REPORT: October 7 Member Meeting

Vaccine Preparedness

Paul Mango

Deputy Chief of Staff for Policy
U.S. Department of Health and Human Services

As Americans urgently anticipate the development of a COVID-19 vaccine, the Senate Presidents’ Forum received a briefing from Paul Mango, the Deputy Chief of Staff for Policy at the U.S. Department of Health and Human Services (HHS), who is one of the leaders of Operation Warp Speed (OWS) in its online Forum on October 7, 2020.

OWS is a partnership between the Defense Department and the HHS, and includes the CDC, FDA, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, in partnership with U.S. pharmaceutical and supply chain industries. Its goal is to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The best of U.S. corporations are involved in this partnership to ensure the health and safety of Americans, Mr. Mango reported. It is a victory for U.S. industry.

Speed

Mr. Mango pointed out that typically clinical trials progress through three phases that assess safety and efficacy. Historically, years can pass between phases before approval, followed by delays for manufacturing and distribution. Under OWS’ accelerated timeframe, only 24 hours will elapse between the three phases, and manufacturing and distribution are being planned simultaneously. OWS is committed to producing and delivering 300 million doses of safe and effective vaccines, with initial doses expected to be available by the end of the 2020.

Manufacturing and distribution are being
planned simultaneously.

Safety

To ensure safety under the accelerated timeframe, current vaccine trials have enrolled between 30,000 and 60,000 participants, compared to 8,000 to 12,000 participants in typical trials. All potential vaccines will be required to meet or exceed the FDA’s rigorous safety and efficacy review.

Efficacy

There are currently six vaccine candidates based on three different technical platforms that are in the clinical trials. Supporting diverse technical approaches increases the likelihood of developing an effective vaccine, Mr. Mango said. For example, early phase trials demonstrated that Moderna’s candidate was more effective in people over 65 years, while Pfizer’s drug showed greater efficacy in those younger than 65.

Manufacturing

OWS has funded numerous drug manufacturers to reserve production capacity for millions of doses of COVID-19 vaccine, so that production can proceed as soon as an approval is granted by the FDA. Producing and stockpiling required materials for vaccine administration, including needles, syringes, and glass vials, will help ensure people can receive the vaccine 24 hours after FDA approval, Mr. Mango reported.

Distribution

Plans for the widespread and equitable distribution not only of the vaccine but also the required ancillary materials (e.g., syringes, hypodermic needles and vials) are in place. Mr. Mango said OWS has partnered with distribution giants including McKesson, AmerisourceBergen, plus Federal Express and UPS, and 19 major pharmacy chains including Wal-Mart, Walgreens and CVS to be ready to move materials as soon as the FDA approves a vaccine. Oracle, additionally, is helping with IT.

Therapeutics

While the push for a vaccine continues, Mr. Mango noted that 450 trials of COVID-19 therapeutics (i.e., treatments administered after infection) are also ongoing. For example, Eli Lilly’s monoclonal antibody — currently in FDA review — significantly reduced mortality in COVID-19-infected older obese adults, a particularly vulnerable population. As healthcare systems have become more experienced in treating COVID-19, mortality has declined by 75% since April 2020. “We are in a totally different world than we were five months ago,” Mr. Mango concluded.

“We can say with better than 80% surety that we will be able to give the first doses of a safe, effective vaccine by the end of the year.” — Paul Mango

Discussion

Tom Finneran (Moderator): Are the kits with vials of vaccine, needles, syringes, and bandages on the shelf and ready to go?

 

 

Mr. Mango: In February, the Defense Production Act allowed funds to be allocated for a vaccine administration kit assembly. Currently, four million kits are assembled, each kit supporting 100 doses. Once approved, the vaccine vials will be shipped with the kits. There are a lot of logistical elements to be managed. For example, different vaccines require different gauge needles and syringe sizes; some have to be mixed with an adjuvant (enhancing agent) that would have to be added to the kit; some require freezing and others refrigeration; some are only good for a few days after thawing; and some require one dose while others require two. Therefore, logistics for many different scenarios are planned.

Mr. Finneran: If a vaccine developed outside the U.S. became available sooner, would OWS adopt it?

Mr. Mango: The vaccine would have to meet all of the vigorous, high U.S. standards, demonstrating safety and a minimum 50% efficacy. Current vaccine candidates are showing 70% to 80% efficacy.

