“We are on the brink of seeing the fruits of our labor,” said Gen. Gustave Perna, chief operating officer for Operation Warp Speed, the initiative created by the administration to get a safe vaccine approved and distributed as quickly as possible.
The administration is working on two parallel tracks to get a vaccine approved and ready to distribute.
Perna said he, along with Warp Speed chief Moncef Slaoui, recently visited the Tennessee offices of McKesson, the major vaccine distributor that has contracted with the government to head up distribution of eventual coronavirus vaccines.
“At the end of the day I chose [McKesson] because they know how to do it,” Perna said.
Once the Food and Drug Administration approves a coronavirus vaccine for emergency use — expected to happen in late November or early December if trials continue going well — McKesson will partner with FedEx and UPS, along with a number of pharmacies and grocery stores including Walmart, CVS, Walgreens and Kroger, to get the doses shipped around the country, Perna said.
The Defense Department is closely involved in the effort, prompting concerns that an agency not accustomed to delivering vaccines might be charged with the critical task. Perna insisted, however, that the department is helping with logistics and program support — not distribution.
“There will not be this vision some people have of army trucks driving through the street delivering vaccine,” he told listeners on the online forum. “This is not feasible nor the proper way to do this.”
States also have a role to play. They’ve all submitted to the federal government plans for distributing a vaccine, with varying standards for who should get a vaccine first and how quickly the process should move.
The vaccine news couldn't come at a more critical time as cases of the novel coronavirus are surging across the country – and public health officials warn things could deteriorate further over the winter. Trump, however, continues to insist the country is “rounding the corner” in the disease as the election approaches next Tuesday, and his chief of staff said this weekend that the virus could only be controlled through a vaccine and therapeutics.
The process is moving with unprecedented speed, but there are plenty of challenges.
For one thing, vaccines require cold storage. Medical professionals distributing a vaccine will also need equipment including needles, syringes, alcohol, pads, bandages and masks.
And government officials say it’s critical to track who is getting the vaccine and where. Five of the six vaccines being developed as part of Warp Speed — excluding the vaccine being developed by Johnson & Johnson — require two doses. People who receive a first dose will need to be given the same vaccine in their second dose.
“We need to know where every vial is, whether it was in the factory or on a truck or distributed to a vaccination site,” said Matthew Hepburn, head of vaccine development for Operation Warp Speed.
The White House claimed yesterday it has successfully ended the pandemic, even as infections and hospitalizations grow.
The White House Office of Science and Technology Policy wrote that it considered “ending the covid-19 pandemic” to be one of the president's major first term accomplishments.
The report, which listed achievements of the Trump administration in the area of science and innovation, prompted heated pushback – including among health officials and scientists working on the coronavirus task force.
Four officials told The Daily Beast they viewed the White House statement as a personal slight and a public rebuke of their efforts to try and get control of the virus.
“It’s mind-boggling,” one official said of the White House’s assertion it had ended the pandemic. “There’s no world in which anyone can think that [statement] is true. Maybe the president. But I don’t see how even he can believe that. We have more than 70,000 new cases each day.”
Meanwhile, Perna and Hepburn said they expect tens of millions of vaccine doses to be ready by the end of the year.
And that supply will ramp up dramatically within weeks, according to Hepburn, who said hundreds of millions of doses will be available in January, February and March.
They pointed to several massive final-stage trials that are moving quickly. As of Thursday, Moderna had fully enrolled 30,000 people in its Stage 3 vaccine trial. Yesterday, Pfizer announced its own trial has neared its goal of enrolling 44,000 people. Nearly 36,000 of the participants have received the second of two doses of the vaccine.
And Johnson & Johnson is preparing to resume recruitment in its Phase 3 trial after pausing it because of an unexplained illness earlier this month.
Hepburn noted how massive the trials are, saying the size of the testing pool can give Americans confidence that an FDA-approved vaccine can be trusted. Final-stage trials typically involve 5,000 or maybe 8,000 people; these involve tens of thousands of volunteers.
“Over 60,000 Americans have decided to say: ‘I will volunteer,’ ” Hepburn said. “We’re very proud of that spirit of volunteerism we see in America.”
Even critics of the Trump administration have called its vaccine development effort excellent.
“Going from where we were in January and February — where we are going to be hit by this tsunami — to very likely having a vaccine, or more than one vaccine, that is proven safe and effective within a year, is staggeringly impressive, and would only have happened with strong and effective federal action,” Robert Wachter, chair of the department of medicine at the University of California at San Francisco, told my colleague Carolyn Y. Johnson last week.
Wachter has strongly criticized the administration’s response to the pandemic, but he called the vaccine effort “nearly flawless” so far — words he said he found difficult to say, Carolyn wrote.
Ahh, oof and ouch
AHH: Health-care systems are stretched to the limit as coronavirus hospitalizations surge.
“More than 42,000 people were hospitalized nationally with the virus Monday, a figure that is steadily climbing toward the midsummer peak caused by massive outbreaks in the Sun Belt. In the places hit the hardest, this is nudging hospitals toward the nightmare scenario of rationing care,” Joel Achenbach, Karin Brulliard, Brittany Shammas and Jacqueline Dupree report.
