The Washington PostDemocracy Dies in Darkness

The Health 202: The FDA isn't slowing the development of a coronavirus vaccine as Trump claims

with Alexandra Ellerbeck

President Trump has accused the Food and Drug Administration – which he tweeted over the weekend was part of the “deep state, or whoever” –  of impeding trials for a coronavirus vaccine.

Yet multiple vaccine candidates are moving through the pipeline at breakneck speed.

The United States is just eight months into the coronavirus outbreak (yes, we know it feels like eight years). Nineteen potential vaccines — most of them being developed by U.S. and Chinese companies — are in either Stage 2 or Stage 3 clinical trials, according to The Washington Post’s regularly updated tracker.

Experts acknowledge that having a vaccine ready by the end of 2020 or early 2021 is a distinct possibility, although the country will still face the challenge of distributing it widely. Trump’s second-term agenda includes “develop a vaccine by the end of 2020” among the goals.

If a vaccine is ready six months from now, it will easily break the record for the fastest vaccine development ever. Vaccines take an average of a decade to develop. The polio vaccine took seven years. The chickenpox vaccine took a whopping 34 years.

Seven vaccine candidates, including two developed by U.S. companies, are in Stage 3 clinical trials.

In these final-stage trials, tens of thousands of people are given the vaccine or a placebo and then observed to see how they respond. A dozen more candidates are in Stage 2 trials; one of them, developed by Johnson & Johnson, will be given to a group of 60,000 participants next month, if all goes according to plan.

Trump could tout the rapid progress this week at the Republican National Convention. Instead, he’s throwing out accusations, saying yesterday Democrats are using the pandemic to “steal” the election.

“What they’re doing is using covid to steal an election,” Trump told delegates at the convention gathering in Charlotte. “They’re using covid to defraud the American people, all of our people, of a fair and free election. We can’t do that.”

Over the weekend he targeted the FDA:

Getting a vaccine before the November election was never really on the table, at least according to public health officials.

Top infectious-disease expert Anthony S. Fauci and others have stressed that getting a vaccine ready by early 2021 is already a tall order.

Yet Trump may still be looking to fast-track a vaccine before the November election. The Financial Times reported the administration is considering awarding an emergency use authorization (EUA) to a vaccine being developed by AstraZeneca in partnership with Oxford University. 

But the company, which is planning a trial of 30,000 people in the United States, said it hasn’t talked to the government about an EUA.

“It would be premature to speculate on that possibility,” AstraZeneca spokeswoman Michele Meixell told The Health 202.

When asked what Trump might have meant in his tweet saying trials are being hindered, the company merely said it is “progressing” in its Phase 3 trials.

“AstraZeneca is progressing our Phase III trial plans in the US and we continue to work closely with Operation Warp Speed, HHS and the FDA,” said spokesman Brendan McEvoy.

All Trump’s talk of getting a vaccine quickly has raised safety concerns.

FDA Commissioner Stephen Hahn has spent much time over the past few weeks assuring Americans that safety protocols won’t be skipped in any of the clinical trials.

In an op-ed published by The Post, Hahn didn’t rule out the possibility a vaccine could be awarded emergency use. But he stressed any approved vaccine will meet “appropriate” safety standards and denied the FDA has been under political pressure to move too quickly.

“I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science,” he wrote. “I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment.

The coronavirus pandemic got lots of play on night one of the Republican National Convention.

Multiple speakers painted the administration’s pandemic response as a resounding success — despite the nation’s continual struggle with the virus and the deaths of at least 173,000 people in the United States.

“For at least 40 minutes speaker after speaker praised Trump’s handling of the health and economic crises, making exaggerated claims about the levels of testing and the personal protective equipment used by health-care first responders,” our colleagues report. “Several video images painted Democratic governors as those to blame for the haphazard response.”

It culminated with Trump appearing from the White House with a handful of essential workers.

“We can call it many different things from China virus,” Trump told the small group. “I don’t want to go through all the names because some people may get insulted, but that’s the way it is. These are great, great people. Doctors, nurses, firemen, policemen. We want to thank you all. You, you’ve been incredible. And we want to thank you and all of the millions of people that you represent.”

One man said he is a truck driver, delivering his goods throughout the crisis.

“That’s fantastic. Well, congratulations. I love the truckers. You know, they’re on my side. Thank you. I think all of them, frankly, I think pretty much all of them,” Trump said.

After a police officer from California said he had recovered from covid-19, the disease the virus causes, Trump referred to the use of blood plasma as a treatment, for which the FDA issued an emergency use authorization over the weekend (our colleagues Laurie McGinley, Yasmeen Abutaleb and Lenny Bernstein fact-checked how officials described the effectiveness of blood plasma on covid-19 patients.)

