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.
Airiver medical receives FDA approval for central airway stenosis trial
Talphera reaches enrollment milestone in NEPHRO CRRT pivotal trial
QT Imaging signs exclusive USD33m distribution deal with Gulf Medical in Saudi Arabia
Novocure submits FDA PMA for Tumor Treating Fields therapy in pancreatic cancer
Covalon Technologies secures DTC eligibility to expand US investor access
Navamedic ASA secures final approvals for Flexilev in OraFID across Nordic markets
Oncopeptides partners with SD Pharma to expand Pepaxti access in Spain
Aptar launches bio-based nasal spray pump with Haleon's Otrivin brand
PharmaJet signs MOU with Egyptian UPA and EVA Pharma to introduce needle-free vaccine delivery
Alcon to acquire LumiThera and its FDA-authorised photobiomodulation device for dry AMD treatment
Predictmedix AI launches mobile diabetes screening platform in India
Navamedic's medical device OraFID approved as primary package for a pharmaceutical product
Speranza Therapeutics partners with Sunshine Labs for harm reduction solutions