ACIP Recommendations for Novavax COVID-19 Vaccine in Adults

Abstract and Introduction

Introduction

The NVX-CoV2373 (Novavax) COVID-19 vaccine is a recombinant spike (rS) protein nanoparticle vaccine with Matrix-M adjuvant to protect against infection with SARS-CoV-2, the virus that causes COVID-19. On July 13, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Novavax vaccine for primary COVID-19 immunization of unvaccinated adults aged ≥18 years, administered as 2 doses (5 μg rS and 50 μg Matrix-M adjuvant in each dose) 3 weeks apart.^[1] On July 19, 2022, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Novavax vaccine in persons aged ≥18 years for the prevention of COVID-19.* In the per-protocol^† efficacy analysis, vaccine efficacy (VE) against reverse transcription–polymerase chain reaction (RT-PCR)–confirmed symptomatic COVID-19 was 89.6% (95% CI = 82.4%–93.8%). The Alpha variant (B.1.1.7) of SARS-CoV-2 was the predominant circulating variant during the period of case accrual for VE assessments. Cases of myocarditis or pericarditis were reported in temporal association with vaccination, suggesting a possible causal relationship. The ACIP recommendation for the use of the Novavax COVID-19 vaccine is interim and will be updated as additional information becomes available. The adjuvanted, protein subunit-based Novavax COVID-19 vaccine provides an additional option for unvaccinated adults, increasing flexibility for the public and for vaccine providers. Vaccination is important for protection against COVID-19.

Since June 2020, ACIP has convened 31 public meetings to review data relevant to the epidemiology of COVID-19 and considerations for the use of COVID-19 vaccines, including the Novavax vaccine.^§ The ACIP COVID-19 Vaccines Work Group (Work Group), comprising experts in adult and pediatric medicine, infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings to review COVID-19 surveillance data, evidence for VE, postauthorization effectiveness, safety, and implementation considerations for COVID-19 vaccines. To guide its deliberations regarding recommendations for use of these vaccines, ACIP used the Evidence to Recommendation (EtR) Framework^¶ and incorporated a Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach**.^[2] Within the EtR Framework, ACIP considered the importance of COVID-19 as a public health problem, as well as population values and preferences, acceptability, feasibility, resource use, and equity regarding use of the Novavax COVID-19 vaccine among persons aged ≥18 years. After conducting systematic reviews of published and unpublished evidence for benefits and harms, the Work Group used the GRADE approach to independently assess the certainty of evidence for outcomes related to the Novavax COVID-19 vaccine, rated on a scale of type 1 (high certainty) to type 4 (very low certainty)^††.^[2] Work Group conclusions regarding evidence for use of the Novavax COVID-19 vaccine among persons aged ≥18 years were presented to ACIP at a public meeting on July 19, 2022.