cdc.gov/coronavirus

Evidence to Recommendation Framework: 

Novavax COVID-19 Vaccine,

Adjuvanted in adults ages 18 years

and older

Evelyn Twentyman, MD, MPH

Advisory Committee on Immunization Practices

July 19, 2022
Mechanism of action of authorized COVID-19 vaccines

Source: https://www.who.int/docs/default-source/coronaviruse/risk-comms-updates/update73_covid-19-vaccines-and-immune-response.pdf?sfvrsn=7902cc35_5

mRNA

Pfizer-BioNTech and Moderna

COVID-19 vaccines

Protein subunit

Novavax COVID-19 

vaccine

Viral vector

Janssen/J&J COVID-19 vaccine
 Components of Novavax COVID-19 vaccine, 

Adjuvanted, include:

– SARS-CoV-2 recombinant spike (rS) protein is purified, 

full-length, and stabilized in its prefusion 

conformation

– Matrix-MTM adjuvant facilitates activation of the cells 

of the innate immune system, which enhances the 

magnitude of the spike protein-specific immune 

response

 These two vaccine components elicit

B- and T-cell immune responses to the spike 

protein, including neutralizing antibodies, 

which protect against COVID-19

Mechanism of action of the Novavax COVID-19 vaccine

Source: https://www.fda.gov/media/158914/download; https://www.who.int/docs/default-source/coronaviruse/risk-comms-updates/update73_covid-19-vaccines-and-immuneresponse.pdf?sfvrsn=7902cc35_5
 Should the Novavax COVID-19 vaccine (2 doses, 5μg antigen + 50μg 

Matrix-M adjuvant, IM, 21 days apart) be recommended for persons 

ages 18 years and older under an Emergency Use Authorization?

Policy question
Evidence to Recommendations (EtR) Framework:

PICO Question

5

Population People ages 18 years and older

Intervention Novavax COVID-19 vaccine NVX-CoV2373

(2 doses, 5μg antigen + 50μg Matrix-M adjuvant, IM, 21 days apart) 

Comparison No COVID-19 vaccine

Outcomes

Symptomatic lab-confirmed COVID-19 

Hospitalization due to COVID-19

Death due to COVID-19

Asymptomatic SARS-CoV-2 infection 

Serious adverse events 

Reactogenicity grade ≥3
Evidence to Recommendations (EtR) Framework

EtR Domain Question(s)

Public Health Problem • Is the problem of public health importance?

Benefits and Harms

• How substantial are the desirable anticipated effects?

• How substantial are the undesirable anticipated effects?

• Do the desirable effects outweigh the undesirable effects?

Values

• Does the target population feel the desirable effects are large relative to 

the undesirable effects?

• Is there important variability in how patients value the outcome?

Acceptability • Is the intervention acceptable to key stakeholders?

Feasibility • Is the intervention feasible to implement?

Equity • What would be the impact of the intervention on health equity?

“The intervention” = Novavax COVID-19 vaccine, given to adults ages 18 years and older

“The problem” = COVID-19 
EtR Domain: Public Health Problem
Trends in daily number of COVID-19 cases in the United States 

January 23, 2020—July 14, 2022

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed July 14, 2022 8

89,067,445 total cases
CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed July 15, 2022

In June 2022, 

unvaccinated people 

ages ≥5 years had 2.8X 

higher risk of testing 

positive for COVID-19 

compared to people 

vaccinated with at least 

a primary series

Age-adjusted rates of COVID-19 cases by vaccination status in persons 

ages 5 years and older, April 4, 2021−June 18, 2022 (31 U.S. Jurisdictions)
Weekly trends in rates of COVID-19-associated hospitalizations

— United States

Unified Hospital Dataset: https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions. Accessed July 13, 2022

August 1, 2020 – July 10, 2022
Age-adjusted rates of COVID-19-associated hospitalization by vaccination 

status in adults ages ≥18 years, January 2021–May 2022

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination Accessed July 11, 2022

In May 2022, 

unvaccinated adults ages 

≥18 years had 3.5X 

higher risk of

COVID-19-associated 

hospitalization compared 

to people who have 

received a primary series 

and ≥1 booster dose

Vertical dashed line indicates timepoint 

where 5% of adults ages ≥18 years had 

received primary series and ≥1 booster dose
Trends in daily number of COVID-19 deaths in the United States, 

January 23, 2020—July 14, 2022

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths Accessed July 13, 2022

*Per National Center for Health Statistics Death Certificate Data: Total number of COVID-19 total deaths as of July 13, 2022, were 1,015,431.

https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#AgeAndSex

12

1,018,578 total deaths
Rates of COVID-19 deaths by vaccination status in people aged 5+ 

years, April 4, 2021—May 28, 2022 (30 U.S. jurisdictions)

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed July 15, 2022 

In May 2022, 

unvaccinated people 

ages ≥5 years had 6X

higher risk of

dying from COVID19 compared to people 

who have received a 

primary series
Age-adjusted rates of COVID-19 deaths by vaccination status and receipt of 

booster dose,* September 19, 2021 – May 28, 2022 (29 U.S. Jurisdictions)

*This includes people who received booster doses and people who received additional doses.

Numbers and dashed lines reflect dates of CDC recommendations for booster doses for: 1. Pfizer-BioNTech recipients ages ≥65 years, in certain populations, or in high risk 

occupational or institutional settings, 2. Janssen recipients ages ≥18 years and Moderna recipients ages ≥65 years, in certain populations, or in high risk occupational or 

institutional settings, 3. all adults ≥18 years, 4. including adolescents 16-17 years, 5. all adolescents 12-17 years, 6. 2nd booster for adults ages ≥50 years and 

immunocompromised individuals.

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed July 15, 2022 

In May 2022, 

unvaccinated people 

ages ≥12 years had 9X 

higher risk of dying 

from COVID-19

compared to those with 

a completed primary 

series and a booster 

dose
Daily trends in doses of COVID-19 vaccine administered

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-trends Accessed July 18, 2022

December 14, 2020 – July 13, 2022

15
Primary series completion among adults ages 18 years and 

older, United States, as of July 13, 2022 

CDC COVID Data Tracker. COVID-19 Vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-count-total Accessed July 18, 2022
0

10

20

30

40

50

60

70

80

90

100

Dec

'20

Jan

'21

Feb

'21

Mar

'21

Apr

'21

May

'21

Jun

'21

Jul '21 Aug

'21

Sep

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Oct

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Nov

'21

Dec

'21

Jan

'22

Feb'

22

Mar

'22

Apr

'22

May

'22

Jun

'22

Jul '22

% Receiving ≥ 1 dose 

December 14, 2020 – July 13, 2022

Percent of people with at least one dose of COVID-19 

vaccine, by age and date administered, United States 

*The percent of the population coverage metrics are capped at 95%.

CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed July 18, 2022

Percent Receiving ≥1 dose

75+ years 95.0%

65-74 years 95.0%

50-64 years 93.7%

40-49 years 87.0%

25-39 years 80.7%

18-24 years 79.2%

17
 COVID-19 continues to pose a significant public health problem. COVID-19 

vaccines continue to mitigate cases, hospitalizations, and deaths.

– Unvaccinated people ages ≥5 years had 2.8X risk of testing positive compared to people 

vaccinated with at least a primary series in June 2022.

– Unvaccinated adults ages ≥18 years had 3.5X risk of COVID-19-associated hospitalization 

compared to people who have received a primary series and ≥1 booster dose in May 2022.

– In May 2022, unvaccinated people ages ≥5 years had 6.0X higher risk of dying from COVID19 than those who had completed a primary series, and unvaccinated people ages ≥12 

years had 9.0X higher risk of dying from COVID-19 compared to those with a booster dose.

