COVID-19 Vaccine

Recommendations
Kathleen Dooling, MD, MPH

January 6, 2020

For more information: www.cdc.gov/COVID19

 Objectives
• Vaccine Recommendations
• Pfizer-BioNTech
• Moderna
• Clinical considerations for use
• Anaphylaxis

• Allocation
• Considerations for implementation

• Summary & What’s on the Horizon

ACIP recommendations for
mRNA COVID-19 vaccines
 Messenger RNA vaccines

LNP

Spike protein  Provides instruction directly to the

encoded mRNA immune system (Spike protein)

B cell
 Efficiently creates specific immune
Antigen memory
presenting
CD8+ cell
T cell CD4+
T cell  mRNA can neither interact with
nor integrate into DNA

Source: https://www.fda.gov/media/144583/download
 ACIP recommendations for use of COVID-19 vaccines

• Use of mRNA COVID-19 vaccines under

FDA’s Emergency Use Authorization
• December 12, 2020: Pfizer-BioNTech
• December 19, 2020: Moderna

https://www.cdc.gov/mmwr/volumes/69/wr/mm6950e2.htm?s_cid=mm6950e2_w
https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm?s_cid=mm695152e1_w
mRNA COVID-19 vaccines
• Two mRNA COVID-19 vaccines authorized under Emergency Use
• Pfizer-BioNTech
• Moderna

• Both products demonstrate vaccine efficacy >90%

• Efficacy demonstrated across age groups, racial and ethnic groups

• Vaccine safety profile of both products acceptable

• Imbalance of Bell’s Palsy but still within expected range
• Local and systemic reactogenicity, particularly after second dose
 Dosing and administration
• Authorized age groups:
• Pfizer-BioNTech: ≥ 16 years
• Moderna: ≥ 18 years

• Administration: two-dose series administered intramuscularly

• Pfizer-BioNTech: three weeks apart
• Moderna: four weeks apart

• mRNA vaccines are not interchangeable with each other or other COVID-19 vaccines
• Either vaccine series may be used; ACIP does not state a product preference

• mRNA vaccines should be administered alone, with a minimum interval of 14 days

before or after administration with any other vaccines
 Dosing and administration
• Persons should not be prospectively scheduled to receive the second dose earlier than
recommended (Pfizer-BioNTech= 3 weeks, Moderna=4 weeks)
• Second doses administered within a “grace period” of ≤4 days from the recommended date are
considered valid
• There is no maximum interval between the first and second dose for either vaccine.

• If minimum intervals (between COVID-19 doses or between COVID-19 and other vaccines)
are violated, still consider the COVID-19 dose VALID
• COVID-19 vaccine supply is constrained
• We don’t have data on 3 doses of COVID-19 or doses given with shorter inter-dose intervals
Persons with a history of SARS-CoV-2 infection

 Vaccination should be offered to persons regardless of history of prior

symptomatic or asymptomatic SARS-CoV-2 infection
– Data from clinical trials suggest vaccination safe in these persons

 Viral or serologic testing for acute or prior infection, respectively, is

not recommended for the purpose of vaccine decision-making
Persons with known current SARS-CoV-2 infection

 Vaccination should be deferred until recovery from acute illness (if person
had symptoms) and criteria have been met to discontinue isolation

 No minimal interval between infection and vaccination

 However, current evidence suggests reinfection uncommon in the 90 days

after initial infection, and thus persons with documented acute infection in
the preceding 90 days may defer vaccination until the end of this period, if
desired

https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html
https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html
 Persons with a known SARS-CoV-2 exposure
 Residing in the Community:
– Defer vaccination until quarantine period has ended to avoid exposing healthcare
personnel (HCP) or other persons during vaccination visit

 Residents of congregate healthcare settings (e.g., long-term care facilities):

– May be vaccinated, as likely would not result in additional exposures. HCP are already in
close contact with residents and should employ appropriate infection prevention and
control procedures

 Residents of congregate settings (e.g., correctional facilities, homeless shelters)

– May be vaccinated, in order to avoid delays and missed opportunities for vaccination
– Where feasible, precautions should be taken to limit mixing of these individuals with
other residents or non-essential staff
https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html
https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html
Persons with underlying medical conditions

