with Alexandra Ellerbeck

It's unlikely a coronavirus vaccine will be approved by Election Day, as President Trump is suggesting. 

But whenever the Trump administration does give a nod to a vaccine, it almost certainly won't be available for all Americans. 

The most likely scenario to play out is that the Food and Drug Administration would grant initial approval to vaccinate just front-line health workers, those older than 65 and those with underlying medical conditions, two industry vaccine experts tell me. It would come in the form of an emergency use authorization — a shortcut for the government to approve medicines and treatments in dire circumstances – as large clinical trials continue. 

Full approval to distribute a vaccine to everyone else could take another six months beyond that, illustrating how even in a best-case scenario we're still well into 2021 before most Americans can get inoculated. This is still a significantly sped-up timeline: Trials will continue for about five years to make sure subjects aren't experiencing longer-term side effects. 

The National Academies of Sciences, Engineering, and Medicine said certain groups of people should be prioritized over others for vaccination. 

It laid out two tiers of priority in a discussion draft released last week. The first tier includes health workers, those at greatest risk of severe illness and death, and workers most crucial to maintaining core societal functions, such as teachers or grocery store staff.

The administration is asking states to prepare for distributing a vaccine to some groups by Nov. 1, two days before the election, on the long-shot scenario that a coronavirus vaccine has received an EUA by then. Moncef Slaoui, chief scientific adviser for the Trump administration’s effort to accelerate production of a coronavirus vaccine, called this timeline “possible but very unlikely” in a recent interview with NPR.

The Operation Warp Speed chief and other experts say safety isn't being compromised for speed.

But the whole issue is being politicized on the campaign trail, even as Americans anxiously await a vaccination push that could help restore the nation to some sense of normalcy. 

Trump suggested in a Labor Day news conference that there could be a vaccine “before a very special date.” “This could have taken two or three years, instead it’s going to be done in a very short period of time, could even have it during the month of October,” Trump said. 

“The vaccine will be very safe and very effective and it will be delivered very soon,” he added. “You could have a very big surprise coming up.”

Trump tweeted this earlier in the day:

The FDA is damned if it does, damned if it doesn’t.

The agency — already under heavy pressure to deliver on a vaccine — is in a remarkably sticky position. 

“The FDA is in the middle of pressure on one side to approve early and pressure from the other side not to approve early,” Ronny Gal, a financial analyst with investment research firm Sanford C. Bernstein and Co., told me.

The agency has a moral obligation to move forward with a vaccine as soon as there’s sufficient evidence of safety and efficacy, Slaoui has suggested.

Yet if it grants emergency use authorization for a coronavirus vaccine before Election Day, Democrats will almost certainly claim it caved to heavy political pressure from Trump. Democratic vice presidential nominee Kamala Harris suggested as much over the weekend, telling CNN she “would not trust” Trump on the safety of a vaccine delivered before the election.

“If past is prologue … they’ll be muzzled. They’ll be suppressed,” Harris said, referring to health experts and scientists. “They will be sidelined because he’s looking at an election coming up in less than 60 days, and he’s grasping for whatever he can get to pretend he has been a leader on this issue when he has not.”

Yet Democratic presidential nominee Joe Biden said yesterday that he’d get a vaccine “tomorrow,” even if it cost him the election.

“We need a vaccine and we need it now,” Biden said.

Trump slammed both his opponents in his remarks yesterday, accusing them of “reckless anti-vaccine rhetoric.”

“Biden and his very literal running mate would destroy this country and would destroy this economy,” Trump said, saying their rhetoric “endangers lives and it undermines science.”

The political fires will burn even hotter if Pfizer or Moderna receive an emergency use authorization in October.

It’s a distinct if unlikely possibility, given the speed at which both companies are enrolling patients in final-stage clinical trials. They both announced over the weekend that they’re each nearing their goals of enrolling 30,000 people, with about half given the vaccine and half given a placebo in each trial.

Moderna tweeted this over the weekend:

From Pfizer, on Saturday:

If enrollment continues apace, Pfizer is on track to have fully enrolled its patients and given them the two required shots by the first week of October; Moderna is on track to be finished by the third week of October. 

At that point, it’s a waiting game. 

Researchers first need to wait until a critical number of people exposed to the virus fall ill. Then they can study whether those with the vaccine were at least 50 percent less likely to get sick— the benchmark for judging a vaccine to be effective. Ironically, higher rates of coronavirus transmission in the United States could help facilitate quicker vaccine development because more people would be exposed to the virus faster.

The idea isn’t to wait until results are in from all the patients — they’ll all continue to be observed for at least five more years. Rather, the aim is to get enough indication of the vaccine’s efficacy that the companies can apply to the FDA for emergency use authorization to start giving it to some people.

Oct. 22 could be a key date. That’s when the FDA’s vaccine advisory committee is scheduled to meet. The agenda hasn’t yet been set, but it could include consideration of whether to issue Pfizer or Moderna an EUA.