 Not all people in the U.S. have received the benefits that COVID-19 vaccines provide. 

About 26–37 million US adults have not yet received a single dose of a COVID-19 

vaccine and would benefit from starting a primary series.

Public Health Problem

Summary 

18
Public Health Problem

Work Group Interpretation

Is COVID-19 disease among adults ages 18 years and older of 

public health importance?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Benefits and Harms
 Novavax phase III randomized controlled trial (RCT) (Dunkle 2022, additional data 

obtained from manufacturer)

 Persons ages ≥18 years in the United States and Mexico

 Data evaluated: Data cut-off September 27, 2021; median follow-up: 2.5 months

– Study enrollment and efficacy follow-up occurred during December 27, 2020, 

to September 27, 2021, and mainly when the Alpha variant of SARS-CoV-2 was 

predominant

 Full analysis set: 19,963 vaccine; 9,982 placebo

 Per-protocol set: 17,272 vaccine, 8,385 placebo

– No immunologic or virologic evidence of prior SARS-CoV-2 infection, no major 

protocol deviations

GRADE Evidence

21
Outcome 1: Symptomatic lab-confirmed COVID-19

Studies with unvaccinated comparator (n=1)

22

Population Events/Vaccinea

(n/N)

Events/Placeboa

(n/N)

Vaccine efficacy 

(95% CI)

Primary Outcomeb

Ages ≥18 years 17/17272 79/8385 89.6% (82.4%, 93.8%)

Ages 18–64 years 15/15228 75/7417 90.3% (83.1%, 94.4%)

Ages ≥65 years 2/2044 4/968 76.3% (-29.1%, 95.7%)

Any comorbidityc (18–64 years) 6/6957 38/3451 92.2% (81.5%, 96.7%)

Any comorbidityc (≥65 years) 1/1125 3/580 82.8% (-64.9%, 98.2%)

CI: confidence interval

a. 19,963 and 9,982 persons were randomized to vaccine and placebo

b. Cases diagnosed ≥7 days post dose 2 among persons without evidence of prior SARS-CoV-2 infection

c. Comorbidities: obesity, chronic kidney disease, chronic lung disease, cardiovascular disease, diabetes mellitus type 2
Outcome 1: Symptomatic lab-confirmed COVID-19

Studies with unvaccinated comparator (n=1)

23

Population Events/Vaccinea

(n/N)

Events/Placeboa

(n/N)

Vaccine efficacy 

(95% CI)

Primary Outcomeb

Ages ≥18 years 17/17272 79/8385 89.6% (82.4%, 93.8%)

Ages 18–64 years 15/15228 75/7417 90.3% (83.1%, 94.4%)

Ages ≥65 years 2/2044 4/968 76.3% (-29.1%, 95.7%)

Any comorbidityc (18–64 years) 6/6957 38/3451 92.2% (81.5%, 96.7%)

Any comorbidityc (≥65 years) 1/1125 3/580 82.8% (-64.9%, 98.2%)

a. 19,963 and 9,982 persons were randomized to vaccine and placebo

b. Cases diagnosed ≥7 days post dose 2 among persons without evidence of prior SARS-CoV-2 infection

c. Comorbidities: obesity, chronic kidney disease, chronic lung disease, cardiovascular disease, diabetes mellitus type 2

CI: confidence interval
Outcome 1: Symptomatic lab-confirmed COVID-19

Studies with unvaccinated comparator (n=1)

24

50-64 Yearsa ≥65 Years

Outcome N GMT

(95% CI) N GMT

(95% CI)

GMR

(95% CI)

Met 

Noninferiority 

Objectived

Neutralizing antibody 

level 

by microneutralization 

assayb,c

144 978.6 (770.5, 

1243.0) 358 899.8 (762.9, 

1061.3) 0.91 (0.68, 1.2) Yes

Abbreviations: GMT = geometric mean titer; GMR = geometric mean ratio; CI = confidence interval

a. Post-hoc efficacy analysis in this age group demonstrated a VE of 90.7% (72.9%, 96.8%).

b. Sampling time point was at 14 days after the second dose (day 35).

c. SARS-CoV-2 strain: Wuhan-Hu-1.

d. Confidence interval would have met usual noninferiority criterion as the lower bound of the 2-sided 95% CI for the 

GMR is greater than 0.67.

Immunobridging: Summary of Geometric Mean Ratio (GMR)
Outcome 1: Symptomatic lab-confirmed COVID-19

Studies with unvaccinated comparator (n=1) subgroup analysis

25

Population Events/Vaccinea

(n/N)

Events/Placeboa

(n/N)

Vaccine efficacy 

(95% CI)

Primary Outcomeb

Hispanic or Latino 9/3707 18/1801 75.7% (46.0%, 89.1%)

Not Hispanic or Latino 8/13526 61/6572 93.6% (86.7%, 96.9%)

White 13/13124 59/6350 89.3% (80.6%, 94.1%)

Black or African American 1/1881 8/947 93.7% (49.8%, 99.2%)

American Indian or Alaska 

Native

1/1068 6/522 91.9% (32.5%, 99%)

Asian 0/757 5/375 100%

a. 19,963 and 9,982 persons were randomized to vaccine and placebo

b. Cases diagnosed ≥7 days post dose 2 among persons without evidence of prior SARS-CoV-2 infection

CI: confidence interval
 Measures of effect

– Relative risk: 0.10 (0.06 to 0.18)

– Absolute risk: 848 fewer cases per 100,000 (from 886 fewer to 773 fewer)

 No serious concerns in certainty assessment

 Evidence type: High certainty (type 1)

GRADE: Symptomatic laboratory-confirmed COVID-19
 Novavax phase III randomized controlled trial (RCT) (Dunkle 2022, additional data 

obtained from sponsor)

 Data on severe illness due to COVID-19 per FDA guidance: COVID-19 case with ≥1 of 

following:

– Clinical signs at rest indicative of severe systemic illnessa

– Respiratory failurea

– Evidence of shocka

– Significant acute renal, hepatic, or neurologic dysfunction

– Admission to an intensive care unit

– Death 

 Hospitalizations among severe COVID-19 cases obtainedb

Outcome 2: Hospitalization due to COVID-19

Studies with unvaccinated comparator (n=1)

27

a. Severe systemic illness: respiratory rate ≥30, heart rate ≥125, SpO2 ≤93% on room air at sea level or PaO2/FiO2<300 mm Hg; respiratory failure: needing 

high-flow oxygen, noninvasive ventilation, mechanical ventilation, ECMO; evidence of shock: SBP <90 mm Hg, DBP <60 mm Hg, requiring vasopressors.

b. Source: FDA VRBPAC briefing document, FDA VRBPAC presentation slides
28

Outcome Study/population Events/Vaccine 

(n/N)

Events/Placebo 

(n/N)

Vaccine efficacy 

(95% CI)

Severe COVID-19 & 

hospitalizeda

No evidence of prior 

infection, ≥7 d post dose 2

0/17312 0/8140 NE

Severe COVID-19, 

protocol definitionb,c

No evidence of prior 

infection, ≥7 d post dose 2

0/17272 4/8385 100% 

a. Data cut-off September 27, 2021

b. Data cut-off June 1, 2021

c. Severe COVID-19, defined by FDA guidance: clinical signs at rest indicative of severe systemic illness; respiratory failure; 

evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death

CI: Confidence interval

Outcome 2: Hospitalization due to COVID-19

Studies with unvaccinated comparator (n=1)
 Measures of effecta

–Relative risk: 0.05 (0.00 to 1.00)