El Paso has begun setting up field hospitals to handle patient overflow after its hospital beds reached 100 percent capacity this weekend. Meanwhile, in the entire state of North Dakota, there were only 25 intensive care unit beds staffed and available as of Monday across 11 hospitals.
“The medical community vividly remembers the crisis in New York hospitals in the spring and the catastrophe in northern Italy, where the oldest patients were left untreated so that doctors could try to save younger patients,” Joel, Karin, Brittany and Jacqueline write. “In Utah, the president of that state’s hospital association, Greg Bell, has warned that within two weeks, the hospitals may have to start rationing care among the most seriously ill patients in intensive care units.”
Hospitalizations are still below where they were in July, but experts warn that the situation could get worse. Hospitalizations lag behind infections, which hit a single-day record of 83,000 new cases on Saturday.
Public health officials are also particularly worried about more outbreaks over the holidays, especially as colder weather drives people indoors. One example from abroad offers a stark warning: Canada, which celebrates Thanksgiving about six weeks before the United States, is already seeing a spike in cases tied to the holiday.
OOF: Surging cases are not simply the result of more testing.
Trump has sought to blame the increase in cases on increased testing, tweeting on Monday that the wave of infections was a “media conspiracy.”
But his administration’s testing czar contradicted that theory during a Washington Post Live event on Tuesday. Adm. Brett Giroir, assistant secretary for health for the U.S. Department of Health and Human Services, said that the increase in cases was real.
“Testing may be identifying some more cases, I think that's clearly true, but what we're seeing is a real increase in the numbers,” Giroir said. “We know that not only because the case numbers are up and we can calculate that, but we know that hospitalizations are going up.”
Giroir struck a more optimistic note on vaccines. While he acknowledged that it was unlikely all Americans would get a vaccine until mid-2021, he argued that the country could see massive reductions in mortality once an effective vaccine made its way to the most vulnerable populations.
“We could immunize the most critical ones this year,” Giroir said. “We might be able to save 80 percent of the lives.”
OUCH: Congress has failed to deliver economic relief even as the toll from the pandemic worsens.
“Congress left Washington until after the election without passing any new economic or health-care relief measures even as the coronavirus pandemic surges and the economy sputters,” Erica Werner reports. “Prospects for a stimulus deal remain in doubt and negotiations have largely been shelved after repeated failed attempts to broker a compromise.”
Trump promised on Tuesday that the White House would approve a massive stimulus package after the election, but chances for action during a lame-duck session of Congress are uncertain. Meanwhile, the economy is faltering and many Americans are feeling the strain as other sources of relief dry up.
“The inaction by Congress leaves the public without a lifeline, at a moment when coronavirus cases and hospitalizations are on the rise in multiple Midwestern states and elsewhere. An unprecedented $3 trillion stimulus Congress approved in the spring has largely run its course, with unemployment benefits, aid to small businesses, support for the airline industry, rental assistance and other programs expiring,” Erica writes.
There are multiple reasons for the collapse of the bill, including inconsistent messaging from the White House, opposition from Senate Republicans and the fact that Pelosi is expected to grow her majority after the elections, undercutting any political pressure for her to make a deal.
It’s possible that Congress could pass new relief as part of its early December deadline, but it’s unclear how electoral results will affect negotiations. If Congress does not pass something by Dec. 11, the next possibility for a major relief bill probably will not come until February.
More in coronavirus
Families are being kicked out of their homes despite a Centers for Disease Control and Prevention order restricting evictions.
“Anchored in public health concerns that the economic stress of the pandemic will force millions of renters from the safety of their homes and into the crosshairs of a fast-spreading virus, the CDC order aims to keep the estimated 40 million renters facing eviction this year in place through Jan. 1,” Kyle Swenson reports.
Researchers have found that evictions can contribute to the spread of the coronavirus, a motivating factor behind the order, which is meant to help Americans who have lost income, cannot pay their rent and are likely to become homeless if evicted.
“[But] rather than offer a bubble of stability in the midst of the pandemic, the federal response has injected confusion into housing courts. Because of the order’s wording, which gives local judges room for interpretation, and pushback from landlords, evictions have continued,” Swenson writes. “The CDC order’s biggest loophole, tenant rights lawyers say, may be a single clause in the order that reads: ‘You may be evicted for reasons other than not paying rent.' It gives landlords ways around the moratorium.”
Experts estimate that as many as 40 millions tenants could be evicted by the end of the year as a pandemic-linked recession has pushed many Americans out of jobs. Meanwhile, the health agency issued guidance on Oct. 9 clarifying that property owners can challenge their tenants' claims in court and that they are under no obligation to tell them about the order.
Elsewhere in health care
- A new study in the journal Pediatrics finds that kid influencers — children with large social media followings — are getting sponsorships and endorsements for videos on YouTube that push sugary beverages and junk food, the New York Times's Anahad O’Connor reports.
- A panel of health experts recommends lowering the age for first colonoscopies to 45 from 50. While overall colon cancer rates have been declining, data suggests that young people are getting colon cancer at higher rates, the Associated Press's Marion Renault reports.