Dr. Tony Holtzman speaks about the federal government response to the coronavirus pandemic during a virtual presentation hosted by Historic Saranac Lake on Tuesday. (Enterprise photo — Elizabeth Izzo)

SARANAC LAKE — As he watched the coronavirus spread throughout the United States, with this country surpassing all others in the number of cases reported, Dr. Tony Holtzman sought to answer a question.

“How can it be that the wealthiest country in the world, and among the most technologically advanced countries in the world, fared so badly?” asked the emeritus professor of pediatrics at Johns Hopkins University and author of Adirondack historical fiction.

Holtzman attempted to answer that question as he outlined the results of his research in a virtual presentation Historic Saranac Lake hosted Tuesday, attended by more than 40 people from around the country and from Canada.

Holtzman focused specifically on what’s called “emergency use authorizations” — a mechanism granted by Congress that allows the U.S. Food and Drug Administration, during emergencies, to approve products for use that haven’t gone through the normal review process — and how that mechanism impacted this country’s pandemic response.

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Test development

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Dr. Robert Redfield, head of the U.S. Centers for Disease Control and Prevention, was alerted to the severity of the coronavirus by his Chinese counterpart, George F. Gao, around New Year’s Day last year, the New York Times reported. Redfield’s agency initially moved quickly to quell the threat but faced several setbacks.

The agency created an incident management system and advised travelers to Wuhan, China, to take precautions. Two weeks after receiving information about the virus from Chinese scientists, the CDC had developed a test that could identify whether a person had COVID-19. It was later discovered that the agency’s scientists spent some time attempting to design a test that was far more complicated than one already available from the World Health Organization.

The CDC’s test was ultimately used to identify the United States’ first confirmed case of COVID-19 on Jan. 20, 2020.

China denied early requests from the CDC to send experts there to learn more about the coronavirus, the Times reported. The country also shared limited data with the U.S. At the time, because this version of the coronavirus was so new, there was limited information available on it.

Before the CDC could release coronavirus test kits, the agency needed U.S. Department of Health and Human Services Secretary Alex M. Azar II to formally declare that a public health emergency exists, triggering the FDA’s ability to issue the CDC emergency use authorization for the test kits, Holtzman explained.

Azar issued that declaration on Feb. 4, 2020, and the FDA issued its emergency use authorization that same day. Four days later, public health labs began receiving shipments of the CDC’s test kits.

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Testing misstep

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The United States’ ability to contain the coronavirus, before it spread widely, hinged upon its ability to identify cases, isolate those cases and conduct rigorous contact tracing that would identify any others who may have been exposed before those contacts could potentially infect others, according to Holtzman.

But scientists at public health labs that received the first few CDC test kits discovered something that would eliminate the government’s best hope at curbing the spread of the virus before it was too late. Lab technicians in Manhattan found that the first batch of tests from the CDC produced untrustworthy results, the Washington Post reported. Most labs that received those first few tests found those tests weren’t working, Holtzman said.

He said the CDC “did not use good manufacturing practices.”

An investigation later revealed that those initial tests had been contaminated during the manufacturing process, according to the Post.

The CDC ultimately released effective COVID-19 tests 46 days after the WHO initially shared information on how to configure those tests, the Post reported.

The U.S. was processing about 100 test samples per day by mid-February, according to the CDC.

The country’s testing capabilities ramped up “very rapidly” after other labs and commercial manufacturers of test kits received emergency use authorization from the FDA, according to Holtzman.

The FDA allowed labs to begin testing prior to FDA review, and allowed manufacturers of many tests to move forward while waiving the normal manufacturing requirements, according to Holtzman.

“All restraints on making sure Americans were being administered safe tests were thrown to the wind,” he said.

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Limited testing

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In the weeks after tests became available, testing was restricted “in most parts of the country” to those who were sick, Holtzman said.

Testing capacity was limited. Backlogs at labs across the country — including at New York state’s top lab, the Wadsworth Center in Albany — slowed the process of identifying new cases, and slowed the flow of information to decision-makers.

For several weeks, testing in the North Country region was restricted to health care workers and hospital patients only, which skewed positivity rates higher. There was so little local data available to public health officials that county health departments began to compile data not only on test-confirmed positives, but also on patients suspected of having COVID-19 after receiving a diagnosis from their doctor.

The Essex County Health Department reported suspected cases for the first time on April 2, 2020. Two days later, Franklin County Public Health announced it would also begin collecting data on suspected cases.

It was later discovered that in most cases, the virus is spread by those without symptoms, according to Holtzman. According to the CDC, most cases are tied to either asymptomatic or pre-symptomatic spread, meaning from people who aren’t experiencing symptoms or those who aren’t experiencing symptoms yet.

The coronavirus’ incubation period — the amount of time it takes after an exposure before a person starts experiencing symptoms — ranges anywhere from two to 14 days. People generally begin to experience symptoms five to six days after exposure.

Holtzman pointed to the sluggish test rollout in the U.S., President Donald Trump’s repeated public statements downplaying the severity of the virus, and a lack of a “rigorous contact tracing policy” as elements he believes ultimately set the stage for the virus to spread in this country.

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Vaccines

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Before authorizing a vaccine for emergency use, certain requirements were put in place, Holtzman explained. Manufacturers and research labs had to conduct clinical trials with at least 30,000 participants, and manufacturers had to have the ability to scale up its operations to produce millions of doses of the vaccine. The vaccine also had to have at least a 50% effective rate.

On Dec. 11, 2020, the FDA approved use of a coronavirus vaccine for the first time. The Pfizer vaccine was produced by the pharmaceutical company in collaboration with German company BioNTech. Preliminary data showed the vaccine to be over 90% effective.

The FDA approved a second coronavirus vaccine, this one by Moderna and the National Institutes of Health, on Dec. 18.

The federal government controls the allocation of vaccine doses to each state. Since the vaccines were authorized by the FDA, New York has received about 300,000 doses per week, according to Gov. Andrew Cuomo’s office.

The state has faced criticism over its sluggish vaccine rollout. Cuomo has attributed the delay to both the federal government’s vaccine allocation — Cuomo has said New York needs more doses than it is receiving, and faster — and to hospitals, which were given the responsibility of vaccinating those eligible to be vaccinated in Phase 1A of state’s vaccine rollout program.

Even as the number of doses delivered to New York state falls short of what Cuomo has said the state needs, the number of people eligible expanded further this week from about 2 million people to 7 million people. Now eligible are people ages 65 and older, police officers and other first responders, preschool through 12th-grade teachers and school staff, corrections officers and a number of others in various professions, including grocery store employees.

The COVID-19 Clinic at Adirondack Medical Center in Saranac Lake received “hundreds more” calls than normal after the announcement that eligibility would be opened to those who fall under the state’s Phase 1B of its vaccine rollout plan, as people sought to schedule appointments to be vaccinated, according to Adirondack Health spokesman Matt Scollin.

“We view that as a positive sign,” Scollin said on Tuesday. “That means people are interested in getting vaccinated. We hope that with time that number will continue to grow.”

Appointments have to be scheduled at the state level, however. The state has set up a website at am-i-eligible.covid19vaccine.health.ny.gov, where people can check to see if they qualify, and schedule an appointment at a vaccine distribution site.

With so many more New Yorkers made eligible to get vaccinated within about 48 hours, the state’s system was overwhelmed on Tuesday, and while thousands of people were able to book appointments, many others were not, the Rochester Democrat & Chronicle reported.

Very little is known yet about how long after those who receive the vaccine will be protected from getting sick with COVID-19, according to Holtzman.

“We will have to be very careful over 2021,” he said.