–Absolute risk: 45 fewer cases per 100,000 (from 48 fewer to 0 fewer)

 Serious concern for indirectness because severe COVID-19 is a surrogate 

for hospitalization due to COVID-19

 Serious concern for imprecision due to the small number of events

 Evidence type: Low certainty (type 3)

GRADE: Hospitalization due to COVID-19

Assessed with surrogate measure of severe COVID-19

a. Both relative and absolute measures of effect were calculated using a standard 0.5 offset due to no cases in the vaccine arm.
Outcome 6: Serious Adverse Events (SAE)a

Studies with unvaccinated comparator (n=1)

30

Study/populationb Events/Vaccine 

(n/N)

% SAE

Vaccine

Events/Placebo

(n/N)

% SAE

Placebo

Novavax , phase 3, 

unpublishedc

199 /19735d 1.0 108/9847 1.1

a. SAE is defined as death, life-threatening event, inpatient hospitalization or prolongation of existing 

hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life 

functions, important medical event, or congenital anomaly/birth defect.

b. Included all participants who received at least 1 dose of vaccine.

c. Proportion of participants who reported at least one SAE from dose 1 to primary analysis cut-off date (9/27/21)

d. Five participants in the vaccine arm experienced SAEs that were considered related to vaccination by the 

investigator (n=1 each of headache, angioedema, Basedow’s disease, thrombocytopenia, nervous system 

disorder). Among these, FDA considered the event of angioedema as potentially related to vaccination. There was 

one event of myocarditis in a 67-year-old male, with concomitant COVID-19 infection, 28 days after dose 1, which 

was not considered related to vaccination. Additional cases of myocarditis were observed after placebo crossover.
 Measures of effect

–Relative risk: 0.92 (0.73 to 1.16)

–Absolute risk: 88 fewer SAEs per 100,000 (from 296 fewer to 175 more)

 No serious concerns in the certainty assessment

 Evidence type: High certainty (type 1)

GRADE: Serious Adverse Events
Outcome 7: Reactogenicity, Severe (Grade ≥ 3)a,b

Studies with and without unvaccinated comparator (n=1)

32

Study/population Events/Vaccine 

(n/N)

% Vaccine Events/Placebo

(n/N)

% Placebo

Novavax , phase 3, 

unpublished

3048/18725 16.3 366/9237 4.0

a. Grade 3: prevents daily routine activity or requires use of a pain reliever. Grade 4: requires emergency room visit or 

hospitalization. There were 42 grade 4 systemic adverse reactions, 33 in vaccine group and 9 in placebo group. 

There were 6 grade 4 local adverse reactions, 5 in the vaccine group and 1 in the placebo group. 

b. Includes local and systemic events, grade ≥3.
 Measures of effect

– Relative risk: 4.11 (3.70 to 4.57)

– Absolute risk: 12,323 more per 100,000 (from 10,698 more to 14,146 more)

 No serious concerns in certainty assessment

 Evidence type: High certainty (type 1)

GRADE: Reactogenicity, Severe (Grade ≥3)
Summary of GRADE

34

OutcomeImportance Design

(# of studies)

FindingsEvidence

Type

Benefits

Symptomatic labconfirmed COVID-19

Critical RCT (1) Novavax COVID-19 vaccine is effective in preventing symptomatic COVID-19

 

during a period of Alpha variant predominance 1

Hospitalization due to 

COVID-19

Critical RCT (1) Severe COVID-19 evaluated as a surrogate for this critical outcome. Novavax 

COVID-19 vaccine is effective in preventing severe COVID-19. 3

Death due to COVID-19 Important RCT (1) No events occurred in the study included in the review of evidence. No 

events

Asymptomatic SARSCoV-2 infection Important No studies No systematically collected data on outcome not available in study included 

in the review of evidence. No data

Harms

Serious adverse eventsCritical RCT (1) SAEs were balanced between vaccine and placebo arms. 1

Reactogenicity Important RCT (1) Severe reactions were more common in vaccinated; any grade ≥3 reaction 

was reported by 16.3% of vaccinated vs. 4.0% of placebo group 1

Evidence type: 1=high; 2=moderate; 3=low; 4=very low
 Formal standard evaluation of efficacy, 

immunogenicity, and safety to inform 

vaccine recommendations through 

this explicit, evidence-based approach

 Pre-crossover period of a single 

randomized clinical trial based in the 

US and Mexico

– 2019nCoV-301

 Full analysis set: 19,963 vaccine; 9,982 

placebo

 Per protocol set: 17,272 vaccine, 8,385 

placebo

 Efficacy: observations regarding circulating 

variants; VE in the context of variants

 Safety: broad capture of outcomes across 

all vaccine recipients

– Pre- and post-crossover vaccine recipients of 2019-

nCoV301, plus adolescent and booster expansions of 

2019-nCoV301

– All vaccine recipients across all Novavax clinical trials 

globally:

• 2019nCoV-302

• 2019nCoV-501

• 2019nCoV-101

– Total vaccine recipients aged ≥16 years: 41,546

 Myocarditis and/or pericarditis:

– Broader safety set, plus consideration of publicly 

available global post-authorization data

Data Sources: Efficacy, Immunogenicity, and Safety

GRADE Evidence Additional Evidence to Inform EtR
 Vaccine efficacy in certain populations

– Lower VE in persons ages ≥65 years, with substantial uncertainty: 76.3% (-29.1%, 95.7%)

• Supportive post-hoc immunobridging would have met noninferiority criteria

– Lower VE in persons of Hispanic ethnicity: 75.7% (46.0%, 89.1%)

• No physiologic basis

 Vaccine efficacy against asymptomatic infection

– Not an outcome assessed in study 301

 Vaccine efficacy in the context of Omicron

– Case accrual for study 301 occurred in the period of Alpha predominance

 Vaccine efficacy for new SARS-CoV-2 variants inferred from antibody levels

– Clinical VE only known for Alpha variant; unknown how well antibody levels correlate to 

VE for additional variants

Remaining questions regarding vaccine efficacy

https://www.fda.gov/media/158912/download
 Of 96 cases accrued in 

the primary efficacy 

analysis, pre-crossover, 

December 20, 2020—

September 27, 2021, 

75 had sequence data*:

– 53% Alpha

– 11% Iota

– 7% Epsilon

– 4% Gamma

– 3% Beta

– 1% Delta

– 1% Kappa

– 1% Zeta

Novavax vaccine efficacy in study 301 was assessed during 

the period of Alpha predominance

*Novavax VRBPAC Briefing Document, June 7, 2022.

