U.S. states told prepare yourself to distribute Covid-19 vaccine by Nov 1
03 September, 2020
The Trump administration has urged U.S. states to get ready to distribute a potential Covid-19 vaccine by Nov 1 -- two days prior to the presidential election.
Dallas-based wholesaler McKesson Corp includes a deal with the government and you will be requesting permits to create distribution centers when a vaccine becomes available.
"The normal time necessary to obtain these permits presents a significant barrier to the success of the urgent public health program," Robert Redfield, director of the Centers for Disease Control and Prevention, told states in an August 27 letter.
"CDC urgently requests your assistance in expediting applications for these distribution facilities."
Redfield asked states to consider waiving requirements that could "prevent these facilities from becoming fully operational by Nov. 1, 2020."
The CDC provided states with documents giving information on a vaccine rollout plan, adding that they might either be approved as licensed vaccines or under emergency use authorization.
Recipients would probably need a second "booster" dose, a couple weeks after the first, in line with the documents.
"Vaccine and ancillary supplies will be procured and written by the federal government free to enrolled Covid-19 vaccination providers," say the documents, which also visited NEW YORK, Chicago, Houston, Philadelphia and San Antonio.
Priority will be given to essential workers, national security officials, seniors and members of vulnerable racial and ethnic groups, based on the New York Times.
Three Western drug makers are progressing with their Phase 3 clinical trials, involving thousands of participants.
The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the U.S. National Institutes of Health; and the Pfizer/BioNTech alliance.
By the type of the trials, it is difficult to predict when reliable results will emerge.
Half of the participants in such trials receive an experimental vaccine, as the other half receive a placebo.
Under normal procedures, test administrators must wait -- probably for months -- to see whether there is a statistically factor in the infection rate of both groups.
THE UNITED STATES Food and Drug Administration however has raised the opportunity that a vaccine could be given emergency approval before the end of trials.
A obtain such extraordinary approval would need to come from the vaccine developer, FDA chief Stephen Hahn told the Financial Times within an interview published Sunday.
The FDA has faced mounting criticism from the medical community that it's bowing to political pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one could possibly be ready prior to the election.
In March, the FDA gave emergency authorization for the utilization of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious unwanted effects emerged.
Recently, Hahn delivered a much too optimistic appraisal, during a news conference with Trump, of the potency of convalescent plasma against the virus.
He said it could save 35 out of 100 patients; the much more likely number, experts said, is five in 100.
"This implies mass vaccination nationwide could begin in 59 days. FIFTY-NINE DAYS. Is any #COVID19 #vaccine more likely to have completed Phase 3 safety and efficacy clinical trials, and gone through full scientific and @US_FDA review in 59 days?" award-winning epidemiology writer Laurie Garrett asked on Twitter.
"To my knowledge, none of the united states #COVID19 #vaccines have finished even enrolling test subjects for Phase 3 trials. Rushing this to completion within 59 days is DANGEROUS."
Hahn, however, has insisted he's not acting under pressure from Trump, arguing that any vaccine approval will be a "science, medicine, data decision."
Top government scientist Anthony Fauci has said on several occasions that a vaccine ought to be ready between the end of 2020 and the first half of 2021.
"I assume that by enough time we get to the finish of this twelve months that we will feel safe that people do have a safe and effective vaccine," Fauci told NBC.
The U.S. has registered a lot more than six million Covid-19 cases -- almost 25 % of the global total -- and 185,000 deaths, according to Baltimore-based Johns Hopkins University.
Source: japantoday.com