Washington, United States:
The Trump administration has urged the US states to prepare to distribute a potential Covid-19 vaccine by November 1, two days before the presidential election.
Dallas-based wholesaler McKesson Corp. has a contract with the federal government and will ask for permission to set up distribution centers once a vaccine is available.
“The normal time it takes to obtain these approvals is a significant barrier to the success of this urgent public health program,” said Robert Redfield, director of the Centers for Disease Control and Prevention Letter of August 27 to the States.
“CDC urges you to help expedite applications for these distribution facilities.”
Redfield urged states to consider waiving requirements that would “prevent these facilities from becoming fully operational by November 1, 2020”.
The CDC sent documents to states detailing a vaccine rollout plan, adding that they would either be approved as approved vaccines or under emergency approval.
Recipients would likely need a second “booster” dose a few weeks after the first, the records indicate.
“Vaccines and relief supplies are procured free of charge by the federal government and distributed to registered Covid-19 vaccination providers,” said the documents, which also went to New York, Chicago, Houston, Philadelphia and San Antonio.
Serious side effects
According to the New York Times, priority will be given to key workers, national security officials, the elderly and members of vulnerable racial and ethnic groups.
Three Western drug companies are making progress in their Phase 3 clinical trials, which involve tens of thousands of participants.
The three are AstraZeneca, which works with Oxford University in England; Moderna in collaboration with the US National Institutes of Health; and the Pfizer / BioNTech alliance.
The nature of the trials makes it difficult to predict when reliable results will be available.
Half of the participants in such studies will receive an experimental vaccine, while the other half will receive a placebo.
Under normal procedures, test administrators will have to wait – likely months – to see if there is a statistically significant difference in the rate of infection between the two groups.
However, the U.S. Food and Drug Administration has raised the possibility that a vaccine could get emergency approval before the trials end.
An application for such an extraordinary approval would have to be made by the vaccine developer, FDA chief Stephen Hahn told the Financial Times in an interview published on Sunday.
The FDA has received increasing criticism from the medical community for bowing to political pressure from President Donald Trump, who pushed hard for a vaccine and claims one may be ready before the election.
In March, the FDA granted emergency approval for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use. The approval had to be withdrawn in June after severe side effects occurred.
“Safe and Effective”
More recently, during a press conference with Trump, Hahn made a far too optimistic assessment of the effectiveness of convalescent plasma against the virus.
He said it could save 35 out of 100 patients; The more likely number, experts said, is five out of 100.
“This means nationwide mass vaccination could begin in 59 days. Fifty-nine days. Is it likely that # COVID19 #vaccine will have completed Phase 3 safety and efficacy clinical trials and a full scientific and @ US_FDA review in 59 days.” has gone through? ” asked award-winning epidemiology writer Laurie Garrett on Twitter.
“To the best of my knowledge, none of the US # COVID19 # vaccines have completed subject registrations for Phase 3 trials. It is DANGEROUS to complete this within 59 days.”
However, Hahn has insisted that he is not acting under pressure from Trump, arguing that any vaccine approval would be a “science, medicine, data decision.”
Leading government scientist Anthony Fauci has said several times that a vaccine should be ready between late 2020 and the first half of 2021.
“I believe that by the end of this calendar year we will feel confident that we have a safe and effective vaccine,” Fauci told NBC.
The United States has registered more than six million Covid-19 cases – nearly a quarter of the global total – and 185,000 deaths, according to Johns Hopkins University in Baltimore.
(This story was not edited by GossipMantri staff and is automatically generated from a syndicated feed.)