Spain will continue in the Janssen trial. The Spanish Agency for Medicines and Health Products (Aemps) has given its go-ahead on Wednesday so that Janssen begins phase 3 testing for its vaccine in Spain. The company is a subsidiary of Johnson & Johnson that is dedicated to research and development of drugs, such as a vaccine against COVID-19.
This is the first time a phase 3 trial has been authorized for a COVID-19 vaccine. Although Janssen had already started to test his vaccine with some Spaniards, but in phase 2. In this first part of the trial with people, 190 healthy volunteers were needed, distributed in hospitals in Madrid and Santander.
Now the study will be expanded and more people will be vaccinated in the coming months. Eight Spanish hospitals will participate, according to Aemps in a press release. Total, Janssen seeks to recruit some 30,000 volunteers in nine countries to test its phase 3 vaccine. In addition to Spain, the phase 3 clinical trial will be tested in Belgium, Colombia, France, Germany, the Philippines, South Africa, the United Kingdom and the United States.
This will be the clinical trial of the vaccine
It is a pivotal, multinational trial with a double-blind design. In other words, “the vaccine or a placebo is administered masked in such a way as to prevent its identification with the naked eye,” according to * .. This phase 3 clinical trial by Janssen will study the safety and efficacy of its two-dose vaccine in Spain and eight other countries.
The trial will start “as soon as possible”. Initially, the recruitment of volunteers for the phase three clinical trial will be from healthy people, without comorbidities. However, later on, people with pathologies or characteristics that make them patients at risk for COVID-19 will be recruited, such as people with hypertension, diabetes or COPD. “20% of the patients will be under 40 years old, and 30% over 60 years old,” as reported by Health.
As part of the clinical trial, all volunteers will be closely monitored. In addition, all possible COVID-19 infections that may occur will be identified.
Fight for efficiency
Janssen has yet to comment on the efficacy of its vaccine, especially since it has not started phase 3 clinical trials yet. However, in recent days several pharmaceutical companies have intensified the race for a vaccine against COVID-19.
This same Wednesday, Pfizer made its second announcement and raised the effectiveness of its vaccine to 95%, when a week before it spoke of 90%. Russia’s Sputnik V has reached 92% while Moderna aims for 95% efficiency. We do not know, in any of the three cases, if their data are correct since they have not been published in any scientific journal or peer reviewed.
The article This is what you need to know about the Johnson & Johnson phase 3 clinical trial in Spain was published in Explica.co.