WASHINGTON -- The Centers for Disease Control and Prevention on Wednesday sent all 50 states a "playbook" for distribution of a vaccine to all Americans free of cost when one is proved safe and effective.
President Donald Trump said that a safe and effective vaccine against the coronavirus could be ready as early as next month and in mass distribution soon after.
However, earlier in the day, CDC Director Dr. Robert Redfield said at a congressional hearing that health care workers, first responders and others at high risk would get the vaccine first, perhaps in January or even late this year, but that it was unlikely to be available more broadly before late spring or summer.
After Trump's comments, CDC officials said Wednesday night that the director had thought he was answering a question about when vaccination of all Americans might be completed.
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Redfield wasn't the only top U.S. health official offering a less ambitious forecast for getting a vaccine out to the public. Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services, said it would probably be widely available by the end of March. And Dr. Anthony Fauci, the head of the National Institute for Allergy and Infectious Diseases, forecast a timeline similar to Redfield's.
In an interview Wednesday, Fauci called Mango's first-quarter timeline for full vaccine use "aspirational." It's more likely, Fauci said, that it happens more toward the middle to the end of 2021. "It depends on what the vaccine is," he said.
In an interview for the Bloomberg Equality Summit, which takes place next week, Fauci said he's "reasonably confident" that at least one vaccine will be available by November or December. Wide-scale adoption of a vaccine, along with continuing -- though less intense -- reliance on social distancing and mask-wearing will allow a return to near-normal by the end of 2021, he said.
By then, Fauci said, "I believe we can approach and perhaps reach a degree of normality that closely resembles what we had before this particular outbreak occurred."
GETTING READY
Redfield, masked at times in a Senate hearing room, also spoke of the importance of everyone wearing protective masks to stop the pandemic, which has killed nearly 200,000 Americans. He floated the possibility that a vaccine might be 70% effective in inducing immunity and said, "I might even go so far as to say that this face mask is more guaranteed to protect me against covid than when I take a covid vaccine."
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Trump disagreed with Redfield about the effectiveness of protective masks -- which the president recommends but seldom wears in public -- and said he'd called Redfield to tell him so.
A "vaccine is much more effective than the mask," Trump said.
Potential vaccines are still being tested in human subjects, and some health experts have said they believe a safe and highly effective vaccine is several months way, if not much longer.
The CDC sent a planning document on Wednesday to U.S. states, territories and some big cities. Adding to logistical complications, vaccines likely will have to be given in two doses spaced weeks apart and will have to be refrigerated.
Redfield said states are not ready to deal with the demand for such a distribution and that some $6 billion in new funding would be needed to get the nation prepared. "We do not have the resources to support 64 jurisdictions to get this plan operational. To me, it's an urgency that we get that," Redfield told the Senate Labor, Health and Human Services appropriations subcommittee.
Congress could give the CDC the requested funding in another virus stimulus package or in a funding resolution that would need to be passed before Sept. 30.
Redfield said any vaccine available in November or December would be in "very limited supply" and reserved for first responders and people most vulnerable to covid-19. The shot wouldn't be broadly available until the spring or summer of 2021, he estimated.
APPOINTEE ON LEAVE
Meanwhile, the Health and Human Services Department announced Wednesday that political appointee Michael Caputo would take a leave of absence to "focus on his health and the well-being of his family."
The news followed revelations that Caputo had tried to gain editorial control over the CDC's scientific publications on covid-19. That was followed by reports about a video on his Facebook page in which he likened government scientists to a "resistance" against Trump.
Redfield said that the "scientific integrity" of his agency's reports "has not been compromised, and it will not be compromised under my watch." He also rejected questions about whether the CDC's timeline for states to be ready for a vaccine by Nov. 1 was politically motivated.
"The worst thing that could happen is if we have a vaccine delivered and we're still not ready to distribute," Redfield told Senate lawmakers. "There was absolutely no political thinking about it."
Sen. Patty Murray of Washington, the committee's top Democrat, called for Caputo's resignation and said political interference from Health and Human Services had damaged public trust in the government's health information.
"The Trump administration needs to leave the science to the scientists immediately," Murray said.
Leaving the department is Paul Alexander, who was brought in as a policy adviser to Caputo on a temporary basis, the department's statement said.
Rep. James Clyburn, D-S.C., who leads a special panel overseeing the government's covid-19 response, called the shakeup at Health and Human Services "an important first step." Nonetheless, Clyburn said he has started an investigation into the allegations that Caputo to interfere with the CDC publication.
