Novavax vs Pfizer Vaccines for COVID-19

(SHIELD Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Novavax

Disqualifiers: Other trials, Severe allergy, Recent vaccine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

660 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the impact of reactogenicity among health care workers and first responders receiving an updated 2024-25 Novavax COVID-19 vaccine as compared with those receiving an updated 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not have received a COVID-19 vaccine within 60 days of enrollment and should not plan to receive other vaccines within 7 days after the study vaccination.

What data supports the effectiveness of the Novavax and Pfizer COVID-19 vaccines?

The Novavax COVID-19 vaccine showed 90% effectiveness in preventing symptomatic COVID-19 and 100% effectiveness against hospitalization in a clinical trial. The Pfizer mRNA COVID-19 vaccine has been shown to be highly effective in preventing COVID-19 infection and hospitalization, with effectiveness varying depending on the variant of the virus. ^{1 2 3 4 5}

What safety data exists for the Novavax and Pfizer COVID-19 vaccines?

The Pfizer COVID-19 vaccine has been shown to be generally safe, with most reported side effects being mild, such as headaches and fatigue. Serious side effects are rare, but there have been reports of myocarditis (heart inflammation) and anaphylaxis (severe allergic reaction) after vaccination. The Novavax vaccine is not specifically mentioned in the provided research articles. ^{6 7 8 9 10}

How do the Novavax and Pfizer COVID-19 vaccines differ from other treatments?

The Novavax COVID-19 vaccine is unique because it is the first protein-based vaccine for COVID-19, while the Pfizer vaccine uses a novel messenger RNA (mRNA) technology. Protein-based vaccines like Novavax use harmless pieces of the virus to stimulate an immune response, whereas mRNA vaccines like Pfizer's teach cells to make a protein that triggers an immune response. ^{1 11 12 13 14}

Research Team

Sarang K Yoon, MOH

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for health care workers and first responders in the U.S. who are set to receive the updated 2024-25 COVID-19 vaccines. Specific eligibility criteria details were not provided, so it's unclear who exactly can or cannot participate.

Inclusion Criteria

I understand the study and can give my consent.

I am an adult who has received at least one COVID-19 vaccine in the last 4 years.

Health care workers or first responders who have direct face-to-face contact with patients

Exclusion Criteria

I plan to get other vaccines within a week after getting the study vaccine.

I have received a COVID-19 vaccine in the last 60 days.

Ongoing participation in other vaccine or investigational product trials within 90 days of study enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a single dose of either the 2024-25 Novavax or Pfizer-BioNTech mRNA COVID-19 vaccine

1 day

1 visit (in-person)

Post-vaccination Monitoring

Participants complete a post-vaccination questionnaire 48 hours after vaccine administration to report reactogenicity symptoms and impact on daily activities

2 days

Follow-up

Participants are monitored for safety and effectiveness after vaccination

4 weeks

Treatment Details

Interventions

• Novavax COVID-19 vaccine
• Pfizer mRNA COVID-19 vaccine

Trial Overview The study compares reactogenicity (how the body reacts immediately after vaccination) between those getting an updated Novavax protein subunit vaccine and those receiving an updated Pfizer mRNA vaccine for COVID-19.

Participant Groups

Group I: 2024-25 updated Novavax COVID-19 Active Control 1 Intervention

Participants will receive a single dose (0.5 ml) of study vaccine Novavax COVID-19 vaccine, 2024-2025 formula (JN.1 containing) in the deltoid muscle of the arm.

Group II: Pfizer mRNA COVID-19 Active Control 1 Intervention

Participants will receive a single dose (0.3 ml) of study vaccine Pfizer mRNA COVID-19 vaccine, 2024-2025 formula (KP.2 containing) in the deltoid muscle of the arm.

Who Is Running the Clinical Trial?

Novavax

Lead Sponsor

Trials

51

Recruited

111,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Findings from Research

In a study of over 1.8 million U.S. Veterans, mRNA-1273 (Moderna) showed a significantly lower risk of SARS-CoV-2 infection and related hospitalizations compared to BNT162b2 (Pfizer-BioNTech), with adjusted hazard ratios indicating a 26% and 37% reduced risk, respectively.

The differences in effectiveness were more pronounced during the Delta variant surge, suggesting that mRNA-1273 may offer better protection over time and against more transmissible variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Moderna versus Pfizer-BioNTech COVID-19 vaccine outcomes: A target trial emulation study in the U.S. Veterans Affairs healthcare system. Ioannou, GN., Locke, ER., Green, PK., et al.[2022]

A total of 604,157 adverse events (AEs) were reported for COVID-19 vaccines, with the Pfizer-BioNTech and Moderna vaccines accounting for the majority of reports, indicating a need for ongoing safety monitoring.

While most reported AEs were mild, serious outcomes like hospitalization and life-threatening events were noted, particularly among older adults with pre-existing conditions, highlighting the importance of careful surveillance of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021. Zou, C., Xue, X., Qian, J.[2022]

The NVX-CoV2373 COVID-19 vaccine demonstrated high efficacy rates of 89.7-90.4% in clinical trials, indicating it is effective in preventing COVID-19 in adults aged 18 and older.

The vaccine has an acceptable safety profile, with most adverse reactions being mild to moderate, and serious adverse events occurring at similar low rates in both NVX-CoV2373 and placebo groups, suggesting it is safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. Smith, K., Hegazy, K., Cai, MR., et al.[2023]

In a study of 19 internal medicine residents, the Pfizer-BioNTech COVID-19 vaccine was associated with a decrease in heart rate variability (HRV) after both doses, indicating a physiological response to vaccination.

Participants experienced an initial decrease in sleep duration following vaccination, which then increased over the following days, suggesting that sleep patterns may influence the body's response to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic Response to the Pfizer-BioNTech COVID-19 Vaccine Measured Using Wearable Devices: Prospective Observational Study. Hajduczok, AG., DiJoseph, KM., Bent, B., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of Moderna versus Pfizer-BioNTech COVID-19 vaccine outcomes: A target trial emulation study in the U.S. Veterans Affairs healthcare system. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

NVX-CoV2373 vaccine efficacy against hospitalization: A post hoc analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse reactions to the first and second doses of Pfizer-BioNTech COVID-19 vaccine among healthcare workers. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Antibody Response After Third Vaccination With mRNA-1273 or BNT162b2: Extension of a Randomized Controlled SARS-CoV-2 Noninferiority Vaccine Trial in Patients With Different Levels of Immunosuppression (COVERALL-2). [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Risk for Myocardial Infarction, Stroke, and Pulmonary Embolism Following COVID-19 Vaccines in Adults Younger Than 75 Years in France. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety Monitoring for Adverse Events Using Real-World Data. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Comparability of clinical trials and spontaneous reporting data regarding COVID-19 vaccine safety. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

Physiologic Response to the Pfizer-BioNTech COVID-19 Vaccine Measured Using Wearable Devices: Prospective Observational Study. [2021]

13. Spain pubmed.ncbi.nlm.nih.gov

[Reactogenicity Study of mRNA Vaccines Against COVID-19]. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Heterologous ChAdOx1/BNT162b2 vaccination induces stronger immune response than homologous ChAdOx1 vaccination: The pragmatic, multi-center, three-arm, partially randomized HEVACC trial. [2023]