CDC COVID Data Tracker: Variant Proportions; Lambrou et al. Genomic Surveillance for SARS-CoV-2 Variants: Predominance of the Delta (B.1.617.2) and Omicron (B.1.1.529) 

Variants — United States, June 2021–January 2022 https://www.cdc.gov/mmwr/volumes/71/wr/mm7106a4.htm
Neutralizing activity for 2 doses of mRNA vaccine sera 

against SARS-CoV-2 variants from Alpha to Omicron

LOQ=Limit of quantitation. Zhou B, Davis T, Thornburg N, Wentworth D (CDC), in publication 38

Sera from 2-6 weeks after completing second dose of Moderna (10 sera) and Pfizer-BioNTech (10 sera) 

vaccines, tested with recombinant SARS-CoV-2 reporter viruses
0

10

20

30

40

50

60

70

80

90

100

Mar-21 Apr-21 May-21 Jun-21 Jul-21 Aug-21 Sep-21 Oct-21 Nov-21 Dec-21 Jan-22 Feb-22 Mar-22 Apr-22 May-22 Jun-22

Alpha Delta Omicron BA.1 Omicron BA.2/BA.2.12.1

Vaccine effectiveness for 2 doses of mRNA vaccines against 

COVID-19-associated hospitalization, by variant

Alpha estimates for Pfizer-BioNTech and Moderna separately from: Thompson et al. NEJM https://www.nejm.org/doi/full/10.1056/nejmoa2110362

Delta estimates for mRNA vaccines combined from: Thompson et al. MMWR https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e3.htm

Omicron estimates for mRNA vaccines combined from: Link-Gelles et al. MMWR https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e1.htm 39

Alpha Delta Omicron 

BA.1

Omicron

BA.2/BA.2.12.1
 Among 2684 participants seronegative at baseline, vaccine efficacy against 

symptomatic COVID-19 disease was 49.4% (6.1%, 72.8%)

 Among HIV negative participants who were seronegative at baseline, vaccine efficacy 

was 60.1% (19.9%, 80.1%)

 Of 41 sequenced isolates, 38 (92.7%) were Beta variant

 Post hoc vaccine efficacy against the Beta variant was 51.0% (-0.6%, 76.2%)

Novavax COVID-19 vaccine efficacy against the Beta 

(B.1.351) variant of SARS-CoV-2, South Africa, 2020—2021

Shinde et al. Efficacy of NVX-CoV2372 COVID-19 vaccine against the B.1.351 variant. NEJM 2021; 384:1899-1909.
 Several events of myocarditis and/or pericarditis with possible relationship to 

vaccine detected over the expanded safety data set of approximately 

41,546 vaccine recipients

 One event of angioedema in study 301

 One event of Guillian-Barré syndrome in study 302

Reviewing safety data to identify any serious adverse events 

with possible relationship to vaccine
 Intensive post-authorization COVID-19 vaccine surveillance has 

identified a small risk of myocarditis associated with mRNA 

vaccination, particularly after a second dose in adolescent 

males and young men1

 COVID-19 disease is associated with risk of myocarditis, 

pericarditis, stroke, acute coronary syndrome, myocardial 

infarction, heart failure, arrhythmia, and cardiac death2

Myocarditis/Pericarditis

1Oster et al. JAMA. 2022;327(4):331-340. doi:10.1001/jama.2021.24110; 

2 Basu-Ray I, Almaddah Nk, Adeboye A, et al. Cardiac Manifestations Of Coronavirus (COVID-19) StatPearls Publishing; 2022 Jan. https://www.ncbi.nlm.nih.gov/books/NBK556152/
 COVID-19 

vaccination is the 

best way to protect 

against COVID-19 

and rare cardiac 

complications1

Myocarditis and pericarditis: 

Benefits of COVID-19 vaccination outweigh risks

1 Block JP, Boehmer TK, Forrest CB, et al. Cardiac Complications After SARS-CoV-2 Infection and mRNA COVID-19 Vaccination — PCORnet, United States, January 2021–January 2022. MMWR 

Morb Mortal Wkly Rep 2022;71:517-523. DOI: http://dx.doi.org/10.15585/mmwr.mm7114e1.
VAERS reporting rates of myocarditis/pericarditis (per 1 

million doses administered) after mRNA vaccination*,†

Males Females

0–7 days 8–21 days 0–7 days 8–21 days

Age (yrs) Dose 1 Dose 2 Dose 1 Dose 2 Dose 1 Dose 2 Dose 1 Dose 2

18–24 4.2 38.9 1.1 2.2 0.6 4.0 0.2 0.7

25–29 1.8 15.2 0.4 1.1 0.4 3.5 0.2 0.0

30–39 1.9 7.5 0.4 0.8 0.6 0.9 0.3 0.2

40–49 0.5 3.3 0.2 0.5 0.4 1.6 0.2 0.2

*As of May 26, 2022; reports verified to meet case definition. 

†Bolded cells indicate that reporting rate exceeded estimated background incidence of myocarditis.

VAERS = Vaccine Adverse Event Reporting System

Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Presentation- COVID19- Update on Myocarditis following mRNA vaccination (fda.gov)
Myocarditis/pericarditis in VSD during the 0–7 day-risk 

interval among 18–39-year-olds after mRNA vaccination

Sex mRNA 

Vaccine 

Dose

Events in 

Risk 

Interval

Events in 

Comparison 

Interval*

Adjusted 

Rate 

Ratio†

95% 

Confidence 

Interval

2-sided p 

value

Excess Cases 

in Risk Period 

per Million 

Doses

Males Dose 1 11 18 2.10 0.86–4.97 0.101 5.1

Dose 2 59 11 14.51 7.54–29.88 <0.001 50.6

Females Dose 1 3 2 5.36 0.70–50.71 0.105 1.8

Dose 2 6 1 22.08 3.10–530.11 <0.001 4.4

*Comparison interval is 22-42 days after either dose

†Adjusted for VSD site, 5-year age group, sex, race/ethnicity, and calendar date

VSD =Vaccine Safety Datalink

Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Presentation- COVID19- Update on Myocarditis following mRNA vaccination (fda.gov)
 Total clinical safety database included a total of 41,546 vaccine recipients

 Four cases of myocarditis and/or pericarditis were identified as having a temporal 

relationship and lack of alternative etiology concerning for a causal relationship with vaccine:

– Male, age 16, myocarditis, with onset 2 days post dose 2. Peak troponin ~32,000 and treated with IVIG.

– Male, age 19, myocarditis, with onset 2 days post dose 2. Peak troponin ~7,800.

– Male, age 28, myocarditis vs. non-ST-elevation MI, with onset 3 days post dose 3. Peak troponin ~300.

– Female, age 60, pericarditis, with onset 8 days post dose 2. Troponin normal.

 All four hospitalized with serious events; all experienced complete clinical resolution

 Also identified across clinical trials:

– Male, age 20, pericarditis and myocarditis, 10 days post dose 1, with alternative explanation of streptococcal 

myocarditis. Normal troponin. No hospitalization.

– Male, age 67, myocarditis, 28 days post dose 1 with concomitant COVID-19 disease, considered unrelated to 

vaccine. Hospitalized. Peak troponin 5,329 + AKI.

– Female, age 31, myocarditis, 72 days post placebo dose 2 with alternative explanation, considered unrelated to 

placebo. Hospitalized. Peak troponin 330.

Myocarditis and pericarditis cases identified across Novavax 

clinical trials

FDA VRBPAC Briefing Document. June 7, 2022. https://www.fda.gov/media/158912/download
 As of April 30, 2022, a 

total of 744,235 doses1

of NVX vaccine had 

been administered 

post-authorization 

and/or approval in:

– Australia

– Canada

– European Union

– New Zealand

– South Korea

Myocarditis and pericarditis cases identified in post 

marketing safety data: Context

1 Lee L. FDA review of effectiveness and safety of Novavax COVID-19 vaccine in adults ≥18 years of age. June 7, 2022. https://www.fda.gov/media/159004/download

World map courtesy of the Nations Online Project: https://www.nationsonline.org/oneworld/map/world_map.htm
 35 unique reports including a total of 36 adverse events:

– 29 cases of pericarditis

• Including 5 reports in individuals with a history of pericarditis after mRNA 

vaccine

– 4 cases of myocarditis

– 2 cases of myopericarditis

– 1 case of carditis not otherwise specified

 Limited additional data available:

– Median known age was 34 years (range 23–62)

– Males n=20, females n=15

Myocarditis and pericarditis cases identified in 

post marketing safety data: Cases

Lee L. FDA review of effectiveness and safety of Novavax COVID-19 vaccine in adults ≥18 years of age. June 7 2022. https://www.fda.gov/media/159004/download; 

VRBPAC June 7, 2022 Briefing Document https://www.fda.gov/media/158912/download
Summary of cases of myocarditis and/or pericarditis following 

Novavax vaccination, doses administered & reporting rates

Setting Cases Doses administered Reporting rate** 

(cases/million doses 

administered)

Novavax COVID-19 Vaccine clinical trials1 4–6* 41,546 96–144

Sponsor submission of post-marketing reports in 

Australia, Canada, EU, New Zealand & South Korea2

36 744,235 48

Australia post-marketing reports3 15 160,000 94

1 Total expanded safety population approximated from FDA EUA Novavax Letter of Authorization July 13, 2022: Study 1 = 26,151; Study 2 ≈ 10,800; Study 3 + 4 ≈ 5500.

