Pfizer may seek emergency use for COVID vaccine in November

Henrietta Brewer
October 17, 2020

The drugmaker Pfizer said it will not apply for emergency use authorization for its Covid-19 vaccine candidate until at least the third week of November.

United States pharmaceutical company Johnson & Johnson has announced a pause in its clinical trials for a COVID-19 vaccine candidate.

It says an independent panel will be reviewing and evaluating the participant's illness before a decision is made on whether to resume the trials.

The New Brunswick-based company announced in a statement Monday evening that illnesses, accidents and other so-called adverse events are an expected part of large clinical studies.

Citing privacy reasons, the company said that it could not give more details about the participant. It was also not certain if the reaction was caused by the vaccine or if it occurred in an individual who received a placebo.

"Said Cuomo. "Now let's find out because this virus has been ahead of us every step of the way - it's time this country caught up". "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information". "It's really cramming three to six months worth of strategic discussions. into 30 days", she says. Contrarily, a regulatory hold is a requirement by a regulatory health authority, like the Food and Drug Administration, and those declarations are regularly disclosed, the company said.

Among the trials paused was Johnson & Johnson's multi-country "ENSEMBLE" vaccine, which entered Phase 3 testing in September.

Pfizer's announcement indicates there is no chance its vaccine will be authorized for use before the U.S. election wraps up on November 3. "To me it's reassuring that companies are acting responsibly and pausing when they need to".

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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