Dr. Scott Atlas, a member of the White House COVID-19 task force who is infamous for parroting Trump-friendly but scientifically dubious talking points about the pandemic, brushed off criticism from his fellow team members on Monday night.
Coronavirus Has Now Killed 1 Million People
NEW DELHI (AP) — Joginder Chaudhary was his parents’ greatest pride, raised with the little they earned farming a half-acre plot in central India to become the first doctor from their village.
For the coronavirus, though, he was just one more in a million.
After the virus killed the 27-year-old Chaudhary in late July, his mother wept inconsolably. With her son gone, Premlata Chaudhary said, how could she go on living? Three weeks later, on Aug. 18, the virus took her life, too — yet another number in an unrelenting march toward a woeful milestone.
Now, 8 1/2 months after an infection doctors had never seen before claimed its first victims in China, the pandemic’s confirmed death toll has eclipsed 1 million, according to a count by Johns Hopkins University.
That is partly due to the virus’s quickening spread through India, where reported deaths have topped 96,000 and cases are increasing at the fastest rate in the world.
The United States, where the virus has killed about 205,000 people, accounts for 1 out of 5 deaths worldwide, far more than any other country despite its wealth and medical resources.
“It’s not just a number. It’s human beings. It’s people we love,” said Dr. Howard Markel, a professor of medical history at the University of Michigan who has advised government officials on containing pandemics. On a Thursday morning in February, Markel’s mother, 84 and infirm, was stricken by an illness later diagnosed as COVID-19. She died before midnight.
“It’s our brothers, our sisters. It’s people we know,” Markel said. “And if you don’t have that human factor right in your face, it’s very easy to make it abstract.”
Even at 1 million — greater than the population of Jerusalem or Austin, Texas, more than four times the number killed in the 2004 earthquake and tsunami in the Indian Ocean — the toll is almost certainly a vast undercount.
Many deaths were probably missed because of insufficient testing and inconsistent reporting, and some suspect concealment by countries like Russia and Brazil.
And the number continues to mount. Nearly 5,000 deaths are reported each day on average. Parts of Europe are getting hit by new outbreaks and experts fear a second wave may await the U.S.
“I can understand why … numbers are losing their power to shock, but I still think it’s really important that we understand how big these numbers really are,” said Mark Honigsbaum, the London-based author of “The Pandemic Century: One Hundred Years of Panic, Hysteria and Hubris.”
Few people can testify to those numbers like the Rev. Mario Carminati, a priest in the northern Italian province of Bergamo, which was hit by one of Europe’s first major outbreaks last spring. When the virus overwhelmed local cemeteries, Carminati opened his church to the dead, lining up 80 coffins in the center aisle. After an army convoy carted them to a crematory, another 80 arrived. Then 80 more.
“It was something completely unpredictable that arrived like a bolt of lightning in a clear sky … and struck our reality,” he said.
Eventually the crisis receded and the world’s attention moved on. But the pandemic’s grasp endures. In August, Carminati buried his nephew, 34-year-old Christian Persico.
“This thing should make us all reflect. The problem is that we think we’re all immortal,” Carminati said.
The virus first appeared late last year in patients hospitalized in the Chinese city of Wuhan. The first death was reported there on Jan. 11. By the time authorities locked down the city nearly two weeks later, millions of travelers had come and gone. China’s government has come in for criticism that it did not do enough to alert other countries to the threat.
Government leaders in countries such as Germany, South Korea and New Zealand worked effectively to contain it. Others, like U.S. President Donald Trump and Brazil’s Jair Bolsonaro, dismissed the severity of the threat and the guidance of scientists, even as hospitals filled with gravely ill patients.
Brazil has recorded the second most deaths after the U.S., with about 142,000. India is third and Mexico fourth, with more than 76,000.
Oscar Ortiz, an oil platform worker for Mexico’s state-owned Petroleos Mexicanos, said he felt helpless while ill and quarantined this spring, as 14 of his coworkers died from the virus, three in a single week.
“It’s very painful to see this and not be able to do anything,” said Ortiz, whose company has reported more than 300 deaths in its ranks.
The virus has forced trade-offs between safety and economic well-being. The choices made have left millions of people vulnerable, especially the poor, minorities and the elderly.
India, whose government relaxed tight restrictions in recent months to jump-start an economy where many subsist on earnings from day labor, is the latest example.
