Health Care

Business Operations

What Manufacturers Should Know About Vaccines

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As we wait to get our shots, many people still have questions. Does it matter which vaccine I get? What safety precautions should I continue to take? We talked to highly cited infectious disease expert Dr. Aaron Richterman of Penn Medicine to get some answers to these very real concerns.

Which vaccine? As Richterman tells us, the priority for vaccines is preventing bad outcomes—death and severe illness. And the good news? “The really, really good news is that all of these vaccines that have been tested so far—all of them—prevent severe outcomes.” That list includes vaccines made by Pfizer, Moderna, Johnson & Johnson, AstraZeneca and Novavax. (Only Pfizer and Moderna are approved in the U.S. so far, while the J&J vaccine is expected to be approved soon.)

  • And the clincher? “When you put all the trials together [including the Russian vaccine trial], there are somewhere around 80,000 to 90,000 people total who have received the vaccine, and none of them have required hospitalization—and none have died,” says Richterman.

Let’s talk specifics: What about the different numbers we’ve been seeing? As Richterman points out, we’re all used to seeing different headline numbers—95% effective, or 72%, and so forth. But what does that really mean?

  • What those numbers represent is the “reduction in any symptomatic illness at all,” he explains. But the main thing we should be concerned about is the prevention of severe illness or death—which all the vaccines do extremely well.

When should I get it? As soon as possible, says Richterman. “At this point in time, and probably for the next four to six months in this country, the benefit of getting the first vaccine available to you is going to outweigh any potential benefit from waiting for the next one.” If you are offered an FDA-approved vaccine now, he says: “take it.”

What you should know: Here are some key facts to keep in mind as you read media coverage of vaccinations, says Richterman.

  • Quality: “The quality of evidence underpinning the data for these vaccines […] is grade A plus, top of the line.”
  • Safety: “These are extremely safe vaccines, among the safest out there. Some people will have temporary side effects, but they are very safe.”
  • Prevention of severe outcomes: These vaccines prevent severe outcomes to a “tremendous” degree, Richterman stresses. “If these vaccines can take COVID-19 down to something asymptomatic, or something more like a cold, that’s a big win.”

And lastly, do you have to wear masks and socially distance after being vaccinated? “Especially right now, when there’s a lot of community transmission,” Richterman says, “and we’re still learning about new variants, it’s a good idea to keep things as safe as possible.” However, “people should be informed that the vaccine reduces their risk and the risk for those around them.”

Further reading/viewing: Check out the NAM’s project to increase vaccine acceptance, This Is Our Shot, as well as its continued efforts to promote the use of face coverings.

Press Releases

Manufacturers Outline Executive Action Policy Priorities for Incoming Administration

Washington, D.C. – The National Association of Manufacturers called on President-elect Joe Biden to help ensure the future strength of manufacturing in America by extending key executive orders into the new administration and rescinding those that have harmed manufacturing.

“For decades, we have worked with policymakers from across the ideological spectrum to craft policies that encourage the growth of manufacturing in the United States,” said NAM President and CEO Jay Timmons in a letter to the incoming administration. “Now more than ever, America needs leaders in Washington who are focused on increasing American jobs, wages and investment.”

The letter outlines executive orders that have had a significant impact, positive or negative, on manufacturers over the past four years, and it urges the president-elect “to reverse the most harmful of these orders and keep or expand those that create an environment that is conducive to growing America’s manufacturing sector.”

The NAM’s recommendations will help manufacturers continue to respond to the devastating pandemic and will also power the United States’ economic recovery by setting the stage for manufacturing growth.

To read the full letter, click here.

Background:

The NAM has requested President-elect Biden repeal the following executive orders and consider executive orders for extension.

Executive Orders

Rescind:

  • “Rescission of the Deferred Action for Childhood Arrivals Program”
  • E.O. 13950 – “Combating Race and Sex Stereotyping”
  • E.O. 13672 – “Revocation of Federal Contracting”
  • E.O. 13769 – “Protecting the Nation from Foreign Terrorist Entry into the United States”
  • “President’s Report to Congress on the Proposed Refugee Admissions for FY 21”
  • Presidential Proclamation 10052 – “Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak”
  • E.O. 13944 – “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States”
  • E.O. 13948 – “Lowering Drug Prices by Putting America First”
  • E.O. 13957 – “Creating Schedule F in the Excepted Service”

Extend:

  • E.O. 13771 – “Reducing Regulation and Controlling Regulatory Costs”
  • E.O. 13805 – “Establishing a Presidential Advisory Council on Infrastructure”
  • E.O. 13766 – “Expediting Environmental Reviews and Approvals for High-Priority Infrastructure Projects”
  • E.O. 13845 – “Continuing the President’s National Council for the American Worker and the American Workforce Policy Advisory Board”
  • E.O. 13932 – “Modernizing and Reforming the Assessment and Hiring of Federal Job Candidates”
  • E.O. 13777 – “Enforcing the Regulatory Reform Agenda”
  • E.O. 13806 – “Assessing and Strengthening the Manufacturing and Defense Industrial Base and Supply Chain Resiliency of the United States”
  • E.O.s – “Strengthening the Federal Government’s Anti-Counterfeiting Efforts”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.3 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 62% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

Policy and Legal

EEOC Presents Mandatory Vaccine Guidance

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As the largest inoculation effort in human history kicked off this month, the Equal Employment Opportunity Commission provided guidance on mandatory employee vaccinations. Here is a brief summary, courtesy of NAM Director of Labor and Employment Policy Drew Schneider.

What they’re saying: The EEOC allows employers to require employees to take the vaccine, so long as the company meets requirements under the Americans with Disabilities Act, Title VII of the Civil Rights Act of 1964, and the Genetic Information Nondiscrimination Act.

Equal employment laws still apply during the pandemic, but the EEOC states that they “do not interfere with or prevent employers from following the guidelines and suggestions made by the CDC or state/local public health authorities about steps employers should take regarding COVID-19.”

Disabilities and direct threats: “If an employee is unable to take the vaccine due to a disability, an employer may only exclude the employee from the workplace if that worker presents a ‘direct threat’ to other workers and the employer is unable to provide a reasonable accommodation to the employee that would eliminate or reduce the risk to other employees,” says Schneider.

“If an employer suspects that the employee poses a direct threat, the employer should conduct an individualized assessment of four factors to determine whether direct threat exists: duration of risk, severity of potential harm, likelihood of harm and the imminence of potential harm.”

Religious objections: If an employee objects to the vaccine because of a sincerely held religious practice or belief, an employer must provide reasonable accommodation unless it poses an undue hardship under Title VII of the Civil Rights Act, Schneider explains. According to the EEOC, courts have defined “undue hardship” as having more than a minimal cost to the employer.

The NAM says: NAM President and CEO Timmons said in a recent statement about potential vaccine mandates, “While there are likely legal concerns with blanket mandates, if any of our members believed that a requirement at their company was the right thing to do, we would certainly support that within the bounds of the law. Because America’s future depends on folks rolling up our sleeves in a new way.”

Check out the guidance here.

Press Releases

Manufacturers Secure Priorities in Year-End Stimulus Legislation

Stoick: “We have been fully engaged with House and Senate leaders to keep this vital work going"

Washington, D.C. – Following passage of Senate amendment to H.R. 133 – United States Mexico Economic Partnership Act [Consolidated Appropriations Act, 2021], National Association of Manufacturers Vice President of Government Relations Jordan Stoick released the following statement:

“Manufacturers secured many of our top priorities in this important legislation, including numerous provisions the NAM first proposed in our ‘American Renewal Action Plan.’ The additional funds for the Paycheck Protection Program will provide a continued lifeline for small manufacturers. Furthermore, the resources for testing and vaccine distribution, as well as tax incentives for manufacturers that keep employees on payroll and invest in safety measures, will ensure America’s dedicated, essential manufacturing workers can continue their mission safely.

“Across the country, manufacturers are providing the vaccines, PPE and supplies needed to defeat COVID-19, so we have been fully engaged with House and Senate leaders to keep this vital work going. We have a difficult winter ahead, and this legislation will help save lives and livelihoods and keep manufacturers operating. As folks continue to roll up their sleeves and receive initial doses of the vaccine, we are also looking to the other priorities facing us in the new year—including historic investments in infrastructure, energy innovation and more—to ensure manufacturers can lead a full economic recovery and American renewal.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.35 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 62% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

Press Releases

Manufacturers Welcome COVID-19 Vaccine Authorization

The fight is far from over; Americans need to roll up their sleeves, take the shots in the arm

Washington, D.C. – Following the Food and Drug Administration’s emergency authorization for Pfizer’s COVID-19 vaccine, National Association of Manufacturers President and CEO Jay Timmons released the following statement:

“America’s biopharmaceutical manufacturers have a long history of first-in-the-world research that has yielded amazing results, leading to the eradication of the worst epidemics our country has faced. Today’s remarkable announcement will hopefully go down as yet another lifechanging development, and we are looking forward to future successful clinical trials and FDA approvals, hopefully in the near future.

