cdc.gov/coronavirus

COVID-19 Vaccination Guidance

Elisha Hall, PhD

Clinical Guidelines Lead

COVID-19 Pre-exposure Prophylaxis Guidance

Evelyn Twentyman, MD, MPH

Vaccine Policy Unit Lead

ACIP Meeting

9/01/2022

Interim Clinical Considerations for COVID-19 

Vaccines: Bivalent Boosters
Bivalent Booster Authorized

▪ On August 31, 2022:

– Moderna COVID-19 Vaccine, Bivalent authorized for use in people ages 

18 years and older. 

– Pfizer-BioNTech COVID-19 Vaccine, Bivalent authorized for use in 

people ages 12 years and older

▪ Authorized as single booster dose administered at least 2 months after 

either:

– Completion of primary vaccination with any authorized or approved 

monovalent COVID-19 vaccine, or

– Receipt of the most recent booster dose with any authorized or 

approved monovalent COVID-19 vaccine
mRNA COVID-19 Vaccines No Longer Authorized as 

Booster Doses for People Ages 12 Years and Older

▪ Monovalent mRNA COVID-19 vaccines are no longer authorized as booster 

doses for individuals ages 12 years and older, meaning monovalent booster 

doses can no longer be given to people ages 12 years and older, even if the 

person had not previously received a monovalent booster dose.
Bivalent Booster Recommendations

▪ Everyone ages 12 years and older is recommended to receive 1 ageappropriate bivalent mRNA booster dose after completion of any FDAapproved or FDA-authorized monovalent primary series or last monovalent 

booster dose.

– People cannot get a bivalent booster without first completing at least 

a primary series

– Age-appropriate homologous and heterologous boosters allowed; 

there is no preference

▪ At this time, no changes to schedules for children ages 6 months through 

11 years.
Previous Monovalent Booster Recommendations

▪ The bivalent booster recommendation replaces previous booster 

recommendations for people ages 12 years and older.

▪ This means that everyone ages 5 years and older who are eligible for a 

booster dose will now only be eligible for ONE booster dose.

– People ages 5 through 11 years (who received Pfizer-BioNTech primary 

series): 1 monovalent booster dose

– People ages 12 years and older: 1 bivalent booster dose
Fall Booster “Reset”

▪ Recommendations are simplified

▪ Change from dose counting to 1 bivalent booster for everyone eligible

▪ If eligible, a bivalent should not be denied based on total number of doses

Vaccination history Next dose

Primary series 1 bivalent booster dose

Primary series + 1 booster 1 bivalent booster dose

Primary series + 2 booster 1 bivalent booster dose

At least 

2 months

At least 

2 months

At least 

2 months
COVID-19 Vaccination Schedule for People who are 

NOT Moderately or Severely Immunocompromised

Primary 

Dose

Primary 

Dose

3-8 or 4-8 

weeks*

People ages 12 years and older

Bivalent 

Booster†

At least

2 months

Primary 

Dose

Bivalent 

Booster†

At least 2 

months

*3-8 interval for Novavax and Pfizer-BioNTech; 4-8 interval for 

Moderna

† The bivalent booster dose is administered at least 2 months after 

completion of the primary series. 

For people who previously received a monovalent booster dose(s), 

the bivalent booster dose is administered at least 2 months after the 

last monovalent booster dose. The bivalent booster should be age 

appropriate; Pfizer-BioNTech is authorized for people ages 12 years 

and older and Moderna is authorized for people ages 18 years and 

older. 

Moderna, 

Novavax, or 

Pfizer-BioNTech 

Primary Series

Janssen Primary 

Series Dose

People ages 18 years and older

Regardless of previous monovalent booster doses given

Regardless of previous monovalent booster doses given
COVID-19 Vaccination Schedule for People who ARE 

Moderately or Severely Immunocompromised

Primary Primary

3 or 4 

weeks*

People ages 12 years and older

Primary

At least

4 weeks

People ages 18 years and older who received Janssen

Primary Addl. 

mRNA

At least 

4 weeks

Bivalent 

Booster†

At least

2 months

Bivalent 

Booster†

At least 2 

months

Moderna or 

Pfizer-BioNTech 

Primary Series

Janssen 

Primary Series 

Dose

Bivalent 

Booster†

At least

2 months Novavax 

Primary Series

*3-8 interval for Novavax and Pfizer-BioNTech; 4-8 interval for 

Moderna

† The bivalent booster dose is administered at least 2 months 

after completion of the primary series. 