“We have the whole thing with plasma happening. That means your blood is very valuable,” Trump said.

The Post's Cathleen Decker:

Telehealth, which has expanded dramatically during the pandemic, got a moment in the spotlight.

When the lockdowns began this spring, the Centers for Medicare and Medicaid Services added 80 medical services to the list of telehealth services the Medicare program will pay for.

“President Trump recognized the threat this virus presented for all Americans early on, and made rapid policy changes," Nurse Amy Johnson Ford said. "And as a result, telehealth services are now accessible to more than 71 million Americans.”

Matt Whitlock, senior advisor to the National Republican Senatorial Committee:

Earlier in the day, Trump went after Democratic nominee Joe Biden for saying he would shut down the economy again if necessary.

I would shut it down. I would listen to the scientists, Biden said in an ABC interview on Sunday, when asked whether he would be willing to undergo more closures to head off more infections.

The Washington Examiner’s David M. Drucker:

Ahh, oof and ouch

AHH: Trump also brought up Obamacare and prescription drug pricing – but some of his claims don’t hold up.

Trump claimed his administration had eliminated the Affordable Care Act. That's not true, but as part of its 2017 tax overhaul the administration did with Congress's stamp of approval get rid of the penalty that comes with the individual mandate, a requirement for all Americans to have health insurance.

“We eliminated Obamacare’s horrible and very unfair individual mandate, which basically knocked out Obamacare. We knocked out Obamacare,” Trump said.

The tax bill lowered the penalty for not having insurance under the mandate to $0. Researchers have said elimination of the penalty is likely to cause less people to enroll in insurance over time, and the Kaiser Family Foundation found it may have led to an increase in premiums.

The change is also at the center of a case that will be heard before the Supreme Court in November in which several Republican states argue the ACA without the mandate is unconstitutional. Those states are seeking a ruling not only that the individual mandate is unconstitutional but that the whole law should fall.

Sahil Kapur, national political reporter for NBC News:

Trump also repeatedly claimed he had lowered drug price, now a mainstay of his speeches and political ads often portraying Biden as the candidate most friendly with drug companies. 

Fact checkers, however, have taken issue with this claim. While it is hard to get data measureing the cost of all prescription drugs, many indicators suggest prices have actually increased, albeit at a slower rate in recent years. The Trump administration in July announced four executive orders to lower drug prices, but the impact of those orders remains to be seen.

OOF: The Trump administration is sending rapid coronavirus tests to thousands of nursing homes — but there’s a hitch.

“Two manufacturers that have received Food and Drug Administration authorization and whose instruments are being delivered — Becton, Dickinson and Co., known as BD, and Quidel — say their antigen tests are intended for patients with symptoms, calling into question how valuable the tests would be for broad screening purposes,” Kaiser Health News reports. “The Centers for Disease Control and Prevention estimates 40% of infected people may be asymptomatic.”

The administration plans to distribute the tests, which can be conducted at the point of care and are faster and cheaper than lab-based tests, to 14,000 nursing homes, prioritizing those in coronavirus hot spots. Around 40 percent of coronavirus deaths have occurred in nursing homes, and public health officials have urged institutions to ramp up testing of both symptomatic and asymptomatic residents and workers.

The fear is that the test could produce false negatives. BD has said its tests should not be used on people who are not showing any symptoms. Quidel deferred to FDA guidelines that allow for use of rapid tests to screen asymptomatic individuals suspected of having the coronavirus after close contact with an infected person, Rachana Pradhan reports.

Nursing homes will receive the initial batch of 150 to 900 tests free but then will have to pay for additional supplies.

Some public health officials say that for routine surveillance, the rapid tests are still better than the lab-based tests, which have suffered from shortages and delays.

“I don’t see an avenue where these will not help to stop transmission chains, and I don’t see another option on the table for us,” Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, told KHN.

OUCH: Budget cuts to public health left Florida unprepared for the pandemic.

“Florida is both a microcosm and a cautionary tale for America. As the nation starved the public health system intended to protect communities against disease, staffing and funding fell faster and further in the Sunshine State, leaving it especially unprepared for the worst health crisis in a century,” the Associated Press and Kaiser Health News reported in a joint investigation

While Florida grew by 2.4 million people since 2010, according to the investigation, the state slashed its public health force from 12,422 full-time equivalent workers to 9,125 in 2019.

“When the wave of COVID-19 inundated Florida, the state was caught flat-footed when it mattered most, its main lines of defense eviscerated,” Laura Ungar, Jason Dearen and Hannah Recht report. “Now, confirmed cases have soared past 588,000 and deaths have risen to more than 10,000.”