“While science has a strong hand in eliminating vexing diseases, it is the people behind the vaccine who are to be heralded today—the innovative scientists, the lab workers, the doctors, the nurses and the thousands of volunteers who stepped up to the plate to trial this groundbreaking vaccine.

“But the fight is far from over. Americans need to roll up their sleeves, take the shots in the arm and recognize that it’s our innovation and our actions aimed at the greater good that will put a stop to this pandemic. That’s the obligation we have thanks to the gifts of freedom and free enterprise that have been bestowed on us.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.35 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 62% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

Press Releases

Manufacturers Congratulate McDonough on VA Nomination

Timmons: "He brings a focused, collaborative approach to any mission, and he has proven a strong commitment to our nation’s veterans"

Washington, D.C. – Following President-elect Joe Biden’s announcement nominating Denis McDonough for Secretary of Veterans Affairs, National Association of Manufacturers President and CEO Jay Timmons released this statement:

“Throughout his career, Denis McDonough has proven to be a leader of extraordinary capability. He brings a focused, collaborative approach to any mission, and he has proven a strong commitment to our nation’s veterans. We congratulate him on this announcement.

“Through The Manufacturing Institute’s Heroes MAKE America initiative, manufacturers are working every day to help our veterans and members of the military community find new careers in modern manufacturing. We have been working with the VA to support the veteran community in translating their skills into new opportunities in our industry. We look forward to working with Secretary-designate McDonough and the VA in the Biden administration to build on this work—supporting our heroes and strengthening manufacturing in America.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.35 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 62% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

About the MI

The MI grows and supports the manufacturing industry’s skilled workers for the advancement of modern manufacturing. The MI’s diverse initiatives support all workers in America, including women, veterans and students, through skills training programs, community building and the advancement of their career in manufacturing. As the workforce development and education partner of the NAM, the MI is a trusted adviser to manufacturers, equipping them with resources necessary to solve the industry’s toughest challenges. For more information on the MI, please visit creatorswanted.org 

About Heroes MAKE America

Heroes MAKE America, an initiative launched by the MI to build connections between the military community and manufacturing industry, is a Department of Defense (DoD) SkillBridge approved training program that equips participants with the skills and certifications needed to find and excel in manufacturing careers. Service members, their families, veterans and reservists are eligible for the program which currently operates at military installations in Georgia, North Carolina, Texas, Kentucky and Kansas. The Heroes team recently launched Heroes Connect, a 100 percent virtual offering that allows prospective talent from the military community to connect with hiring managers from manufacturing companies. The new offering was created to supplement a cornerstone of the Heroes program which was to provide weekly tours of manufacturing facilities looking to hire Heroes graduates. For more information on Heroes initiative, please visit themanufacturinginstitute.org/veterans/heroes-make-america

Business Operations

The Timeline for the Vaccine Rollout

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The counteroffensive against the pandemic entered its next phase earlier this week, when 90-year-old Maggie Keenan became the first Brit to receive the initial dose of the United Kingdom’s rollout of Pfizer’s COVID-19 vaccine. Meanwhile, the U.S. effort is also moving forward, with some big milestones coming up this month. Here’s what the timeline looks like.

Dec. 10: The Vaccine Advisory Board at the Food and Drug Administration will meet to consider emergency approval of Pfizer’s COVID-19 vaccine.

Dec. 11 or 12 is likely to see the beginning of U.S. inoculations for the Pfizer vaccine, since they are expected to begin 24–48 hours after FDA approval.

Dec. 17: The Vaccine Advisory Board is expected to consider Moderna’s COVID-19 vaccine.

Dec. 18 or 19: Moderna’s vaccine is set to reach patients.

End of December: 40 million doses of vaccine are expected to be delivered by Pfizer and Moderna, which will cover approximately 20 million people.

January or February 2021: Johnson & Johnson’s single-dose vaccine is expected to come online, offering additional options and capacity for COVID-19 vaccines, while deliveries of the Moderna and Pfizer vaccines are expected to multiply nationally. The goal is to have another 80 million people vaccinated during these two months.

By June 2021: 600 million vaccines in total are expected to be produced by a range of manufacturers, which means that everyone who wants a vaccine will have access to it at little to no cost.

Press Releases

Manufacturers on Incoming COVID-19 Coordinator

Timmons: “Jeff Zients is exactly the right choice to help lead the next administration’s COVID-19 response.”