“When the pandemic actually started to get under control to some extent, the lockdown was eased and then completely lifted,” said K. Srinath Reddy, president of the Public Health Foundation of India. “The virus had a free passage and could spread much more easily.”
With so many of the deaths beyond view in hospital wards and clustered on society’s margins, the milestone recalls the grim pronouncement often attributed to Soviet dictator Josef Stalin: One death is a tragedy, millions of deaths are a statistic.
The pandemic’s toll of 1 million dead in such a limited time rivals some of the gravest threats to public health, past and present.
It exceeds annual deaths from AIDS, which last year killed about 690,000 people worldwide. The virus’s toll is approaching the 1.5 million global deaths each year from tuberculosis, which regularly kills more people than any other infectious disease.
But “COVID’s grip on humanity is incomparably greater than the grip of other causes of death,” said Lawrence Gostin, a professor of global health law at Georgetown University. He noted the unemployment, poverty and despair caused by the pandemic, and deaths from myriad other illnesses that have gone untreated.
To put the death toll, alone, in perspective, look to Brazil.
Nearly a decade ago, more than 900 Brazilians were killed in flooding that was widely described as the country’s worst-ever single day of natural disaster. From late May to late August, the coronavirus killed more Brazilians than that, on average, day after day.
The victims included Caravaldina Oliveira da Costa, who worked for years as a maid in the beach resort of Armacao dos Buzios. She also stood up for her neighbors in Rasa, a poor community filled with the descendants of escaped slaves, becoming their voice in a fight for land rights.
“She brought something to Rasa that no politician would bring: self-confidence,” said Rejane Oliveira, her niece and disciple.
When the elder Oliveira died in June at 79, Buzios’ mayor decreed three days of mourning. But city hall ruled out holding a ceremony. Because of the virus, officials said, it wasn’t safe to gather.
For all its lethality, the virus has claimed far fewer lives than the so-called Spanish flu, which killed an estimated 40 million to 50 million worldwide in two years, just over a century ago.
That pandemic came before scientists had microscopes powerful enough to identify the enemy or antibiotics that could treat the bacterial pneumonia that killed most of the victims. In the U.S., the Spanish flu killed about 675,000. But most of those deaths did not come until a second wave hit over the winter of 1918-19.
Up to now, the disease has left only a faint footprint on Africa, well shy of early modeling that predicted thousands more deaths.
But cases have recently surged in countries like Britain, Spain, Russia and Israel. In the United States, the return of students to college campuses has sparked new outbreaks. With approval and distribution of a vaccine still probably months away and winter approaching in the Northern Hemisphere, the toll will continue to climb.
“We’re only at the beginning of this. We’re going to see many more weeks ahead of this pandemic than we’ve had behind us,” Gostin said.
Already, though, far too many grieve.
“This pandemic has ruined my family,” said Rajendra Chaudhary, who lost his son, the young Indian doctor, and then his wife. “All our aspirations, our dreams, everything is finished.”
___
Associated Press writers Nicole Winfield in Rome, Suman Naishadham in Phoenix and David Biller in Rio de Janeiro contributed to this story. Jain reported from New Delhi and Geller from New York.
Giuliani Baselessly Claims Biden Has Dementia Ahead Of First Debate
Rudy Giuliani, President Donald Trump’s personal attorney, claimed without evidence on Tuesday that Trump’s Democratic rival has dementia.
“Look, the man has dementia,” Giuliani claimed of Democratic presidential nominee Joe Biden on “Fox & Friends” early Tuesday. “There is no doubt about it. I have talked to doctors. I’ve had them look at 100 different tapes of his — five years ago and today.”
On Fox & Friends, Rudy Giuliani says Joe Biden "has dementia. There's no doubt about it. I've talked to doctors. … The president's quite right to say maybe he's taken adderall." The hosts get visibly uncomfortable. pic.twitter.com/2Ma7DKNBpS
— Bobby Lewis (@revrrlewis) September 29, 2020
The comments came as Giuliani predicted that Biden would win the debate “by the crooked media,” adding that he would not judge the presidential debates on their terms.
The Trump loyalist then plowed ahead with a claim that appeared to have no anchor in reality, suggesting not only that Biden couldn’t recite the Pledge of Allegiance, also offering the vague claim that Democratic nominee “can’t do numbers.”
“He actually displays symptoms that two gerontologists told me are classic symptoms of middle level dementia,” Giuliani said.
