collaborating with researchers to develop a new class of antivirals focused on developing

preventive solutions for pandemics to provide rapid response to the current andfuture crisis.

First responder advisory

The American BioDefense Institute is working with Congressional stakeholders to formulate

solutions to reopen the American economy with built-in biodefense and biosecurity measures

meant to minimize the prolonged impact of the COVID 19 pandemic. Our program includes

multi-layered biodefense and bio-hygiene strategy that can be used to eliminate or drastically

reduce the introduction and proliferation of future pandemics globally.

This initiative is not exclusive to scientific safety measures and includes:

TOGETHERWE CAN

DO THIS!

National, State, and localized economic reboot strategy

Bleeding edge infection tracing and disinfecting technology

BioSecurity and BioDefense virtual events for scientific researchers

Federal agency communication of pandemic focused intelligence sharing

Grassroots information socialization strategy

Minority and low-income community outreach program

and more.

ABI has a unified constituency of more than 15,000,000 grassroots enthusiasts to socialize our Reopen

America campaign for a more expedient and enunciated effort for maximum impact. We are able to triple

the distance in a fraction of time for efforts in matters of biodefense. We have taken our process global via

the addition of more than 50 Washington based embassies, which will take our tools, tactics, and procedures

to their nations to reopen their economies in a bio-secure manner.

Find out more about American BioDefense Institute’s “Reopen America” campaign here.

PAGE 26 AUGUST 2020

https://americanbiodefenseinstitute.org/blog/

https://americanbiodefenseinstitute.org/fellows-program/

CONGRESS IN FOCUS

These are the members of Congress and the

Senate whose activities in the next few months

are worth following.

Rep. James R. Langevin is the U.S.

Representative for Rhode Island's 2nd

congressional district. He has been a long-term

proponent of affordable quality healthcare.

Rep. Jim Langevin co-sponsored, among others,

the following bills:

H.R.6848 - Pandemic Protection for Transition-

age Foster Youth Act

H.R.6466 - Relaunching America's Workforce

Act

H.R.5730 - National Strategy for Pandemic

Influenza Update Act

Rep. Paul Gosar is the U.S. Representative for

Arizona's 4th congressional district. He has been

one of the first U.S. politicians to come into

contact with COVID-19, going into self –

imposed two-week quarantine in early March,

and advocating “being proactive and cautious”.

Rep. Paul Gosar co-sponsored, among others,


H.R.6405 - Chinese Government COVID-19

Accountability Act

H.R.6338 - Pandemic Healthcare Access Act

H.R.6594 - Equal Access to COVID-19 Relief Act

Sen. Tom Cotton is the junior U.S. senator from

Arkansas. He was one of the early voices warning

about the dangers posed by COVID-19,

advocating travel restrictions as early as January

2020.

Sen. Tom Cotton co-sponsored, among others,


S.3837 - COVID-19 Vaccine Protection Act

S.3635 - Protecting Our Pharmaceutical Supply

Chain from China Act of 2020

S.3521 - Coronavirus Economic Stimulus Act

Rep. Ralph Abraham is the U.S. Representative

for Louisiana's 5th congressional district.

Rep. Abraham advocated for state-of-the-art

COVID testing for oil and gas workers in the

Gulf of Mexico.

Rep. Ralph Abraham co-sponsored, among

others, the following bills:

H.R.7710 - To provide liability protection for

elementary schools, secondary schools,

and institutions of higher education during the

COVID-19 public health emergency, and for

other purposes.

H.R.7690- To establish a payment program for

unexpected loss of markets and revenues to

timber harvesting and timber hauling businesses

due to the COVID-19 pandemic, and for other

purposes.

H.R.3502- Protecting People From Surprise

Medical Bills Act

Rep.Michael Waltz is the U.S. Representative

for Florida's 6th congressional district. Rep.

Michael Waltz has been a strong advocate of

expanding the testing for COVID-19 since the

start of the pandemic.

Rep. Michael Waltz co-sponsored, among

others, the following bills:

H.R.7029 - Protect our Children from COVID-19

Act

H.R.6822 - National Public Health Corps Act of

2020

H.R.6405 - Chinese Government COVID-19

Accountability Act

PAGE 28 AUGUST 2020

On behalf of the American BioDefense Institute, we commend the initiative by Rep.Paul Gosar of Arizona to establish a program for the development of rapid and cost-effective medical countermeasures to pandemics under the auspices of theDepartment of Defense. We submit this statement for the record to urge the Congressto expedite this bill, to provide effective rapid pandemic response capabilities.

This bill would promote the development of the Pandemic Prevention Platform: aprogram “to implement and advance the development of rapid and cost-effectivemedical countermeasures to pandemics.” The objective is to ensure that an efficientmedical countermeasure (an antibody or a biological product) is developed anddelivered to the population at risk within 60 days of identifying a virus or otherpathogen. In addition, every effort will be made to reduce this time frame to 28 days.This would provide unprecedented capabilities to contain and suppress any pandemicbefore it spreads.

This initiative addresses a bipartisan issue. Congressman Gosar has rightlyhighlighted that pandemic prevention is a vital issue that has not been adequatelyrecognized until now. Given the current COVID-19 pandemic and its widespreadhumanitarian, economic, and social implications, it is necessary to recognize thevulnerability of our nation to a pandemic outbreak and make sure that all manner ofprotection is provided for the American people against pandemic infectious diseases.

One of the vital provisions of this bill is the challenge to the American ingenuity toreduce the time frame of the rapid pandemic response from 60 days to 28 days. In thefirst 60 days of the pandemic, every day can make a big difference, and thedeployment of pandemic countermeasures as early as possible can save a lot oflives.

