Even as Governor Cuomo touted vaccine approvals by a state-appointed panel of experts, his office was withholding the group’s detailed findings from public view.

The governor’s six-member Clinical Advisory Task Force, which is co-chaired by a Nobel laureate, issued formal statements on the Pfizer and Moderna vaccines in December and on the Johnson & Johnson vaccine in February.

Although Cuomo briefly announced each of the task force’s decisions shortly after it was made, the panel’s statements have remained unpublished until now.

The existence of the statements did not come to light until the Executive Chamber recently turned them over to the Empire Center under the state’s Freedom of Information Law.

Why these reports stayed hidden is a mystery. Sharing them with the public would have been more consistent with Cuomo’s stated goal in establishing the task force—which was to reassure New Yorkers that the FDA’s scientific judgments had been scrutinized by independent experts.

“Once the FDA says it’s safe, we’ll have a New York group of doctors and some of the best doctors around the world review what FDA did so I’ll be able to say to New Yorkers it is safe,” Cuomo declared when he appointed the task force

“After careful review of the available information, the Task Force enthusiastically supports the FDA’s issuance of the [emergency use authorization],” the group wrote at the end of its five-page report on the Pfizer vaccine. “Access to the vaccine is important for the health and welfare of the citizens of the state of New York.”

Although the task force’s statements contain no surprises, they include expert perspective that New Yorkers might have found reassuring or enlightening. They noted, for example, that some higher-risk populations, such immunocompromised patients, were excluded from the clinical trials.

“These higher-risk patients and their healthcare providers deserve the flexibility to decide whether to vaccinate based on analyses of the risks and benefits for each patient,” the task force wrote in its Pfizer statement. “The Task Force encourages close follow-up as these populations are vaccinated to ensure that the vaccine is still efficacious and there are no unexpected adverse events.”

In response to the center’s request, the governor’s office also released video recordings of three on-line meetings of the task force, including Dec. 10 and 17 sessions at which the group discussed and approved the Pfizer and Moderna vaccines. The meetings were not open to the public and attended only by task force members and Health Department officials.

The videos and other records make clear that the task force’s work mostly piggy-backed on the lengthier and more transparent review by the FDA. Members of the state panel read a selection of reports and studies that were compiled by the federal agency, watched key FDA deliberations on-line, then quickly formulated their own endorsements in anticipation of the FDA’s final action.

The Dec. 10 and 17 meetings were held immediately after sessions of an FDA panel that voted to recommend the Pfizer and Moderna vaccines for emergency authorization. Members of the state task force showed no hesitation about ratifying the FDA committee’s judgments, and spent most of their time fine-tuning statements that were clearly intended for public consumption.

The resulting statements were consistent with what the FDA and other experts have said. Beyond signaling the panel’s unanimous approval, task force members explained the science behind each medication, summarized the results of clinical trials, raised cautions about gaps in the evidence, and pointed to questions in need of further research.

They hailed the “messenger RNA”-based technology behind the Pfizer and Moderna vaccines as “a major public health advance which has the potential to become a landmark in our fight against infectious disease.”

With each vaccine, Cuomo himself gave the first and only public word of the task force’s recommendations—usually boiling it down to a sentence or two—and appears to have consistently done so before he had a final report in hand to read.

The task force’s Pfizer letter was dated Dec. 14, which was three days after Cuomo announced its findings at a Dec. 11 briefing. (Dec. 14 was also the same day that the nation’s first shot was administered to a nurse on Long Island.)

The task force’s Moderna statement was dated Dec. 19, one day after Cuomo revealed its findings. The Johnson & Johnson statement was dated March 3, two days after a gubernatorial announcement

Not only did the administration fail to publish the reports, it postponed responding to the Empire Center’s Dec. 22 FOIL request three times, first to Feb. 16, then to March 16 and finally to April 13. It released the records on April 8 after the Empire Center filed an appeal on grounds that the delay was excessive.

In addition to the formal reports and the meeting videos, the state also provided email records referencing five task force-related meetings on Nov. 11, Nov. 24, Dec. 1, Dec. 10 and Dec. 17. No emails or recordings related to the Johnson & Johnson meeting on Feb. 26 were released, possibly because it occurred after the date of the FOIL request.

Invitees were almost entirely task force members and state officials only, with two exceptions: Glen Santiago, an aide from Rockefeller University, and Dennis Whalen, a longtime former state official and vice president of Northwell Health whom Cuomo had briefly tapped to coordinate the state’s vaccine rollout. Neither appeared to attend any of the three recorded meetings.

Health Commissioner Howard Zucker attended and participated in all three of the recorded meetings.

Some of what the Empire Center requested is missing from the records provided by the state—such as minutes or agendas from the first two meetings and copies of written guidance or instructions provided to the task force. It was unclear whether these records are being withheld or simply do not exist.

The center also requested copies of “studies, research reports and data” provided to task force members. In its response, the governor’s office said: “Please be advised that the Clinical Advisory Task Force reviewed publicly available data, including but not limited to safety and efficacy data from the clinical trials of the vaccines, as well as the findings of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee.”

The task force consisted of Scott Hammer, M.D., of New York-Presbyterian Hospital and Columbia University Medical Center (co-chair), Charles Rice, Ph.D., of Rockefeller University (co-chair), Adolfo Garcia-Sastre, Ph.D., of the Icahn School of Medicine at Mount Sinai, Sharon Nachman, M.D., of the Renaissance School of Medicine at Stony Brook University, Kelvin Lee, M.D., of the Roswell Park Comprehensive Cancer Center, and Bruce Farber, M.D., of Northwell Health.

Shortly after his appointment, Rice was one of three scientists awarded the 2020 Nobel Prize in Medicine for virology research that led to a cure for hepatitis C.

A seventh appointee, Shawneequa Callier, M.A., J.D., of the George Washington University School of Medicine and Health Science, dropped off the task force before it issued any recommendations – a change that went unannounced at the time.

Clinical Advisory Task Force meeting, unknown date

 

CATF meeting on Pfizer vaccine, Dec. 10

 

CATF meeting on Moderna vaccine, Dec. 17

About the Author

Bill Hammond

As the Empire Center’s senior fellow for health policy, Bill Hammond tracks fast-moving developments in New York’s massive health care industry, with a focus on how decisions made in Albany and Washington affect the well-being of patients, providers, taxpayers and the state’s economy.

Read more by Bill Hammond

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