Experts say the cuts happened in the wake of the 2008 financial crisis and as part of a broader move by the state to transition public services to for-profit companies. 

Leading the White House coronavirus task force has been Vice President Pence’s most public role in the administration.

The Post spoke with more than 25 current and former senior administration officials for a profile of Pence, who will accept the party’s nomination for a second term as vice president on Wednesday. 

“Administration officials say Pence’s stewardship of the coronavirus task force has been mixed,” Ashley Parker, Josh Dawsey and Philip Rucker report. Some administration officials say “the vice president and his staff have been overly preoccupied with the public relations aspect of the virus — catering to a president obsessed with how he and the administration are covered by the media.”

But he has also been praised for his command of  biefings and for building a good rapport with governors. In calls with governors, Pence rarely mentions Trump, according to a review of audio recordings and video conferences.

Critics said task force meetings could be plagued by “indecision” and Pence was initially dubious of masks. Some staffers said not enough time was spent formulating a national testing strategy. Another issue appeared to be that Jared Kushner, Trump’s son-in-law and senior adviser, was not always present at task force meetings, even though he made key decisions.

Fauci, the nation’s leading infectious-disease expert, defended Pence. In an email to The Post, he described the vice president as a “truly decent person, and very smart, who is trying to do his best in a very difficult and fluid situation.”

While Fauci said Pence was “an optimist” and a “glass half full type of person,” he said the vice president never got in his way when Fauci sought to present negative news to the president.

“I am sometimes referred to as ‘the skunk at the picnic’ but Pence never directly asks me, the skunk, to be quiet or leave,” Fauci wrote to The Post. “Some may say that Pence and his team are ‘too ideological’ but they are after all political people. This is not unexpected.”

Coronavirus latest

Scientists at the University of Hong Kong claim to have the first evidence of coronavirus reinfection.

“Genetic tests revealed that a 33-year-old man returning to Hong Kong from a trip to Spain in mid-August had a different strain of the coronavirus than the one he’d previously been infected with in March,” the Associated Press reports.

A paper detailing the case has been accepted by the journal Clinical Infectious Diseases but hasn't been published. Whether people can get the coronavirus a second time has massive implications for reopening schools and workplaces and could also influence vaccine development. If immunity is short-lived, it may mean people need to get booster vaccines. It’s possible that even if people can be reinfected they have some protection against serious illness because their immune system may still recognize the virus.

“We don’t know how many people can get reinfected. There are probably more out there,” Kelvin Kai-Wang To, the microbiologist who led the research, told the Associated Press. People who have already been infected with the coronavirus “should not be complacent about prevention measures” like social distancing or mask-wearing, he said.

The ongoing debate over reopening schools

  • A Florida circuit court judge granted a temporary injunction against the state’s order requiring schools to reopen five days a week for in-person classes. The judge said the order failed to consider safety. On Monday evening, the state filed an appeal, which means school districts cannot move to immediately change their plans for reopening, Valerie Strauss reports.
  • Pennsylvania State University students will be asked to wear masks and social distance, but they will also be asked to monitor their sense of smell using scratch-and-sniff postcards. This virus containment measure has some sound science behind it as coronavirus is more likely to cause loss of smell than fever, and some health experts have said reduced sensitivity to scents is one of the best and earliest indicators of infection, Kaiser Health News reports.
  • Zoom went down for hours on Monday, disrupting businesses and online classrooms, which have increasingly come to rely on the platform during the pandemic. The company said it resolved the issue after around four hours of partial outages on Monday, Hamza Shaban reports.

Elsewhere in health care

  • President Trump keeps promoting an executive order that would tie drug prices in the United States to the amount that pharmaceutical companies charge in Europe and other countries. One of four orders aimed at reducing the cost of drugs, Trump has published the other three, but withheld the last one to negotiate with drug companies. He vowed to release the order on Aug. 24 if the drug companies did not act on their own, but that hasn't yet happened. The only glimpse the public has of the order was captured in an AP photograph when the president displayed it at an event last month, the New York Times reports.
  • Dementia’s death rate has slowed by 13 percent in each of the past three decades. If this trend continues, 60 million fewer people than expected will develop dementia worldwide by 2040. Better control of heart disease and blood pressure could contribute to the lower rates. But because of increases in population and life expectancy, the total number of people with dementia is expected to continue growing, Linda Searing reports.

Sugar rush

The Washington Post's Rick Noack attended a concert in Germany co-organized by one of the country's university hospitals in the name of science. (Video: Stefan Czimmek/The Washington Post)
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