For people who previously received a monovalent booster 

dose(s), the bivalent booster dose is administered at least 2 

months after the last monovalent booster dose. The bivalent 

booster should be age appropriate; Pfizer-BioNTech is 

authorized for people ages 12 years and older and Moderna is 

authorized for people ages 18 years and older. 

Regardless of previous monovalent booster doses given

Primary Primary

3 weeks

Regardless of previous monovalent booster doses given

Regardless of previous monovalent booster doses given
Who may benefit from Evusheld? 

▪ People ages ≥12 years: 

– With moderate to severe immune 

compromise 

– For whom vaccination with any available 

COVID-19 vaccine is not recommended 

due to a history of severe adverse 

reaction to a COVID-19 vaccine(s) 

and/or COVID-19 vaccine component(s)

Evusheld Healthcare Providers FS 06292022 (fda.gov)

Image: ASPR Webinar: What is Evusheld? https://aspr.hhs.gov/COVID-19/Therapeutics/Products/Evusheld/Pages/default.aspx
Tixagevimab/Cilgavimab (EVUSHELDTM)

▪ Combination of two long-acting human monoclonal antibodies derived from B-cells donated by 

convalescent patients after SARS-CoV-2 infection

▪ FDA’s Emergency Use Authorization (EUA):

– Issued 12/8/21 for pre-exposure prophylaxis in individuals with moderate/severe 

immunocompromise or for whom COVID-19 vaccination is not recommended

– Revised 2/24/22 to increase dose to 300mg/300mg (accounting for decreased neutralization 

activity against Omicron)

▪ Fact sheet for healthcare providers revised 6/29/22 for Evusheld to be administered every 6 months

▪ Evusheld must be prescribed by a healthcare provider

▪ Doses can be found through the USG therapeutic locator tool: https://covid-19-therapeutics-locatordhhs.hub.arcgis.com/

▪ There are two ways for providers to order Evusheld:

– HHS Health Partner Order Portal (HPOP), for large orders through the HPOP distribution process

– A new direct clinical pathway established in July 2022 for Small Volume Orders of up to three 

doses, for providers not participating in the HPOP distribution process
Use of Evusheld is evidence-based

▪ A randomized clinical trial1 and multiple 

retrospective and other studies2-5show that 

Evusheld has efficacy against severe COVID-19 

outcomes and provides protection against 

Omicron. 

▪ In vitro studies show that Evusheld is predicted 

to work against BA.4/56

1. Levin et al, Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19, New England Journal of Medicine, 2022

2. Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA Electronic Data | medRxiv

3. Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving monoclonal antibodies | Nature Medicine

4. Al Jurdi et al., American Journal of Transplantation;June 2022

5. Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality | Clinical Infectious Diseases | Oxford Academic (oup.com)

6. Takashita E, et al, Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12.1, BA.4, and BA.5 Subvariants. N Engl J Med. 2022.
Most immunocompromised people in the US have not 

received Evusheld

▪ Number of individuals age ≥12 in the United States:

~290 million people2

▪ Roughly 3% of U.S. population is immunocompromised: 

~8.7 million people

▪ Therefore, % protected with Evusheld:

~5.3% of individuals who are eligible

1. National population estimates: CDC wonder (wonder.cdc.gov) 

2. Data source: HHS-Tiberius: https://aspr.hhs.gov/COVID-19/Therapeutics/orders/Pages/default.aspx

Therapeutic2 Courses Ordered Courses Administered

Evusheld (300 mg doses) 850,106 459,572

Data is for states, territories, and federal entities, including HRSA. 

