Trump administration to block FDA guidelines that could delay coronavirus vaccine

[lindamy]

Trump administration to block FDA ttguidelines that could delay coronavirus vaccine: report

The FDA proposed stricter guidance last month that could prolong the timeline for a vaccine

Trump administration to block FDA guidelines that could delay coronavirus vaccine: report

The FDA proposed stricter guidance last month that could prolong the timeline for a vaccine.

www.foxnews.com

 

[ccc]

作！

 

[贵圈]

的确是作！开放使用HCQ，让疫苗慢慢发展吧。

 

[XCYM]

both

 

[lindamy]

45 min ago
First indications of vaccine candidates' safety not expected until at least November, official says
From CNN Lauren Mascarenhas

Moncef Slaoui listens as US President Donald Trump delivers remarks about coronavirus vaccine development in the Rose Garden of the White House on May 15 in Washington. Drew Angerer/Getty Images

The first indications of whether early coronavirus vaccine candidates are safe and effective won’t be ready until November or December, Dr. Moncef Slaoui, chief adviser to the federal government’s Operation Warp Speed, said Tuesday.

“We're reasonably pleased with the progress. It's been really fast, and we expect to have three waves of efficacy readouts over the next several months,” Slaoui said at a vaccine symposium hosted by Johns Hopkins University.

“First wave with the RNA vaccines imminently November/December, a second wave with the non-replicating vectors vaccine In January or February,” he said, adding that the third wave with a protein platform is expected in March or April.

Slaoui said that the expectation is that companies will file for emergency use authorization or full approval of their vaccines following the readouts.

 

[lindamy]

1 hr 30 min ago
Updated FDA guidelines close door on vaccine manufacturers getting an EUA before Election Day
From CNN's Maggie Fox

Sandra Rodriguez, 63, receives a Covid-19 vaccination from Yaquelin De La Cruz at the Research Centers of America (RCA) in Hollywood, Florida, on August 13. Chandan Khanna/AFP/Getty Images

The US Food and Drug Administration posted guidance Tuesday for companies hoping to get emergency use authorization (EUA) for coronavirus vaccines, and said they will have to include at least two months of follow-up after volunteers get their second dose of vaccine.

That would mean no company could seek an EUA before mid-November, because the vaccines furthest along in clinical trials – those made by Pfizer and Moderna – both require waiting either 21 or 28 days between doses.

“Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect,” the FDA said in the guidance.

"Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research.

“The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."

The FDA earlier Tuesday posted discussion documents for vaccine advisers with similar language.

 

[lindamy]

1 hr 27 min ago
NIH director says he is "optimistic" a coronavirus vaccine will be proven safe and effective by 2021
From CNN’s Lauren Mascarenhas

Dr. Francis Collins, Director of the National Institutes of Health (NIH), holds up a model of the coronavirus during a US Senate Appropriations subcommittee hearing on Operation Warp Speed on July 2 on Capitol Hill in Washington. Saul Loeb/Pool/Getty Images

Dr. Francis Collins, director of the National Institutes of Health, said he's optimistic that the US will have a vaccine by the end of this year or the beginning of 2021.

“I'm one of those who's optimistic we will have one or more vaccines that turn out to be safe and effective by sometime around the end of this year, maybe a little bit into January,” he said.

The politicization of the vaccine development process has been a distraction, one that has polarized many people, Collins noted during a Johns Hopkins University and University of Washington virtual symposium on vaccine development.

“Putting all that aside and dealing with the fact that we have this huge problem of vaccine hesitancy that needs to be dealt with, I am still guardedly optimistic that come 2021, we're going to be on a path – over many months, let's not talk about this being a quick solution, but on a path – where we can eventually put Covid-19 in the rear view mirror, although we will be changed by it, and I think he will be around us globally for quite a long time to come,” said Collins.