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Spain To Begin Clinical Trials Of Johnson & Johnson COVID-19 Vaccine On September 14

Phase 1 trials of Coronavirus vaccine developed by US corporation Johnson & Johnson were held in the United States and Belgium

Spain To Begin Clinical Trials Of Johnson & Johnson COVID-19 Vaccine On September 14
  • Three Spanish hospitals will be administering coronavirus vaccine trials
  • Expected pool of participants for vaccine trials includes 190 volunteers
  • Participants will get either 1 shot of the vaccine or 2 shots a month apart

Madrid: Spain’s first trials of a coronavirus vaccine are scheduled to begin on Monday (September 14), Alberto Borobia, the chief of the clinical trials unit of the La Paz University Hospital in Madrid, said on Sunday (September 13). The vaccine to be tested was developed by US corporation Johnson & Johnson. Phase 1 trials were held in the United States and Belgium. The trials in Spain will fall under Phase 2, to be also held in Germany and Belgium.

Three Spanish hospitals will be administering the trials — the Marques de Valdecilla hospital in Santander will launch then on Monday and the La Paz and La Princesa university hospitals in Madrid will join in on Tuesday, according to Alberto Borobia.

Also Read: AstraZeneca Vaccine Trial Pause A ‘Wake-Up Call’, Says WHO

The expected pool of participants includes 190 volunteers, of which La Paz University Hospital’s share will be 50 adults aged 18-55 and 25 seniors aged over 65, Alberto Borobia told Spanish news agency Servimedia.

The participants will get either one shot of the vaccine or two shots a month apart. There will also be a group that will be given a placebo. Doctors will monitor the participants throughout the entire period of trials.

If everything goes well, Alberto Borobia said, the first wave of vaccination will end on September 22.

While the final results on the vaccine’s safety and effectiveness are expected no sooner than in 16 months, Alberto Borobia said the transition to Phase 3 clinical trials was permissible upon satisfactory preliminary results.

Also Read: COVID-19 Vaccine Roundup: Trials Of Oxford Vaccine Candidate, A Frontrunner In The Global Race, Are Paused After Unexplained Illness Occurred In A Volunteer

The epidemiological situation in Spain, which used to be Europe’s second-worst outbreak at the beginning of the year, worsened again in July. More than 560,000 cases were confirmed by Spanish health authorities, as of Sunday. Over the past week alone, 53,000 new cases were detected and 241 people died from the coronavirus.

According to WHO protocols, a candidate vaccine has to complete three phases of clinical trials to be approved for industrial production.

Also Read: Significant Movement On Russia’s Offer For Phase 3 Testing, Manufacture Of Its COVID-19 Vaccine In India: NITI Aayog Member

Phase 1 normally involves small-scale studies on up to 100 participants to determine a candidate vaccine’s safety and clinical tolerance. Phase 2 can include up to 1,000 and is more representative in terms of their age, ethnicity, and other statistically significant factors. This phase pursues to determine the optimal dose, intervals between doses, and the minimum necessary number of doses in a target population.

Phase 3 trials are the largest and can include up to 10,000 participants with the maximum representation of target population categories. A candidate vaccine is ready to move into industrial production if this last phase provides clear and definitive evidence of its safety and efficacy.

Also Read: Clinical Trials Of Sputnik V Coronavirus Vaccine To Begin This Month In Countries Including India

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.) 

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene.  


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