Despite the politicization, experts say the FDA is following due process for ensuring a vaccine is safe and effective.

Esther Krofah, executive director of FasterCures, a center of the Santa Monica, Calif.-based Milken Institute, told me she doesn’t expect any EUAs until late November or December but conceded earlier approval is technically possible.

She stressed that enough long-standing structures and practices are in place such as expert-led boards that review the trial data that she believes any emergency authorization would be based on the data, not politics.

I will say the scientists that are working on this have a high level of commitment to the science,” she told me. “Unfortunately, we’re in a very challenging set of political circumstances, but the scientists are focused on trying to solve this pandemic and provide the public with a vaccine.”

Ahh, oof and ouch

AHH: A former top Obama administration official is writing a book about the U.S. response to the pandemic.

Andy Slavitt, who headed the Centers for Medicare and Medicaid Services from 2015 to 2017 and helped fix the HealthCare.gov website, intends for the book to give an “inside account of the United States’ failed response to the coronavirus pandemic,” according to a release provided first to The Health 202. 

Slavitt is a leading voice on health policy and helped found the nonprofit group United States of Care, which seeks to give every American access to quality, affordable health care.

“The pandemic in the U.S. is a story of how our great nation has failed at some of the most basic things and exposed some long broken parts of our society — the indifference to our essential workforce, the money that makes our health care system go around, our media and political culture, and our obsession with individual liberties but unwillingness to sacrifice when it counts,” Slavitt said in a statement.

The book, “Preventable: The Inside Story of How Leadership Failures, Politics, and Selfishness Doomed the U.S. Coronavirus Response,” will be published by St. Martin’s Press on March 16, 2021, to mark the nation’s widespread shutdowns one year earlier.

OOF: As the U.S. celebrated Labor Day weekend, coronavirus cases were rising in 22 states.

“While cases nationally have dropped from a peak in July, the United States is going into the Labor Day holiday weekend with an average of 44,000 new cases a day — double the number ahead of the May 23-25 Memorial Day weekend,” Reuters’s Lisa Shumaker reports.

The analysis suggests a worrisome trend. Only three weeks ago, a Reuters analysis showed that cases were rising in only three states.

Many health experts partly blame the nation's July spike in cases on Memorial Day weekend celebrations and worry about new outbreaks starting during another holiday weekend. The reopening of schools may also fuel new cases.

“Most of the 22 states where cases are now rising are in the less-populated parts of the Midwest and South,” Shumaker writes. “The increases are masked nationwide by decreasing new infections in the most populous states of California, Florida and Texas.”

The country continues to average around 1,000 deaths from the virus each day. For some, the Labor Day holiday also marked a time to remember those among the dead who contracted the virus in their workplaces.

Iowa State Sen. Robert Hogg tweeted: 

OUCH: A new forecast predicts that deaths from the coronavirus could double by the end of the year — but some experts are skeptical.

A new forecast from the Institute for Health Metrics and Evaluation at the University of Washington projects U.S. fatalities could reach 410,000 by Jan. 1. The current death toll is estimated at 186,000. The model gives a range of predictions from a best-case scenario of 288,381 deaths and a worst-case of 620,029 deaths.

“The scenarios pivot on human behavior and public policy. The best-case scenario would result from near-universal mask-wearing and the maintenance of social distancing and government mandates limiting the size of indoor gatherings,” Joel Achenbach and William Wan report. “The worst-case scenario assumes that people and their communities stop taking precautions.”

The prediction reinforces concerns that colder weather could cause people to spend more time inside, where the virus spreads more easily. Colder, drier weather can also help viruses remain viable longer and spread more easily.

IHME models were highly influential early on in the pandemic but were criticized by some experts for trying to forecast too far into the future with uncertain data. The early models ended up significantly underestimating deaths from the virus.

Now, some experts think the newest prediction might be an overestimate.

Ashish K. Jha, the dean of Brown University School of Public Health:

Joshua Salomon, the director of Stanford’s Prevention Policy Modeling Lab, did a deep dive and asked some questions about the assumptions in the model:

More evidence showing links between vaping and the coronavirus is emerging.

“Since the start of the pandemic, experts have warned that the coronavirus — a respiratory pathogen — most likely capitalizes on the scarred lungs of smokers and vapers,” the New York Times’s Katherine J. Wu reports. “Doctors and researchers are now starting to pinpoint the ways in which smoking and vaping seem to enhance the virus’s ability to spread from person to person, infiltrate the lungs and spark some of Covid-19’s worst symptoms.”

A recent study published in the Journal of Adolescent Health found that adolescents and young adults who used e-cigarettes were five times as likely to receive a covid-19 diagnosis. 

Though a strong body of research shows how cigarette smoking weakens the immune system, scars the lungs and leaves the body more vulnerable to infection, evidence on the link between e-cigarettes and infectious disease is only starting to emerge. Studies in mice find that vaping makes the animals more susceptible to viruses and bacteria. 

