Johnson & Johnson has published interim data from a Phase I/IIa sub-study, showing that its single-dose Covid-19 vaccine induced antibody and T-cell immune responses that were durable through the eight-month timeframe evaluated following vaccination. The study found that B-cell response matured with no need for additional boosting. Responses were observed against SARS-CoV-2 original strain as well as variants, including Delta, Beta, Kappa, Gamma, Epsilon and Alpha variants.
The European Medicines Agency is assessing nine cases of auto-immune blood disorder after vaccination with Moderna’s Spikevax Covid-19 vaccine. The disorder, called immune thrombocytopenia, is characterised by low platelet levels that can cause bruising and bleeding, the agency said. A link between Moderna’s vaccine and these cases has not yet been established.
Kintor Pharmaceutical has signed a licensing deal with Shanghai Fosun Pharmaceutical Development to commercialise proxalutamide for Covid-19 treatment in India and 28 African countries. The companies will work together on emergency use authorisation filings, promotion and sales of the drug. Fosun Pharma will gain exclusive rights for registration and marketing in the regions covered under the agreement and will make payments of up to $86.6m (RMB560m) to Kintor.
ImmunityBio has secured approval from the South Africa Health Products Regulatory Authority to assess its hAd5 viral-vector vaccine in the Phase I/II/III South Africa Sisonke T-Cell Universal Boost clinical trial. Set to commence in the third quarter of this year, the trial will test the efficacy, safety and immunogenicity of the Spike plus Nucleocapsid vaccine as a booster in healthcare workers who received a Spike-only vaccine previously.