US states told be ready to distribute COVID-19 vaccine by November 1
WASHINGTON, United States — The Trump administration has urged US states to get ready to distribute a potential Covid-19 vaccine by November 1 — two days before the presidential election.
Dallas-based wholesaler McKesson Corp. has a deal with the federal government and will be requesting permits to set up distribution centers when a vaccine becomes available.
"The normal time required to obtain these permits presents a significant barrier to the success of this 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 would "prevent these facilities from becoming fully operational by Nov. 1, 2020."
The CDC provided states with documents giving details of a vaccine rollout plan, adding that they would either be approved as licensed vaccines or under emergency use authorization.
Recipients would probably require a second "booster" dose, a few weeks after the first, according to the documents.
"Vaccine and ancillary supplies will be procured and distributed by the federal government at no cost to enrolled Covid-19 vaccination providers," say the documents, which also went to New York City, Chicago, Houston, Philadelphia and San Antonio.
Serious side effects
Priority will be given to essential workers, national security officials, seniors and members of vulnerable racial and ethnic groups, according to The New York Times.
Three Western drug makers are progressing with their Phase 3 clinical trials, involving tens of thousands of participants.
The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health; and the Pfizer/BioNTech alliance.
By the nature of the trials, it is difficult to predict when reliable results will emerge.
Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo.
Under normal procedures, test administrators must wait -- probably for months -- to see whether there is a statistically significant difference in the infection rate of the two groups.
The US Food and Drug Administration however has raised the possibility that a vaccine might be given emergency approval before the end of trials.
A request for such extraordinary approval would have to come from the vaccine developer, FDA chief Stephen Hahn told the Financial Times in an interview published Sunday.
The FDA has faced mounting criticism from the medical community that it is bowing to political pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before the election.
In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.
'Safe and effective'
More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, 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 in 100.
"This means mass vaccination nationwide could start in 59 days. FIFTY-NINE DAYS. Is any #COVID19 #vaccine 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 US #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 is not acting under pressure from Trump, arguing that any vaccine approval would be a "science, medicine, data decision."
Top government scientist Anthony Fauci has said on several occasions that a vaccine should be ready between the end of 2020 and the first half of 2021.
"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.
The US has registered more than six million Covid-19 cases -- almost a quarter of the global total -- and 185,000 deaths, according to Baltimore-based Johns Hopkins University.
Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."
This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)
As negotiations towards a new pandemic treaty pick up pace, observers warn of watered-down efforts to ensure equitable access to the medical products needed to battle future Covid-like threats.
Shaken by the pandemic, the World Health Organization's 194 member states are negotiating an international accord aimed at ensuring countries are better equipped to deal with the next catastrophe, or even prevent it altogether.
The process is still in the early stages, with the aim of reaching an agreement by May 2024.
But critics warn that revisions being made to the preliminary negotiating text are weakening the language -- notably in a key area aimed at preventing the rampant inequity seen in access to vaccines and other medical products during the Covid pandemic.
"I think it is a real step backwards," Suerie Moon, co-director of the Global Health Centre at the Geneva Graduate Institute, told AFP. — AFP
Africa's first mRNA vaccine hub is ceremonially launched on Thursday to acclaim from the UN's global health chief, who hailed it as a historic shift to help poor countries gain access to life-saving jabs.
The facility was set up in the South African city of Cape Town in 2021 on the back of the success of revolutionary anti-Covid vaccines introduced by Pfizer/BioNTech and Moderna.
"This precious project... will bring a paradigm shift in addressing the serious problem we faced, the equity problem, during the pandemic, so (that) it's not repeated again," World Health Organization (WHO) head Tedros Adhanom Ghebreyesus tells a media briefing to mark the inauguration. — AFP
China has approved its first locally developed messenger RNA (mRNA) vaccine against Covid-19, its manufacturer said Wednesday, months after the relaxation of strict Covid-zero regulations sparked a surge in cases.
The vaccine, developed by CSPC Pharmaceutical Group Ltd, has been approved for "emergency use" by Beijing's health regulator, the company said in a statement.
It showed high efficacy in a trial in which it was used as a booster shot for people who have been given other types of vaccines, the company added, without offering further details. — AFP
COVID-19 vaccine maker Novavax raises doubts about its ability to continue its business, announcing plans to cut spending after struggles in rolling out its coronavirus jab.
Shares of Novavax plummeted 25 percent in extended trading, after the company reported fourth-quarter earnings that missed analyst estimates.
While the firm should have enough money to fund operations, the situation is "subject to significant uncertainty," it says in a statement. — AFP
The protection against Covid-19 from being previously infected lasts at least as long as that offered by vaccination, one of the largest studies conducted on the subject says.
Ten months after getting Covid, people still had an 88% lower risk of reinfection, hospitalisation and death, according to the study published in the Lancet journal.
That makes this natural immunity "at least as durable, if not more so" than two doses of Pfizer or Moderna's vaccines, the study says.
The authors nevertheless emphasized that their findings should not discourage vaccination, which remains the safest way to get immunity. — AFP
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