“Early evidence hints that the [coronavirus] may have an easier time breaking into the bodies of smokers and vapers,” Wu writes. “Smoking appears to alter the surfaces of certain cells, prompting them to coat themselves with more of a molecule called ACE-2 — the protein the coronavirus uses to break into its targets.”

The social nature of vaping — sharing equipment and not wearing a mask while smoking of vaping — could also play a role in explaining the increased number of infections.

It's almost flu season

Health officials are trying to make sure it’s easy to get flu shots amid the pandemic.

Health providers concerned about the double threat of the coronavirus and the flu are “trying to make it easier and safer to get the flu vaccine, aware that many people still are afraid to leave home for fear of catching the coronavirus,” Marlene Cimons reports. “One idea gaining in popularity is to give the shots outdoors.”

Flu vaccines will not only prevent deaths from influenza, but they will also help protect health-care capacity. More than half of Americans didn't get a flu vaccine last year, and there is concern that the numbers could drop this year if people are afraid of going inside clinics or pharmacies for fear of contracting the coronavirus. Many workplace flu drives will also be canceled because staff is remote.

To counter this, some pharmacies are offering drive-through flu vaccinations, while some doctors are setting up tents to vaccinate outside. Vaccine manufacturers, meanwhile, have boosted production of this year’s flu vaccine.

“Trying to overcome the limitations is very important. There’s no point in producing 80 million doses of influenza vaccine if they don’t end up in someone’s arm,” said Elaine O’Hara, who heads vaccine manufacturer Sanofi Pasteur’s North America vaccine program.

The flu season begins in October and peaks between December and February.  

Coronavirus latest

  • Several prominent Republican politicians, including Trump, Sen. Joni Ernst (R-Iowa), Rep. Roger Marshall (R-Kan.), have promoted a debunked conspiracy theory that claims that the death toll from the virus is significantly lower than official numbers, the Hill’s Peter Sullivan writes.

    White House coronavirus adviser Anthony S. Fauci refuted the misinformation in an interview with Good Morning America last week:
     
  • Data from 14 states and New York City shows widespread reluctance by the public to participating in contact tracing. In California three-quarters of people interviewed refused to identify family members or contacts who may have been exposed. Conspiracy theories and distrust of public health officials play a role in the refusal to cooperate with public health programs, Politico’s Alice Miranda Ollstein and Darius Tahir report.
  • New regulations in New York will increase post-mortem testing for both the coronavirus and flu to help officials track the prevalence of both, the New York Times’s Katherine J. Wu reports.
  • Members were named on Thursday to an independent panel charged with investigating the World Health Organization’s response to the pandemic. The panel, co-chaired by former Liberian President Ellen Johnson Sirleaf and former New Zealand Prime Minister Helen Clark, said it will have full access to internal United Nations documents, the Associated Press’s Maria Cheng reports.
  • People suffering from lingering, long-term effects after recovering from covid-19 are struggling with anxiety, depression and fears that they will never feel fully recovered, the New York Times’s Emma Goldberg reports.
  • The percent of American adults struggling with mental health symptoms tied to the pandemic increased from 32 percent in March to 53 percent in July, according to a report from the Kaiser Family Foundation. Rates of alcohol consumption and the number of adults who report contemplating suicide have also increased, Linda Searing reports.

The debate over reopening schools

  • A tracker from Davidson College in North Carolina shows that 20 percent of colleges plan to open primarily or exclusively in person. But those colleges facing coronavirus outbreaks are debating whether to forge ahead with in-person classes, send students home or have them shelter in place. If schools opt to send asymptomatic students back home, it could spark outbreaks across the country, Politico’s Dan Goldberg and Brianna Ehley write.
  • Colleges are testing the sewage system for genetic material from the virus and using that information to quarantine certain residence halls. The tests can’t tell how many people have the virus, nor the stage of infection, but it can spot trends, the Associated Press’s Lindsay Whitehurst reports.
  • As schools reopen, pediatricians are scrambling to prepare for an influx of coronavirus cases and for the tricky task of distinguishing between the coronavirus, the flu and the common cold in the absence of resources that would allow for testing every child who comes in with symptoms, Marlene Cimons writes.

Elsewhere in healthcare

A new plan released by the U.S. Department of Health and Human Services aims to improve rural health care.

“Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer and older than the rest of the country,” Kaiser Health News's Sarah Jane Tribble reports. The new plan “acknowledges the gaps in health care” and “lists a litany of projects and directives, with many already underway or announced within federal agencies.”

The plan places a heavy emphasis on telehealth, which is mentioned at least 90 times in the 70-page plan. It also includes proposals for a shift in payment for small rural hospitals and a change in workforce licensing requirements, as well as technical initiatives, such as an increase in funding for school-based mental health care and a contract to help clinics and hospitals integrate care.  

“In the past few months, rural health care has increasingly become a focus for Trump, whose polling numbers are souring as covid-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products and spreads through meatpacking plants,” Tribble writes.

Sugar rush