Moderna’s mRNA COVID-19 vaccine candidate has reported vaccine efficacy of 94.5% in the first Phase 3 interim analysis, released this morning. "This is a pivotal moment," says Moderna's CEO.
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines in preparation for the first three vaccines likely to be launched in Europe.
Sinovac’s Phase 3 COVID-19 vaccine trial has been put on hold in Brazil after a serious adverse event. But in a statement this morning, the company says the event is not related to the vaccine.
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Novavax’s COVID-19 vaccine. Novavax plans to start Phase 3 trials for the candidate in the US and Mexico by the end of the month.
Pfizer says its COVID-19 vaccine candidate is more than 90% effective in preventing COVID-19, releasing interim analysis from its Phase 3 study this morning. “Today is a great day for science and humanity,” says the company’s CEO.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a text on analytical strategy options for the control of COVID-19 recombinant viral vectored vaccines.
Sanofi is eying up the European biopharmaceutical company’s proprietary next generation natural killer (K-NK) cell platform and pipeline of cell-based cancer immune-therapeutics and infectious disease therapies.
Novartis has acquired Vedere Bio, giving the company a new platform for AAV-based delivery of gene therapies and an optogenetics program for the treatment and prevention of vision loss and blindness.
Novavax’s Phase 3 COVID-19 vaccine trial in the UK has been expanded to 15,000 participants; while a 30,000 strong Phase 3 clinical trial is due to start in the US and Mexico next month.