 Vaccine may be administered to persons with underlying medical

conditions who have no contraindications to vaccination

 Clinical trials demonstrate similar safety and efficacy profiles in persons

with underlying medical conditions, including those that place them at
increased risk for severe COVID-19, compared to persons without
comorbidities

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
Immunocompromised persons

 Persons with HIV infection, other immunocompromising conditions, or who take

immunosuppressive medications or therapies might be at increased risk for severe
COVID-19

 Data not currently available to establish safety and efficacy of vaccine in these groups

 These individuals may still receive COVID-19 vaccine unless otherwise contraindicated

 Individuals should be counseled about:

– Unknown vaccine safety and efficacy profiles in immunocompromised persons
– Potential for reduced immune responses
– Need to continue to follow all current guidance to protect themselves against COVID-19

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
 Pregnant women
 COVID-19 and pregnancy
– Increased risk of severe illness (ICU admission, mechanical ventilation and death)
– Might be an increased risk of adverse pregnancy outcomes, such as preterm birth

 There are limited data on the safety of COVID-19 vaccines in pregnant women
– Limited animal developmental and reproductive toxicity (DART) data
– Studies in humans are ongoing and more planned

 If a woman is part of a group (e.g., healthcare personnel) who is

recommended to receive a COVID-19 vaccine and is pregnant, she may
choose to be vaccinated.

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnancy-breastfeeding.html
Pregnant women

 Considerations for vaccination:

– Level of COVID-19 community transmission (risk of acquisition)
– Personal risk of contracting COVID-19 (by occupation or other activities)
– Risks of COVID-19 to her and potential risks to the fetus
– Efficacy of the vaccine
– Known side effects of the vaccine
– Lack of data about the vaccine during pregnancy
 Post-Vaccination Symptoms- Reactogenicity

 Before vaccination, providers should counsel vaccine recipients about expected

local and systemic post-vaccination symptoms
 Depending on vaccine product, age group, and dose:
– 80-89% of clinical trial participants reported ≥1 local reaction (e.g., pain or swelling at
injection site; swollen lymph nodes on same side as vaccinated arm)
– 55-83% of clinical trial participants reported ≥1 systemic reaction (e.g., fever, fatigue,
muscle aches, headache, chills)
– Most are mild-moderate in severity, occur within first 3 days of vaccination, and resolve
within 1-2 days of onset
– More frequent and severe following the second dose and among younger age groups
https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html
https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html
 Infection prevention and control recommendations for
persons with post-vaccination symptoms

 Healthcare personnel

 Long-term care facility residents

https://www.cdc.gov/coronavirus/2019-ncov/hcp/post-vaccine-considerations-healthcare-personnel.html
https://www.cdc.gov/coronavirus/2019-ncov/hcp/post-vaccine-considerations-residents.html
Contraindications and Precautions
Contraindications to vaccination

 Prescribing information for both Pfizer-BioNTech and Moderna

COVID-19 vaccines:
– Severe allergic reaction (e.g., anaphylaxis) to any component of the
vaccine is a contraindication to vaccination
– Appropriate medical treatment used to manage immediate allergic
reactions must be immediately available in the event an acute anaphylactic
reaction occurs following administration of the vaccine
Precautions to vaccination: mRNA COVID-19 vaccines

 History of severe allergic reaction (e.g., anaphylaxis) to any other vaccine or

injectable therapy (e.g., intramuscular, intravenous, or subcutaneous)
– Risk assessment should be conducted in persons who report history of severe allergic
reaction (e.g., whether reaction required use of epinephrine [EpiPen®, etc.], resulted in
hospitalization)

 These persons may still receive vaccination, but should be counseled about
the unknown risks of developing a severe allergic reaction and balance these
risks against the benefits of vaccination

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
Observation period following vaccination
 Vaccine providers should observe patients after vaccination to monitor for the
occurrence of immediate adverse reactions:

Persons with a history of All other persons

anaphylaxis (due to any cause)