Sen. Andrea Stewart-Cousins (NY): Have the clinical trials enrolled ethnically and racially diverse participants, reflecting U.S. population demographics?

 

Sen. Cathy Giessel (AK): Echoing the concern about minority representation in clinical trials of vaccines, note that Alaskan Native Americans faced devastation from the influenza epidemic in the early 1900s and should be included in trials.

 

Mr. Mango: The parameters for clinical trial enrollment were set by National Institutes of Health Director Dr. Francis Collins and NIH's National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. They are designed to reflect the U.S. population, but also to include more of the most vulnerable populations such as those with obesity or comorbid conditions. COVID-19 is a thousand times more deadly for a 75 year old with underlying medical conditions than for a teenager. The trials have to prove that the most vulnerable people will be protected by the vaccine.

Sen. Brent Hill (ID): What happens if, among the six companies and three technical platforms, one vaccine gets approved first, but a subsequent approved vaccine is more effective? Can people get more than one kind of vaccine? Will people want to wait to see how this plays out?

Mr. Mango: There is an ethical consideration here. Ordinarily, if a vaccine were 90% effective, the other trials would be discontinued because it would be unethical to give any participants a placebo. However, we are not likely to have sufficient quantities with the first vaccine that’s approved to terminate the other platforms. By April, we anticipate having six million to seven million vaccine doses.

The FDA’s Advisory Committee on Immunization Practices sets the priorities for who gets vaccinated first, including front-line healthcare workers, seniors who live in congregate settings (e.g., nursing homes) and first responders. It would not be feasible to re-vaccinate anyone until all these prioritized groups were fully covered.

Sen. Ron Kouchi (HI): When Hawaii was hard hit by the pandemic, the Surgeon General came to the Island with 60,000 COVID-19 test kits, and 60,000 tests were completed within one week, for which we were very grateful. We are re-opening tourism with a requirement for testing, but testing supplies are running low again.

Mr. Mango: The government has acquired 150 million BinaxNOW™ tests, a 15-minute test with high sensitivity and specificity. Several hundred thousand Binax tests will be sent to Hawaii.  Furthermore, because Hawaii had a significant COVID-19 outbreak, several clinical trials sites are set up there, so Hawaii’s diverse population is well represented in the trials.

Going forward, testing capacity will not be a problem. Since the start of the pandemic, 117 million tests have been completed. Now 120 million tests can be produced in only a month.

Sen. Charles Schneider (IA): What is the prioritization for delivery of the vaccines to the states? Will vaccines be equally distributed or are some criteria applied?

 

Sen. Andrea Stewart-Cousins (NY): Developing the vaccine is a win for U.S. businesses, but what about the people on the ground who administer it, how will they be reimbursed? Will people need to pay for it out of pocket?

Mr. Mango: There are three components to the program: product development, distribution, and administration. The Federal government is covering the costs of product development and distribution. For administration, Medicaid recipients have no co-pay, commercial insurers are waiving co-pays, and the Provider Relief Fund will pay administration costs for underinsured people. Medicare currently pays the provider $17 for administration, and the patient is responsible for a $3.50 co-pay. Discussions are underway to eliminate this co-pay. The bottom-line is that every provider will be paid.

“It’s prudent to plan on testing through Spring 2021. By Fall 2021, testing may not be necessary.”  — Paul Mango

Sen. Peter Courtney (OR): I have concerns about bringing the legislature back together in person for our session starting January 11. What’s the chance of having a vaccine by then?

 

Mr. Mango: We can’t say for sure; however, the Vaccine Development Team is committed to having one, two or three vaccines available in large quantities by December 31, 2020. The challenge is that some of the vaccines require multiple doses over several weeks and it could take 10 weeks for immunity. We can say with better than 80% surety that we will be able to give the first doses of a safe, effective vaccine by the end of the year.

Sen. Thomas Alexander (SC): Our state is doing a lot of testing. Once the vaccine is available, should we continue testing or reallocate resources to administering vaccinations?

 

Mr. Mango: This depends on the willingness of citizens to get vaccinated. CDC Director Dr. Robert Redfield noted that it could take six to eight months to overcome people’s hesitancy to get vaccinated. Also, it will take time to get vaccinations done; therefore, it’s prudent to plan on testing through Spring 2021. By Fall 2021, testing may not be necessary.