Courses administered is based on 92% of sites as of August 21, 2022

▪ Supply far exceeds administration to patients: 

>390,000 doses available

▪ Evusheld is distributed by the US government at 

no cost to recipients, although there may be 

administration fees depending on location 
Supplementing COVID-19 vaccination with preexposure prophylaxis

Any dose 

(primary or 

booster)

Any 

subsequent 

COVID-19 

vaccine dose

In at least 2 

weeks

At least 2 weeks from 

COVID-19 vaccine to 

EVUSHELDTM

No minimum interval 

from EVUSHELDTM to 

COVID-19 vaccine EVUSHELDTM

dose every 6 

months

Monoclonal antibodies (EVUSHELDTM) for COVID-19 pre-exposure prophylaxis

People ages 12 years and older (must weigh at least 40 kg)
CDC Webpage pre-exposure prophylaxis updates for 

healthcare providers and the public

▪ Updated website content for healthcare providers:

– Patient eligibility

– Evusheld administration guidance

▪ Updated website content for the public:

– How to know if you’re eligible for Evusheld

– How to access Evusheld

▪ Updated website language for Interim Clinical Considerations

– How use of Evusheld compliments COVID-19 vaccination in people 

with moderate or severe immunocompromise
COVID-19 Vaccination Schedule Timing Considerations

▪ Timing considerations for people with current or prior SARS-CoV-2 infection

▪ Coadministration 
Timing Considerations for People with Current or Prior 

SARS-CoV-2 Infection

▪ At a minimum, defer any COVID-19 vaccination, including bivalent booster 

vaccination, at least until recovery from the acute illness (if symptoms were 

present) and criteria to discontinue isolation have been met.

▪ In addition, people who recently had SARS-CoV-2 infection may consider 

delaying any COVID-19 vaccination, including bivalent booster vaccination, 

by 3 months from symptom onset or positive test (if infection was 

asymptomatic). 

▪ Individual factors such as risk of COVID-19 severe disease, COVID-19 

community level, or characteristics of the predominant SARS-CoV-2 strain 

should be taken into account when determining whether to delay getting a 

COVID-19 vaccination after infection.
Coadministration of COVID-19 Vaccines with Other 

Vaccines

▪ Routine administration of all age-appropriate doses of vaccines 

simultaneously is recommended as best practice for people for whom no 

specific contraindications exist at the time of the healthcare visit. 

▪ Extensive experience with non-COVID 19 vaccines has demonstrated that 

immunogenicity and adverse event profiles are generally similar when 

vaccines are administered simultaneously as when they are administered 

alone.

▪ Providers should offer all vaccines for which a person is eligible at the 

same visit.
Coadministration of Influenza with COVID-19 Vaccines

▪ Providers should offer influenza and COVID-19 vaccines at the same visit, if 

eligible.

– This includes adjuvanted or high-dose influenza vaccines; administer in 

separate limbs.

▪ With both influenza and SARS-CoV-2 circulating, getting both vaccines is 

important for prevention of severe disease, hospitalization, and death.

▪ Getting both vaccines at the same visit increases the chance that a person 

will be up to date with their vaccinations.
Coadministration of Influenza and COVID-19 Vaccines

▪ Studies looking at coadministration have shown that immunogenicity is 

similar between those who received coadministered COVID-19 vaccine and 

seasonal influenza vaccine (SIV) and those who received these vaccines 

seperately2-4

▪ 9.4% (~92,000) v-safe participants reported simultaneous vaccination with 

an mRNA COVID-19 vaccine and SIV5

▪ 8.7% (~454,000) of persons enrolled in the Vaccine Safety Datalink (VSD) 

received simultaneous vaccination with a COVID-19 booster and SIV during 

the 2021-2022 influenza season 

1. https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf

2. Lazarus R, Baos S, Cappel-Porter H, et al. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): A multicentre, randomised, controlled, phase 4 trial. Lancet 2021, 398, 2277–2287.