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In a Health and Human Services podcast July 31, Caputo spoke of having "a target on my back." He also accused the news media and Democrats in the government of not wanting a vaccine so as to punish the president.
Democratic presidential nominee Joe Biden said while campaigning that he trusts what scientists say about a potential vaccine. Biden has said he would take a vaccine "tomorrow" if it were available but that he would want to "see what the scientists said" first.
PLAN FOR STATES
As for the planned vaccine campaign, Redfield said his agency will be working with state health officials to implement the preparations in coming days.
Among the highlights of the plan:
• 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, and the focus will be on protecting health workers, other essential employees, and people in vulnerable groups. A second and third phase would expand vaccination to the entire population.
• The vaccines will be free of charge, thanks to billions of dollars in taxpayer funding approved by Congress and allocated by the Trump administration. The goal is that patients won't be separately charged for administration of their shots, and officials say they are working to ensure that's the case for all Medicare recipients and uninsured people as well as those covered by insurance at their jobs.
• 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.
• A widespread information technology effort will be needed to track who is getting which vaccines and when, and the key challenge involves getting multiple public and private databases to link with each other.
WARP SPEED
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. Distribution is under the umbrella of Operation Warp Speed.
Scott Atlas, an adviser to the president, said during Trump's news conference Wednesday that 24 hours after a vaccine is approved on an emergency basis by the Food and Drug Administration, the government will start delivering the shots to the public.
The U.S., through its Operation Warp Speed program, has already secured supply of vaccines furthest along in clinical trials, including those being developed by Pfizer and BioNTech, AstraZenca in partnership with the University of Oxford, and Moderna.
Operation Warp Speed was formed by the Trump administration to unite health agencies and the Department of Defense with the objective of accelerating the development and production of a coronavirus vaccine. The medicines typically require years to develop and test before they're approved for sale.
Mango, speaking in a telephone interview, said the administration is confident it will have 100 million doses of an effective vaccine for elderly people, who are more vulnerable to the virus, available before the end of the year. He stressed that "there's never a 100% guarantee" that timelines will be met.
If a vaccine is approved in October, only about 20 million doses will be ready for distribution and use, he said.
"Whether that happens in October, November or December is a bit out of our hands," Mango said, referring to a vaccine approval. "I would say it's possible, it's certainly possible, it happens in October. It's more likely it happens in November or December."
IN EUROPE
Elsewhere, European Commission President Ursula von der Leyen said Wednesday that the bloc must rise above its fragmented approach on dealing with the coronavirus by centralizing more decision-making on health issues.
She also told European Union legislators that Italy will host a global health summit next year, during its Group of 20 presidency.
Von der Leyen fully acknowledged the fragile state that the pandemic has left EU in, with the death toll closing in on 150,000 and the economy facing the worst slump in the bloc's history.
To counter this, von der Leyen said, she wants more money poured into research and development and more powers going to EU-wide institutions like the European Medicines Agency.
In Spain, pneumonia, a common acute manifestation of the covid-19 disease, is keeping intensive care wards busy again. And it's also leaving medical workers who are still recovering from the pandemic's peak with an anxious sense of deja vu.
With 1,281 patients in ICUs as of Wednesday, Spain has roughly as many beds devoted to treat gravely ill patients of covid-19 as France, the United Kingdom, Germany and Italy together. And 359 of them are in the Madrid region, which for the past week has accounted for roughly one-third of a national average of 8,200 new infections per day.
Spain's virus caseload, above 600,000, is one of the world's highest. More than 30,000 have died in the country because of the coronavirus.
In the United Kingdom, lawmakers criticized the government's handling of the testing crisis for a second day Wednesday, as opposition leaders claimed Prime Minister Boris Johnson lacked a cohesive plan to tackle the virus at a time when the country faces a second wave in the pandemic.
Johnson defended his efforts to increase testing capacity, telling the House of Commons that the government was responding to a "colossal" increase in demand and arguing that Britain is testing more people than other European countries.
Information for this article was contributed by Matthew Perrone, Ricardo Alonso-Zaldivar, Michael Stobbe, Aritz Parra, Danica Kirka, Sylvia Hui, Richard Lardner, Mary Clare Jalonick, Eric Tucker and Alexandra Jaffe of The Associated Press; and by Shira Stein and Jack Fitzpatrick of Bloomberg News.
