2- Tuesday Pharmacy Practice News – 28th December

 1 – Study Assessing Pfizer-BioNTech COVID-19 Vaccine in Children Aged 6 Months to Under 5 Years Will Continue, Assess a Third Dose

• Based on the trial results, investigators in the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months to under 5 years explained that their research will continue with new changes.
• According to a press release, the study will now include an evaluation of a third dose of 3 µg at least 2 months after the second dose of the 2-dose series to provide high levels of protection in the younger age groups.
• A pre-specified immunogenicity analysis was conducted on the subset of the study population 1 month following the second dose.
• In comparison to the 16- to 25-year-old population, where high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population, but not for the 2- to under-5-year-old population.
• Additionally, no safety concerns were identified and the 3 µg dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.

Source: Pharmacy Times

2 – Ferric Carboxymaltose Injection Receives FDA Approval for Pediatric Patients With Iron Deficiency Anemia

• The FDA has approved ferric carboxymaltose injection for the treatment of children aged 1 year or older with iron deficiency anemia who are intolerant to oral iron or who have had an unsatisfactory response to oral iron.
• The treatment was first approved in 2013 for adults as a 1500 mg course of treatment, administered as 2 doses of 750 mg each, separated by at least 7 days.
• For all patients weighing less than 50 kg, the recommended dosage is 15 mg/ per kg of body weight intravenously in 2 doses separated by at least 7 days.
• In 2 randomized clinical studies, a total of 1775 patients were exposed to ferric carboxymaltose injection. Adverse effects (AEs) reported in 2% or more of patients treated with ferric carboxymaltose injection.

Source: Pharmacy Times

3 – Certain Patients With Blood Disorders Do Not Produce Antibodies Following COVID-19 Vaccination

• Approximately 15% of people with blood cancers and other blood disorders had no vaccination-related antibodies after receiving a COVID-19 vaccine, according to a study
• The investigators said that although it was encouraging that 85% of participants did have a measurable antibody response, the findings suggest that additional precautions may be warranted to prevent COVID-19 infection among people with blood disorders
• The study examined antibody levels following COVID-19 vaccination in patients with blood disorders, including lymphoid and myeloid neoplasms, autoimmune disorders, and non-cancerous disorders of blood or immune cells.
• The study data suggest patients with lymphoma and those currently receiving treatment are the least likely to develop antibodies in response to a COVID-19 vaccine, according to the researchers.

Source: Pharmacy Times

4- Moderna COVID-19 Vaccine Effective Against Viral Variants, Delta Protection Wanes Over Time

• Two doses of the Moderna COVID-19 vaccine were highly effective against all SARS-CoV-2 variants, according to a study published in The British Medical Journal. However, the vaccine’s efficacy against the Delta variant moderately declined over time following vaccination.
• While this study provides reassuring evidence of the effectiveness of 2 doses of Moderna COVID-19 vaccine in preventing COVID-19 infection and hospitalization due to variants including delta, it also has implications for booster shots.
• The findings of moderately reduced vaccine effectiveness of Moderna COVID-19 vaccine over time against Delta infection supports current booster dose recommendations.

Source: Pharmacy Times

5 – Phase 3 Trial to Evaluate IVIG, Aspirin, Prednisolone Combination Therapy in Patients With Kawasaki Disease

• Investigators are currently recruiting for the first multicenter randomized controlled trial to evaluate the efficacy of the combination therapy intravenous immunoglobulin (IVIG) plus aspirin plus prednisolone in Chinese pediatric patients with Kawasaki disease (KD), according to an article published in Trials.
• The study is designed to provide high-level evidence for improving the initial treatment for acute KD.
• According to the investigators, corticosteroids are controversial in the treatment of KD.
• Early meta-analysis indicated that the use of corticosteroids in aspirin-containing regimens for the primary treatment of KD could reduce the incidence of coronary aneurysms, which was maintained when IVIG was added to the treatment regimen.
• This study is a multicenter, prospective, open label, randomized controlled trial, which is expected to be conducted in more than 20 hospitals in China, with the aim of assessing the efficacy and safety of IVIG plus prednisolone treatment compared to standard treatment

Source: Pharmacy Times

6 – Preliminary Data Suggest GSK, Sanofi COVID-19 Booster Effective Regardless of Initial Vaccine

• A single booster dose of the GlaxoSmithKline (GSK) and Sanofi recombinant adjuvanted COVID-19 vaccine candidate delivered consistent and strong immune responses regardless of the primary vaccine received, according to the preliminary results of the VAT0002 trial.
• The booster was also well-tolerated, with a safety profile similar to currently approved COVID-19 vaccines.
• As the pandemic threat continues with the current dominant Delta variant and Omicron rapidly gaining ground, booster vaccines will continue to be needed to help protect people over time.
• The preliminary results of the trial found that neutralizing antibodies in individuals given the booster increased 9- to 43-fold regardless of the primary vaccine received.

Source: Pharmacy Times

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