AstraZeneca, J&J vaccine trials back on track in US

A vaccine volunteer receives an injection at the Chris Hani Baragwanath hospital in Soweto Johannesburg

The trial began in September and is aiming to enroll up to 60,000 people in the USA and several other countries, to test whether a single dose safely protects people from Covid-19.

The Drugs Controller General of India (DCGI) had on Friday permitted Bharat Biotech to conduct phase 3 clinical trials of its indigenously developed Covid-19 vaccine with certain conditions. The study was paused earlier this month after a patient became sick, but the company said no clear cause of the illness had been identified.

The drugmakers said they got the go-ahead Friday from the Food and Drug Administration to restart tests in the U.S. In a statement, the company didn't disclose the nature of the volunteer's illness but said a thorough evaluation "found no evidence that the vaccine candidate caused the event".

"The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial", AstraZeneca said. During the pause, in addition to its own careful review, J&J also had three independent outside medical consultants analyze what happened in detail, said Paul Stoffels, J&J's chief scientific officer.

Reuters earlier this week reported that the FDA had completed its review and that the AstraZeneca U.S. trial was set to resume as early as this week, citing four sources familiar with the situation.

UK scientists confirm efficacy of AstraZeneca’s Covid-19 vaccine, day after one volunteer reported dead in Brazil
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American pharmaceutical company Johnson & Johnson announced halting its COVID-19 vaccine clinical trials on 12 October after one of its program participants exhibited an "unexplained illness".

Reports indicate that 53 out of 30,000 participants need to be sick with COVID-19, and 40 out of 53 infected volunteers need to be participants who received the placebo.

The committees are related to the National Vaccination Policy, Suitable Vaccine Selection, Logistics Registration, Vaccine Development, Financial and Procurement as well as Communications involving vaccine procurement.

AstraZeneca, one of the leading vaccine developers, paused its USA trial on September 6 after a report of a serious neurological illness, believed to be transverse myelitis, in a participant in the company's United Kingdom trial. Moncef Slaoui, the head of the Operation Warp Speed program that is racing to develop shots in the US, said in an interview earlier this week that the trials could resume in the coming days.


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