Vaccine approved for use during the third trimester of pregnancy to prevent pertussis
Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) is now approved for administration during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. Given during pregnancy, Boostrix boosts the mother's antibodies, which are transferred to the developing fetus.
Boostrix was initially approved in 2005 for booster immunization against tetanus, diphtheria, and pertussis in individuals 10 to 18 years of age. It was later approved to include use in individuals 19 years of age and older and to include use of an additional dose 9 years or more after the initial dose of a Tdap vaccine.
Boostrix has always been approved for use during pregnancy to protect the vaccinated individual. Recent studies of Boostrix administered during the third trimester of pregnancy did not identify any vaccine-related adverse reactions on pregnancy or on the fetus/newborn. The FDA estimates the effectiveness of Boostrix administered during the third trimester to prevent pertussis in infants younger than 2 months of age to be 78%.
CDC's ACIP voted to add COVID-19 vaccines to panel of routine immunizations
The CDC's Advisory Committee on Immunization Practices (ACIP) voted unanimously to add COVID-19 vaccination to its 2023 panel of routine immunizations for both children and adults. The vote does not mandate vaccination for children or adults or prevent unvaccinated children from attending school.
The 2023 Child and Adolescent Immunization Schedule for those 18 years of age and younger will now include Pfizer-BioNTech's COVID-19 vaccine, Moderna's COVID-19 vaccine, Pfizer and Moderna's bivalent vaccines, and Novavax's COVID-19 vaccine.
Each year, the ACIP Combined Immunization Schedule work group updates the child/adolescent and adult immunization schedules, which are then approved by the full advisory committee.
FDA approves new treatment option for ALS
The FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS). The efficacy of Relyvrio for ALS treatment was demonstrated in a 24-week multicenter, randomized, double-blind, placebo-controlled, parallel-group study in which 137 adult patients with ALS were randomized to receive either Relyvrio or placebo. The patients treated with Relyvrio experienced a slower rate of decline on a clinical assessment of daily functioning compared with those receiving placebo. Longer overall survival was observed in a post-hoc, long-term analysis of patients who originally received Relyvrio versus those who originally received placebo. Relyvrio can be taken orally or administered through a feeding tube. The medication should be taken before a snack or meal.
The most common adverse reactions associated with Relyvrio were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Relyvrio is a product of Amylyx Pharmaceuticals, Inc.
FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 boosters in younger age groups
The FDA amended the emergency use authorizations of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose at least 2 months following primary or booster vaccination in younger age groups. The bivalent vaccines, called "updated boosters," contain two mRNA components of SARS-CoV-2 virus: one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the Omicron variant of SARS-CoV-2.
* Moderna's bivalent updated booster is authorized for use as a single booster dose in individuals 6 years of age and older.
* The Pfizer-BioNTech bivalent booster is authorized for use as a single booster dose in individuals 5 years of age and older.
With this latest authorization, the monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized as a booster dose for individuals 5 to 11 years of age.