Precise denominators requested of the sponsor.

2 Lee L. FDA review of effectiveness and safety of Novavax COVID-19 vaccine in adults ≥18 years of age. June 7, 2022. https://www.fda.gov/media/159004/download. 3 https://www.tga.gov.au/periodic/covid-19-vaccine-safety-report-30-06-2022#section-1865. Of these 15 cases reported in Australia, 3 were likely to represent 

myocarditis; 12 were likely to represent pericarditis.

*Includes a 16-year-old vaccine recipient from the adolescent safety data set; 4 = cases in temporal relationship without alternative etiology, 5 = cases in temporal 

relationship, with or without alternative etiology, 6 = all cases in vaccine recipients in clinical trials, regardless of temporal relationship or alternative etiology

**Reporting rate calculated as: (# cases)/(# doses administered*1,000,000)
Warning: Myocarditis and Pericarditis: “Clinical trials data provide evidence for 

increased risks of myocarditis and pericarditis following administration of Novavax 

COVID-19 Vaccine, Adjuvanted”1

Recipients cautioned to tell the vaccination provider about all medical conditions, 

including “if you have had myocarditis (inflammation of the heart muscle) or 

pericarditis (inflammation of the lining outside the heart)”2

“Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the 

lining outside the heart) have occurred in some people who have received the vaccine. 

In most of these people, symptoms began within 10 days following vaccination. The 

chance of having this occur is very low. You should seek medical attention right away if 

you have any of the following symptoms after receiving the vaccine: Chest pain; 

Shortness of breath; Feelings of having a fast-beating, fluttering, or pounding heart”2

Myocarditis and pericarditis: 

FDA guidance in EUA Fact Sheets

1 FDA. EUA Novavax HCP Fact Sheet. July 13, 2022. https://www.fda.gov/media/159897/download

2 FDA. EUA Novavax Fact Sheet for Recipients and Caregivers. https://www.fda.gov/media/159898/download
 Novavax COVID-19 vaccine had high efficacy in setting of Alpha (B.1.1.7) variant

– Consistent with other authorized COVID-19 vaccines at that time

– Efficacy with recent SARS-CoV-2 variants unknown

– Reactogenicity reported after Novavax COVID-19 vaccine similar to what has been 

reported for other COVID-19 vaccine primary series

 Reports of myocarditis after Novavax COVID-19 vaccine during clinical trials and early 

post-authorization data

 Based on available data, cannot directly compare VE or myocarditis rates for 

Novavax and mRNA COVID-19 vaccines

– Post-authorization monitoring for both vaccine effectiveness and safety will be important

Benefits and Harms

Summary 

51
Benefits and Harms

How substantial are the desirable anticipated effects?

• How substantial are the anticipated effect for each main outcome for which 

there is a desirable effect?

o Minimal oSmall o Moderate oLarge oVaries o Don’t know
Benefits and Harms

How substantial are the undesirable anticipated effects?

• How substantial are the anticipated effect for each main outcome for which 

there is an undesirable effect?

o Minimal oSmall o Moderate oLarge oVaries o Don’t know
Benefits and Harms

Do the desirable effects outweigh the undesirable effects?

• What is the balance between the desirable effects relative to the 

undesirable effects?

oFavors intervention (Novavax COVID-19 vaccine)

oFavors comparison (no vaccine)

oFavors both

oFavors neither

oUnclear
EtR Domain: Values
 Survey designed to assess vaccination intentions for protein-based COVID vaccine 

with/without adjuvant among unvaccinated Americans

 Data collection period: January 27 – February 2, 2022

 Current unvaccinated sample (N = 541)

Survey of vaccination intent for a protein-based COVID 

vaccine among unvaccinated adults

NOTE: Weights based on population gender, age, and race/ethnicity will be created once data collection is complete 

CDC and University of Iowa/RAND survey, unpublished 

Partial or Unvaccinated 59% Female

41% Male or Other Gender 

Identity

43% 18-39 Years

39% 40-59 Years

18% 60+ Years

38% Non-Hispanic White

34% Non-Hispanic Black

28% Hispanic

GENDER AGE RACE/ETHNICITY
16% of unvaccinated respondents “probably” or “definitely” 

would get an adjuvanted protein-based COVID-19 vaccine

CDC and University of Iowa/RAND survey, unpublished 
52% of unvaccinated respondents “probably” or “definitely” 

would not get an adjuvanted protein-based COVID-19 

vaccine

CDC and University of Iowa/RAND survey, unpublished 
 Vaccination intentions were significantly higher among men (21.9%) than among 

women (11.9%)

 Vaccination intentions were significantly lower among non-Hispanic White adults 

(9.6%) than among non-Hispanic Black adults (20.1%) or among Hispanic adults 

(19.5%)

 Vaccine intentions did not vary by US region, metropolitan status, age, or education

Adjuvanted protein subunit vaccine intentions by 

demographic characteristics among unvaccinated adults, 

United States, January—February 2022

CDC and University of Iowa/RAND survey, unpublished
 Unvaccinated adults were asked if they would get a traditional protein-based COVID19 vaccine if one were authorized for use in the U.S.

Few unvaccinated adults are interested in traditional 

protein-based COVID-19 vaccines 

Survey conducted June 18-23, 2022, among a representative sample of 1,788 unvaccinated U.S. adults, with an unweighted margin of error of +/-2 percentage points.

Morning Consult. July 5, 2022. Novavax Protein-Based COVID Vaccine Survey. https://morningconsult.com/2022/07/05/novavax-protein-based-covid-vaccine-survey/ Accessed 

July 18, 2022

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Age 65+

Age 45-64

Age 35-44

Age 18-34

Hispanic adults

Black adults

White adults

Rural adults

Suburban adults

Urban adults

All adults

89%

79%

78%

71%

70%

61%

80%

78%

80%

70%

77%

5%

9%

9%

13%

14%

18%

8%

9%

9%

14%

10%

No, probably or definitely not

Yes, probably or definitely
 The share of unvaccinated adults who said the following are major reasons why they 

wouldn’t get a protein-based COVID-19 vaccine:

Side effects are top concern among unvaccinated adults 

who don’t want protein-based COVID-19 vaccines 

Survey conducted June 18-23, 2022, among a representative sample of 1,788 unvaccinated U.S. adults, with an unweighted margin of error of +/-2 percentage points.

Morning Consult. July 5, 2022. Novavax Protein-Based COVID Vaccine Survey. https://morningconsult.com/2022/07/05/novavax-protein-based-covid-vaccine-survey/

Accessed July 18, 2022

0% 10% 20% 30% 40% 50% 60% 70% 80%

Against vaccines more generally

The risk of getting COVID-19 is small

Don't trust the company making the vaccine

Don't think the vaccine will be effective

Worried the vaccine moved through clinical trials too fast

Concern about side effects

26%

31%

49%

51%

66%

72%
 U.S. adults were asked to what extent they view traditional protein-based and mRNA 

vaccines as safe:

Unvaccinated adults are less likely to view vaccines in 

general as safe 

Survey conducted June 18-23, 2022, among a representative sample of 1,788 unvaccinated U.S. adults, with an unweighted margin of error of +/-2 percentage points.

