Bavarian Nordic

Bavarian Nordic has entered into a licensing and supply agreement with Shanghai-based Nuance Pharma to develop and commercialize Bavarian’s RSV vaccine candidate (MVA-BN RSV) for adults in China and other Asian markets, the Danish company announced Monday. Under the deal, Nuance Pharma will pay $12.5 million upfront and up to $212.5 million in milestones.

Nuance will run Phase 1 and 3 trials in China and push Asian regulatory approval for the vaccine, according to the press release.

Bavarian Nordic’s RSV vaccine candidate (MVA-BN RSV) has notched U.S. FDA Breakthrough Therapy designation for adults age 60 and older on the strength of preliminary clinical evidence, the Denmark-based company announced Monday. The news follows earlier Phase 2 data showing the candidate resulted in a “statistically significant” reduction of viral load and up to 79% efficacy in preventing symptomatic RSV infections in adults ages 18-50.

The company said it plans to start a Phase 3…

The state of the fight: 

New studies supported heterologous primary regimens and heterologous boosters.
  Serum Institute of India is weighing slashing Covishield production by 50%.
  The U.S. FDA OK’d AstraZeneca’s Evusheld long-acting monoclonal antibody therapy as PrEP for certain groups.



Mixing the AstraZeneca/Oxford or Pfizer/BioNTech vaccines with a second dose of Moderna’s shot generated non-inferior immune responses …

J&J touted positive Phase 3 data Monday showing that its Janssen subsidiary’s Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) Ebola vaccine regimen—co-developed with Bavarian Nordic—induced antibody responses against the Ebola Zaire virus in 98% of children and adults 21 days after the second dose.

In the adult cohort, immune responses persisted for at least two years, while a booster dose with Zabdeno after two years induced a strong immune response within seven days, per the…

The state of the fight: 

AstraZeneca and the E.U. reached a settlement following a monthslong legal battle over vaccine delivery.
  COVAX released an updated vaccine supply forecast that reduced the number of doses it expects to receive in 2021 by 25%.
  Cuba began vaccinating children as young as age 2 with its homegrown Abdala and Soberana vaccines. Approved or authorized vaccines

J&J’s adenoviral-vectored jab cut the risk of Covid-19 infection by about…

Bavarian Nordic announced Wednesday that its RSV vaccine candidate, MVA-BN RSV, showed a “statistically significant” reduction of viral load in a Phase 2 challenge trial, meeting the primary endpoint. The candidate also showed up to 79% efficacy in preventing symptomatic RSV, according to the press release. The company said it expects to announce next steps for the product later this year.

Other competitors in the race to develop the world’s first RSV vaccine include Advaccine, GSK,…

WHO released detailed notes last week from the March 22-24 virtual meeting of its Strategic Advisory Group of Experts (SAGE) on Immunization.

As in the last SAGE meeting in October 2020, the impact of the pandemic on immunization as well as guidance on Covid-19 vaccines dominated the discussion. WHO’s Immunization, Vaccines and Biologicals (IVB) department director compared the scope of Covid-19 to that of the 1918 influenza pandemic. IVB noted, however, “promising signs” of response…

J&J announced last week that it will donate up to 200,000 doses of its Ebola vaccine regimen (developed with Bavarian Nordic) to Sierra Leone as part of a WHO early access clinical program to prevent disease spread in the region. Neighboring Guinea declared a new Ebola outbreak in February.

WHO awarded prequalification status last month to the dual-shot regimen, comprised of Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo).

The state of the hunt:

J&J’s vaccine became the first single-dose Covid-19 jab to receive EUL from the World Health Organization.
  A growing list of countries—including at least one COVAX AMC participant—suspended their rollouts of AstraZeneca’s vaccine over safety concerns.
  Monoclonal antibodies from Lilly and a separate mAb from GSK and Vir substantially cut the risk of hospitalization or death in people with mild or moderate Covid-19 at high risk of progression…

The state of the hunt:

Moderna’s and Pfizer/BioNTech’s vaccines entered 30,000-participant late-stage trials in the United States.
  Britain and the United States entered supply deals for at least 160 million doses of the GSK/Sanofi vaccine candidate.
  Gavi identified 92 LMICs eligible for its COVAX Advance Market Commitment.



Clinical trials:

Moderna reaches Phase 3: The Massachusetts-based company has begun dosing in a study of its…