But the clips Giuliani appeared to reference were edited by the Trump campaign and its allies in an apparent attempt to make Biden look confused or senile, an effort that has been made a key yet unfounded campaign attack against the Democratic nominee.
The Fox News hosts became visibly uncomfortable before co-host Steve Doocy interjected — “the Biden people say he is fine.”
But Giuliani, who loyally distracts from the President’s rhetorical missteps, swooped in further to sow doubt about the Democratic candidate’s mental acuity.
“I think the president is quite right to say maybe [Biden] is taking Adderall or some kind of an attention-deficit disorder thing,” Giuliani said.
For months, Trump has challenged the mental sharpness of his opponent.
In June, the President repeatedly bragged about how well he’d “aced” remembering five different words in order for a 10-minute cognitive test, suggesting at the time that Biden wouldn’t have performed nearly as well. But the Montreal Cognitive Assessment Trump spoke of was designed to detect early signs of dementia and is usually administered to those with related concerns, experts told the Washington Post. It was not, in fact, evidence of Trump’s innate intelligence although he has appeared to tout it as such.
President Trump told reporters on Sunday that Giuliani and former New Jersey Gov. Chris Christie (R) were helping him prepare for the upcoming presidential debate, which will be moderated by Fox News’ Chris Wallace on Tuesday night.
The former New York mayor, has a record of trying to smear Biden — last year he met with a Ukrainian parliamentarian in Kyiv who has since been sanctioned by the Treasury Department for offering the attorney documents in an attempt to dig up dirt on Biden ahead of the 2020 presidential election.
Topping a list of 17 questions that the Trump campaign wants Biden to answer during this week’s debate is likely related to the documents obtained by Giuliani from the Ukrainian MP that seek to smear Biden by going after transactions made by his son.
Trump Denies Hyping Ivanka As His Potential Running Mate In 2016: ‘Totally Ridiculous’
President Donald Trump on Monday night denied reports that he had insisted on making his daughter, Ivanka Trump, his running mate during the 2016 elections.
WH Pressured CDC To Downplay Risk To Children In Reopening Schools
Top White House officials pressured the Centers for Disease Control and Prevention this summer to minimize the risk of sending children back to school, according to a New York Times report.
Interviews with White House officials past and present, as well as the Times’ review of internal documents revealed that White House officials actively sought data to publicly portray a weakening pandemic that posed little danger to children in an attempt to workaround CDC scientists.
The Times’ report shows how White House spent weeks trying to press public health professionals to promote messaging that fit President Donald Trump’s election-year agenda to swiftly reopen schools even though data on the issue has not reinforced its safety.
Olivia Troye, a former top aide to Vice President Mike Pence who was involved in the task force, said she was repeatedly asked by Pence’s chief of staff, Marc Short, to get the agency to develop reports that showed declining COVID-19 cases among younger populations.
Troye told CNN’s Chris Cuomo in an interview Monday, that the situation was a “nightmare.”
“Unfortunately, this was an effort, you know, at times where I would get blindsided, where there would be junior staffers being tasked to find different data for charts to show that the virus wasn’t as bad for certain populations, ages or demographics,” Troye said.
She told the Times that she believed pressure from the White House was driven by Trump’s political agenda to have schools running when voters cast ballots.
“You’re exchanging votes for lives, and I have a serious problem with that,” Troye told the Times in an interview. The former official has become increasingly vocal speaking out against Trump since leaving the White House in August.
According to Troye, Short told other members of the vice president’s staff to dig for data that might bolster the White House’s reopening message for schools.
In one example, Dr. Deborah Birx, the White House coronavirus response coordinator, pressured the CDC to incorporate claims made by the Substance Abuse and Mental Health Services Administration warning that shuttered schools would have a long-term effect on children’s mental health.
White House spokesman Brian Morgenstern contended in a statement to the Times that top health officials were in agreement about the reopening of schools and how its risks were weighed.
“President Trump relies on the advice of all of his top health officials who agree that it is in the public health interest to safely reopen schools, and that the relative risks posed by the virus to young people are outweighed by the risks of keeping children out of school indefinitely,” Morgenstern said.
Trump has repeatedly pushed for schools to be opened quickly. He falsely told Fox News in August that children were “almost immune” to the disease. He has also sought to undermine the wisdom of health officials in his administration, complaining about the CDC’s stringent recommendations.
