The FDA has authorized the bivalent Moderna and Pfizer-BioNTech COVID-19 Vaccines as a single booster dose at least 2 months following the primary or booster vaccination.
These recommendations apply only to individuals without a history of CVD and who are not already taking statins.
The FDA has expanded the EUA for the Novavax COVID-19 Vaccine, Adjuvanted to include adolescents 12 to 17 years of age to prevent COVID-19.
The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October.
Under the EUA, Jynneos can be administered either intradermally for individuals aged ≥18 years or subcutaneously for individuals aged <18 years.
The approval is supported by evidence from adequate and well-controlled studies of Stelara.
An individual is considered fully vaccinated about 2 weeks after the second dose of Jynneos and 4 weeks after receiving ACAM2000.
The sNDA is supported by data from the phase 3 CANDLE study.
The Novavax COVID-19 Vaccine, Adjuvanted is administered intramuscularly as a 2-dose primary series (0.5mL each), separated by 3 weeks.
The biomarker test measures NfL levels through standard blood collection.
