When Pfizer representatives met with senior U.S. government health officials on July 12, they laid out why they thought booster shots would soon be necessary in the United States. Data from Israel showed the vaccine’s effectiveness waned over time, especially in older and immunocompromised people.
But officials from the Centers for Disease Control and Prevention disagreed, saying their own data showed something quite different, according to four people with direct knowledge of the meeting who requested anonymity to speak candidly.
Other senior health officials in the meeting were stunned. Why hadn’t the CDC looped other government officials on the data? Could the agency share it — at least with the Food and Drug Administration, which was responsible for deciding whether booster shots were necessary? But CDC officials demurred, saying they planned to publish it soon.
That episode, say senior administration officials and outside experts, illustrates the growing frustration with the CDC’s slow and siloed approach to sharing data, which prevented officials across the government from getting real-time information about how the delta variant was bearing down on the United States and behaving with greater ferocity than earlier variants — an information gap they say stymied the response.
The CDC’s fumbles on the delta variant, following a year when its missteps were often attributed to Trump administration meddling, tell a more complicated story — that the once-storied agency faces other challenges that have hampered an agile response to the pandemic.
Critics lament that the most up-to-date data about the delta variant has come from other countries, such as Israel, Great Britain and Singapore. And they say the CDC’s inability to share real-time information led top administration officials, including the president himself, to offer overly rosy assessments of the vaccines’ effectiveness against delta that may have lulled Americans into a false sense of security, even as a more wily and formidable variant was taking hold.
Some inside the agency share those criticisms.
“It’s not acceptable how long it takes for this data to be made available,” said a senior CDC official, who spoke on the condition of anonymity to discuss internal matters. “It’s done in a very academic way. Cross every ‘t,’ and dot every ‘i,’ and unfortunately, we don’t have that luxury in a global pandemic. There’s going to be a need to have a significant cultural shift in the agency.”
There are signs of change: On Wednesday, CDC Director Rochelle Walensky announced plans to develop a new forecasting and outbreak analytics center to analyze data in real time to better predict disease threats. She said it would be the country’s first governmentwide forecasting center.
Walensky was unavailable for comment on this story. But CDC spokeswoman Kristen Nordlund responded to criticisms of the agency’s slowness to share data, saying that researchers across the country have “worked tirelessly every day throughout this pandemic to gather and analyze data so that we could make the best possible decisions for public health.”
Gathering and analyzing data -— especially in a crisis — needs to balance accuracy and speed, Nordlund said. The pandemic has underscored the continued and substantial need for modernizing public health data infrastructure at all levels, she said, and Walensky has put initiatives in place to improve the agency’s ability to provide “relevant, current data” to inform policy decisions.
“Just this week, CDC was able to collect, analyze and publish 10-day old data … that resulted in actionable policy decisions to work toward COVID-19 booster shots for all Americans,” Nordlund said, referring to the Biden administration’s recommendation Wednesday that millions of vaccinated Americans get booster shots.
There were clues beginning in May and June that the delta variant might upend the nation’s progress against the coronavirus, even as the CDC told vaccinated people on May 13 they could remove their masks, and President Joe Biden vowed a return to normalcy around July Fourth if enough Americans got the shots.
Reports from other countries battling the delta variant, with similar or higher vaccination rates to the United States, began to show the vaccines appeared less effective at preventing mild to moderate infections, although they were still offering robust protection against severe illness.
But the CDC was not releasing real-time data. Public confusion began to grow as high-profile sports figures, celebrities and others reported contracting mild cases of the virus despite being fully vaccinated, which increased pressure on the CDC to provide more information.
“They try very hard to get things right and they keep things very closely held until it pops … and it’s not as real time as people would like,” said one senior administration official who requested anonymity to speak candidly. “They’re not meeting a need. Why are we dependent on Israeli public health data?”
Another data decision provoked more bafflement — the agency’s announcement in May that it would track only the most severe breakthrough infections in vaccinated individuals that result in hospitalizations and deaths. Some critics argued that approach would make it more difficult to gain visibility into real-time changes in the pandemic.
“It’s quite clear in my opinion that their [decision] backing off monitoring breakthrough infections pre-delta was a mistake,” said Ezekiel Emanuel, a bioethicist at the University of Pennsylvania who was part Biden’s COVID-19 transition task force. “I’ve been arguing to do more monitoring, not less, and the CDC has been going in the wrong direction.”
CDC officials and other experts argue that a better approach is studies the agency is conducting that track tens of thousands of people, including health care and essential workers and residents of long-term care facilities, to see how well vaccines are working. Some people are tested weekly, whether they show symptoms or not, Walensky said at a recent White House briefing.
“I would rather see a smaller population studied very, very well than a large population where you arrive at the wrong answers,” said Natalie Dean, a biostatistician at Emory University Rollins School of Public Health, adding that officials need to collect information about participants’ occupations, previous COVID infections, vaccination dates and underlying health conditions. That’s much harder to do if all breakthrough infections are tracked because “it’s too many people,” she said.
But even those who support the agency’s approach note that until now, it has issued only a handful of reports from those studies —and none based on data more recent than April, well before the delta variant began making inroads.
“What is very concerning is that we’re not seeing the data come out,” said Tom Frieden, a former CDC director who served under President Barack Obama. “It needs to come out. What you can criticize CDC for, validly, is why aren’t you talking about the studies you’re doing of breakthroughs? Even like, what’s the methodology. Where are they being done? What are the results so far?”
The CDC “will tell us just how bad this delta wave was with beautiful science in four months, published in JAMA,” said Scott Gottlieb, former FDA commissioner under President Donald Trump and a Pfizer board member, referring to the prestigious medical journal. “It’s not an indictment of them. It’s the wrong agency. Their mind-set is we should polish it, vet it, peer review it.”
Both current and former CDC officials say bureaucratic realities hamper the agency’s ability to turn out real-time updates. The agency has nearly 200 separate budget line items, appropriated by Congress. That makes it difficult for even the director to move people and resources around to address urgent concerns.
The agency has flu experts, respiratory disease experts, virology lab experts, Frieden said, “but you really don’t have, structurally in your organization, groups that think broadly about where we are, what we need to be doing.”