“The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program,” Redfield wrote, according to The Hill. “CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”
Documents outlining the distribution of two potential vaccines were also sent last week to every state and US territory, along with five major cities, according to The New York Times: New York, Chicago, Houston, Philadelphia and San Antonio.
The documents describe two unnamed vaccine candidates, each of which would require two doses spaced a few weeks apart, The Times reported.
Essential workers, national security employees, seniors and members of particularly vulnerable racial and ethnic groups would be among those prioritized for the treatments, the documents reportedly said.
Leading US health officials have voiced skepticism that a vaccine could be developed and approved before the end of the calendar year, while President Trump has accused federal officials of slow-walking the process to hurt his chances of re-election.
Key Points
"The Centers for Disease Control and Prevention has asked governors and health departments to prepare to distribute a vaccine as soon as Nov. 1. In a letter dated Aug. 27, CDC Director Dr. Robert Redfield said states will soon receive permit applications from medical supply company McKesson, which the Department of Health and Human Services tapped to help distribute the vaccine. He said they may need to waive some licensing and permit requirements that could delay the process.
The deadline — just two days before the federal elections — raised concerns among public health experts and scientists that approval of a vaccine will be politically motivated and the White House may be pressuring regulators to get a vaccine to the market ahead of Nov. 3.
Earlier Thursday, Health and Human Services Secretary Alex Azar insisted that the government’s Nov. 1 deadline for states is not linked to the presidential election.
“It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives,” Azar said on the program “CBS This Morning.” “Whether it’s Oct. 15, whether it’s Nov. 1, whether it’s Nov 15, it’s all about saving lives but meeting the FDA standards of safety and efficacy.”
The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces the risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC. Dr. Stephen Hahn, commissioner of the FDA, previously said the agency wouldn’t authorize a vaccine that’s not safe, even if it is fairly effective.
“We’re going to be very, very, very carefully looking at those safety data and we’re going to be transparent about what we’ve seen,” he said July 30.
However, Hahn told the Financial Times earlier this week that the agency is prepared to bypass the full federal approval process in order to make a Covid-19 vaccine available as soon as possible.
Insisting the agency wasn’t being pressured by President Donald Trump to fast-track a vaccine, Hahn said an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
The comment raised concerns that a vaccine could be authorized before it is ready.
When asked on Thursday whether he would hesitate to take a vaccine, Fauci said, “not at all.”
“I would look at the data and assume that a vaccine would not be approved for the public unless it was safe and effective,” he said. “And I keep emphasizing both safe and effective. If that’s the case, I would not hesitate for a moment to take the vaccine myself and recommend it for my family.”
"The first COVID-19 death associated with a massive biker rally in Sturgis, South Dakota has been reported weeks after the event attracted more than 400,000 vehicles and drew widespread concern from public health officials.
The death was reported by Minnesota Department of Health Infectious Disease Director Kris Ehresmann at a Wednesday briefing. Minnesota — South Dakota's neighbor to the east — is tracking an ongoing outbreak of 50 cases tied to the August event, Ehresmann said. That outbreak only includes people who attended the event.
A Minnesota man who died was in his 60s and had underlying health conditions. The rally went forward despite fears it could become a super-spread event. South Dakota Gov. Kristi Noem welcomed bikers and the tourist dollars they spend."
metmike: Funny how contact tracers are not even allowed to ask a person that tests positive if they had been to a rally because it violates their rights..............so we have millions of people protesting............and still no COVID cases from it.
And people believe that.
Covering up massive COVID being spread from protests-8/8 update below
25 responses |
Started by metmike - July 30, 2020, 7:28 p.m.
Interesting take on the COVID vaccine news by some in the MSM.
Instead of celebrating this possibility and giving Americans hope and sharing good news.........many are concerned that it might get Trump elected.
More important to stop that than to save thousands of American lives.
"To date, Warp Speed has invested more than $10 billion in eight vaccine candidates. Much of that money goes to “at-risk” purchasing of vaccines, which means the companies will produce hundreds of millions of doses that may wind up in the garbage if those candidates do not prove safe and effective. Three of the vaccines are now in large-scale efficacy trials, and interim looks at their data by independent safety and monitoring boards could reveal efficacy signals as early as October. If that happens, a vaccine could become quickly available through what’s known as an emergency use authorization (EUA), a regulatory pathway that the Food and Drug Administration (FDA) has for diagnostics, treatments, and vaccines.
Talking to ScienceInsider today, Slaoui insisted he won’t be swayed by political pressures to rush an unsafe or ineffective vaccine, and that science will carry the day—or he’ll quit.
Slaoui has given few interviews since taking the Warp Speed job and he has taken something of a beating in the media for his financial holdings in companies working on COVID-19 vaccines—he was on the board of Moderna and has since stepped down, but he retains his GlaxoSmithKline stock. And Warp Speed has been slammed for a lack of transparency on its decisions.