Morning Consult. July 5, 2022. Novavax Protein-Based COVID Vaccine Survey. https://morningconsult.com/2022/07/05/novavax-protein-based-covid-vaccine-survey/ Accessed 

July 18, 2022
 When asked in early 2022, 16% of unvaccinated respondents “probably” or “definitely” 

would get an adjuvanted protein-based COVID-19 vaccine

– However, 52% of unvaccinated respondents “probably” or “definitely” would not get an adjuvanted 

protein-based COVID-19 vaccine

 There were no significant differences in vaccination intentions by US region, 

metropolitan status, age group and education

– However, vaccination intentions were significantly lower for females than males and adjuvanted vaccination 

intentions were significantly lower for non-Hispanic White adults 

 77% of unvaccinated adults said they wouldn’t get a traditional protein-based COVID-19 

shot if one were authorized for use in the United States1

 Among unvaccinated adults, 28% said they view traditional protein-based vaccines as 

safe, compared with 17% who said mRNA shots are safe1

Values

Summary

1. Morning Consult. July 5, 2022. Novavax Protein-Based COVID Vaccine Survey. https://morningconsult.com/2022/07/05/novavax-protein-based-covid-vaccine-survey/

Accessed July 18, 2022
Values

Criteria 1:

Does the target population feel that the desirable effects are large relative to 

undesirable effects?

• How does the target population view the balance of desirable versus undesirable 

effects? 

• Would patients/caregivers feel that the benefits outweigh the harms and burden?

• Does the population appreciate and value the Novavax COVID-19 vaccine?

o Minimal o Small o Moderate o Large oVaries o Don’t know
Values

oImportant uncertainty or variability

oProbably important uncertainty or variability

oProbably not important uncertainty or variability

oNo important uncertainty or variability

oNo known undesirable outcomes

Criteria 2:

Is there important uncertainty about, or variability in, how much people value 

the main outcomes?

• How much do individuals value each outcome in relation to the other outcomes?

• Is there evidence to support those value judgements?

• Is there evidence that the variability is large enough to lead to different decisions?
EtR Domain: Acceptability
 Percent of adults who say they have a great deal or a fair amount of trust in the 

following to provide reliable information about COVID-19 vaccines: 

Personal doctors are most trusted for COVID-19 vaccine 

information 

*Among those who are parents or guardians of children under 18. **Among those who are employed and not self-employed. ***Among those who are insured. 

The survey was conducted April 13-26, 2022, among a nationally representative random digit dial telephone sample of 1,889 adults ages 18 and older. 

KFF COVID-19 Vaccine Monitor (April 13-26, 2022). https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2022/ Accessed July 7, 2022

54%

62%

64%

68%

73%

77%

83%

85%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

Their state government officials

The FDA

The CDC

Their local public health department

Their health insurance company***

Their employer**

Their child's pediatrician*

Their own doctor

Trust in COVID-19 Vaccine Information

Total (%)
 CDC works with national, state, tribal, territorial, local, and community partners to 

promote COVID-19 vaccination. To support these partnerships, CDC has provided 

funding for organizations, which includes:

– $3 billion awarded to 64 jurisdictions to support local health departments and community-based organizations 

in launching new programs and initiatives to increase vaccine access, acceptance, and uptake in communities 

disproportionately impacted by COVID-19

– $2.25 billion awarded to health departments across the United States and its territories to work in 

collaboration with community partners to support efforts to address COVID-19 health disparities

– $348 million to organizations for community health worker (CHW) services to support COVID-19 prevention 

and control, and $32 million to organizations for CHW services to support training, technical assistance, and 

evaluation, all funded through the CDC’s Community Health Workers for COVID Response and Resilient 

Communities initiative

 CDC also works with the Federal Retail Pharmacy Program to conduct communitybased activities and use data to ensure COVID-19 vaccines are accessible in all 

communities

CDC partnerships and funding for COVID-19 vaccines

CDC. COVID-19 Vaccine Equity for Racial and Ethnic Minority Groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html

Accessed July 7, 2022
 Most participants would order Novavax 

COVID-19 vaccine, if it were available 

 Participants expressed high interest in 

support related to Novavax, including: 

– Storage and handling information

– Estimated ordering quantities ahead of time

– Talking points/communications packages

 Intent of use varied substantially, 

including: 

– Private provider offices

– Pharmacies

– Local health departments

– All of the above

0%

10%

20%

30%

40%

50%

60%

70%

80%

Yes (19/26) No (0/26) Unsure (7/26)

“Would you order Novavax, if available?” 

Impressions from a jurisdictional partner listening session, 

26 jurisdictions present: July 7, 2022
 The majority of adults (85%) trust their own doctors to provide reliable 

information about COVID-19 vaccines

 CDC works with national, state, tribal, territorial, local, and community 

partners to promote COVID-19 vaccination in addition to the provision of 

funding for organizations to increase vaccine access, acceptance, and uptake in 

communities disproportionately impacted by COVID-19

 As with other COVID-19 vaccines, Novavax COVID-19 Vaccine is likely to be 

acceptable to implementing partners 

Acceptability

Summary
Acceptability

Is the Novavax COVID-19 vaccine acceptable to key stakeholders?

• Are there key stakeholders that would not accept the distribution of benefits 

and harms? 

• Are there key stakeholders that would not accept the undesirable effects in 

the short term for the desirable effects (benefits) in the future?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Feasibility
 Barriers to implementation may include:

– Complexity of recommendations

– Vaccine storage and handling requirements

– Financial barriers

– Supply barriers

Feasibility of vaccine implementation 

73
 Novavax EUA

– Primary series for individuals ages 18+ years

 Moderna EUA

– Primary series for individuals ages 6 months 

through 17 years 

– Third primary series dose for individuals ages 6 

months and older that are immunocompromised

– First booster dose for individuals 18+

– Heterologous booster dose for individuals 18 

years and older who have completed primary 

vaccination with another COVID-19 vaccine

– Second booster dose for individuals 50+

– Second booster dose for individuals 18+ who are 

immunocompromised 

 Pfizer EUA

– Primary series for individuals ages 6 months 

through 11 years 

– Third primary series dose for individuals ages 5 

years and older who are immunocompromised 

– First booster for people 5 years and older 

– Heterologous booster for people 18 years and 

older who have completed primary vaccination 

with another COVID-19 vaccine

– Second booster dose for individuals 50+

– Second booster dose for individuals 18+ who are 

immunocompromised 

 Janssen EUA

– Singe primary dose

– Single booster dose

– Heterologous booster dose following completion 

of another COVID-19 vaccine 

Complexity of recommendations

The Novavax COVID-19 vaccine will be the fourth COVID-19 vaccine with an Emergency Use Authorization (EUA) 
 The Novavax COVID-19 Vaccine, Adjuvanted is supplied in a carton containing 10

multiple-dose vials

 Each multiple-dose vial contains a maximum of 10 doses of 0.5 mL each

 Store unpunctured multi-dose vials of the Novavax COVID-19 vaccine, Adjuvanted in 

a standard refrigerator at 36–46°F (2–8°C)

– The vial should be stored in the original carton to protect from light

– DO NOT FREEZE

 After the first needle puncture, store the vial at 36–77°F (2–25°C) for up to 6 hours