Recent data from the American Academy of Pediatrics shows however that hospitalizations and COVID-19 deaths have increased at a more rapid rate in children and teenagers than among the general population.
The administration worked hard at whittling away the CDC’s cautious guidance on schools reopening to realize Trump’s vision, an effort that was reflected in a final document on the opening schools published under the doctored White House-approved title: “The Importance of Reopening America’s Schools This Fall.” The document contained information suggesting that the coronavirus was less deadly to children than the seasonal flu, a claim that had elicited clear objections from CDC officials.
NYT: Trump Used ‘The Apprentice’ Fame To Get Involved In Shady MLMs, Tax Returns Show
The New York Times dropped another report on President Donald Trump’s tax returns on Monday night that not only exposed the extent to which Trump used his fame from “The Apprentice” to cultivate an image of a cunning businessman despite repeated financial failures, but also to boost shady multi-level marketing companies, including one allegedly involved in a pyramid scheme-like practices.
Fauci Suggests Trump’s COVID Adviser Is ‘Outlier’ On WH Coronavirus Task Force
Dr. Anthony Fauci on Monday joined fellow White House coronavirus task members Dr. Deborah Birx and Centers for Disease Control Director Dr. Robert Redfield in expressing his concerns that President Trump’s new favorite COVID-19 adviser, Dr. Scott Atlas, is feeding the President misinformation amid the pandemic. Continue reading “Fauci Suggests Trump’s COVID Adviser Is ‘Outlier’ On WH Coronavirus Task Force”
Ross Sets ‘Target Date’ For Ending Census That Seems To Flout Judge’s Order
The Census Bureau said Monday that Commerce Secretary Wilbur Ross had set Oct. 5 as a “target date” for finishing data collection for 2020’s count — an announcement that seems to fly in the face of a federal judge’s order that those operations continue through the end of October.
Continue reading “Ross Sets ‘Target Date’ For Ending Census That Seems To Flout Judge’s Order”
Five Points On The Many Questions Raised By Trump’s Tax Returns
After years and countless court battles spent shielding them, President Trump’s tax returns are finally out.
Continue reading “Five Points On The Many Questions Raised By Trump’s Tax Returns”
A Real Vaccine Before the Election? It’d Take a Miracle.
This story first appeared at ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.
Despite President Donald Trump’s promises of a vaccine next month and pundits’ speculation about how an “October surprise” could upend the presidential campaign, any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time.
In short, it would take a miracle.
We talked to companies, regulators, scientific advisers and analysts and reviewed hundreds of pages of transcripts and study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use. As you’ll see, it’s a long shot in 38 days.
There are three key milestones that must be met:
- A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo. Right now, Pfizer’s trial is the furthest along. Pfizer has said it expects results by the end of October, but analysts who follow the company aren’t so sure it’ll be that soon or whether the results will be conclusive.
- Pfizer would have to turn its trial data into an application to the Food and Drug Administration. The company could either apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization, which is more flexible. Pfizer has said it could submit its application almost immediately.
- The FDA has to review the data and decide whether the vaccine is ready to go to market. That could take several weeks to a month, said Dr. Mark McClellan, who led the FDA from 2002 to 2004.
“All of this put together makes it more likely that it’ll be a late 2020 availability,” McClellan said.
None of this is to say that Trump couldn’t suddenly call a White House press conference to try to grab headlines and declare victory. But knowing all the steps that would have to come first can help the public discern between a true, scientifically validated vaccine and a mere political stunt.
Yes, Pfizer could have trial results by the end of October.
Results from ongoing trials are closely guarded so that researchers (and investors) have no opportunity to mess with them. Under strict trial rules that vaccine makers and the FDA set up in advance, there are only a few predetermined times when a data monitoring board is scheduled to look at the data. The purpose of those check-ins (known as “interim analyses”) is to see if there’s already enough evidence to conclude that the vaccine either works or doesn’t.
According to the trial rules that Pfizer released last week, it has four of these check-ins before the final analysis. The first one occurs when 32 people in the trial get sick with COVID-19.
Yes, that is a tiny number in a study designed to enroll 30,000 participants. But it could be enough to show that the vaccine works if far more of the infections occur in people who took the placebo than in those who got the vaccine, so much so that it’s probably not random.
The vaccine “would have to be way, way better to meet an interim stopping boundary,” said Frank Harrell Jr., professor of biostatistics at Vanderbilt University.
