Immunization

Dynavax plans to meet with the FDA to discuss how the company can provide additional data to support the approval of its 4-dose Heplisav-B regimen and expand protection for adults with end-stage renal disease (ESRD) on hemodialysis.

A recent study found that, of 423 participants who were initially low responders, 90% increased their antibody concentrations to more than 400 AU/mL.

WGc-043 is the first and only vaccine approved for this use.

The federal agency said the delay was due to administrative constraints and did not cite any vaccine safety, efficacy or quality issues.

The clinical manifestations of shingles can be divided into 3 phases.

Findings indicating that socioeconomic disparities widened gaps in vaccination timeliness signal the need for increased efforts to promote timely vaccination among children from families with lower income and those without private insurance.

The company’s investigational ABCWY vaccine candidate will be reviewed by the FDA by February 14, 2025.

Abrysvo is currently approved to treat RSV-associated lower respiratory tract disease in adults aged 60 years and older, and in infants through the immunization of pregnant individuals.

Following quality concerns voiced by the FDA regarding plastic syringes made in China, medical technology company BD has announced it will increase its production of plastic syringes in the US.

mRNA-1283 generated a stronger immune response against both the Omicron BA.4/BA.5 and the original virus strains of SARS-CoV-2 compared with Spikevax, Moderna’s licensed COVID-19 vaccine.

Posters presented at the APhA 2024 Annual Meeting and Exposition discussed pharmacist barriers in pediatric immunizations, a novel meningococcal vaccine, and the need for inpatient reviews of vaccination history.

The biotechnology company’s recombinant spike protein-based vaccine demonstrated an efficacy of 88% after 40 days, 82% after 120 days, and 77% after 180 days during the PREVENT-19 trial.

Moderna, Merck, and Pfizer-BioNTech are leading the charge with new vaccines for respiratory viruses in development.

See what's trending in pharmacy with a preview the Drug Topics March issue.

Since changes in vaccine composition can sometimes lead to confusion or misinformation, effective communication is crucial to promote vaccine uptake.

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Pfizer's RSV vaccine received FDA approval on May 31, 2023.

With over 3% of the world’s population affected by chronic hepatitis B, TherVacB has the potential to address a critical unmet need for a cure.

Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.

Drug Topics talked with Gregg Sylvester, MD, chief health officer and vice president of medical affairs at CSL Seqirus, about what we can learn from this unique situation to improve future vaccine development and distribution.

Patients with SCD are more vulnerable to hospitalization due, in part, to SCD’s impact on the spleen, which filters infections in the blood and is a crucial organ for the immune system.

The vaccine showed an overall efficacy of 80% in the per-protocol analysis, with a risk reduction of 6.1 typhoid infections per 1000 vaccinated children.

Approximately 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer in the United States per year are attributed to HPV.

Investigators noted that findings data should inform public health policy and reassure providers and expectant mothers.

Findings from a recent study showed that participants who watched a video discussing COVID-19 vaccination had significantly higher knowledge scores compared to those who did not watch it.

A new study found that switching from a primary national plan of egg-based vaccines to cell-based vaccines for the flu would significantly reduce the impact of the seasonal virus at a lesser production and distribution cost.

Study results found that maternal COVID-19 vaccination was safe from the perspective of infant neurodevelopment up to 18 months of age, addressing concerns about in utero vaccine exposure.

In 2023, the FDA approved six vaccines, including 2 for respiratory syncytial virus (RSV), and the first vaccine to prevent the mosquito-borne virus chikungunya.

A panel of clinicians gathered to address concerns and report preliminary findings around rates of RSV incidence, hospitalization, and vaccination.

Data has indicated a potential association between COVID-19 vaccination and menstruation, but there is little evidence about this association based on chart-reviewed medical record data.