Clinical trials of Covid-19 vaccine in Spain.

Clinical trials of Covid-19 vaccine in Spain.

17-11-2020Ultima Hora

The first clinical trial of the Covid-19 vaccine by Janssen has been authorised by the Spanish Agency for Medicines & Health Products or AEMPS.

30,000 volunteers from Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and America are taking part in the multinational trial and will be given 2 doses of either the vaccine or a placebo.

The Phase III clinical trial will begin as soon as possible at 9 Spanish hospitals with volunteers who meet the specified criteria.

Participants who don’t have diseases associated with an increased risk of developing severe coronavirus will be vaccinated and after a safety evaluation by an independent surveillance committee the study will eventually include participants with concomitant diseases that are associated with a greater risk.

20% of the patients will be under 40 years old and 30% will be over 60 and they'll all be closely monitored throughout the trial to identify cases of Covid-19 in order to carry out preliminary analysis with intermediate data.

The AEMP says it will have to wait until the clinical trial is finished to analyse the data and draw its final conclusions.

All investigational vaccines must undergo clinical trials to demonstrate their quality, safety and efficacy and can only be authorised for commercial use if they comply with regulatory standards.

The Ad26.COV2.S vaccine is based on a solidly documented technology with a non-replicative recombinant adenovirus, to generate an immune response against one of the coronavirus proteins known as spike protein S.

The Ministry of Health is maintaining contact with different companies that have proposed including Spanish centres in clinical trials to find a vaccine for Covid-19.

Health Minister Salvador Illa described the start of the clinical trials as "one more milestone on the path that will lead to the authorisation and availability of safe and effective vaccines for the public."


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