If six or fewer of the first 32 cases are people who got the vaccine, that suggests the vaccine reduced COVID-19 cases by 76%. Under Pfizer’s trial rules, the company can then conclude that its vaccine is effective enough to submit its application to the FDA. If, on the other hand, 15 or more of the first 32 infections are people who got the vaccine, it would mean the vaccine doesn’t work and the study ends.
The better the vaccine works, the longer it would take to reach 32 cases, because fewer vaccinated people would get sick and more of the infections would have to occur in the placebo group.
So when exactly will Pfizer get to 32 cases?
Analysts at JPMorgan estimate that this first readout would occur on Oct. 31 if the vaccine is 70% effective, or on Nov. 2 if the vaccine is 80%. Their model also estimates that Pfizer is more than twice as likely to be able to file for approval at 80% effectiveness vs 70% effectiveness.
The JPMorgan analysts’ prediction is roughly in line with official public statements from Pfizer, though the company has projected even more confidence. “We have a good chance that we will know if the product works by the end of October,” CEO Albert Bourla said Sept. 13 on CBS’ “Face the Nation.”
The key thing we don’t know is how fast people in Pfizer’s trial are getting sick. The trial doesn’t intentionally expose people to the virus; it waits to see who catches it on their own. Even though the pandemic is far from under control, the coronavirus is not spreading as fast as it was a few months ago. The study started with a baseline assumption that just 1.3% of participants would be infected over the course of a year.
It’s possible that the thousands of people who signed up for Pfizer’s study could be getting sick faster or slower than that, depending on how bad the outbreak is where they are. If Pfizer’s trial infection rate is 1.5 to 2 times faster than publicly reported case counts, then Pfizer’s first readout could be Oct. 12-19 with a 70% effective vaccine, or Oct. 14-22 with 80% efficacy, according to JPMorgan’s model.
“When the trials started there were a lot more cases in the U.S. at that time,” said Dr. Vamil Divan, an analyst at the bank Mizuho. “That’s a key unknown. How many of these participants are enrolled in hotter areas versus New York or Boston?”
To protect the integrity of trials like this, the drugmakers running them aren’t supposed to know what the data is showing as it comes in. And yet, company executives have led some observers to believe they know how many people have tested positive for COVID-19.
“They’re making projections based on how rapidly they’re accruing data, and they probably know the total number of events,” said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.
“When they say things like that, first of all, it does some wonders for their stock prices,” she added.
In a statement, Pfizer said that it expects results “as early as the end of October” based on current infection rates. The trial, the company said, “was designed to evaluate the safety and efficacy of the vaccine candidate as fast as possible.”
“Having said that,” the company added, “neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial.”
It’s highly unlikely that the next front-runner, Moderna, could have results before the election. The JPMorgan analysts’ model suggests that infection rates would have to be four times the publicly reported rate for Moderna to be able to report results before Nov. 3.
Dr. Tal Zaks, Moderna’s chief medical officer, told investors on Sept. 17 that “some time in November is sort of a reasonable base case” for the first look at Moderna’s results. (ProPublica’s board chairman, Paul Sagan, is a member of Moderna’s board and a company stockholder.)
Other developers are further behind. AstraZeneca’s trial is paused in the U.S. while the company investigates what happened with a participant who had a bad reaction. Johnson & Johnson is just beginning its large-scale, end-stage trial, months behind the other three.
So Pfizer is the only company with a shot at results before the election. And if the company has results to share, it’s unlikely to let political implications get in the way. The company has an ethical obligation not to delay a product that is ready to save lives, despite the risk that a vaccine announced on the eve of a contentious election could stoke partisan perceptions.
“Once you have signs of a vaccine’s effectiveness, it’s very difficult to argue anything is ethical other than making it available to those most at risk,” Dr. Mani Foroohar, an analyst with the investment bank SVB Leerink, said. “But it’s also very difficult to make the argument that you should do anything that undermines public trust. That’s one of the problems when you introduce powerful political pressures into what is meant to be a boring, dry, unemotional process.”
Once Pfizer gets results, it’s poised to seek the FDA’s go-ahead swiftly.
As soon as Pfizer has conclusive data, it will submit an application to the FDA. The application will include data from all previous trials as well as proof that the company can consistently manufacture millions of vaccine doses.
