Health Care

Placebo group: What happens after a Covid vaccine is authorized?

Placebo group: What happens after a Covid vaccine is authorized?”

Half the volunteers in the final-stage clinical trial - a double-blind, randomized, controlled study - receive a placebo, IDOR said. Candidates are being developed all over the world, with Russian, Chinese, UK, and US-based companies now running vaccines through stage-three testing. The person's death has apparently occurred as a result of "complications from COVID-19", the Globa newspaper reported. The reports say the volunteer was infected with the coronavirus in September.

Now tens of thousands of people in the United States and other countries are participating as volunteers in what are known as phase three clinical trials. "They are yet to inform us when they are going to begin the trials here", said Khobragade. Another vaccine maker, Johnson & Johnson, said earlier this month that it would pause its trial to investigate an illness in a study participant. However, the independent committee overseeing these trials concluded that the woman's case was either unlikely to be connected to the vaccine or that there wasn't enough evidence to confirm one way or the other.

Azar declined to speculate on when the US would return to a semblance of pre-pandemic life, but expressed optimism that a vaccine may be available to some by the end of the year. Bloomberg News, citing an anonymous source, also reports that the participant received a placebo.

India is the manufacturing partner of the vaccine candidate named Covishield, developed jointly by the University of Oxford's Jenner Institute's and AstraZeneca.

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In continuation of the subject expert meeting held on October 5, the Hyderabad based firm presented their data from phase 1 and 2 along with animal challenge data in two species including non-human primates (NHP) on the inactivated coronavirus vaccine (BBV152) along with the proposal to conduct event driven phase 3 clinical trial to assess the efficacy of the vaccine, the recommendations stated. "Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue", Oxford University told CNN in an emailed statement on Wednesday.

J&J, in its comments, said a discussion is needed on the potential challenges of maintaining trial enrollment in ongoing large studies, especially after initial vaccines become available.

The country has recorded more than 154,000 deaths since the beginning of the pandemic, the second deadliest outbreak in the world, behind the US.



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