Janssen gets approval to start phase III COVID-19 vaccine trial in SpainNovember 23, 2020 0 By FM
The Agency for Medicines and Health Products (AEMPS) in Spain recently gave nod to the Johnson & Johnson (J&J) unit Janssen to initiate the company’s phase 3 trial of its COVID-19 vaccine candidate Ad26COV2 in the country.
In the trial, the subjects will receive a 2-dose regimen of the Ad26COV2 vaccine or placebo. It will be conducted across 9 hospitals in the country. The trial will enrol 20% of participants younger than 40 years old and will have 30% of subjects more than 60 years in age, the AEMPS said.
In September, J&J initiated phase II trials in Spain and other countries, as well as started a late-stage trial in the UK earlier this week. The two-dose regimen of the vaccine trial will be carried out in parallel with one-dose regimen trials involving 60,000 participants launched in September.
Approximately 30,000 volunteers in nine countries will take part in the phase III trials evaluating the safety of the vaccine. Apart from Spain, Belgium, Colombia, France, Germany, the Philippines, South Africa, the UK and the US are part of the phase III trial.
Earlier in November, Aspen Pharmacare signed a preliminary agreement with two J&J subsidiaries for the technical transfer and proposed commercial manufacture of Ad26COV2 vaccine candidate. On obtaining clear and definitive evidence of its safety and efficacy, the vaccine candidate can move into industrial production.