The Centers for Disease Control and Prevention had errors with the first test it created, stalling testing as the virus spread through the US. The Food and Drug Administration, that must approve the test, was slow to realize that commercial labs and hospitals would need to be used for testing… as the virus spread through the US.
Now, even with tests, supplies are low in some areas of the country, forcing doctors to prioritize their use. Lines are impossibly long at some test sights, where sick people sit in cars, waiting for hours, only to be turned away when tests run out.
For others who get the test, a week or more can pass before they receive results.
Government regulatory agencies are set up to monitor safety and efficacy rather than speed and efficiency. They require leadership to identify a crisis and cut through the regulatory maze.
From December 2019 (some say earlier) to the end of February 2020, when the first community spread of the virus in the US was detected, we had an opportunity to develop and disseminate tests in order to identify the spread of the virus, in order to contain it.
Here’s a look at how it all unfolded.
You can decide where leadership fell short or came through.
In 2017, our leaders knew we weren’t prepared for a pandemic.
The Obama administration produced in-depth reports on lessons-learned from Ebola, and how they should inform pandemic preparations for the future. In order to check on our progress, officials from the Obama administration along with officials from the Trump administration (listed below) together ran a mock pandemic event.
The training event revealed: the government was underfunded, underprepared and uncoordinated in the face of a pandemic.
Read the report here.
The 60-page report details a lack of clarity of the chain of command and responsibilities between federal agencies, huge shortages of healthcare equipment, and a lack of coordination between federal, state, and local governments.
Here’s a list of attendees for the mock pandemic exercise:
Steven Mnuchin, Rep. Mike Pompeo, Wilbur Ross, Betsy DeVos, Dr. Ben Carson, Elaine Chao, Stephen Miller, Marc Short, Reince Priebus (resigned), Rex Tillerson (fired), Gen. James Mattis (fired), Rep. Ryan Zinke (resigned), Sen. Jeff Sessions (resigned), Sen. Dan Coats (fired), Andrew Puzder (not confirmed), Dr. Tom Price (resigned), Gov. Rick Perry (resigned), Dr. David Shulkin (fired), Gen. John Kelly (resigned), Rep. Mick Mulvaney, Linda McMahon (resigned), Sean Spicer (fired), Joe Hagin (resigned), Joshua Pitcock (resigned), Tom Bossert (fired), KT McFarland (resigned), Gen. Michael Flynn (awaiting criminal sentencing), Gary Cohn (resigned), Katie Walsh (resigned), and Rick Dearborn (resigned).
Global Health Security Team created in response to a lack of preparation for the Ebola outbreak
The Obama administration’s identification of a lack of preparation for the Ebola outbreak also prompted it to create a Global Health Security Team in the National Security Council.
In May of 2018, Trump disbanded the team, saying “I’m a business person. I don’t like having thousands of people around when you don’t need them.”
The problem: The government is not run like a business but rather it is an organization that prepares for low-probability events, like disasters, wars, plagues, etc, that they hope to never see.
The Intelligence Community’s Worldwide Threat Assessment in its annual report to Congress lists a pandemic as a major US threat.
The Director of National Intelligence Dan Coats writes, “A novel or reemerging microbe that is easily transmissible between humans and is highly pathogenic remains a major threat because such an organism has the potential to spread rapidly and kill millions.”
The Intelligence Community’s Worldwide Threat Assessment in its annual report to Congress again lists a pandemic as a major US threat.
In written testimony before Congress on the presentation of the Intelligence Community’s Worldwide Threat Assessment, the Director of National Intelligence Dan Coats writes,
The increase in frequency and diversity of reported disease outbreaks—such as dengue and Zika—probably will continue through 2018, including the potential for a severe global health emergency that could lead to major economic and societal disruptions, strain governmental and international resources, and increase calls on the United States for support. A novel strain of a virulent microbe that is easily transmissible between humans continues to be a major threat, with pathogens such as H5N1 and H7N9 influenza and Middle East Respiratory Syndrome Coronavirus having pandemic potential if they were to acquire efficient human-to-human transmissibility.
The Intelligence Community’s Worldwide Threat Assessment again lists a pandemic as a major US threat.
The Office of the Director of National Intelligence warns that a major disease outbreak is one of the top global threats in the world, writing, “We assess that the United States and the world will remain vulnerable to the next flu pandemic or large-scale outbreak of a contagious disease that could lead to massive rates of death and disability, severely affect the world economy, strain international resources, and increase calls on the United States for support.”
The Trump administration removes a US public health official stationed in China within China’s disease control agency. The official worked with Chinese epidemiologists to help detect and contain diseases.
The President’s Council of Economic Advisors warns that an influenza pandemic may cause tremendous health and economic losses.
The CEA warns that there will be large health and economic losses if an influenza-like pandemic occurs in the United States.