“You can have confidence that the best of America’s corporations are deeply involved, deeply committed — some of them doing this for free, by the way. It’s really quite spectacular.”  — Paul Mango

Sen. Larry Taylor (TX): What assurances can we give people about the safety of the vaccine? What about long-term side effects?

 

 

Mr. Mango: All the vaccines must pass the FDA’s conservative and tough safety and efficacy tests in all the three phases of clinical trials, and enroll a large number of participants including diverse and vulnerable populations. The safety controls are stringent. For example, the AstraZeneca trial with 70,000 participants was halted because one person had an adverse event. We may actually be over-indexing for safety; U.S. standards are much higher than European standards. We anticipate some hesitancy in accepting the vaccine until about 200,000 Americans have been vaccinated without adverse effects.

Concerning long-term safety, we won’t know the final answer for a couple of years. However, in most vaccine trials, 90% of adverse events happen within 42 days, and 97% within 60 days. The FDA will not grant an Emergency Use Authorization (EUA) until the median study participant has had a second dose and 60 days have elapsed. All people who get the vaccine will be studied in Phase 4, which is the real-world follow-up study to assess long-term effects.

Mr. Finneran: What final thoughts or advice do you have for state senate leaders?

Mr. Mango:

1. The vaccines will meet or exceed every safety and effectiveness measure ever used.

2. The program is not only a government project but has been a huge, positive effort from U.S. industries that have delivered safe and effective medicines for years.

3. Encourage people to participate in clinical trials. 500,000 people have signed up, but we still need to enroll more people from ethnic and racial minorities.

4. We are going to lick beat this virus. The mortality rate has dropped by 75%. We have a more responsive healthcare system with adequate masks, ventilators and personal protective equipment.

5. Personal responsibility remains important. People should wear masks and practice social distancing.

Speaker Biography

Paul Mango

Deputy Chief of Staff for Policy

U.S. Department of Health and Human Services

Prior to joining HHS, Paul served as the Chief Principal Deputy Administrator and Chief of Staff at the Centers for Medicare & Medicaid Services, and he was a senior partner at McKinsey & Company. He is a veteran of the 82nd Airborne Division and a graduate of U.S. Army Ranger School; the United States Military Academy at West Point, where he was a Distinguished Cadet; and of Harvard Business School, where he was a Baker Scholar.

CONTACT US

Senate Presidents’ Forum

579 Broadway

Hastings-on-Hudson, NY 10706

 

Tel: 914-693-1818

Copyright © 2020 Senate Presidents' Forum. All rights reserved.

REPORT: October 7 Member Meeting

Vaccine Preparedness

Paul Mango

Deputy Chief of Staff for Policy
U.S. Department of Health and Human Services

As Americans urgently anticipate the development of a COVID-19 vaccine, the Senate Presidents’ Forum received a briefing from Paul Mango, the Deputy Chief of Staff for Policy at the U.S. Department of Health and Human Services (HHS), who is one of the leaders of Operation Warp Speed (OWS) in its online Forum on October 7, 2020.

OWS is a partnership between the Defense Department and the HHS, and includes the CDC, FDA, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, in partnership with U.S. pharmaceutical and supply chain industries. Its goal is to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The best of U.S. corporations are involved in this partnership to ensure the health and safety of Americans, Mr. Mango reported. It is a victory for U.S. industry.

Speed

Mr. Mango pointed out that typically clinical trials progress through three phases that assess safety and efficacy. Historically, years can pass between phases before approval, followed by delays for manufacturing and distribution. Under OWS’ accelerated timeframe, only 24 hours will elapse between the three phases, and manufacturing and distribution are being planned simultaneously. OWS is committed to producing and delivering 300 million doses of safe and effective vaccines, with initial doses expected to be available by the end of the 2020.

Manufacturing and distribution are being
planned simultaneously.

Safety

To ensure safety under the accelerated timeframe, current vaccine trials have enrolled between 30,000 and 60,000 participants, compared to 8,000 to 12,000 participants in typical trials. All potential vaccines will be required to meet or exceed the FDA’s rigorous safety and efficacy review.