Slaoui spoke with ScienceInsider today for 25 minutes about his role, the challenges of the job, and the growing fear that politics and the upcoming elections on 3 November might influence the vaccine approval process. The interview has been edited for brevity and clarity."
metmike: The man should have quit a long time ago then, if he's going to quit if politics is being applied in the realm of COVID instead science. How in the world do you think the vaccine got advanced this far so quickly?
The science has been there for every other new drug that takes many years to make it to the market but the biggest difference this time.......the thing that sped things along on the fast track.....happened because of the politics....to change the rules.
Politics has ruled on the spread of COVID at protests.
Politics has played a big role on the opening up process being different in different states.
Politics has really dominated on the discussion of hydroxychloroquine
Politics are also playing a role in the development and availability of the vaccine.
Trump is obviously applying political pressure to have the vaccine ready ASAP.
Whether it helps him get votes or not..............we shouldn't care. The important fact is that the pandemic will continue to rage until the vaccine crushes it.
Under normal circumstances, it could take years — if not decades — to bring a new vaccine to market. The COVID-19 pandemic has changed all that. In May, the Trump administration launched Operation Warp Speed with the goal of delivering initial doses of a safe and effective vaccine by January 2021 — shortening the development time from years to months.
Some worry that to meet that ambitious schedule, the administration might cut important scientific corners. They fear that President Trump could announce an "October surprise" — declaring that a vaccine works before it has passed scientific muster in order to enhance his reelection chances.
metmike: They are mainly worried that this might get Trump elected, not that it might not be safe. Otherwise, they would not have encourage millions to protest and thousands to get COVID at protests.
After all, the president ballyhooed supposed virtues of hydroxychloroquine when most scientists thought the drug was not helpful, and maybe downright dangerous in treating or preventing coronavirus infections. This week, the FDA granted authorization for using convalescent plasma as a treatment for COVID-19, a move some say was done under political pressure from the White House.
metmike: They continue to totally bs us about hydroxychloroquine.
https://www.marketforum.com/forum/topic/56930/
FDA officials have maintained that all their decisions are based on science, not politics.
In June, the agency released guidancefor what it would require before granting any kind of approval for the COVID-19 vaccine.
The guidance states that at a minimum, the FDA wants to see any vaccine tested in thousands of people so that any relatively rare side effects can be caught, and to see if the vaccine is actually preventing disease. The agency also says the vaccine doesn't have to prevent 100% of disease to get a green light; just 50% would be sufficient.
How long it would take to show that depends on several factors, including how fast volunteers can be enrolled in trials and how much virus is circulating where the trials are taking place. Certainly it's a process that would take months.
The Trump administration has vowed to cut red tape to speed the approval process, and the normal process does require a lot of data and a lot of paperwork.
But the FDA has also said it would consider granting something called an Emergency Use Authorization, or EUA, to the makers of a vaccine candidate that appeared to be safe and effective.
That's where critics worry political influence could creep in.
"The EUA rules are loose," says Paul Offit, a vaccine developer at Children's Hospital of Philadelphia and a member of the FDA's Vaccines and Related Biological Products Advisory Committee. Usually, the FDA would rely on the independent scientists on that committee to advise it about important decisions concerning new therapies and vaccines. Offit worries the FDA could be pressured into issuing an EUA with little or no scrutiny of that decision.
It's a concern echoed by the leadership of the Infectious Diseases Society of America and HIV Medicine Association. In a letter to the FDA, they write, "We want to underscore that it is critical that FDA ensures sufficient safety and efficacy data are available and have been reviewed by internal as well as independent experts prior to granting an EUA."
FDA Commissioner Stephen Hahn has tried to assure skeptics that won't happen. He wrote an editorial dated Aug. 7 in the medical journal JAMA.
"The physician leadership of the U.S. Food and Drug Administration (including the authors of this Viewpoint) unequivocally state that candidate COVID-19 vaccines will be reviewed according to the established legal and regulatory standards for medical products," Hahn wrote.
metmike: Of course this is very political. Everybody knows it. This is why it's not 2022, with us still waiting on the drug with 1 million dead in the US by that time.
Politics from Trump has sped up the process and he will obviously continue to try to exert maximum political pressure to have the drug ready ASAP...this is what he does.
This WILL FOR SURE save many thousands of lives.
Will it get him elected? We will see but everybody should be for saving many thousands of lives, not just people that want Trump to be elected for a 2nd term.
Instead of celebrating this possibility and giving Americans hope and sharing good news.........many are concerned that it might get Trump elected.
More important to stop that than to save thousands of American lives.
But we are dealing with a group that has members who prefer a meteor strike that ends life on Earth to another Trump term. A pandemic with a 99+/-% survival rate is a relatively small price to pay.