Review by CDC finds past guidance issues

WASHINGTON — Federal health officials have identified several pandemic recommendations released during the Trump administration that they say were “not primarily authored” by staffers and do not reflect the best scientific evidence, based on a review ordered by the new director of the Centers for Disease Control and Prevention.

The review identified three documents that had already been removed from the agency’s website:

■ One, released in July, delivered an argument for school reopenings and minimized health risks.

■ A set of guidelines about the country’s reopening was released in April by the White House and was less detailed than what had been drafted by the CDC and the Federal Emergency Management Agency.

■ A guidance issued in August discouraged the testing of people without covid-19 symptoms even when they had contact with infected individuals. That was replaced in September after experts inside and outside the agency raised alarms.

CDC Director Rochelle Walensky ordered the review as part of her pledge to restore public trust in the agency, which had seen its recommendations watered down or ignored during the Trump administration as the then-president attempted to downplay the severity of the pandemic.

“I am focused on moving

CDC forward with science, transparency and clarity leading the way,” Walensky said in a statement Monday. “It is imperative for the American people to trust CDC. If they don’t, preventable illness and injury can occur — and, tragically, lives can and will be lost.

“This agency and its critical health information cannot be vulnerable to undue influence, and this report helps outline our path to rebuilding confidence and ensuring the information that CDC shares with the American people is based on sound science that will keep us, our loved ones, and our communities healthy and safe.”

The review was conducted “to ensure that all of CDC’s existing covid-19 guidance is evidence-based and free of politics,” according to a memo from the agency’s principal deputy director, Anne Schuchat. She conducted the review, which was posted on the agency’s website Monday. Officials said they are revamping all pandemic-related guidance to ensure that science and transparency are paramount.

The July school-reopening guidance was contentious because it was released weeks after Trump criticized the agency’s earlier recommendations as being “very tough and expensive.” The preamble extolling the importance of inschool classes was presented as a CDC document, but the agency was not part of the discussion or drafting, Walensky said. That guidance was removed in October.

“This is something that I will not allow as CDC director,” Walensky said. “The processes we have in place moving forward will ensure this cannot and will not occur.”

AVOIDING POLITICS

Schuchat does not identify the outside authors who wrote the three guidances not developed by CDC staffers, nor does her memo mention political interference by the Trump administration. The word “politics” appears only once, and Walensky and Schuchat appeared to go out of their way in interviews to avoid discussing it.

But the review provides official confirmation of what was widely reported in news accounts at the time — that political appointees ordered revisions to critical CDC guidance. In addition to the three documents not written by CDC staffers, the review also cited recommendations that should have used stronger language and that should have cited supporting scientific briefs.

The memo said that too often, it was difficult to “decipher the core recommendations” in long guidance documents and that “the crux of what was new or changed was difficult to find.” But the memo, a copy of which was shared with The Washington Post, does not provide specifics.

Walensky said she plans to adopt Schuchat’s recommendations to ensure that scientific rationale for major guidance is clearly communicated — with executive summaries that identify what’s new. She said key guidance will be reviewed quarterly and that briefings will be held for the media and public-health groups when it is issued.

The review found instances in which guidance used weaker language, such as “considerations” and “if feasible,” even though evidence supported a stronger recommendation.

“I can’t speak to how the decisions were made or why the language was less directive than we wanted it to be,” Walensky said. “We need to have language that needs to be clear when the evidence base is sufficiently strong.”

President Joe Biden’s administration is focusing on the need to “offer the public a unifying message about what we’re doing and help rebuild their faith in government,” said one health official who spoke on condition of anonymity to talk about internal policy discussions. The official added that it’s harder to rebuild faith in government when people are “constantly reminded of how [the CDC] has been overridden.”

Schuchat and 15 to 20 CDC staff members assessed the major guidance to “identify primary documents that needed updating or removal,” the memo said. Agency officials had already in October begun assessing key recommendations related to testing and schools because of concerns from clinicians and others about the need for updates as coronavirus cases surged in the fall, Schuchat said in an interview.

Regarding testing recommendations alone, the CDC has “36 different testing guidances that descend from one,” Schuchat said. The agency is working on a major update, including recommendations for prisons, homeless shelters and other workplaces, the memo said. The CDC is trying to streamline the process so one major document can cover many circumstances.

