White House says coronavirus vaccines will ship within 24 HOURS of FDA approval as it unveils 'playbook' to start giving FREE coronavirus immunizations to all Americans by January (all we need now is a vaccine!)
* Health officials and the Department of Defense outlined their 'playbook' for states to start giving out free coronavirus
vaccines before Congress Wednesday
* The Pentagon will help roll out the shots which will be administered by health workers
* Americans could start getting vaccinated as early as January of next year or late this year
* Vaccination will not be required, but anyone who wants a shot will be able to get it for free
* Multiple drugmakers will provide shots to the US, with most coming in two doses delivered 21 to 28 days apart
The Trump administration plans to start shipping coronavirus vaccines within 24 hours of approval from regulators, the government announced Wednesday in its 'playbook' to make vaccines for COVID-19 available for free to all Americans as early as January.
In accompanying testimony before a Senate committee, Centers for Disease Control and Prevention (CDC) director Robert Redfield said a vaccine likely won't be available to the public until spring or summer of 2021.
No companies have completed testing for their coronavirus vaccines or gotten Food and Drug Administration (FDA) approval for them.
Yet Trump has continued to insist that a vaccine will be ready in a matter of weeks - ahead of Election Day on November 3.
In a report to Congress and an accompanying 'playbook' for states and localities, federal health agencies and the Defense Department sketched out complex plans for a vaccination campaign to begin gradually in January or possibly later this year, eventually ramping up to reach any American who wants a shot.
Vaccines will be available to anyone, regardless of whether or not they have health insurance.
Whenever a vaccine to combat the virus that has infected more than 6.6 million Americans and killed nearly 196,000 people in the US, the Pentagon plans to be involved with the distribution of vaccines, but civilian health workers will be the ones giving shots.
The campaign is 'much larger in scope and complexity than seasonal influenza or other previous outbreak-related vaccination responses,' said the playbook for states from the CDC.
President Trump tweeted: 'Vaccines are moving along fast and safely!' following the report's presentation on Wednesday, as the US recorded an uptick of more than 51,000 cases and over 1,400 deaths over the past 24 hours.
Among the highlights in the 'playbook':
For most vaccines, people will need two doses, 21 to 28 days apart. Double-dose vaccines will have to come from the same drugmaker. There could be several vaccines from different manufacturers approved and available.
Vaccination of the U.S. population won't be a sprint but a marathon. Initially there may be a limited supply of vaccines available, and the focus will be on protecting health workers, other essential employees, and people in vulnerable groups. The National Academy of Medicine is working on priorities for the first phase. A second and third phase would expand vaccination to the entire country.
The vaccine itself will be free of charge, and patients won't be charged out of pocket for the administration of shots, thanks to billions of dollars in taxpayer funding approved by Congress and allocated by the Trump administration.
States and local communities will need to devise precise plans for receiving and locally distributing vaccines, some of which will require special handling such as refrigeration or freezing. States and cities have a month to submit plans.
Some of the broad components of the federal plan have already been discussed, but Wednesday's reports attempt to put the key details into a comprehensive framework.
Nonetheless, some experts are concerned that these plans are being made and presented prematurely.
'Isn't this putting the cart before the horse?' Dr Peter Hotez, dean of the Baylor College of Medicine's National School of Tropical Medicine, said in an interview with DailyMail.com.
'We don't really understand the full extent of efficacy or safety of these vaccines, and each vaccine may be different.
'Some may prevent infection versus some [others that] will reduce the severity of illness. So it's very complicated to understand the different variations in terms of efficacy and safety and come up with a full plan.'
Dr Hotez also questioned the impetus for the report, wondering whether Congress had asked to see a plan like that laid out on Wednesday, or if it was something 'the WHite House is promoting.'
Either way, 'this is unprecedented,' he said.
Distribution is happening under the umbrella of Operation Warp Speed, a White House-backed initiative to have millions of doses ready to ship once a vaccine is given what's expected to be an emergency use approval by the Food and Drug Administration (FDA). Several formulations are undergoing final trials.
But the whole enterprise is facing public skepticism. Only about half of Americans said they'd get vaccinated in an Associated Press poll taken in May.
Of those who wouldn't get vaccinated, the overwhelming majority said they were worried about safety.
To effectively protect the nation from the coronavirus, experts say upwards of 70 percent of Americans must either be vaccinated or have their own immunity from fighting off COVID-19.
Since the poll, questions have only mounted about whether the government is trying to rush COVID-19 treatments and vaccines to help President Donald Trump's reelection chances.
Before the Republican National Convention in August, the FDA granted authorization for treatment of COVID-19 patients with plasma from people who have recovered, even though some government scientists were not convinced the clinical evidence was sufficiently strong.
