Hepatitis B Vaccine (Recombinant)

The CDC updated HepB vaccination recommendations for pregnant women, adding Heplisav-B. A study of 75 pregnant women showed no increased risk of major birth defects or miscarriage. Heplisav-B is now recommended alongside Engerix-B, Recombivax HB, and Twinrix.

Vir Biotechnology announced that tobevibart and elebsiran received US FDA breakthrough therapy and EMA PRIME designations for chronic hepatitis delta treatment, supported by phase 2 SOLSTICE trial data. The phase 3 ECLIPSE program will start in 2025.

The FDA granted breakthrough therapy designation to tobevibart and elebsiran for chronic hepatitis delta (CHD) treatment, based on positive phase 2 SOLSTICE trial results. Both agents, administered subcutaneously, target hepatitis B and delta viruses, showing rapid and deep viral suppression. The combination achieved undetectable HDV RNA in 64% of patients at week 36 and HBsAg suppression in 90% at week 24, with sustained responses. Safety profiles were consistent with previous studies, with no treatment-related SAEs.

Kennedy's vaccine skepticism raises concerns; he aims to improve vaccine safety science for informed choices. Lawyer Aaron Siri petitions FDA to suspend hepatitis B vaccine approval and pause distribution of 13 others until aluminum use disclosure. Kennedy and Siri advocate for vaccine transparency and choice. Polio vaccine removal could have severe consequences.

Vir Biotechnology's tobevibart and elebsiran received FDA Breakthrough Therapy and EMA PRIME designations for treating chronic hepatitis delta (CHD), supported by positive SOLSTICE trial data. The combination therapy rapidly suppresses hepatitis delta virus (HDV) to undetectable levels, with 80% of participants in the rollover cohort achieving no detectable viral RNA by week 60. The phase 3 ECLIPSE program is planned for 2025.

Vir Biotechnology's tobevibart and elebsiran granted Breakthrough Therapy and PRIME designations for chronic hepatitis delta treatment. Phase 2 SOLSTICE trial results show potential to suppress hepatitis delta virus. Company plans Phase 3 ECLIPSE program for 2025. Analysts revise earnings upwards despite stock decline.

Vir Biotechnology receives FDA Breakthrough Therapy and EMA PRIME designations for tobevibart and elebsiran in chronic hepatitis delta, supported by Phase 2 SOLSTICE trial data. Phase 3 ECLIPSE program to start in H1 2025.