3. Izikson R, Brune D, Bolduc JS, et al. Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged ≥65 years: A phase 2, randomised, open-label study. Lancet Respir. Med. 2022.

4. Toback S, Galiza E, Cosgrove C, et al. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: An exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. Lancet Respir. Med. 2021,10, 167–179.

5. Hause AM, Zhang B, Yue X, et al. Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US. JAMA Netw Open. 2022;5(7):e2222241. Domnich A, Grassi R, Fallani E, Ciccone R, Bruzzone B, Panatto D, Ferrari A, Salvatore M, Cambiaggi M, Vasco A, Orsi A, Icardi G. Acceptance of COVID-19 and Influenza 

Vaccine Co-Administration: Insights from a Representative Italian Survey. Journal of Personalized Medicine. 2022; 12(2):139.
Reactogenicity of Coadministered COVID-19 Vaccine 

and SIV

1.2

7.3

-3.3

-5.3

12.5

0.9

2.7

6.2

6.7

-12.9

-3.7

14.4

0.0

3.8

-15.0 -10.0 -5.0 0.0 5.0 10.0 15.0

Pfizer + QIVc [4]

Pfizer + QIVr [4]

Pfizer + aTIV [4]

Moderna + hdQIV [3]

Novavax + Either aTIV or QIVc [2]

Pfizer+ Any SIV [1]

Moderna + Any SIV [1]

Systemic Reactions Local Reactions

More reactogenicity in COVID-19 alone | More reactogenicity in COVID-19 + SIV

Percent difference in participants reporting reactogenicity between COVID-19 + SIV vs COVID-19 alone

1. Hause AM, Zhang B, Yue X, et al. Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US. JAMA Netw Open. 2022;5(7):e2222241. 

2. Toback S, Galiza E, Cosgrove C, et al. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: An exploratory substudy of a randomised, observer-blinded, placebocontrolled, phase 3 trial. Lancet Respir. Med. 2021,10, 167–179.

3. Izikson R, Brune D, Bolduc JS, et al. Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged ≥65 years: A phase 2, 

randomised, open-label study. Lancet Respir. Med. 2022.

4. Lazarus R, Baos S, Cappel-Porter H, et al. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): A multicentre, 

randomised, controlled, phase 4 trial. Lancet 2021, 398, 2277–2287.

SIV: seasonal influenza vaccine; aTIV: adjuvanted trivalent influenza vaccine; QIVc: quadrivalent influenza cell-based vaccine; hdQIVc: high-dose quadrivalent influenza vaccine; QIVr recombinant quadrivalent vaccine 
Reactogenicity of Coadministered COVID-19 Vaccine 

and SIV

▪ Generally, COVID-19 vaccines administered with seasonal influenza vaccine 

(SIV) showed similar or slightly higher reactogenicity, however no specific 

safety concerns were identified.

1. Hause AM, Zhang B, Yue X, et al. Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US. JAMA Netw Open. 2022;5(7):e2222241. 

2. Toback S, Galiza E, Cosgrove C, et al. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: An exploratory substudy of a randomised, observer-blinded, placebocontrolled, phase 3 trial. Lancet Respir. Med. 2021,10, 167–179.

3. Izikson R, Brune D, Bolduc JS, et al. Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged ≥65 years: A phase 2, 

randomised, open-label study. Lancet Respir. Med. 2022.

4. Lazarus R, Baos S, Cappel-Porter H, et al. Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): A multicentre, 

randomised, controlled, phase 4 trial. Lancet 2021, 398, 2277–2287.
Best Practices for Multiple Injections

▪ Label each syringe with the name and the dosage (amount) of the vaccine, 

lot number, initials of the preparer, and exact beyond-use time, if 

applicable.

▪ Administer each vaccine in a different injection site; separate injection sites 

by 1 inch or more, if possible.

▪ Administer the COVID-19 vaccine and vaccines that may be more likely to 

cause a local reaction in different limbs, if possible.