Dear Colleagues and Peers,

America's BioDefense Institute

American BioDefense Institute800 Maine Ave SW #200

Washington, DC 20024

(202) [email protected] www.americanbiodefenseinstitute.org

The development of rapid pandemic countermeasures will help to prevent anyemerging infectious disease from spreading worldwide by containing and eradicatingit if it reaches the U.S. These tools can be simultaneously used as (i) therapy forinfected patients and, (ii) as a passive immunization method to prevent furtherinfections and spread of disease.

The American BioDefense Institute urges the Congress to expedite the adoption ofthis bill and recognize its importance in the face of the pandemic. It will ensure thatthe U.S. healthcare system is equipped to deal with any future pandemic effectivelyand that the American people are given the pandemic protection they deserve. Theongoing COVID-19 pandemic has shown that this is a vital issue of both nationalsecurity and public health, and a necessary measure to protect the U.S. economy andthe American way of life.

Warm regards,

continued,

Ravi Starzl PhDExecutive DirectorAmerican BioDefense Institute

America's BioDefense Institute

American BioDefense Institute800 Maine Ave SW #200

Washington, DC 20024

(202) [email protected] www.americanbiodefenseinstitute.org

CONGRESSIONAL BRIEFING:NOVEL G4 H1N1 INFLUENZA

The high degree of national vulnerability to infectious respiratory disease observed during the COVID-

19 pandemic brings into focus the need for rapid identification of similar emerging biothreats, to both

enable early containment and development of countermeasures. The H1N1 influenza virus represents

just such a threat – it is a known killer with a deadly history that possesses the ability to evolve serotypes

that are both highly infectious and for which there is no established herd immunity. The possibility of a

widespread H1N1 outbreak during the COVID-19 pandemic would compound the strain

on regional medical systems, as there is no cross-protection between COVID-19 and H1N1 influenza

immunity.

H1N1 is an influenza A subtype whose strains had been responsible for several known major flu

epidemics, including the deadliest known flu pandemic in 1918-19. Different strains of the H1N1 virus

are endemic to humans, pigs, and birds.

There have been three pandemics of influenza in the 20th century and one in the 21st century

(Kilbourne, 2006). The H1N1 virus caused a significant and best-known pandemic in 1918-19 and the

most recent one in 2009-10. In addition, there were three other notable epidemics in the 20th century

that were not considered pandemics: (i) a pseudo pandemic in 1947 (that was not considered pandemic

due to low death rates), (ii) 1977 epidemic that was pandemic in children, (iii) an abortive epidemic of

swine flu in 1976 in Fort Dix, NJ. All of these were caused by strains of the H1N1 virus.

An antigenic variation of H1N1 caused the 1947 epidemic. One remarkable feature of this epidemic was

the complete failure of the H1N1 vaccine with the 1943 H1N1 strain due to the antigenic drift of the 1947

virus. Millions of U.S. military personnel that were vaccinated were found to have no protection against

the new strain of the H1N1 virus. Luckily, the epidemic caused relatively few deaths and is, therefore,

considered to be a pseudo pandemic.

The 1976 outbreak of H1N1 was confined to Fort Dix, NJ, although it triggered a mass vaccination

program that planned to vaccinate 43 million Americans. The vaccination was suspended after repeated

reports of Guillain-Barré syndrome affecting vaccinated individuals in around a dozen states and seven

times the higher reported incidence of swine flu in vaccinated individuals.

Complete Downloadable Report HERE → H1N1 Report

PAGE 31 AUGUST 2020

https://americanbiodefenseinstitute.org/novel-g4-h1n1-influenza/

PASSIVE IMMUNITYTHE NEXT GENERATION OF

PANDEMIC RESPONSEImmunization is a process of fortifying an individual’s immune system against an agent, typically

disease-causing pathogen or a toxin. When the immune system is exposed to foreign molecules, this

will trigger an immune response. Because of immunological memory, our immune system is also

able to develop the ability to respond quickly to any subsequent encounter with the same agent, which

is a function of the adaptive immune system – a subsystem which responds within 4-7 days to a

previously encountered foreign molecule. The concept of exposing the body to a foreign agent in a

controlled manner to artificially activate the immune system and impart the ability of a quick response

to a subsequent encounter due to immunological memory is called active immunization.

Active immunization gives the body the ability to produce antibodies to counter the pathogen or a

toxin on its own. The most common technique of active immunization is vaccination, a process of

introducing a microorganism or a virus in a weakened, live or killed state, or proteins or toxins from

that microorganism, triggering the body’s adaptive immunity. This allows the body to quickly respond

to a next encounter with the same pathogen or toxin. Inoculation refers to a method where the body is

exposed to a milder form of a disease to induce immunity. It originated as a method of preventing

smallpox, where dried smallpox macules were used to induce a generally milder form of the disease,

which still induced full immunity to the disease. Compared to vaccination, it is inferior due to

significantly higher risk – vaccination does not cause disease, even in its milder form, while inoculation

does.

Passive immunization is a process of introducing antibodies into the body directly, rather than

imparting on the body the ability to produce them. This still imparts immunity, however, because this

immunity is not caused by the body’s immune system, it will only last as long as the introduced

antibodies as present in the organism. This is called transient immunity. Antibodies have been used for

the prevention and treatment of various diseases for centuries (Keller, 2000). Immunization by the

administration of antibodies is a very efficient way of obtaining immediate, short-lived protection

against infection or the disease-causing effects of toxins from microbial pathogens or other sources.

Complete Downloadable Report HERE → Passive Immunity

PAGE 32 AUGUST 2020

https://americanbiodefenseinstitute.org/passive-immunity/

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