Efficacy

There are currently six vaccine candidates based on three different technical platforms that are in the clinical trials. Supporting diverse technical approaches increases the likelihood of developing an effective vaccine, Mr. Mango said. For example, early phase trials demonstrated that Moderna’s candidate was more effective in people over 65 years, while Pfizer’s drug showed greater efficacy in those younger than 65.

Manufacturing

OWS has funded numerous drug manufacturers to reserve production capacity for millions of doses of COVID-19 vaccine, so that production can proceed as soon as an approval is granted by the FDA. Producing and stockpiling required materials for vaccine administration, including needles, syringes, and glass vials, will help ensure people can receive the vaccine 24 hours after FDA approval, Mr. Mango reported.

Distribution

Plans for the widespread and equitable distribution not only of the vaccine but also the required ancillary materials (e.g., syringes, hypodermic needles and vials) are in place. Mr. Mango said OWS has partnered with distribution giants including McKesson, AmerisourceBergen, plus Federal Express and UPS, and 19 major pharmacy chains including Wal-Mart, Walgreens and CVS to be ready to move materials as soon as the FDA approves a vaccine. Oracle, additionally, is helping with IT.

Therapeutics

While the push for a vaccine continues, Mr. Mango noted that 450 trials of COVID-19 therapeutics (i.e., treatments administered after infection) are also ongoing. For example, Eli Lilly’s monoclonal antibody — currently in FDA review — significantly reduced mortality in COVID-19-infected older obese adults, a particularly vulnerable population. As healthcare systems have become more experienced in treating COVID-19, mortality has declined by 75% since April 2020. “We are in a totally different world than we were five months ago,” Mr. Mango concluded.

“We can say with better than 80% surety that we will be able to give the first doses of a safe, effective vaccine by the end of the year.”— Paul Mango

Discussion

Tom Finneran (Moderator): Are the kits with vials of vaccine, needles, syringes, and bandages on the shelf and ready to go?

 

 

Mr. Mango: In February, the Defense Production Act allowed funds to be allocated for a vaccine administration kit assembly. Currently, four million kits are assembled, each kit supporting 100 doses. Once approved, the vaccine vials will be shipped with the kits. There are a lot of logistical elements to be managed. For example, different vaccines require different gauge needles and syringe sizes; some have to be mixed with an adjuvant (enhancing agent) that would have to be added to the kit; some require freezing and others refrigeration; some are only good for a few days after thawing; and some require one dose while others require two. Therefore, logistics for many different scenarios are planned.

Mr. Finneran: If a vaccine developed outside the U.S. became available sooner, would OWS adopt it?

Mr. Mango: The vaccine would have to meet all of the vigorous, high U.S. standards, demonstrating safety and a minimum 50% efficacy. Current vaccine candidates are showing 70% to 80% efficacy.

Sen. Andrea Stewart-Cousins (NY): Have the clinical trials enrolled ethnically and racially diverse participants, reflecting U.S. population demographics?

 

Sen. Cathy Giessel (AK): Echoing the concern about minority representation in clinical trials of vaccines, note that Alaskan Native Americans faced devastation from the influenza epidemic in the early 1900s and should be included in trials.

Mr. Mango: The parameters for clinical trial enrollment were set by National Institutes of Health Director Dr. Francis Collins and NIH's National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. They are designed to reflect the U.S. population, but also to include more of the most vulnerable populations such as those with obesity or comorbid conditions. COVID-19 is a thousand times more deadly for a 75 year old with underlying medical conditions than for a teenager. The trials have to prove that the most vulnerable people will be protected by the vaccine.

Sen. Brent Hill (ID): What happens if, among the six companies and three technical platforms, one vaccine gets approved first, but a subsequent approved vaccine is more effective? Can people get more than one kind of vaccine? Will people want to wait to see how this plays out?

Mr. Mango: There is an ethical consideration here. Ordinarily, if a vaccine were 90% effective, the other trials would be discontinued because it would be unethical to give any participants a placebo. However, we are not likely to have sufficient quantities with the first vaccine that’s approved to terminate the other platforms. By April, we anticipate having six million to seven million vaccine doses.

The FDA’s Advisory Committee on Immunization Practices sets the priorities for who gets vaccinated first, including front-line healthcare workers, seniors who live in congregate settings (e.g., nursing homes) and first responders. It would not be feasible to re-vaccinate anyone until all these prioritized groups were fully covered.

