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US Coronavirus: Pfizer Proposes Expanding Covid-19 Vaccine Study



One such candidate is in the development of the American pharmaceutical company Pfizer, which announced on Saturday, together with its German partner BioNTech, that it is proposing to expand the clinical phase 3 studies to 44,000 participants and more diverse patient groups, including people aged 16 and over .

The proposal, which would have to be approved by the Food and Drug Administration, would allow companies to collect more data on the safety and efficacy of the vaccine candidate while diversifying the pool of participants.

“I think we should strive to have as diverse a population as possible,” Pfizer CEO Albert Bourla told Face the Nation to CBS on Sunday, emphasizing the importance of having a diverse group of volunteers to have as Covid-1

9 had a bigger impact on color communities.

“But right now we’re not bad. In fact, we have a population of only 60% Caucasians worldwide, roughly 40% minorities,” he said.

Bourla told CBS that there was a “pretty good chance” that the team testing the vaccine candidate will know if it will work by the end of October. When asked if people would have to wait until 2021 to get the vaccine, Bourla said he didn’t know how long it could take for regulators to approve it.

Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, which is working with Moderna on its own vaccine candidate, said Friday that he remains “cautiously optimistic” that a vaccine will be ready by the end of the year.

Satisfying the high demand will come with its own logistical challenges, however, and Fauci said life is unlikely to return to normal before 2021.

“It won’t be to turn a switch off and on,” he told CNN’s Wolf Blitzer. “It will be gradual and I think it will be a few months before we reach the point where we can really feel something that is roughly what it usually was before Covid-19.”

As of Sunday, more than 6.5 million cases of coronavirus had been reported in the United States, according to Johns Hopkins University. More than 193,000 people have died.

35 vaccines in human studies

The fact that finding a coronavirus vaccine is so critical has resulted in an accelerated schedule for vaccine development, which has raised some safety concerns.

Earlier this week, nine companies signed a security pledge pledging not to seek early approval for a vaccine, and Dr. Fauci has reiterated that Americans should have confidence in the approval process.
There are 35 vaccines in human studies worldwide. According to the World Health Organization, eight are in large, late-stage clinical trials on Friday, including Pfizer’s and a candidate from AstraZeneca and the University of Oxford, who have announced the study will resume in the UK after suffering an unexplained illness last week one of the volunteers – a move experts said is not unprecedented.

“In large studies like this one, some participants are expected to feel uncomfortable and each case needs to be carefully assessed to ensure a thorough safety assessment,” Oxford said in a statement.

Interrupting a vaccine study is a standard precaution, said Dr. Francis Collins, director of the US National Institutes of Health, at a Senate hearing on Wednesday. He said it is to make sure experimental vaccines don’t cause serious reactions.

University cities are struggling after the fall semester begins

While many colleges have moved classes online, that hasn’t necessarily stopped students from congregating. And now some university towns are struggling with Covid-19 outbreaks as the start of the fall semester makes local responses to the pandemic difficult.

Michigan State University students requested self-quarantine following the Covid-19 outbreak
“We challenge students to understand the imperative role they play in stopping the spread of this community and ultimately saving lives,” said Aaron Stephens, Mayor of East Lansing, Michigan, where students from Michigan State University were asked To Quarantine According to Local Health The department reported 342 new cases among university-affiliated people as of Aug. 24.

“The MSU is doing everything it can to prevent the spread of COVID-19,” said MSU doctor David Weismantel. “The safety of our entire community is a priority and we all have a role to play in preventing the virus from spreading.”

Kelly Girtz, the mayor of Athens-Clarke County, Georgia – home of the University of Georgia – told CNN on Saturday that his city had seen “dramatic increases” in cases after maintaining small and death numbers all summer. UGA classes began on August 20th.

“It is clearly the return to campus of a large number of students who are not here in the summer,” he said.

Ohio college students were quoted after throwing a house party despite testing positive for Covid-19
Six Miami University in Ohio students were cited after a house party, despite at least one of them testing positive for Covid-19, according to police records. The university declined to comment, citing federal data protection laws, but said students would face disciplinary action if they violated quarantine orders or city ordinances at mass gatherings.

CNN’s Lauren Mascarenhas, Naomi Thomas, Maggie Fox and John Bonifield contributed to this report.


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