Therapy Areas: Devices
Spain's medicine agency authorises Phase III trial of Johnson & Johnson COVID-19 vaccine
18 November 2020 -

The Spanish Agency of Medicines and Medical Devices, AEMPS, has authorised the launch of late-stage trials of US pharmaceutical company Johnson & Johnson's (J&J) (NYSE:JNJ) COVID-19 vaccine on 18 November 2020, Reuters news agency reported on Wednesday.

AEMPS agency said in a statement that the Phase III trial of the two-dose vaccination will be carried out in nine hospitals throughout Spain on volunteers both with and without previous health conditions.

Reportedly, J&J had started mid-stage phase II trials in Spain and other countries in September 2020 and launched a late-stage trial in Britain on 16 November 2020.

Phase III trials will be carried out on 30,000 volunteers in nine countries. The two-dose study will run in parallel with a trials of a single shot regimen involving 60,000 participants which was launched in September 2020.

The AEMPS said that the Spanish hospitals involved in the trials will enrol volunteers as soon as possible, adding that 20% will be younger than 40 and 30% older than 60.

These volunteers will be given a first dose of either a placebo or the experimental shot, currently called Ad26COV2, followed by a second dose or placebo later.

Conclusions will only be available after analysing the data at the end of the trials, the AEMPS added.