CDC alerts states: Be ready to
distribute vaccines on Nov. 1
2 September, 2020
The federal government has told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1.
In a letter to governors dated Aug. 27, Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, said states “in the near future” will receive permit applications from McKesson Corp., which has contracted with CDC to distribute vaccines to places including state and local health departments and hospitals.
“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,” Redfield wrote.
He wrote that any waivers will not compromise the safety or effectiveness of the vaccine. The Associated Press obtained the letter, which was first reported by McClatchy.
Redfield told Yahoo Finance that officials were preparing “for what I anticipate will be reality, is that there’ll be one or more vaccines available for us in November, December.”
James S. Blumenstock, a senior vice president at the Association of State and Territorial Health Officials, said the CDC was offering “an aggressive but necessary timetable” but that public health agencies were mobilizing to prepare detailed plans.
Several vaccine and public health experts pointed out that final stage trials of experimental vaccines are still recruiting, and are at best halfway through that process. The vaccines are two doses, and each is given a month apart. Several experts told the AP they did not understand how there could be adequate data on whether the vaccines work and are safe before Nov. 1.
“Being ready is reasonable. Cutting short phase 3 trials before you get the information you need isn’t,” said Dr. Paul Offit, a Children’s Hospital of Philadelphia immunization expert who sits on the FDA’s vaccine advisory committee.
Peter Hotez, dean of Baylor University’s tropical medicine school, said he was “very concerned” about whether the Food and Drug Administration would use an emergency use authorization to approve a vaccine before knowing whether it works and is safe.
“It gives the appearance of a stunt rather than an expression of public health concern,″ Hotez said
Michael Osterholm, a University of Minnesota infectious disease expert, said he was concerned about an “October surprise” with a vaccine being rushed through ahead of the election.
“The public health community wants a safe and effective vaccine as much as anybody could want it,” Osterholm said. “But the data have to be clear and compelling, that the vaccine is effective and that it’s safe.”
FAUCI: WE COULD CUT
TRIALS SHORT AND GIVE
OUT COVID VACCINE
“RIGHT NOW”
"I'M NOT CONCERNED ABOUT POLITICAL PRESSURE."
2 September, 2020
According to Anthony Fauci, the United States’ top infectious disease expert, there could be a safe way to start giving out a COVID vaccine earlier than expected.
Fauci said during a Tuesday interview with Kaiser Health News that the Data and Safety Monitoring Board, a committee made up of independent experts who evaluate the safety of vaccine development, could decide that “‘the data is so good right now that you can say it’s safe and effective.'”
In other words, researchers could end the trials early and start giving out the vaccine.
Three COVID vaccines have reached late stage large-scale trials in the US, according to CNN, including one by pharmaceutical company Moderna.
It’s a touchy subject — and complicating matters is the politicization of the vaccine by U.S. president Donald Trump. Experts have claimed that Trump is pressuring regulators to release a vaccine early to help with his reelection later this year.
Fauci remained steadfast during Tuesday’s interview. “If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. “I’m not concerned about political pressure.”
Health experts are reluctant to make any claims as to when a coronavirus vaccine will be made available. Some claim that ending trials early would likely come with inherent safety risks, as CNN reports.
Fauci is optimistic. He believes that we could make rapid progress before the end of 2020.
“I believe that by the time we get to the end of this calendar year that we will feel comfortable that we do have a safe and effective vaccine,” Fauci told NBC today.
Fauci’s main concern right now, actually, is the upcoming flu season, something the nation needs to get ahead of.
“What I’d really like to see is a full court press to get us way down as a baseline, so that when you get these cases in the fall, they won’t surge up,” Fauci added.
READ MORE: There’s a legitimate way to end coronavirus vaccine trials early, Fauci says [CNN]
According to the Financial Times, the Trump administration wants to fast-track a vaccine developed by Oxford University and pharmaceutical company AstraZeneca by October — in time for the November presidential election.
But AstraZeneca insisted in response to the news that it has never discussed such an option with the White House, as The Guardian reports.
Late phase 2 and 3 trials, which are extremely important stages in the development of a safe and effective vaccine, are still ongoing in the UK.
The news comes on the heels of a whirlwind of erratic behavior by President Donald Trump, who also gloated over the FDA authorization of a new COVID-19 treatment using blood plasma from recovered patients, Reuters reports.
Trump also accused the Food and Drug Administration this weekend of purposefully delaying COVID-19 vaccine trials without showing any evidence, CNN reports.
Trump even pressured FDA commissioner Stephen Hahn, who was nominated to the position last year, in a Saturday tweet to act faster.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump wrote in a Saturday tweet, tagging Hahn’s official Twitter account.
“Obviously, they are hoping to delay the answer until after November 3rd,” Trump added, referring to the fall presidential election. “Must focus on speed, and saving lives!”
There’s currently zero evidence of the FDA intentionally delaying the development of a life-saving vaccine.
House Speaker Nancy Pelosi told reporters that “the FDA has a responsibility to approve drugs, judging on their safety and their efficacy, not by a declaration from the White House about speed and politicizing the FDA,” as quoted by CNN.
Pelosi also called Trump’s statements “very dangerous” and that “even for him, it went beyond the pale.”
The news also comes after Russia faced steep criticism from the scientific community over announcing the approval of an untested coronavirus vaccine that had yet to show any scientific merit or evidence that it’s safe for humans.
This week, 40,000 volunteers in Russia are set to be getting injected with the vaccine.
https://futurism.com/neoscope/trump-approve-covid-vaccine-before-done-testing
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