Officials have released or updated more than a dozen major guidances, eight of them since Jan. 20, when Walensky became director. They include recommendations for wearing properly fitted masks, including double masks; a road map for safely opening schools; and guidelines for fully vaccinated people.

WASTED VACCINE

Meanwhile, as millions of Americans continue to wait their turn for covid-19 shots, small but steady amounts of the precious doses have gone to waste across the country.

It’s a reality that experts acknowledged was always likely to occur. Thousands of shots have been wasted in Tennessee, Florida, Ohio and many other states. The reasons vary, including shoddy record-keeping and accidentally trashing hundreds of shots. However, just how many of the vials have been tossed remains largely unknown despite assurance from many local officials that the number remains low.

Waste is common in global inoculation campaigns, with millions of doses of flu shots trashed each year. By one World Health Organization estimate, as many as half of vaccine doses in previous campaigns worldwide have been thrown away because they were mishandled, unclaimed or expired.

By comparison, waste of the covid-19 vaccines appears to be quite small, though the U.S. government has yet to release numbers shedding insight on its extent. Officials have promised that may change soon as more data is collected from the states.

In the interim, state health agencies are much more inclined to tout how fast they’ve administered the shots while keeping quiet on the number of doses that end up in the trash.

Ohio’s Department of Health resisted use of the term “wasted” when asked by The Associated Press for a total number of tossed doses. Instead, a spokesperson said the state tracks “unusable” vaccine doses reported by state providers.

“With 3.2 million doses administered as of March 9, 2021, the 3,396 unusable doses reported by state providers make up about 0.1% of the doses administered — less than the CDC expectation of 5% of unusable doses,” Alicia Shoults, an Ohio Department of Health spokesperson, said in an email.

According to a log sheet provided by the department, Ohio providers reported almost 60 incidents in which doses were unused. The largest incident occurred when a pharmacy responsible for distributing the vaccine to nursing homes failed to document storage temperatures for leftover shots, resulting in 890 doses being wasted.

In Tennessee, wasted, spoiled or unused doses aren’t publicly disclosed on the state’s online covid-19 vaccine dashboard. However, after nearly 4,500 doses were ruined in February, the state’s Department of Health scrambled to find answers.

It started with nearly 1,000 doses reported missing in eastern Tennessee’s Knox County, where local leaders told reporters that a shipment was accidentally tossed by an employee who believed the box contained dry ice.

Shortly after, a little more than 2,500 doses were reported wasted in Shelby County, which encompasses Memphis. A state investigation concluded the spoilage occurred over multiple incidents because of substandard pharmacy practices, a lack of standard operating procedures for storage and handling, disorganized record-keeping and deficient management of soon-to-expire doses.

Another 1,000 doses were reported spoiled in middle Tennessee after a school district noted a storage error.

Despite the recent string of wasted-vaccine incidents, the health agency stressed that the number represents just a sliver of the nearly 1.9 million doses the state has received since December.

“We don’t believe there is a systemic issue statewide, but we’re ramping up our efforts for compliance just to be sure,” state Health Commissioner Lisa Piercey told reporters.

Piercey said Tennessee will soon conduct a review of the state’s vaccine distribution efforts to prevent future waste and that it will eventually hire a separate company to conduct the quality checks.

‘THIS STUFF IS GOLD’

Meanwhile, in Florida, Surgeon General Dr. Scott Rivkees recently called for an audit after more than 1,000 doses were reported damaged last month in Palm Beach County.

Like other states, Florida doesn’t regularly publish how many doses don’t end up in arms, but a spokesperson for the state Health Department said 4,435 doses had been reported wasted as of Monday.

In Louisiana, health officials give updated totals of wasted doses to reporters at the governor’s weekly covid-19 briefing. Out of 1.2 million vaccine doses, fewer than 1,500 had been wasted as of March 9, said Dr. Joe Kanter, the governor’s chief public health adviser.

Ohio’s Health Department reported 2,349 doses wasted or spoiled as of February. Officials stress that the wasted amount is extremely low compared with the total doses that ended up in arms. However, they noted, that doesn’t make the situation any less upsetting.

“Here’s the bottom line: This stuff is gold,” said Julie Willems Van Dijk, deputy secretary of the Wisconsin Department of Health Services. “I think every vaccinator who touches a bottle of Pfizer, Moderna or J&J knows it. … I’ve talked to people with these wasted vaccine, and they are heartbroken.”