Frequently Asked Questions about the COVID-19 Vaccine Candidates - Prepared by: Toni P. Brown Chief Administrative Officer Delaware River Port ...
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Frequently Asked Questions about the COVID-19 Vaccine Candidates Prepared by: Toni P. Brown Chief Administrative Officer Delaware River Port Authority December 3, 2020
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64.4 million
Confirmed COVID-19 Cases Worldwide
1.4 million
COVID-19-Related Deaths Worldwide
2.18%
Rate of COVID-19-Related Deaths Worldwide
3
Data current as of 12/2/2020
14 million
Confirmed COVID-19 Cases in the U.S.
273,000
COVID-19-Related Deaths in the U.S.
1.95%
Rate of COVID-19-Related Deaths in the U.S.
4 Data current as of 12/2/2020
1. When will I be able to get vaccinated?
▸ That depends on your job, your age, and your health.
▸ Certain groups will be given preference based on a framework developed by
the Advisory Committee on Immunization Practices (ACIP) and approved by
the Centers for Disease Control and Prevention (CDC).
▸ State governors will consider the CDC recommended framework when
developing the vaccination plan for their states.
▸ Most adults won’t have access to the vaccine until spring/summer 2021.
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2. How many doses will we need?
▸ Pfizer and Moderna vaccines require two doses.
▸ Pfizer’s vaccine: initial dose followed three weeks later by a booster shot.
▸ Moderna’s vaccine: doses must be spaced four weeks apart.
▹ The U.S. plans to give individuals paper cards to remind them to return
for their second COVID-19 vaccine dose.
▹ States and pharmacies will make their own plans to remind individuals
when they should return to get their second dose.
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“ The COVID-19 vaccine is our duty and
passion. We’re not important.”
Dr. Ugur Sahin and Dr. Ozlem Tureci
The couple behind BioNTech, say they are driven by altruism
rather than riches.
https://www.thetimes.co.uk/article/the-vaccine-is-our-duty-and-
passion-were-not-important-qxj0bnkw6
7
“
If taken correctly, early trial data indicates
the vaccines will be highly effective at
preventing individuals from getting COVID-
19. A Pfizer analysis of late-stage trial data
found its shot is 95% effectiveness in
preventing COVID-19, exceeding scientists’
exectations. Moderna said its vaccine was
94.1% effective at protecting against
COVID-19.”
Business Insider, www.businessinsider.com
83. Why will it take so long for a COVID-19 vaccine to
become widely available?
▸ Pfizer and Moderna recently filed applications for “emergency use use
authorization” of their COVID-19 vaccines. An independent advisory
committee will meet on December 10 to decide whether to recommend
FDA approval of Pfizer’s vaccine, and on December 17 to recommend FDA
approval of Moderna’s vaccine.
▸ Once EUA approvals are granted it will take time to manufacture the multi-
dose vaccines, and prepare and distribute the “ancillary kits” that include
needles and syringes for doctor’s offices and pharmacies. The kits will also
include the paper reminder cards.
▸ Doses will be extremely limited at first.
94. How will the vaccines be shipped? Pfizer
▸ Multiple steps will be needed to deliver the glass vials of vaccine to local
hospitals and pharmacies.
▸ The Pfizer vaccine must be kept at -94° F (-70° C) during transport, although
the pharmaceutical manufacturer said it can be kept at 36° F to 46° F (2° C
to 8° C) for a maximum of five days in refrigeration units at hospitals.
▸ Once transferred to a refrigerator, it must be administered within five days.
104.1. How will the vaccines be shipped? Pfizer, continued
▸ Pfizer will make its U.S. vaccine in Kalamazoo, Michigan.
▸ Pfizer is not distributing through Operation Warp Speed.
▸ Pfizer has developed “thermal shippers” which can use dry ice and maintain
the -94° F temperature. The thermal shippers can be refilled with dry ice
after arrival if an ultra-low temperature freezer or hospital refrigeration unit
is not available.
▸ Pfizer will ship large thermal boxes of filled vials, jammed with dry ice, using
companies such as UPS, FedEx, American Airlines and United Airlines, to
locations around the country.
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4.3. How will the vaccines be shipped? Moderna
▸ In the U.S., Moderna will manufacture its vaccine in New Hampshire,
Pennsylvania and Indiana. It will ship vials to a distribution center in Irving,
Texas.
▸ Moderna also plans to manufacture the vaccine in Switzerland and Spain.
▸ The Moderna vaccine is stored frozen at -20 degrees Celsius, but it keeps for
a month at refrigerator temperatures.
134.4. How will the vaccines be shipped?
Moderna, continued
▸ Shipping and long-term storage conditions at standard freezer
temperatures of -20 degrees Celsius (-4 degrees Farenheit) for six months.