 Discard the vial if the vaccine is not used within 6 hours after first puncture

 The vaccine is preservative free and does not require reconstitution or dilution

Vaccine storage and handling requirements 

Novavax HCP Fact Sheet 07132022 (fda.gov). Accessed July 14, 2022
Additional storage and handling requirements 

 The Novavax COVID-19 vaccine, Adjuvanted 

vial and carton do not have an expiration 

date

 To find the expiration date, access 

www.NovavaxCovidVaccine.com, navigate to 

the United States Healthcare Professional 

section of the website, and enter the lot 

number printed on the carton or vial into 

the “Expiry Date Checker” tool1

1 CDC. Novavax COVID-19 Vaccine Adjuvanted FAQs for CDC. 

2 Drugs.com. COVID-19 Vaccine Novavax. https://www.drugs.com/pro/covid-19-vaccine-novavax.html Accessed July 7, 2022

Novavax Label2
77

 All COVID-19 vaccines will be provided to U.S. population free of charge

 Health systems or health departments incur costs for vaccine implementation, 

clinics, outreach, and education

 Financial hardship may arise if vaccine recipients need to take time off to 

receive the vaccine or experience post-vaccination reactogenicity that 

prevents them from working

Financial barriers
 As of July 13, 2022, over 599 million doses of COVID-19 vaccine have been 

administered in the United States, demonstrating that vaccine per se is 

demonstrably feasible to implement broadly1

 Purchase of Novavax COVID-19 vaccine includes 3.2 million doses to date, with 

intent to distribute following ACIP recommendation, if indeed recommended

Supply barriers

1 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed July 18, 2022.
 Relative logistical advantages of Novavax 

COVID-19 vaccine

– Easy storage: standard refrigerator; 36–46○F

– Familiar schedule: 2 primary doses, 3–8 

weeks apart

– Easy preparation: no diluent

 Relative logistical disadvantages of 

Novavax COVID-19 vaccine

– Short seal beyond use date (BUD) time: 

Vial to be discarded if the vaccine is not 

used with 6 hours after first puncture

• Additionally, no recommendations for 

any unrefrigerated storage prior to 

puncture

– 10 dose packaging

• As it is currently only authorized 

for use as primary series, possibility 

for increased wastage

– Product less familiar for providers

Novavax COVID-19 vaccine: qualitative logistical 

comparisons with current COVID-19 vaccines
 The Novavax COVID-19 vaccine will be the fourth COVID-19 vaccine with an EUA

 All COVID-19 vaccines will be provided to U.S. population free of charge

 As of July 13, 2022, over 599 million doses of COVID-19 vaccine have been 

administered in the United States

– 3.2 million doses of Novavax COVID-19 vaccine purchased currently

 Relative logistical advantages of Novavax COVID-19 vaccine – Easy storage: standard refrigerator; 36–46○F

– Familiar schedule: 2 primary doses, 3–8 weeks apart

– Easy preparation: no diluent

 Relative logistical disadvantages of Novavax COVID-19 vaccine – Vial to be discarded if the vaccine is not used within 6 hours after first puncture

– 10 dose packaging (possibility for increased wastage)

– Product less familiar to providers

Feasibility

Summary 

1 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed July 13, 2022.
Feasibility

Is the Novavax COVID-19 vaccine feasible to

implement among adults ages 18 years and older?

• Is the Novavax COVID-19 vaccine program sustainable?

• Are there barriers that are likely to limit the feasibility of implementing the 

Novavax COVID-19 vaccine or require considerations when implementing it? 

• Is access to Novavax COVID-19 vaccine an important concern?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain: Equity
 Disparities in COVID-19 outcomes are both a manifestation of longstanding inequities 

and a contributor to continued and future inequities

 We need to do everything we can to reduce health inequities – this is fundamental to 

our mission in public health

 No single vaccine has the ability to overcome all disparities

– Neither the vaccine under discussion today, nor any other single vaccine

 We will discuss several issues related to vaccine equity and health equity in this 

section

– It is critical to continue to investigate persistent health inequities and do everything in our power to 

resolve them

– Any inequity in COVID-19 vaccine access or use has the potential to further exacerbate disparities in 

COVID-19 disease impact

Equity: a consideration of fundamental importance

https://www.cdc.gov/media/releases/2021/s0408-racism-health.html; https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/vaccine-equity.html
Rate ratios 

compared to 

White, NonHispanic persons

American Indian or 

Alaska Native, NonHispanic persons

Asian, NonHispanic persons

Black or African 

American, NonHispanic persons

Hispanic or Latino 

persons

Cases1 1.5x 0.8x 1.1x 1.5x

Hospitalization2 3.0x 0.8x 2.3x 2.2x

Death3, 4 2.1x 0.8x 1.7x 1.8x

Risk for COVID-19 infection, hospitalization, and death by 

race/ethnicity, age-adjusted

1 Data source: Data reported by state and territorial jurisdictions (accessed June 22, 2022). Numbers are ratios of age-adjusted rates standardized to the 2019 U.S. intercensal population estimate. Calculations 

use only the 66% of case reports that have race and ethnicity; this can result in inaccurate estimates of the relative risk among groups.

2 Data source: COVID-NET (March 1, 2020 through June 11, 2022). Numbers are ratios of age-adjusted rates standardized to the 2020 US standard COVID-NET catchment population. Starting the week ending 

12/4/2021, Maryland temporarily halted data transmission of COVID-19 associated hospitalizations, impacting COVID-NET age-adjusted and cumulative rate calculations. Hospitalization rates are likely 

underestimated (link). As of June 11, 2022, this situation remains unchanged.

3 Data source: National Center for Health Statistics provisional death counts (https://data.cdc.gov/NCHS/Provisional-Death-Counts-for-Coronavirus-Disease-C/pj7m-y5uh, data through May 29, 2022). Numbers 

are ratios of age-adjusted rates standardized to the 2019 U.S. intercensal population estimate.

4 Data on COVID-19 deaths comes from the National Vital Statistics System (NVSS). The NVSS COVID-19 surveillance webpages and data file updates are paused between June 6, 2022 through June 21, 2022. 

COVID-19 data updates are expected to resume on June 22, 2022.

https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html. Updated June 24, 2022 and accessed July 14, 2022. 

Race and ethnicity are risk markers for other underlying conditions that affect health, including 

socioeconomic status, access to health care, and exposure to the virus related to occupation, e.g., 

frontline, essential, and critical infrastructure workers.
95% Confidence intervals shown by error bars

Source: COVIDVaxView. Estimates produced by NORC at the University of Chicago using CDC’s National Immunization Survey-Adult COVID-19 Module (NIS-ACM). 

https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html. Accessed July 14, 2022

2.1

12.8

14.2

14.3

14.7

20.6

22.1

0 5 10 15 20 25 30

Asian, non-Hispanic

Black, non-Hispanic

White, non-Hispanic

Hispanic

Native Hawaiian/Pacific Islander, non-Hispanic

American Indian/Alaska Native, non-Hispanic

Other or multiple races, non-Hispanic

Percent of U.S. adults not yet receiving a COVID-19 vaccine by 

race/ethnicity — May 1–28, 2022
95% Confidence intervals shown by error bars

Source: COVIDVaxView. Estimates produced by NORC at the University of Chicago using CDC’s National Immunization Survey-Adult COVID-19 Module (NIS-ACM). 

https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html. Accessed July 14, 2022

12.0

12.9

22.1

0 10 20 30 40

Urban

Suburban

Rural

Percent of U.S. adults not yet receiving a COVID-19 vaccine by 

metropolitan statistical area — May 1–28, 2022
95% Confidence intervals shown by error bars