Sen. Ron Kouchi (HI): When Hawaii was hard hit by the pandemic, the Surgeon General came to the Island with 60,000 COVID-19 test kits, and 60,000 tests were completed within one week, for which we were very grateful. We are re-opening tourism with a requirement for testing, but testing supplies are running low again.

Mr. Mango: The government has acquired 150 million BinaxNOW™ tests, a 15-minute test with high sensitivity and specificity. Several hundred thousand Binax tests will be sent to Hawaii.  Furthermore, because Hawaii had a significant COVID-19 outbreak, several clinical trials sites are set up there, so Hawaii’s diverse population is well represented in the trials.

Going forward, testing capacity will not be a problem. Since the start of the pandemic, 117 million tests have been completed. Now 120 million tests can be produced in only a month.

Sen. Charles Schneider (IA): What is the prioritization for delivery of the vaccines to the states? Will vaccines be equally distributed or are some criteria applied?

 

Sen. Andrea Stewart-Cousins (NY): Developing the vaccine is a win for U.S. businesses, but what about the people on the ground who administer it, how will they be reimbursed? Will people need to pay for it out of pocket?

Mr. Mango: There are three components to the program: product development, distribution, and administration. The Federal government is covering the costs of product development and distribution. For administration, Medicaid recipients have no co-pay, commercial insurers are waiving co-pays, and the Provider Relief Fund will pay administration costs for underinsured people. Medicare currently pays the provider $17 for administration, and the patient is responsible for a $3.50 co-pay. Discussions are underway to eliminate this co-pay. The bottom-line is that every provider will be paid.

“It’s prudent to plan on testing through Spring 2021. By Fall 2021, testing may not be necessary.”  — Paul Mango

Sen. Peter Courtney (OR): I have concerns about bringing the legislature back together in person for our session starting January 11. What’s the chance of having a vaccine by then?

 

Mr. Mango: We can’t say for sure; however, the Vaccine Development Team is committed to having one, two or three vaccines available in large quantities by December 31, 2020. The challenge is that some of the vaccines require multiple doses over several weeks and it could take 10 weeks for immunity. We can say with better than 80% surety that we will be able to give the first doses of a safe, effective vaccine by the end of the year.

Sen. Thomas Alexander (SC): Our state is doing a lot of testing. Once the vaccine is available, should we continue testing or reallocate resources to administering vaccinations?

 

Mr. Mango: This depends on the willingness of citizens to get vaccinated. CDC Director Dr. Robert Redfield noted that it could take six to eight months to overcome people’s hesitancy to get vaccinated. Also, it will take time to get vaccinations done; therefore, it’s prudent to plan on testing through Spring 2021. By Fall 2021, testing may not be necessary.

“You can have confidence that the best of America’s corporations are deeply involved, deeply committed — some of them doing this for free, by the way. It’s really quite spectacular.”— Paul Mango

Sen. Larry Taylor (TX): What assurances can we give people about the safety of the vaccine? What about long-term side effects?

 

Mr. Mango: All the vaccines must pass the FDA’s conservative and tough safety and efficacy tests in all the three phases of clinical trials, and enroll a large number of participants including diverse and vulnerable populations. The safety controls are stringent. For example, the AstraZeneca trial with 70,000 participants was halted because one person had an adverse event. We may actually be over-indexing for safety; U.S. standards are much higher than European standards. We anticipate some hesitancy in accepting the vaccine until about 200,000 Americans have been vaccinated without adverse effects.

Concerning long-term safety, we won’t know the final answer for a couple of years. However, in most vaccine trials, 90% of adverse events happen within 42 days, and 97% within 60 days. The FDA will not grant an Emergency Use Authorization (EUA) until the median study participant has had a second dose and 60 days have elapsed. All people who get the vaccine will be studied in Phase 4, which is the real-world follow-up study to assess long-term effects.

Mr. Finneran: What final thoughts or advice do you have for state senate leaders?

Mr. Mango:

1. The vaccines will meet or exceed every safety and effectiveness measure ever used.

2. The program is not only a government project but has been a huge, positive effort from U.S. industries that have delivered safe and effective medicines for years.

3. Encourage people to participate in clinical trials. 500,000 people have signed up, but we still need to enroll more people from ethnic and racial minorities.