30 minutes 15 minutes
 Ingredients* included in mRNA COVID-19 vaccines
Description Pfizer-BioNTech COVID-19 vaccine Moderna COVID-19 vaccine
mRNA nucleoside-modified mRNA encoding the viral spike (S) nucleoside-modified mRNA encoding the viral spike
glycoprotein of SARS-CoV-2 (S) glycoprotein of SARS-CoV-2
Lipids 2[(polyethylene glycol)-2000]-N,N- 1 monomethoxypolyethyleneglycol-2,3-
ditetradecylacetamide dimyristylglycerol with polyethylene glycol of
average molecular weight 2000 (PEG2000-DMG)
1,2-distearoyl-sn-glycero-3-phosphocholine 1,2-distearoyl-sn-glycero-3-phosphocholine
cholesterol cholesterol
(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-
hexyldecanoate) (undecyloxy) hexyl) amino) octanoate
Salts and potassium chloride Tris buffer containing sucrose and sodium acetate
Sugars monobasic potassium phosphate
sodium chloride
dibasic sodium phosphate dihydrate
sucrose

*As reported in the prescribing information

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
 Additional tools to identify
persons with contraindications
and precautions to vaccination

Interim considerations:
Preparing for the potential
management of anaphylaxis
at COVID-19 vaccination sites

https://www.cdc.gov/vaccines/covid-19/downloads/pre-vaccination-screening-form.pdf
https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html
 Recommended medications and supplies for the
management of anaphylaxis at COVID-19 vaccination sites
Should be available at all sites Include at sites where feasible
Epinephrine prefilled syringe or autoinjector* Pulse oximeter
H1 antihistamine (e.g., diphenhydramine)† Oxygen

Blood pressure cuff Bronchodilator (e.g., albuterol)

Stethoscope H2 antihistamine (e.g., famotidine, cimetidine)

Timing device to assess pulse Intravenous fluids

Intubation kit

Adult-sized pocket mask with one-way valve (also known

as cardiopulmonary resuscitation (CPR) mask)
*COVID-19 vaccination sites should have at least 5 doses of epinephrine on hand at any given time.
†Antihistamines may be given as adjunctive treatment and should not be used as initial or sole treatment for anaphylaxis. Additionally, caution should be used if oral
medications are administered to persons with impending airway obstruction.

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html
Key messages
Preparing for the potential management of anaphylaxis at COVID-19 vaccination sites

Early recognition of Prompt treatment with Activation of emergency

anaphylaxis symptoms epinephrine medical services

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html
Anaphylaxis in persons following mRNA COVID-19 vaccines

 Cases of anaphylaxis have been reported (as of Dec 19/2020, following Pfizer-
BioNTech COVID-19 vaccination)
– 2 cases in United Kingdom
– 6 cases* in United States (~272K doses administered)

 US cases:
– Rapid onset following vaccination
– One person had prior history of anaphylaxis (to rabies vaccine)

* 6 confirmed cases meeting Brighton Collaboration criteria 1 or 2, through December 18, 2020 at 2300 hrs EST
Your role
 Recognize, respond, and report anaphylaxis following COVID-19
vaccination to VAERS 
 Report adverse events to VAERS in accordance with FDA EUA
reporting requirements and CDC guidance 
 Participate in CDC’s v-safe program yourself when you get
vaccinated and encourage patients to participate in v-safe 
 Communicate with patients on vaccine safety 
ACIP recommendations for
Vaccine allocation/prioritization
ACIP recommendations for use of COVID-19 vaccines

 Phased allocation of COVID-19 vaccines

https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm
https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_w
COVID-19 vaccination phases
Phased allocation: Balancing Goals
Prevention of Preservation of
Morbidity & Mortality Societal Functioning

1a LTCF residents Health care personnel

1b Persons 75 years and older Frontline Essential Workers

Persons 65-74 years

1c Persons 16-64 with high-risk Other Essential Workers
medical conditions

●Ensure safety and effectiveness of COVID-19 vaccines●

●Ensure equity in vaccine allocation and distribution●
 Essential Workers
Frontline Essential Workers (~30M) Other Essential Workers (~57M)
 First Responders (Firefighters, Police)  Transportation and logistics
 Education (teachers, support staff, daycare)  Food Service
 Food & Agriculture  Shelter & Housing (construction)
 Manufacturing  Finance
 Corrections workers  IT & Communication
 U.S. Postal service workers  Energy
 Public transit workers  Media
 Grocery store workers  Legal
 Public Safety (Engineers)
 Water & Wastewater
Frontline Essential Workers: workers who are in sectors essential to the functioning of society and are at
substantially higher risk of exposure to SARS-CoV-2
*CISA: Essential Critical Infrastructure Workers: https://www.cisa.gov/news/2020/08/18/cisa-releases-updated-guidance-essential-critical-infrastructure-workers
Example of Phase 1 & Phase 2 COVID-19 vaccine roll-out
 Transitioning Between Phases
 Strategy for transitioning between phases will be necessary to move to the
next phase as supply increases and exceeds demand for the current phase
 Phases may overlap; not necessary to fully complete vaccination in one
phase before moving to the next phase
 Decisions on moving to the next phase made at a state/local level

