US Coronavirus: Pfizer proposes expansion of Kovid-19 vaccine trial



One such candidate has been developed by American pharmaceutical company Pfizer, which announced on Saturday with its German partner BioNotech that they proposed to expand Phase 3 clinical trials to include 44,000 participants and a more diverse patient population. Placed, which includes people up to the age of 16 years.

The proposal, which would require approval 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 for a more diverse population as possible,” Pfizer CEO Albert Borla told CBS on Sunday on “Face the Nation”, emphasizing the importance of a diverse group of volunteers as Kovid-19 Influenced. Communities of color.

“But right now we are not bad. In fact, our population is that only 60% of Caucasians globally, 40%, almost, are minorities,” he said.

Borla told CBS that there was a “fairly good chance” that the team testing the vaccine candidate would know if it worked until the end of October. But when asked if people would have to wait until 2021 to get the vaccine, Borla said he did not know how long it might take for regulators to approve it.

Director of the National Institute of Allergy and Infectious Diseases, Drs. Anthony Fauci – who is working with Modern on his own vaccine candidate – said on Friday he remains “cautiously optimistic” that a vaccine will be ready by the end of the year.

But meeting high demand will present its own logistic challenges, and Fauci said that life before 2021 is unlikely to be normal.

“It’s not going to turn the switch off and on,” he told CNN’s Wolf Blitzer. “It’s going to be gradual and I think it’s going to take us several months before we get to the point where we can actually feel something that tells what it’s normally like before Kovid-19 Was. “

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

35 vaccines in human trials

The fact that detection of a coronavirus virus is very important has led to an accelerated timeline for vaccine development, raising some concerns over safety.

Earlier this week, nine companies signed a pledge letter promising that they would not seek premature approval for a vaccine, and that Dr. Fauci has reiterated that Americans should believe in the approval process.
There are 35 vaccines in human trials worldwide. According to the World Health Organization, there have been major clinical trials by Friday, including Pfizer and AstraZeneca and a candidate from the University of Oxford, who announced to resume in the United Kingdom after its completion last week. Unexplained illness in one of the volunteers – a move experts said is not unprecedented.

“In such large trials, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure a careful assessment of safety,” Oxford said in a statement.

Director of the National Institutes of Health of America, Dr. Francis Collins said during a vaccine test Wednesday that this was a standard precaution. He said this is to ensure that experimental vaccines do not cause severe reactions.

Semester starts after college town conflict

While many colleges have moved classes online, it is not necessary to prevent students from gathering. And now some college cities are struggling with the Kovid-19 outbreak as the start of the fall semester complicates local responses to the epidemic.

Michigan State University students asked to self-quarantine after Kovid-19 outbreak
“We are urging students to play a role in preventing the spread of this community and ultimately saving lives,” said Aaron Stephens, former mayor of Lansing, Michigan, where Michigan State University students need to quarantine after local health Was asked for The department has since August 24 registered 342 new cases among people associated with the university.

“We do everything we can to stop the spread of COVID-19,” said MSU Physician David Weissmantle. “” The safety of our entire community is a priority and we all have a role in preventing the spread of the virus. ”

Home to the University of Georgia – Athens-Clarke County, Georgia Mayor Kelly Gertz said, CNN reported Saturday that her city saw a “dramatic spike” in cases after maintaining a low summer case count and death count is. UGA classes began August 20.

“Clearly, this is a return to campus with a large number of students who are not here during the summer,” he said.

Ohio College students were cited after hosting a house party despite testing positive for Kovid-19
Six students at Miami University in Ohio were cited after holding a house party, although at least one of them tested positive for Kovid-19 according to police records. The university declined to comment, citing federal privacy laws, but said students would face disciplinary action if they violated quarantine orders or violated city ordinance at mass ceremonies.

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

.