Spanish vaccine approved for first human clinical trial

Spanish vaccine approved for first human clinical trial. This is the first Spanish made vaccine that has made it to the human trial stage.

The Spanish Agency for Medicines and Health Products (AEMPS), which reports to the Ministry of Health, have given the go-ahead for first human clinical trial of the PHH-1V vaccine against the coronavirus. The vaccine is made by the company Hipra and this is the first human trial for a Spanish vaccine.

Several hospitals will take part in the trial and volunteers will be selected as soon as possible. Volunteers will need to be between 18 and 39 years of age.

The trial will see volunteers divided into groups, the first of which will be given the lowest dose of the vaccine. The data will then be assessed by an independent monitoring commission. Further doses could then be given if there are no safety concerns. This first stage of the trial aims to find the optimal vaccine dose.

As reported 20 minutes, “The Ministry of Health and the Ministry of Science and Innovation are in contact with other research groups that are developing vaccines against COVID-19 in Spain to support them in the regulatory process and facilitate the process, while ensuring that these vaccines have all the guarantees of quality, safety and efficacy necessary to finally be authorised.”

Throughout the trial all the volunteers will obviously be closely monitored. The Ministry of Health have highlighted the fact that: “it will be necessary to wait until the clinical trial has been completed to be able to analyse all the data and draw final conclusions”.

“These clinical trials are part of the requirements that all investigational vaccines must undergo to demonstrate their quality, safety and efficacy. Only after they have been evaluated and if they meet regulatory standards will they be authorised for marketing.”

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