4. We are going to lick beat this virus. The mortality rate has dropped by 75%. We have a more responsive healthcare system with adequate masks, ventilators and personal protective equipment.

5. Personal responsibility remains important. People should wear masks and practice social distancing.

Speaker Biography

Paul Mango

Deputy Chief of Staff for Policy

U.S. Department of Health and Human Services

Prior to joining HHS, Paul served as the Chief Principal Deputy Administrator and Chief of Staff at the Centers for Medicare & Medicaid Services, and he was a senior partner at McKinsey & Company. He is a veteran of the 82nd Airborne Division and a graduate of U.S. Army Ranger School; the United States Military Academy at West Point, where he was a Distinguished Cadet; and of Harvard Business School, where he was a Baker Scholar.

CONTACT US

Senate Presidents’ Forum

579 Broadway

Hastings-on-Hudson, NY 10706

 

Tel: 914-693-1818

Copyright © 2020 Senate Presidents' Forum. All rights reserved.

REPORT: October 7 Member Meeting

Vaccine Preparedness

Paul Mango

Deputy Chief of Staff for Policy
U.S. Department of Health and Human Services

Download PDF of article

As Americans urgently anticipate the development of a COVID-19 vaccine, the Senate Presidents’ Forum received a briefing from Paul Mango, the Deputy Chief of Staff for Policy at the U.S. Department of Health and Human Services (HHS), who is one of the leaders of Operation Warp Speed (OWS) in its online Forum on October 7, 2020.

OWS is a partnership between the Defense Department and the HHS, and includes the CDC, FDA, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, in partnership with U.S. pharmaceutical and supply chain industries. Its goal is to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The best of U.S. corporations are involved in this partnership to ensure the health and safety of Americans, Mr. Mango reported. It is a victory for U.S. industry.

Key insights provided to state leaders1. COVID-19 vaccines will meet or exceed every safety and effectiveness measure ever used.2. Operation Warp Speed is not only a government project but has been a huge, positive effort from U.S. industries that have delivered safe and effective medicines for years.3. Participation in clinical trials should be encouraged. 500,000 people have signed up, but more ethnic and racial minorities are needed as participants.4. We are going to defeat this virus. The mortality rate has dropped by 75%. The U.S. has a more responsive healthcare system with adequate masks, ventilators and personal protective equipment.5. Personal responsibility remains important. People should wear masks and practice social distancing.

Visit the Operation Warp Speed portal for more information on vaccine development, timelines, and distribution strategy.

Speed

Mr. Mango pointed out that typically clinical trials progress through three phases that assess safety and efficacy. Historically, years can pass between phases before approval, followed by delays for manufacturing and distribution. Under OWS’ accelerated timeframe, only 24 hours will elapse between the three phases, and manufacturing and distribution are being planned simultaneously. OWS is committed to producing and delivering 300 million doses of safe and effective vaccines, with initial doses expected to be available by the end of the 2020.

Manufacturing and distribution are being
planned simultaneously.

Safety

To ensure safety under the accelerated timeframe, current vaccine trials have enrolled between 30,000 and 60,000 participants, compared to 8,000 to 12,000 participants in typical trials. All potential vaccines will be required to meet or exceed the FDA’s rigorous safety and efficacy review.

Efficacy

There are currently six vaccine candidates based on three different technical platforms that are in the clinical trials. Supporting diverse technical approaches increases the likelihood of developing an effective vaccine, Mr. Mango said. For example, early phase trials demonstrated that Moderna’s candidate was more effective in people over 65 years, while Pfizer’s drug showed greater efficacy in those younger than 65.

Manufacturing

OWS has funded numerous drug manufacturers to reserve production capacity for millions of doses of COVID-19 vaccine, so that production can proceed as soon as an approval is granted by the FDA. Producing and stockpiling required materials for vaccine administration, including needles, syringes, and glass vials, will help ensure people can receive the vaccine 24 hours after FDA approval, Mr. Mango reported.

CDC’s Interim PlaybookThe CDC has published guidance on how to plan and operationalize a vaccination response to COVID-19 within U.S. jurisdictions. The contents at this link are in pdf format and expected to be updated.COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations

Distribution

Plans for the widespread and equitable distribution not only of the vaccine but also the required ancillary materials (e.g., syringes, hypodermic needles and vials) are in place. Mr. Mango said OWS has partnered with distribution giants including McKesson, AmerisourceBergen, plus Federal Express and UPS, and 19 major pharmacy chains including Wal-Mart, Walgreens and CVS to be ready to move materials as soon as the FDA approves a vaccine. Oracle, additionally, is helping with IT.