https://www.cdc.gov/vaccines/covid-19/phased-implementation.html
Considerations for transitioning between phases
 When demand in the current phase appears to have been met (e.g., appointments
for vaccination are < 80% filled for several days)
 When supply of authorized vaccine increases substantially (e.g., more vaccine doses
are available than are necessary to complete vaccination of persons in the current
phase)
 When most people in the current phase are vaccinated (e.g., when approximately
60-70% of the target population in a phase has been vaccinated)
 When vaccine supply within a certain location is in danger of going unused unless
vaccination is expanded to persons in the next phase

https://www.cdc.gov/vaccines/covid-19/phased-implementation.html
Considerations- sub prioritization
 Groups of workers that are the most critical to maintaining core societal
functions
 Groups of workers with unavoidable higher risk of exposure
 Groups of workers in sites where high rates of transmission and outbreaks
can occur regularly (e.g., correctional and detention facility workers)

 Considerations for sub-prioritization may be informed by CDC’s Social

Vulnerability Index or other similar indices
Summary & what’s on the horizon
Public health recommendations for vaccinated persons
 Protection from vaccine is not immediate; vaccine is a 2-dose series and will take 1 to 2
weeks following the second dose to be considered fully vaccinated

 No vaccine is 100% effective

 Given the currently limited information on how well the vaccine works in the general
population; how much it may reduce disease, severity, or transmission; and how long
protection lasts, vaccinated persons should continue to follow all current guidance to
protect themselves and others, including:
– Wearing a mask
– Staying at least 6 feet away from others
– Avoiding crowds
– Washing hands often
– Following CDC travel guidance
– Following quarantine guidance after an exposure to someone with COVID-19
– Following any applicable workplace or school guidance
https://www.cdc.gov/coronavirus/2019-ncov/index.html
Summary
 2 mRNA vaccines currently authorized for use in U.S.
– >90% VE
– Moderate self-limited reactogenicity
– Higher than expected anaphylaxis– vaccination sites must be ready to manage

 Phased allocation of vaccine is necessary while demand > supply

– Equitable and fair
– Use all doses in a timely way

 Next few months

– Increased production of mRNA vaccines
– Viral vector vaccines (Janssen and AstraZeneca)
 Resources
MMWRs
Pfizer-BioNTech: https://www.cdc.gov/mmwr/volumes/69/wr/mm6950e2.htm?s_cid=mm6950e2_w
Moderna: https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm?s_cid=mm695152e1_w
Vaccine Allocation: https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm
https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_w

CDC considerations
Pregnancy: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnancy-breastfeeding.html
Underlying medical conditions: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

Vaccine Safety
VAERS: http://vaers.hhs.gov
VSAFE: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html

Other CDC resources

Vaccine tracker: https://covid.cdc.gov/covid-data-tracker
For Healthcare Professionals: https://www.cdc.gov/vaccines/covid-19/hcp/index.html
Engaging in Effective COVID-19 Vaccine Conversations https://www.cdc.gov/vaccines/covid-19/hcp/engaging-patients.htm
Questions?
Back-up slides
 Pregnant women
 COVID-19 and pregnancy
– Increased risk of severe illness (ICU admission, mechanical ventilation and death)
– Might be an increased risk of adverse pregnancy outcomes, such as preterm birth

 There are limited data on the safety of COVID-19 vaccines in pregnant women
– Limited animal developmental and reproductive toxicity (DART) data
– Studies in humans are ongoing and more planned

 If a woman is part of a group (e.g., healthcare personnel) who is

recommended to receive a COVID-19 vaccine and is pregnant, she may
choose to be vaccinated.

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnancy-breastfeeding.html 12/21/20
Moderna: Efficacy post ONLY 1 dose

Moderna FDA VRBPAC Briefing Document: https://www.fda.gov/media/144434/download

 Pfizer: efficacy post dose 1

Pfizer FDA VRBPAC Briefing: https://www.fda.gov/media/144245/download