And last week it was reported that Michael Caputo, a Health and Human Services (HHS) Department political appointee, tried to gain editorial control over a weekly scientific publication from the Centers for Disease Control and Prevention (CDC).
As public confidence in core health agencies has taken a beating, Trump administration officials have been forced to play defense.
'We are working closely with our state and local public health partners...to ensure that Americans can receive the vaccine as soon as possible and vaccinate with confidence,' HHS Secretary Alex Azar said in a statement Wednesday.
'Americans should know that the vaccine development process is being driven completely by science and the data.'
That could be a tough sell. In the AP poll, one in five Americans said they would not get a coronavirus vaccine, and 31 percent said they were unsure.
And the timeline for vaccine approval being touted by Trump is suspiciously serendipitous.
In late August, the CDC sent guidance to US states instructing them to prepare for the possible approval and arrival of coronavirus vaccines as early as the end of October.
The announcement was met with outcry and skepticism from many health experts, appalled that the CDC would tease an arrival date for shots before any have been approved by the FDA regulators and concerned that the rush to get a shot approved by the end of next month could result in an unsafe, unproven vaccine.
Many, including Dr Hotez, speculated that it was a politically-motivated timeline after the documents detailing instructions for the states were leaked to the New York Times.
Subsequently, Trump hinted that vaccines could be approved 'before a very special date,' likely referring to the November 3 election.
In response, nine major companies developing coronavirus vaccines - including Pfizer, AstraZeneca and Moderna, which are currently leading the shot development race - pledged that they would not seek approval for a shot without being absolutely certain their respective vaccines were safe.
Top health officials, including Surgeon General Dr Jerome Adams, vaccine czar Dr Moncef Slaoui and Dr Anthony Fauci said it possible, but unlikely that a COVID-19 vaccine would be ready that early - although Dr Fauci also acknowledged that a company could end its vaccine trial early, expediting the approval process, if there was overwhelming evidence that the vaccine worked, and was safe.
US Reports An Uptick In Average Daily COVID-19 Cases And Deaths For The First Time Since July As North Dakota, Wisconsin And South Carolina All Record Single-Day Highs
The United States is showing a slight uptick in the average number of daily coronavirus cases and deaths - as about 20 states reported increases in new infections in the past week.
The average number of infections per day was at more than 37,000 on Tuesday after increasing steadily since the weekend.
Cases, on average, have been trending downwards nationally since July when about 70,000 infections were being reported daily.
Daily deaths are now averaging at just over 840 per day after the average number of fatalities dropped to 720 a week ago.
Deaths in the US have been declining steadily since mid-August when an average of 1,000 American were dying each day.
More than 195,000 Americans have now died from COVID-19 and there has been over 6.6 million infections.
The uptick in cases comes after health officials had warned there could be increases following the Labor Day weekend.
It comes as 20 states reported an uptick in cases within the last week with North Dakota, Wisconsin and South Carolina all recording single-day highs in new infections.
South Carolina's infection peaked at 2,454 on September 11 with the state now recording more than 133,00 cases.
North Dakota's cases spiked to a record 467 on September 12 and now total more than 16,000.
Cases in Wisconsin surged to a single day high of 1,624 on September 13. Infections in the state have risen 38 per cent in the last week, bringing the total to more than 96,900.
Twelve of the 20 states that have seen increases in the last week have high case numbers in relation to the population.
They include North Dakota, Wisconsin, South Carolina, Missouri, Oklahoma, Arkansas, Tennessee, Nebraska, Kentucky, Utah and Louisiana.
An indoor event in Henderson, Nevada drew thousands on Sunday.
Trump on Monday also drew hundreds of supporters to an indoor event in Phoenix, Arizona that his campaign advertised as a 'Latinos for Trump roundtable'.
Trump has made the case that if demonstrators can gather en masse for protests over racial injustice, so can his supporters. His campaign has insisted that it takes appropriate health precautions, including handing out masks and hand sanitizer and checking the temperatures of those in attendance.
It comes after it emerged last week that Trump had referred to the virus as 'deadly stuff' in a private conversation with Bernstein's former reporting partner Bob Woodward.
Trump, at the same time, was publicly downplaying the threat of COVID-19.
Three days after delivering his 'deadly' assessment in a private call with Woodward, he told a New Hampshire rally on February 10 that 'it's going to be fine'.
Trump's acknowledgment in Woodward's new book 'Rage' that he was minimizing the severity of the virus in public to avoid causing panic has triggered waves of criticism that he wasn't leveling with the American people.
The president told Woodward on March 19 that he had deliberately minimized the danger. 'I wanted to always play it down,' the president said. 'I still like playing it down because I don´t want to create a panic.'
Community Forum
Topic: White House says coronavirus vaccines will ship within 24 HOURS of FDA approval (Read 989 times)
November 27, 2009, 04:43:15 pm