Pfizer’s CEO has indicated that the company is ready to turn around its application in a flash, if not on the same day it has results. “We will try to be able to be ready to submit with the speed of light, once we have the results ready,” Bourla said at an investor presentation on Sept. 16.
Pfizer has two options when submitting its FDA application. It can apply for an EUA or a full approval, known as a biologics license application, or BLA. An EUA would only allow Pfizer to market its vaccine for the pandemic’s duration — during the declared “emergency” period that we are currently in. If the company receives full licensure, on the other hand, its product can remain on the market forever. In its statement, Pfizer said it plans to continue its study after a possible EUA to collect more long-term data.
The bar for an EUA is lower than for full approval. By law, an EUA can be issued so long as “the product may be effective in diagnosing, treating, or preventing” the disease and “the known and potential benefits of the product … outweigh the known and potential risks.” In contrast, the standard for a full approval requires a drugmaker to prove not only that the product is safe and effective, but also that the product is pure and can be consistently made, because vaccines are biological products made from living materials.
For the COVID-19 vaccine, the FDA has said that it is going to raise the bar for an EUA, going beyond the usual requirements. Previously, the FDA has said a vaccine should be at least 50% effective. The FDA is reportedly close to announcing new standards to include at least two months of monitoring the health of trial participants after they receive their second shot. That could end up being the biggest hurdle to authorizing a vaccine before the election. Trump said on Wednesday that he might reject the new guidelines, but companies and FDA officials might still choose to observe them.
In a statement, the FDA said that “for a vaccine for which there is adequate manufacturing information,” an EUA “may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or the FDA has completed its formal review of the biologics license application.”
Pfizer said in a statement that it anticipates providing the agency safety data, including the median of two months safety information after the second dose, on a rolling basis. The trial has enrolled more than 31,000 participants, and 19,000 have received the second dose so far, the company said.
“The standards FDA is reportedly considering for a covid vaccine EUA represent appropriate balance between speed and safety in a crisis,” Dr. Scott Gottlieb, who led the FDA earlier in the Trump administration and serves on Pfizer’s board, tweeted on Thursday. “Even under EUA; you want higher assurance of safety and benefit for vaccine given to healthy people vs. drug given to those already sick.”
“Any political effort to shortcut [the] process or degrade reasonable standards will be [a] Pyrrhic victory if people lack confidence in a vaccine,” Gottlieb added.
The FDA will thoroughly review the application, and that’ll take a while.
Once the FDA receives a company’s submission, the agency’s review process consists of several steps which, put together, could take weeks to complete.
The FDA is the only health regulator in the world that asks drugmakers for raw data files and does its own analysis, said Dr. Joshua Sharfstein, the FDA’s former principal deputy commissioner from 2009 to 2011. “Now would not be the moment to stop” that practice, he said, despite the urgent need for a vaccine.
Besides reviewing clinical trial data, the FDA also inspects vaccine developers’ manufacturing capabilities to ensure that every vaccine batch can be made consistently and that the process is squeaky clean, so that no impurities can make their way into a vial of product. This process involves a lot of paperwork sent from the companies to the agency and also, usually, on-site inspections at manufacturing plants. The agency declined to comment on whether it had already completed on-site inspections for Pfizer and Moderna.
After the FDA finishes its assessment of the company’s application, it typically presents the data to an external advisory committee in a public meeting. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, has said that the agency is committed to holding advisory committee meetings to review individual vaccine candidates.
Those meetings will take time to schedule, but it’s an essential step, according to experts both inside and outside the agency.
“How will [the public] know that we’re not, like, holding something in and sweeping something under the rug? Well, the way they’re going to know that is because any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting,” Marks said in a Sept. 10 webinar hosted by the Duke Margolis Center for Health Policy. “It’ll be critical for people to see what’s in the briefing packages, they’ll be able to see the discussion among an impartial group of advisers, they’ll see the committee recommendation and they’ll see the public dialogue that will take place at that committee.”
Advisory committee members vote on whether they recommend product approval. While the FDA does not have to follow the committee’s recommendations, the votes are public.
“It protects against political interference — it’s important,” Sharfstein said.
We contacted every advisory committee member and interviewed six of them about how they would evaluate an EUA application for a COVID-19 vaccine. These members (speaking for themselves, not for the FDA) indicated they would expect to see a level of evidence that could be tough to meet in the next 38 days.
One factor in their caution is that a premature EUA could make it harder to definitively evaluate an effective vaccine, because subjects in ongoing trials may drop out and new enrollments in trials with placebos would no longer be feasible.
