New COVID-19 Vaccines Approved
On Aug. 22, 2024, the U.S. Food and Drug Administration (FDA) approved and granted Emergency Use Authorization (EUA) for an updated version of the COVID-19 vaccines, Spikevax® (Moderna) and Comirnaty® (Pfizer/BioNTech). The vaccines will now cover the Omicron variant KP.2 strain of SARS-CoV-2 that started to spread in early 2024; however, the strain now only makes up around 3.2% of circulating strains in the U.S. The manufacturers stated that the shots may still offer benefits against other strains that are currently circulating. In June 2024, the Centers for Disease Control and Prevention (CDC) recommended that everyone aged six months and older should receive an updated booster. Each is given by healthcare providers as intramuscular (IM) injections. The latest versions of the vaccine are approved only for individuals aged 12 years and older but are authorized under EUA for children from six months to 11 years old. The vaccines listed under EUA are the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine. If a child is unvaccinated and aged six months to four years, they can receive three doses of the Pfizer-BioNTech Vaccine or two doses of Moderna’s Vaccine. Children aged six months to four years who have been previously vaccinated can now receive updated Moderna or Pfizer-BioNTech COVID-19 vaccines, as appropriate based on their previous vaccination history. Children between the ages of five years and 11 years, regardless of prior vaccination, can get a single dose of the authorized updated Moderna or Pfizer-BioNTech COVID-19 vaccines. If they’ve been vaccinated before, the dose should be given at least two months after the last dose of any COVID-19 vaccine. Individuals aged 12 years and older are now eligible to receive a single dose of either of the updated vaccines. For those who have received prior vaccinations, it is recommended to wait a minimum of two months from the last dose of any COVID-19 vaccine before receiving an updated dose. Additional doses have been authorized for specific immunocompromised individuals between the ages of six months and 11 years, by the guidelines outlined in the fact sheets for the Moderna Vaccine and the Pfizer-BioNTech Vaccine. Vaccines should be available starting in the coming days. For the prescribing information on Comirnaty, see here and for Spikevax see here. EUA fact sheets can be found here and here, respectively.
Interchangeable Status for Amjevita
On Aug. 20, 2024, several formulations of Amgen’s low-concentration (50mg/mL) Amjevita™ (adalimumab-atto) were designated by the FDA as interchangeable with AbbVie’s low-concentration Humira® (adalimumab). The interchangeable Amjevita formulations include the 40mg/0.8mL single-dose prefilled SureClick® autoinjectors as well as the 40mg/0.8mL, 20mg/0.4mL and 10mg/0.2mL single-dose prefilled syringes. In states that allow substitution, these strengths now can be dispensed instead of Humira without contacting the prescriber for permission to substitute. The FDA has approved several other interchangeable biosimilars to Humira including certain formulations of Abrilada™ (adalimumab-afzb – Pfizer), Cyltezo® (adalimumab-adbm – Boehringer Ingelheim), Hadlima™ (adalimumab-bwwd – Samsung Bioepis/Organon), Hyrimoz™ (adalimumab-adaz – Sandoz) and Simlandi® (adalimumab-ryvk – Teva/Alvotech). Adalimumab is a monoclonal antibody that inhibits tumor necrosis factor (TNF), to reduce inflammation. It treats inflammatory conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, uveitis, ulcerative colitis and Crohn’s disease. Adalimumab is given by subcutaneous (SC) injections — usually once every two weeks. A boxed warning on the labels of all TNF blockers describes the increased risks of cancer and serious infections that may be associated with their use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Updated prescribing information for Amjevita is here.