Additional “Booster” Dose of COVID-19 Vaccine Found To be Safe

The NIAID-sponsored research study analyzed dose in adults fully vaccinated with any EUA or accepted COVID-19 vaccine.

According to preliminary clinical trial results reported in The New England Journal of Medicine, an extra dose of vaccine is safe for adults who had formerly received a complete regimen of any of three COVID-19 vaccines provided by the Emergency Use Authorization (EUA), or approved by the Food and Drug Administration (FDA). The extra dose triggered an immune response.

The discoveries worked as the basis for recommendations by the FDA and the Centers for Disease Control and Prevention in late autumn 2021 to allow mix-and-match COVID-19 booster vaccinations in the United States. Additional data from the in-progress Phase 1/2 trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are anticipated in the coming months.

The clinical trials for the booster dose

Consequently, the new report details discoveries from 458 adults totally vaccinated with any one of three EUA COVID-19 vaccines a minimum of 12 weeks prior to enrollment and had no reported history of SARS-CoV-2 infection. Each participant received a singular booster dose at enrollment: 150 received Janssen/Johnson & Johnson’s Ad26.COV2.S vaccine; 154 got Moderna’s mRNA-1273 vaccine; and 154 got Pfizer-BioNTech’s BNT162b2 vaccine. They used a different booster vaccine (heterologous or blended) or the very same (matched or homologous) as the initial vaccine depending on the initial vaccine regimen received by the participant.

The trial individuals kept diaries of any type of adverse effects. Over half of individuals reported headaches, pain at the injection site, muscle pains, and malaise. No vaccine-related severe harmful events were reported.

All combinations of primary and booster vaccines led to raised counteracting antibody levels (ranging from 4.2- to 76-fold higher levels than those found before boost.) Likewise, all primary-boost mixtures raised binding antibody levels 4.6- to 56-fold. For every primary EUA COVID-19 vaccine, an heterologous boosts generated comparable or higher antibody responses than responses to a homologous booster. Cellular responses (CD4 and CD8 T cell) similarly increased in all except the homologous Ad26.CoV2.S-boosted team. Though CD8+ T cells were highest at baseline in those individuals who had actually received the Ad26.CoV2.S EUA vaccine.

Taken combined, the investigators figured, “these data strongly imply that heterologous and homologous booster vaccine will raise protective efficacy against symptomatic SARS-CoV-2 infection.”

The investigation continues…

These interim results cover available immunogenicity information through the initial 29 days following booster vaccination. Investigators will follow individuals for one year to assess the effect of booster vaccination on longer-term immune responses. Other arms of the trial might test other investigational, EUA, or FDA-approved COVID-19 vaccines and/or vaccines based upon SARS-CoV-2 variants as the boosting vaccine.

The trial began in May 2021 and is continuing to sign up individuals. Its principal investigators are Robert L. Atmar, M.D., of Baylor College of Medicine, Houston; and Kirsten E. Lyke, M.D., of the University of Maryland School of Medicine, Baltimore. It is being performed through NIAID’s Infectious Diseases Clinical Research Consortium, a clinical trials network that incorporates the Institute’s longstanding Vaccine and Treatment Evaluation Units (VTEUs). More details about the trial, including a listing of trial sites signing up volunteers, is available at ClinicalTrials.gov using the identifier NCT04889209.

Read the original article on Scitech Daily.

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Reference: “Homologous and heterologous COVID-19 booster vaccinations” by RL Atmar et al., 26 January 2022, The New England Journal of Medicine.
DOI: 10.1056/NEJMoa2116414

NIAID grants supporting this research were UM1AI48372, UM1AI148373, UM1AI148450, UM1AI148452, UM1AI148573, UM1AI148574, UM1AI148575, UM1AI148576, UM1AI148684 and UM1AI148689. Contract 75N93019C00050 from the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) also provided support.