What to Know About Virus Variants, New Vaccine Efficacies & Availability, and a Roundup of Ways Manufacturing Has Changed Since COVID-19 with Renowned Epidemiologist Ben Miller, Ph.D., MPH, from The Acheson Group.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Is a Return to Normalcy in Sight?
(Vaccine Updates and More)
with Ben Miller, PhD, MPH, The Acheson Group
April 30, 2021

2. Monthly Industry Update:
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS

3. Casual but Professional Format
✔Ask questions! (Q&A at end)
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✔Recording link will be shared
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Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started
FSMA FRIDAYS

4. Featured Panelist: Dr. Ben Miller
FSMA FRIDAYS
Aaron Bolshaw
VP Marketing
Ben Miller, Ph.D, MPH
Senior Director of Regulatory and Scientific Affairs
● 20+ years industry experience in public health, food
regulation and food safety management
● Division Director of the Food and Feed Safety
Division at the Minnesota Department of Agriculture
● Epidemiologist at the Minnesota Department of
Health

5. Is a Return to
Normalcy in
Sight?
(Vaccine Updates,
FSMA News, and More)
Dr. Ben Miller, PhD, MPH

6. Title
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com
Overview
• Why do we care about COVID-19?
• Herd Immunity
• Vaccines for COVID-19 – Safety and Efficacy
• Variants and Boosters?
• The future and the New Normal
• What mitigation measures are here to stay

7. Title
Why do we care?
Excess Mortality
https://www.healthsystemtracker.org/brief/covid-19-
pandemic-related-excess-mortality-and-potential-years-of-
life-lost-in-the-u-s-and-peer-countries
Doctors and scientists are
working to estimate the
mortality rate of COVID-19,
but at present, it is thought to
be substantially higher
(possibly 10 times or more)
than that of most strains of
the flu.
https://www.hopkinsmedicine.org/health/conditions-and-
diseases/coronavirus/coronavirus-disease-2019-vs-the-flu
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

8. Title
Why do we care?
Examples from India
https://www.nytimes.com/interactive/2020/world/asia/india-coronavirus-cases.html
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

9. Herd Immunity
• When enough people have
immunity, disease spread
diminishes
• May occur through natural
infection or vaccination
• Estimates vary of 75%-90%
immunity
https://www.nytimes.com/interactive/2021/02/20/us/us-herd-immunity-covid.html
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

10. Title
Types of Vaccine
• Whole virus that has been attenuated
so it does not cause the disease –
Vaccines don’t cause COVID-19
infection!
• Nucleic acid using genetic material
(mRNA) from the virus that is packaged
for delivery to the human cells (Pfizer
and Moderna)
• Viral vector using a harmless virus to
deliver COVID-19 genetic material (J&J)
https://www.nytimes.com/interactive/2021/03/03/science/vaccine-efficacy-coronavirus.html
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

11. Common Side Effects
https://www.cdc.gov/mmwr/volumes/70/wr/mm7008e3.htm#F1_down
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

12. Title
Concerns around J&J vaccine
• Antibody response to platelets in blood
• Triggered by the vaccine in some people
• Females more than males
• Younger age (less than 50)
• Same issue seen with Astra Zeneca vaccine
• Blood clots in major blood vessels in brain and
intestine
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

13. Title
Good news – these vaccines work well!
Thompson, M.G., Burgess, J.L., Naleway, A.L., Tyner, H.L., Yoon, S.K., Meece, J., Olsho, L.E., Caban-Martinez, A.J., Fowlkes, A., Lutrick, K. and Kuntz, J.L.,
2021. Interim estimates of vaccine effectiveness of BNT162b2 and mRNA-1273 COVID-19 vaccines in preventing SARS-CoV-2 infection among health care
personnel, first responders, and other essential and frontline workers—eight US locations, December 2020–March 2021. Morbidity and Mortality Weekly
Report, 70(13), p.495.
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

14. Title
New Variants
• Predominant strain in the US is B.1.1.7 (UK origin)
• Vaccines mostly effective
• Concerns about B.1.351 (South Africa)
• Israeli study showing breakthrough with Pfizer vaccine
• New variants emerging in India B.1.617
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

15. Title
Storm Clouds on the Horizon?
• Variants
• Rising cases in some places
• Vaccinating the world takes time!
• Vaccine hesitancy
• Will we hit herd immunity?
• Where do we go from here?
• Boosters?
• Already under development
• Could protect against multiple variants
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

16. Quick Poll
16
What types of COVID-19 protocols and
procedures are your facilities running?
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

17. Title
Vaccine Policy – Addressing the Risks
• Educate
• Encourage and facilitate
• Incentivize
• Mandate
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

18. Title
What does the Future
Look Like?
• More research being done on how
vaccines reduce transmission
• Mid-Summer 2021 – Continued
decrease in case rates
• Increase in community
vaccination rates
• Mid to Late Summer 2021 –
reduction in risk prevention
measures (physical distancing,
masking, etc.)
• Depends on vaccination rate in the
community and place of
employment
• Testing will continue to play a role
https://www.npr.org/sections/health-shots/2021/01/28/960901166/how-is-the-covid-19-vaccination-campaign-going-in-your-state
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

19. Title
Dialing Back on COVID-19 – Key Criteria
• Vaccination coverage increasing
• Number of cases decreasing
• Breaking interventions into five levels
• 5 – Continue with current maximum
interventions
• 4 – Special conditions for fully vaccinated
• 3 – Repopulation of indoor spaces
• 2 – Easing other restrictions
• 1 – New Normal
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

20. Title
Dialing Back on COVID-19
FSMA Friday is sponsored by SafetyChain and The Acheson Group www.achesongroup.com

21. Q & A
FSMA FRIDAY

22. ✔ FSMA Friday Session Recordings & Content Library
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AchesonGroup.com
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Resources & Future Events
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May 21, 2021: (note the early date)
Making Sense of the FDA’s Reportable Food Registry
Mary Hoffman, Director, Food Safety