▸ This could make it easier to distribute this vaccine to pharmacies and rural
areas that don’t have specialized freezers.
14The COVID Cold Chain: How a Vaccine Will Get to You https://www.scientificamerican.com/article/the-covid-cold- chain-how-a-vaccine-will-get-to-you/
5. Is there a COVID-19 vaccine for children?
▸ So far, there is no vaccine for children under the age of 16. That's because
very few children have been part of the clinical trials to date. Vaccines can’t
be given to children unless they’ve been tested in their age group.
▸ The American Academy of Pediatrics has called on researchers to broaden
their trials to include more children.
16“
"Children are not just small adults," said Dr.
Sallie Permar, a professor of pediatrics,
microbiology and immunology at the Duke
University School of Medicine, in an interview
with NPR's All Things Considered.
A child's immune system is different from an
adult's, Permar said. "There are certain vaccines
that work better in children than adults. And
there are certain vaccines that work less well in
children compared to adults," she said. "So they
do have to be specifically studied in the pediatric
population."
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6. What does the phrase ‘shedding the virus’ mean?
▸ Viral shedding occurs when a virus replicates inside your body and is
released into the environment. At that point, it may be contagious. When
an individual gets infected with the COVID-19 virus, the virus particles bind
to the various types of viral receptors that line the respiratory tract.
Throughout this ongoing process, infected individuals, who may not yet be
experiencing any of the viral symptoms, shed viral particles when they talk,
exhale, eat, and perform other normal daily activities.
197. What is herd immunity?
▸ ‘Herd immunity,’ also known as ‘population immunity,’ is a concept used for
vaccination. Herd immunity occurs when a large portion of the community
(the herd) becomes immune to a disease, usually through vaccination. As a
result, the whole community becomes protected, not just those who are
immune. (www.mayoclinic.org; www.who.int )
▸ It’s estimated that between 75-80% of the population will need to be
vaccinated to reach herd immunity against the COVID-19 virus.
208. Will I still need to socially distance after
the vaccine?
▸ Yes. Even after a vaccine is approved, experts say people will need to wear
masks and socially distance, in part because, at first, the vaccine doses will
be limited, and it will take time to immunize enough of the population to
stop the virus from spreading.
219. Will I have a choice on which vaccine to take assuming
more than one is approved?
▸ Supply will be far short of demand initially, so you likely will not be offered
an option.
▸ The vaccines have different storage and handling requirements making it
likely that each administration site will only have one vaccine on hand, at
least initially.
2210. If I already had the COVID-19 virus should I get the vaccine?
▸ Scientists are still learning how long immunity to the virus lasts, after an
infection or vaccination.
▸ The COVID-19 Phase 3 trials did not exclude people who already had been
infected; full data from those trials and Phase 4 (Quality Control) may help
reveal how the vaccine performed in those people.
▸ Until the CDC committee evaluates the full data on an authorized vaccine,
the agency won’t make recommendations about whether people who
already were infected should receive it.
23Thanks
Any questions?
You can find me at:
▸ tpbrown@drpa.org
24Credits
▸ Centers for Disease Control COVD-19 Vaccine Recommendations Vaccines | CDC
▸ New Jersey Department of Health (NJ DOH) COVID-19 Information Hub New Jersey COVID-19 Information Hub
(nj.gov)
▸ Pennsylvania Department of Health (PA DOH) COVID-19 in Pennsylvania Coronavirus in Pennsylvania (pa.gov);
and COVID-19 Data and Dashboard Pennsylvania Data (pa.gov)
▸ Pfizer Vaccine Our COVID-19 Vaccine Study – What’s Next? | Pfizer
▸ FDA Emergency Use Authorization (EUA) COVID-19 Vaccines | FDA
▸ FDA Pfizer EUA Advisory Committee December 10, 2020 coronavirus (COVID-19) Update: FDA Announces
Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate | FDA; and Vaccines and Related
Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020 -
12/10/2020 | FDA
25Credits
▸ Moderna Vaccine Moderna’s Work on a COVID-19 Vaccine Candidate | Moderna, Inc. (modernatx.com)
▸ www.BusinessInsider.com
▸ Moderna Press Release, November 16, 2020
▸ Coronavirus World Map, Tracking The Global Outbreak – The New York TimePresentation
▸ https://www.scientificamerican.com/article/the-covid-cold-chain-how-a-vaccine-willget-to-you
▸ www.mayoclinic.org
▸ www.who.int
▸ https://www.thetimes.co.uk/article/the-vaccine-is-our-duty-and-passion-were-notimportant-qxj0bnkw6
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