Washington, D.C. – Following President-elect Joe Biden’s announcement of Jeff Zients to lead the Biden administration’s response to the COVID-19 pandemic, National Association of Manufacturers President and CEO Jay Timmons released this statement:

“Jeff Zients is exactly the right choice to help lead the next administration’s COVID-19 response. The NAM always enjoyed a strong and productive relationship with Jeff in his previous role, and he is the right person for this job. He is well suited for addressing both the economic and public health challenges we face. Manufacturers can always count on him to be responsive and candid, and you can’t overstate how valuable it is to have that open channel of communication—especially now that his new role will involve helping to lead America out of this ongoing crisis.

“Manufacturers are encouraged that alongside Jeff will be experienced medical experts to effectively communicate and implement the policies needed to move our country forward. Throughout the pandemic, manufacturers have stepped up to provide leadership for our country—from encouraging smart health practices to producing personal protective equipment and developing vaccines. We are committed to continuing that leadership until we defeat COVID-19, and we are ready to work closely with Jeff, and the rest of the incoming administration, to achieve a strong economic recovery and American renewal.”

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.35 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 62% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org

Business Operations

How Pfizer Will Deliver Its Vaccines

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Pfizer is working around the clock to ensure an efficient and speedy distribution of its potential COVID-19 vaccine, pending emergency use authorization in the United States. To do so, it has developed an innovative packaging and storage solution that just might help save the world.

The challenge: Beyond developing a vaccine in the shortest time frame ever attempted, researchers at Pfizer must ensure that hundreds of millions of vials of its potential COVID-19 vaccine are kept frozen at extreme temperatures (-70 degrees Celsius) as they are shipped across the globe.  

The solution: Pfizer got to work designing, engineering and manufacturing temperature-controlled thermal shippers that use dry ice to maintain the required temperature until the point of vaccination.

Once in transit: Pfizer will monitor GPS-enabled thermal sensors in every thermal shipper from a control tower, which will track the location and temperature of each vaccine shipment along its preset route. That means Pfizer can prevent unwanted deviations before they happen. 

Once on site: After arriving at the points of use, providers will have three options for storage:

  • Ultralow temperature freezers, which are commercially available now and can extend shelf life for up to six months.
  • Refrigeration units commonly available in hospitals, which can safely store the vaccine for up to five days at 2–8 degrees Celsius.
  • The same Pfizer thermal shippers that carry doses during shipping; these can serve as temporary storage units for up to 15 days as long as they are refilled with dry ice.

The last words: “We have developed detailed logistical plans and innovative tools to support effective vaccine transport, storage and continuous temperature monitoring. Leveraging those resources and based on our track record, we are very confident in our ability to distribute large quantities of our potential COVID-19 vaccine to customers with different infrastructures in all parts of the country and all markets across the globe,” said Pfizer Vice President, BioPharma Global Supply Chain Tanya Alcorn.

“Pfizer is proving yet again that manufacturers’ ingenuity knows no bounds. The progress they have made on a vaccine alone is incredible, and the innovative way they have now addressed these distribution challenges is impressive. It shows manufacturers’ unwavering commitment to saving lives and helping to lead America out of this crisis,” said NAM President and CEO Jay Timmons.

Press Releases

Manufacturers Disagree with HHS Socialistic Price-Setting Plan

Timmons: “What this dangerous precedent will do is stifle the development of treatments and vaccines to combat future pandemics”

Washington, D.C. – Following the Trump Administration’s announcement on implementing a Most Favored Nation approach to pricing of Medicare Part B drugs, National Association of Manufacturers President and CEO Jay Timmons released the following statement:

“Manufacturers in America are driving global pharmaceutical innovation. Recent COVID-19 vaccine and therapy developments underscore the value of that leadership. As the coronavirus tightens its grip on the country, we should not be looking at failed price-setting schemes as a solution. While producing the essential supplies needed to fight the virus, manufacturers are also working to provide affordable medicines and therapies to the public. We believe strongly in lowering health care costs, but the socialist policies outlined today will not aid in the effort.

“What this dangerous precedent will do is stifle the development of treatments and vaccines to combat future pandemics, Alzheimer’s or cancer while also limiting access to critical products for those most in need. Competition and free market principles are the foundation of a strong economy, and now is not the time to abandon those values.”

Currently, the NAM is running an ad on the dangers of price indexing. To view the ad, click here.

-NAM-

The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.37 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 63% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.

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