US states told be ready to distribute COVID-19 vaccine by November 1
In this file photo taken on April 24, 2020, shows the Centers for Disease Control (CDC) headquarters in Atlanta, Georgia. The Trump administration has urged US states to get ready to distribute a potential Covid-19 vaccine by November 1, media reported on September 2, 2020, in the latest sign of the accelerating race to deliver a vaccine by year's end. "CDC urgently requests your assistance in expediting applications for these distribution facilities," read a letter from Robert Redfield, director of the Centers for Disease Control and Prevention, quoted by The Wall Street Journal.
AFP/Tami Chappell
US states told be ready to distribute COVID-19 vaccine by November 1
Frankie Taggart (Agence France-Presse) - September 3, 2020 - 8:15am

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.

COVID-19 VACCINE NOVEL CORONAVIRUS UNITED STATES
As It Happens
LATEST UPDATE: November 26, 2020 - 11:53am

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)

November 26, 2020 - 11:53am

Cash-strapped Latin American governments face severe geographical, economic and social challenges in trying to ensure life-saving COVID-19 vaccines are made available to vulnerable populations, experts say. 

Megacities like Sao Paulo, mountain ranges like the Andes as well as the vast Amazon basin pose just a few of the geographical problems for distributors, given the vital need to maintain the cold chain to preserve the vaccines.

Transporting vaccines "to the most distant parts of the big cities and to peripheral neighborhoods, with the need to conserve the cold chain, will be the first major challenge," Colombian epidemiologist Carlos Trillos told AFP.

Governments also face a race against time to provide training to those handling the doses throughout the cold chain, he said. — AFP

November 25, 2020 - 10:47am

The United States plans to distribute 6.4 million doses of the Pfizer-BioNTech COVID-19 vaccine in the first week after it is cleared for emergency use, which is likely next month, officials say Tuesday.

A committee of the Food and Drug Administration meets on December 10 to decide whether to green light the medicine, with the US confronted by soaring numbers of deaths and new cases.

Latest figures on Tuesday showed that the country had recorded a total of 259,600 COVID deaths and 12.5 million cases — with over 2,000 deaths and 167,000 new cases in just the last 24 hours.

General Gustave Perna, chief operations officer for the government's Operation Warp Speed, told reporters some 40 million doses of vaccine would be available by the end of December.

That figure includes another vaccine developed by Moderna and the National Institutes for Health, which announced some preliminary efficacy results last week and is also close to applying for emergency approval. — AFP

November 25, 2020 - 10:33am

The United States plans to distribute 6.4 million doses of the Pfizer-BioNTech COVID-19 vaccine in the first week after it is cleared for emergency use, which is likely next month, officials say.

A committee of the Food and Drug Administration meets on December 10 to decide whether to green light the medicine, with the US confronted by soaring numbers of deaths and new cases. — AFP 

November 24, 2020 - 6:48pm

Russia's Sputnik V coronavirus vaccine is 95% effective according to a second interim analysis of clinical trial data, its developers said on Tuesday.

The calculations were based on preliminary data obtained 42 days after the first dose, Russia's health ministry, the state-run Gamaleya research centre and the Russian Direct Investment Fund (RDIF) said in a statement. 

They did not note the number of cases used to make the calculation, however. — AFP

November 23, 2020 - 5:20pm

European stock markets opened firmer Monday, buoyed as positive news on another coronavirus vaccine trial helped offset concerns over soaring case numbers, dealers said.

In London, the FTSE 100 index of leading shares was up 0.5 percent at 6,382.36 points.

In the Eurozone, the Paris CAC 40 gained nearly one percent to 5,543.83 points and the Frankfurt DAX put on 0.6 percent to 13,219.25 points.

Shortly before the markets opened, British drugs group AstraZeneca and the University of Oxford said their jointly-developed vaccine against COVID-19 has shown "an average efficacy of 70 percent" in trials, and up to 90 percent in one dosage combination. — AFP

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