– Example: Adjuvanted or high-dose influenza vaccine and COVID-19 

vaccine
Pfizer-BioNTech COVID-19 Vaccines

Monovalent Product Bivalent Product

Authorized for ages 12 years and older 12 years and older

Authorized for doses Primary series doses Booster doses

Vial cap color Gray Gray

Dose (mRNA concentration) 30 mcg 30 mcg

(15 mcg original, 15 mcg Omicron BA.4/BA.5)

Vaccine composition Monovalent—Original Bivalent—Original and Omicron BA.4/BA.5

Injection volume 0.3 mL 0.3 mL

Dilution required No No

Beyond-use date 12 hours after puncture 12 hours after puncture

Storage Ultra-cold freezer until expiration; 

Refrigerator (2oC-8oC) up to 10 weeks

Ultra-cold freezer until expiration; 

Refrigerator (2oC-8oC) up to 10 weeks
Pfizer-BioNTech Labels

Monovalent label 

Primary series only

Ages 12 years and older

Bivalent label 

Booster dose only

Ages 12 years and older
Monovalent 

Product

Monovalent 

Product

Bivalent 

Product

Authorized for ages 12 years and older 6–11 years 18 years and older

Vial cap color Red Dark blue Dark blue

Label border color Light blue Purple Gray

Dose (mRNA 

concentration)

100 mcg (primary dose) 50 mcg (primary dose) 50 mcg (booster dose)

(25 mcg original, 25 mcg Omicron BA.4/BA.5)

Injection volume 0.5 mL 0.5 mL 0.5 mL

Dilution required No No No

Beyond-use date 12 hours 12 hours 12 hours

Storage Freezer (-15oC to -50oC) until 

expiration; Refrigerator (2oC 

to 8oC) up to 30 days

Freezer (-15oC to -50oC) until 

expiration; Refrigerator (2oC 

to 8oC) up to 30 days

Freezer (-15oC to -50oC) until 

expiration; Refrigerator (2oC 

to 8oC) up to 30 days

Moderna COVID-19 Vaccines Formulations
Monovalent 

Product

Bivalent 

Product

Authorized for ages 12 years and older 18 years and older

Vial cap color Red Dark blue

Label border color Light blue Gray

Dose (mRNA 

concentration)

100 mcg (primary dose) 50 mcg (booster dose)

(25 mcg original, 25 mcg Omicron BA.4/BA.5)

Injection volume 0.5 mL 0.5 mL

Dilution required No No

Beyond-use date 12 hours 12 hours

Storage Freezer (-15oC to -50oC) until 

expiration; Refrigerator (2oC 

to 8oC) up to 30 days

Freezer (-15oC to -50oC) until 

expiration; Refrigerator (2oC 

to 8oC) up to 30 days

Moderna COVID-19 Vaccines Formulations
Moderna Labels

Monovalent label 

Primary series only 

Ages 12 years and older

Bivalent label 

Booster dose only

Ages 18 years and older
Monovalent 

Product

Bivalent 

Product

Authorized for ages 6–11 years 18 years and older

Vial cap color Dark blue Dark blue

Label border color Purple Gray

Dose (mRNA 

concentration)

50 mcg (primary dose) 50 mcg (booster dose)

(25 mcg original, 25 mcg Omicron BA.4/BA.5)

Injection volume 0.5 mL 0.5 mL

Dilution required No No

Beyond-use date 12 hours 12 hours

Storage Freezer (-15oC to -50oC) until 

expiration; Refrigerator (2oC 

to 8oC) up to 30 days

Freezer (-15oC to -50oC) until 

expiration; Refrigerator (2oC 

to 8oC) up to 30 days

Moderna COVID-19 Vaccines Formulations
Moderna Labels

Monovalent label 

Primary series only

Ages 6–11 years

Bivalent label 

Booster dose only

Ages 18 years and older

Despite label, do NOT use for booster doses
Staying Up To Date

▪ CDC encourages people to “Stay up to date with your COVID-19 vaccines”.

▪ Staying up to date keeps people current with COVID-19 vaccine 

recommendations.

▪ You are up to date if you have completed a primary series and received the 

most recent booster dose recommended for you by CDC. 
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.