Therapeutics

While the push for a vaccine continues, Mr. Mango noted that 450 trials of COVID-19 therapeutics (i.e., treatments administered after infection) are also ongoing. For example, Eli Lilly’s monoclonal antibody — currently in FDA review — significantly reduced mortality in COVID-19-infected older obese adults, a particularly vulnerable population. As healthcare systems have become more experienced in treating COVID-19, mortality has declined by 75% since April 2020. “We are in a totally different world than we were five months ago,” Mr. Mango concluded.

“We can say with better than 80% surety that we will be able to give the first doses of a safe, effective vaccine by the end of the year.”— Paul Mango

Discussion

Tom Finneran (Moderator): Are the kits with vials of vaccine, needles, syringes, and bandages on the shelf and ready to go?

 

Mr. Mango: In February, the Defense Production Act allowed funds to be allocated for a vaccine administration kit assembly. Currently, four million kits are assembled, each kit supporting 100 doses. Once approved, the vaccine vials will be shipped with the kits. There are a lot of logistical elements to be managed. For example, different vaccines require different gauge needles and syringe sizes; some have to be mixed with an adjuvant (enhancing agent) that would have to be added to the kit; some require freezing and others refrigeration; some are only good for a few days after thawing; and some require one dose while others require two. Therefore, logistics for many different scenarios are planned.

Mr. Finneran: If a vaccine developed outside the U.S. became available sooner, would OWS adopt it?

Mr. Mango: The vaccine would have to meet all of the vigorous, high U.S. standards, demonstrating safety and a minimum 50% efficacy. Current vaccine candidates are showing 70% to 80% efficacy.

Sen. Andrea Stewart-Cousins (NY): Have the clinical trials enrolled ethnically and racially diverse participants, reflecting U.S. population demographics?

 

Sen. Cathy Giessel (AK): Echoing the concern about minority representation in clinical trials of vaccines, note that Alaskan Native Americans faced devastation from the influenza epidemic in the early 1900s and should be included in trials.

Mr. Mango: The parameters for clinical trial enrollment were set by National Institutes of Health Director Dr. Francis Collins and NIH's National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. They are designed to reflect the U.S. population, but also to include more of the most vulnerable populations such as those with obesity or comorbid conditions. COVID-19 is a thousand times more deadly for a 75 year old with underlying medical conditions than for a teenager. The trials have to prove that the most vulnerable people will be protected by the vaccine.

Sen. Brent Hill (ID): What happens if, among the six companies and three technical platforms, one vaccine gets approved first, but a subsequent approved vaccine is more effective? Can people get more than one kind of vaccine? Will people want to wait to see how this plays out?

Mr. Mango: There is an ethical consideration here. Ordinarily, if a vaccine were 90% effective, the other trials would be discontinued because it would be unethical to give any participants a placebo. However, we are not likely to have sufficient quantities with the first vaccine that’s approved to terminate the other platforms. By April, we anticipate having six million to seven million vaccine doses.

The FDA’s Advisory Committee on Immunization Practices sets the priorities for who gets vaccinated first, including front-line healthcare workers, seniors who live in congregate settings (e.g., nursing homes) and first responders. It would not be feasible to re-vaccinate anyone until all these prioritized groups were fully covered.

Sen. Ron Kouchi (HI): When Hawaii was hard hit by the pandemic, the Surgeon General came to the Island with 60,000 COVID-19 test kits, and 60,000 tests were completed within one week, for which we were very grateful. We are re-opening tourism with a requirement for testing, but testing supplies are running low again.

Mr. Mango: The government has acquired 150 million BinaxNOW™ tests, a 15-minute test with high sensitivity and specificity. Several hundred thousand Binax tests will be sent to Hawaii.  Furthermore, because Hawaii had a significant COVID-19 outbreak, several clinical trials sites are set up there, so Hawaii’s diverse population is well represented in the trials.

Going forward, testing capacity will not be a problem. Since the start of the pandemic, 117 million tests have been completed. Now 120 million tests can be produced in only a month.

