- On Tuesday, the FDA amended the emergency use authorizations (EUAs) of Moderna Inc and Pfizer Inc , and BioNTech SE's COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule.
- This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals six months of age and older, including for an additional dose or doses for certain populations.
- The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized in the U.S.
- Those 65 and older can get a second dose of the updated versions of Pfizer-BioNTech's and Moderna's Covid booster at least four months after their last dose, the FDA said in a statement.
- According to the agency, most immunocompromised people can get an additional dose at least two months after their last dose.
- Most unvaccinated individuals may receive a single dose of a bivalent vaccine rather than multiple doses of the original monovalent mRNA vaccines, FDA said.
- Unvaccinated children six months through 5 years can receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine.
- Children five years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
- The booster shots were reformulated last August to target the BA.4 and BA.5 omicron subvariants in addition to the original strain of the virus.
- Evaxion Biotech A/S presented clinical data from its Phase 1/2a first-in-human study of its DNA-based personalized cancer immunotherapy, EVX-02, in combination with the checkpoint inhibitor Bristol Myers Squibb Co Inc's Opdivo (nivolumab).
- The study, in patients with resected melanoma, showed that all ten patients who received the full dosing schedule of 8 immunizations with EVX-02 were relapse-free at their last assessment.
- Of these ten patients, 9 completed the full study and were relapse-free at the 12-month end-of-study visit.
- One patient was prematurely terminated due to non-EVX-02 related adverse events (AEs) and was relapse-free at the last nine-month visit.
- The combination of EVX-02 and nivolumab was well tolerated, and only mild EVX-02-associated AEs were observed.
- Robust and long-lasting neoantigen-specific T-cell immune responses were confirmed in all EVX-02 completers.
- The induced T-cell immune responses involved both CD4+ and CD8+ T cells.
- Evaxion Biotech announced interim safety and immunogenicity data from the Phase 1/2a study EVX-02 in November last year.
- The company said the data from the first eight patients demonstrated a specific T-cell immune response induced by the treatment.