“If an EUA came too soon where we don’t have sufficient clinical efficacy data, it would make it very hard to actually complete the study as written,” Dr. Paul Spearman, director of infectious diseases at Cincinnati Children’s Hospital, said. “You would want to have enough clinical efficacy data by the time of an EUA to be pretty darn certain.”
Another committee member is Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine. She also expressed caution about basing a hugely consequential decision on such a small number of cases, like the 32 in Pfizer’s first look.
“It’s hard for me to say with these small numbers will we have meaningful data to make a decision on,” Chatterjee said. “I have not made up my mind on any of this because I need to see and discuss with colleagues what the data are and what the implications might be.”
One option would be for the FDA to grant an EUA for a specific group of people, such as health care workers or the elderly, who are more vulnerable to COVID-19.
The data would have to support a specific vaccine use that aligns with a recognized unmet medical need, said Dr. Michael Kurilla, an advisory committee member and the director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, part of the National Institutes of Health. For example, it’s possible a vaccine could work well in young people but not so well in older people. In that case, it might not be that beneficial, because older people are much more vulnerable to serious disease.
“It’s not simply a matter of saying we will EUA this product,” Kurilla said. “We have to be very careful to define what it is we’re trying to address.”
Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, said he would like to see robust safety data, to make sure there are no neurological side effects, from Pfizer and Moderna. Both companies are developing so-called mRNA vaccines, a type of vaccine technology that has never been approved before. He noted that most people who get vaccines are healthy, so the bar for letting a vaccine go to market is necessarily much higher than for treatments intended for severely ill COVID-19 patients.
Finally, the FDA considers the committee’s advice and makes its final decision on whether it will greenlight the product. Normally, the FDA aims to review applications for full approval within 10 months for standard reviews and six months for priority reviews.
It’s unclear exactly how quickly an EUA review can be completed for the COVID-19 vaccine. The only other vaccine that has ever received an EUA was an anthrax vaccine, but it’s not a useful comparison because the vaccine was already in use and the 2005 authorization was granted to allow the US. Department of Defense to resume giving the shots to military personnel after the mandatory vaccination program had been suspended.
Some steps could potentially be skipped when doing a review for an EUA as compared with a full approval, according to McClellan, the former FDA commissioner. For example, any vaccines needed for this pandemic won’t need long-term storage, because they’ll all be used quickly, so companies won’t need to run tests and demonstrate to the agency that their vaccines can be stored for months on end. But to receive full approval, the agency might require that.
Still, McClellan estimated, the agency’s review process from the time it receives an application to issuing an EUA could take up to a month.
All of this is just to get to yes on a vaccine. Getting shots in millions of people’s arms is another story. The two vaccine front-runners from Pfizer and Moderna pose additional logistical challenges because they have to be kept frozen.
What could go wrong?
Having read through all these steps, you can start to see the points where the process could break down and how the public might find out about it.
- If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies’ own standards to prove it works. If they unexpectedly change their schedules or the standards, that’s concerning.
- If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency’s leaders reject the committee’s advice, it would be a sign that they’re acting under political pressure without scientific support.
- If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Marks, head of the biologics division. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks’ decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn’s call.
- If FDA officials quit. Marks has said he’d resign if the agency authorizes an unproven or unsafe vaccine.
Ultimately, the FDA and everyone involved in vaccine development are seeking the perfect balance between speed and caution: Faced with a deadly virus that’s taken the lives of more than 200,000 Americans and upended life, devastating the economy and tearing away the livelihoods of so many, of course there is an imperative not to waste any time and an urgent desire for a vaccine.
Yet a bad vaccine could do more harm than good, and even the perception of a vaccine that is not thoroughly vetted could be just as bad, if the public doesn’t feel confident in taking it.
“A vaccine only works if it’s safe, effective and administered,” meaning people have to be willing to take it, said Bruce Mehlman, a political adviser to companies at the lobbying firm Mehlman Castagnetti Rosen & Thomas. (He doesn’t represent any pharmaceutical clients.) “If it becomes another culture war football like masks, it will not help us get past the virus and return to normal.”
It’s unlikely we’ll see a vaccine authorized in October, but to ensure the shot is safe, effective, pure and trustworthy, waiting a little longer with the knowledge that no steps have been skipped may be well worth it.
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