Source: COVIDVaxView. Estimates produced by NORC at the University of Chicago using CDC’s National Immunization Survey-Adult COVID-19 Module (NIS-ACM). 

https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html. Accessed July 14, 2022

15.8

9.8

15.1

19.9

0 5 10 15 20 25 30 35 40

Unknown income

Above poverty, income ≥$75k

Above poverty, income <$75k

Below poverty

Percent of U.S. adults not yet receiving a COVID-19 vaccine by 

income and poverty status — May 1–28, 2022
12.0

31.9

11.3

23.5

0 5 10 15 20 25 30 35 40

Insured

Not insured

Yes

No

95% Confidence intervals shown by error bars

Source: COVIDVaxView. Estimates produced by NORC at the University of Chicago using CDC’s National Immunization Survey-Adult COVID-19 Module (NIS-ACM). 

https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html. Accessed July 14, 2022

Health insurance status

Have a regular physician or provider for primary

care

Percent of U.S. adults not yet receiving a COVID-19 vaccine by 

markers of access to health care— May 1–28, 2022
 According to the December 2021 U.S. Census Bureau Household Pulse Survey (HPS), 

adults who had not received any doses of the COVID vaccine differed from those 

who had received at least one dose of a COVID vaccine across several measures

– Younger

– Lower levels of education

– More likely to be non-White

– Less likely to be married

– More economically disadvantaged

– More likely to report a disability

U.S. Census Bureau Household Pulse Survey (HPS)

United States Census Bureau. Who Are the Adults Not Vaccinated Against COVID? https://www.census.gov/library/stories/2021/12/who-are-the-adults-not-vaccinatedagainst-covid.html Accessed February 24, 2022
 Through the Partnering for Vaccine Equity program and broader adult immunization 

efforts, CDC aims to improve equity in adult immunization across disproportionately 

affected populations, including racial and ethnic minority groups, through 

partnerships that drive community-level action.

 The partner network includes:

Equity in adult vaccination: partnering for vaccine equity 

CDC Vaccines & Immunizations. Equity in Adult Vaccination. https://www.cdc.gov/vaccines/health-equity/index.html Accessed July 1, 2022 
 Individuals can visit the Partnering for Vaccine Equity’s Home | Vaccine Resource Hub

to access hundreds of free and accurate educational materials to support COVID-19 

vaccination in their community

Additional resources 

CDC Vaccines & Immunizations. Equity in Adult Vaccination. https://www.cdc.gov/vaccines/health-equity/index.html Accessed July 1, 2022 
 There are noted disparities in COVID-19 cases, hospitalizations and mortality 

rates by race and ethnicity

 Vaccination status differs by age, level of education and race and ethnicity

 An additional COVID-19 vaccine, utilizing traditional vaccine technology, will 

provide an additional option for unvaccinated individuals

 Improving vaccine equity requires continued efforts

– National, state, local and community-level partners are focused on diverse endeavors to 

improve equity in adult immunizations among disproportionately affected populations

Equity

Summary
Equity

What would be the impact of the Novavax COVID-19 vaccine 

among adults ages 18 years and older on health equity?

• Are there groups or settings that might be disadvantaged in relation to 

COVID-19 disease burden or receipt of the Novavax COVID-19 vaccine?

• Are there considerations that should be made when implementing the 

Novavax COVID-19 vaccine program to ensure that inequities are reduced 

whenever possible, and that they are not increased?

o Reduced o Probably reduced oProbably no impact

o Probably increased o Increased oVaries o Don’t know
Summary 
95

EtR DomainQuestionWork Group Judgments

Public Health 

Problem

Is COVID-19 of public health importance?Yes

Benefits and 

Harms

How substantial are the desirable anticipated effects? Large

How substantial are the undesirable anticipated effects? Small

Do the desirable effects outweigh the undesirable effects? Favors intervention

What is the overall certainty of the evidence for the critical 

outcomes?

1 (high) for prevention of 

symptomatic COVID-19

3 (low) for hospitalization

1 (high) for SAEs

Values

Does the target population feel the desirable effects are large 

relative to the undesirable effects?

Varies

Is there important variability in how patients value the outcomes? Probably important uncertainty 

or variability 

Acceptability

Is the Novavax COVID-19 vaccine acceptable to key stakeholders?Probably yes

Feasibility

Is the Novavax COVID-19 vaccine feasible to implement?Yes

Resource Use

Is Novavax COVID-19 vaccine a reasonable and efficient allocation of 

resources?

N/A

Equity

What would be the impact of the intervention on health equity?Probably no impact 
 Novavax COVID-19 vaccine had high efficacy against symptomatic COVID-19 

disease in setting of Alpha predominance 

 Reports of myocarditis after Novavax COVID-19 vaccine during clinical trial and 

early post-authorization data 

 Based on available data, cannot directly compare VE or myocarditis rates for 

Novavax and mRNA COVID-19 vaccines

– Post-authorization monitoring for both vaccine effectiveness and safety will be important

 Vaccination remains the best way to protect against SARS-CoV-2 and rare 

cardiac risks of COVID-19 disease 

Work Group interpretation
 As always, the top priority remains vaccination of unvaccinated individuals

 An additional COVID-19 vaccine, utilizing traditional vaccine technology, will 

provide an additional option for unvaccinated individuals

 Overall, benefits of Novavax COVID-19 vaccine outweigh risks

Work Group interpretation
98

Evidence to Recommendations Framework

Summary: Work Group Interpretations

Balance of 

consequences

Undesirable 

consequences 

clearly 

outweigh 

desirable 

consequences 

in most 

settings

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences 

in most 

settings

The balance 

between 

desirable and 

undesirable 

consequences 

is closely 

balanced or 

uncertain

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences 

in most 

settings

Desirable 

consequences 

clearly 

outweigh 

undesirable 

consequences 

in most 

settings

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences
99

Evidence to Recommendations Framework

Summary: Work Group Interpretations

Type of 

recommendation

We do not recommend 

the intervention

We recommend the 

intervention for individuals 

based on shared clinical 

decision-making

We recommend the 

intervention 
For primary series vaccination:

mRNA COVID-19 vaccines (i.e., Moderna and Pfizer-BioNTech) and Novavax 

COVID-19 vaccines are recommended

For booster vaccination:

mRNA vaccines are recommended

Novavax COVID-19 vaccines are not currently authorized for booster doses

No current COVID-19 vaccines are currently authorized for booster dose use 

in Novavax COVID-19 vaccine primary series recipients

Janssen COVID-19 vaccine should only be used in limited situations1

COVID-19 vaccine recommendations

1Details provided in Interim Clinical Considerations: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#covid-vaccines
 Monica Godfrey

 Sara Oliver

 Megan Wallace

 Hannah Rosenblum

 Katherine Fleming-Dutra

 Lauren Roper

 Joy Hsu

 Danielle Moulia

 Sarah Meyer

 Tara Anderson

 Amy Rubis

 Roodly Archer

 Susan Goldstein

 Mary Chamberland

 Elisha Hall

 Valerie Morelli

 JoEllen Wolicki

 Meg Freedman

 Heather Scobie

 Ruth Link-Gelles

 Sierra Scarbrough

 Jefferson Jones

 Stephen Hadler

 Eddie Shanley

 Epi Task Force

 Data Analytics and Visualization Task Force

 Respiratory Viruses Branch

 National Center for Immunization and Respiratory 

Diseases

Acknowledgments
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.

Thank you
A two-dose Novavax COVID-19 vaccine, adjuvanted is recommended as a

COVID-19 vaccine primary series for persons ages 18 years and older

under the EUA issued by FDA

ACIP Vote

Interim Recommendation