COVID-19 vaccine manufacturer to push for emergency approval in November

Johnson & Johnson places COVID-19 on pause after ‘unexplained illness

A document was sent to outside researchers running the 60,000-patient clinical trial stating that a "pausing rule" has been met, that the online system used to enroll patients in the study has been closed. "Following our guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board, as well as our internal clinical and safety physicians".

"We are in discussions with numerous parties including the United Kingdom government around a COVID-19 challenge study, and once any of those contracts are signed we will make an announcement", said Open Orphan's executive chairman, Cathal Friel.

In a significant development, Johnson & Johnson on Monday (October 12) announced that it had temporarily halted the trial of its coronavirus COVID-19 vaccine after one of its participants fell ill. "If we get those hot days, we want to obviously ensure that we maintain the integrity of the vaccine", says Limbrick of the Houston Department of Health, and they have to think about taking care of the medical staff who have to administer the vaccine in those conditions.

In a statement, the company said an illness during a clinical trial is "not uncommon and is reasonably expected". There were 100 volunteers in phase one and phase two trials and all feel fine, Vector General Director Rinat Maksyutov said last week.

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The FDA noted that a vaccine candidate must be at least 50% effective to receive emergency use authorization. "We also know that preventing this disease could require multiple vaccines and we're investing in those that we believe have the greatest potential for success".

A study pause holds off further recruitment of a trial, and the company does not typically communicate study pauses publicly.

Coronavirus vaccines should be rolled out in four phases, with initial supply going to front-line health workers and first responders, an independent expert panel tapped by top US health officials recommended earlier this month.

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