Sen. Charles Schneider (IA): What is the prioritization for delivery of the vaccines to the states? Will vaccines be equally distributed or are some criteria applied?

 

Sen. Andrea Stewart-Cousins (NY): Developing the vaccine is a win for U.S. businesses, but what about the people on the ground who administer it, how will they be reimbursed? Will people need to pay for it out of pocket?

Mr. Mango: There are three components to the program: product development, distribution, and administration. The Federal government is covering the costs of product development and distribution. For administration, Medicaid recipients have no co-pay, commercial insurers are waiving co-pays, and the Provider Relief Fund will pay administration costs for underinsured people. Medicare currently pays the provider $17 for administration, and the patient is responsible for a $3.50 co-pay. Discussions are underway to eliminate this co-pay. The bottom-line is that every provider will be paid.

“It’s prudent to plan on testing through Spring 2021. By Fall 2021, testing may not be necessary.” — Paul Mango

Sen. Peter Courtney (OR): I have concerns about bringing the legislature back together in person for our session starting January 11. What’s the chance of having a vaccine by then?

 

Mr. Mango: We can’t say for sure; however, the Vaccine Development Team is committed to having one, two or three vaccines available in large quantities by December 31, 2020. The challenge is that some of the vaccines require multiple doses over several weeks and it could take 10 weeks for immunity. We can say with better than 80% surety that we will be able to give the first doses of a safe, effective vaccine by the end of the year.

Sen. Thomas Alexander (SC): Our state is doing a lot of testing. Once the vaccine is available, should we continue testing or reallocate resources to administering vaccinations?

 

Mr. Mango: This depends on the willingness of citizens to get vaccinated. CDC Director Dr. Robert Redfield noted that it could take six to eight months to overcome people’s hesitancy to get vaccinated. Also, it will take time to get vaccinations done; therefore, it’s prudent to plan on testing through Spring 2021. By Fall 2021, testing may not be necessary.

“You can have confidence that the best of America’s corporations are deeply involved, deeply committed — some of them doing this for free, by the way. It’s really quite spectacular.”— Paul Mango

Sen. Larry Taylor (TX): What assurances can we give people about the safety of the vaccine? What about long-term side effects?

 

Mr. Mango: All the vaccines must pass the FDA’s conservative and tough safety and efficacy tests in all the three phases of clinical trials, and enroll a large number of participants including diverse and vulnerable populations. The safety controls are stringent. For example, the AstraZeneca trial with 70,000 participants was halted because one person had an adverse event. We may actually be over-indexing for safety; U.S. standards are much higher than European standards. We anticipate some hesitancy in accepting the vaccine until about 200,000 Americans have been vaccinated without adverse effects.

Concerning long-term safety, we won’t know the final answer for a couple of years. However, in most vaccine trials, 90% of adverse events happen within 42 days, and 97% within 60 days. The FDA will not grant an Emergency Use Authorization (EUA) until the median study participant has had a second dose and 60 days have elapsed. All people who get the vaccine will be studied in Phase 4, which is the real-world follow-up study to assess long-term effects.

Mr. Finneran: What final thoughts or advice do you have for state senate leaders?

Mr. Mango:

1. The vaccines will meet or exceed every safety and effectiveness measure ever used.

2. The program is not only a government project but has been a huge, positive effort from U.S. industries that have delivered safe and effective medicines for years.

3. Encourage people to participate in clinical trials. 500,000 people have signed up, but we still need to enroll more people from ethnic and racial minorities.

4. We are going to lick beat this virus. The mortality rate has dropped by 75%. We have a more responsive healthcare system with adequate masks, ventilators and personal protective equipment.

5. Personal responsibility remains important. People should wear masks and practice social distancing.

Speaker Biography

Paul Mango

Deputy Chief of Staff for Policy

U.S. Department of Health and Human Services

Prior to joining HHS, Paul served as the Chief Principal Deputy Administrator and Chief of Staff at the Centers for Medicare & Medicaid Services, and he was a senior partner at McKinsey & Company. He is a veteran of the 82nd Airborne Division and a graduate of U.S. Army Ranger School; the United States Military Academy at West Point, where he was a Distinguished Cadet; and of Harvard Business School, where he was a Baker Scholar.

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