“The United States is unprepared to deliver a sufficient number of vaccine doses quickly enough to stop the rapid initial spread of a pandemic virus,” the Council reports. “Pandemic influenza is a low-probability but high-cost problem that should not be ignored. The current influenza vaccine manufacturing infrastructure in the U.S. is dependent on egg-based production that is too slow to produce adequate doses of vaccines for unexpected pandemic outbreaks and may impair vaccine efficacy. This could lead to tremendous, avoidable costs.”
COVID-19 appears in China.
December 31, 2019
China tells the WHO about a cluster of pneumonia cases in Wuhan.
January 3, 2020
The Trump administration receives an official report about the coronavirus in China.
The CDC alerts doctors to be on the look-out for patients with respiratory symptoms and a history of travel to Wuhan, China.
China posts a genetic sequence of the virus for the world, identifying it as a new coronavirus.
This is the break the world needs to develop a diagnostic test that could enable leaders to identify and shutdown hotspots, thereby stopping the spread of the disease.
A German lab uses the sequencing to begin development of a vaccine. US commercial labs and scientists at hospitals and universities also mobilize to develop tests to detect the virus. While academic labs don’t have the capacity to process the millions of tests a pandemic could demand, they knew that partnering with commercial labs could bring testing to scale–which would be essential to control the spread of the virus.
This is how South Korea got on top of its problem: by giving testing authority to commercial labs almost immediately. The US was slower to make this adjustment.
Coronavirus infection is reported in Thailand. The virus has left mainland China.
German researchers develop a diagnostic test for COVID-19.
Impeachment trial begins in Senate.
The WHO develops a protocol for the development of a test.
Alex Azar, US Secretary of Health and Human Services, speaks to President Trump on the phone for the first time about the virus.
COVID-19 is confirmed in the US.
A Washington state man is confirmed to have coronavirus (he landed in the US on the 15th). The first case is also confirmed in South Korea.
China closes off Wuhan. All transportation to and from the area is halted.
The virus is in Thailand, South Korea and the US.
“We have it totally under control,” President Trump reports. “It’s one person coming in from China, and we have it under control. It’s going to be just fine.”
China has been working very hard to contain the Coronavirus. The United States greatly appreciates their efforts and transparency. It will all work out well. In particular, on behalf of the American People, I want to thank President Xi!
— Donald J. Trump (@realDonaldTrump) January 24, 2020
“It will all work out well,” Trump tells a reporter.
The President’s Coronavirus Task Force begins daily meetings.
Now one week after the coronavirus was confirmed, officials in South Korea tell private companies that they should start developing testing kits as quickly as possible, promising fast regulatory approval.
The CDC has a test ready to go but its test can only be run at CDC labs. In order for outside labs to run tests, the FDA needs to approve them.
The CDC also limits access to testing to a narrow group of individuals with known exposure–until evidence of community transmission in multiple states is unmistakeable. Unfortunately, the virus had already spread by this point.
Senator Tom Cotton, a member of U.S. Senate Select Committee on Intelligence (SSCI), urges Secretaries Mike Pompeo, Alex Azar, and Chad Wolf to impose a travel ban on China and warns the senior White House officials not to trust Chinese authorities.
Economic Advisor Peter Navarro urgently recommends that President Trump impose a travel ban on China. His memo includes a detailed economic analysis of the potential for loss of economic activity as well as loss of human life.
The WHO declares the virus a public-health emergency.
Trump announces a ban on foreign nationals from entering the US if they were in China within the prior two weeks.
This ban does not include US citizens. It also does not ban other areas with known outbreaks, like Italy where a large number of New York area cases can be traced. Also notable, the first case in Missouri came from Italy, the first case in Rhode Island came from Italy, the first case in Puerto Rico came from Italy. First cases in Maine, Florida, Georgia, Oklahoma, Colorado, New Hampshire and South Carolina also came from Italy, not China.
President Trump tells a reporter, “We only have five people. Hopefully, everything’s going to be great.” He hosts a campaign rally in Iowa.
Health and Human Services Secretary Alex Azar announces a health emergency in the United States. At the time, Azar was the leader of the White House’s coronavirus task force.
Problem is: This declaration makes it even more difficult for labs outside of the CDC to gain permission to make and use their own tests.
While the health emergency status gives the FDA the flexibility to speed up approvals for critical medical products, including commercial diagnostic tests, it also triggers strict limits on scientists in government-certified clinical labs at universities, research centers and hospitals.
Those labs are usually permitted by the FDA to make and use their own tests without government approval, including to make decisions about patient care, as long as they use them only in their own facilities and don’t sell them.
But once Azar announces a public health emergency, tests created in such laboratories need to receive an “emergency use authorization,” or EUA, from the FDA. The additional regulation is intended to ensure the accuracy of tests in public health crises in which inaccurate results could be damaging.
But the new rule slows the efforts to get lab tests done.
There are six confirmed cases in the US.
Trump’s travel ban goes into effect.
It follows 45 other countries that have already implemented travel restrictions on China. The ban also allows tens of thousands of people from China to enter the United States, along with people from areas known to be infected with coronavirus but were outside of China.
“We pretty much shut it down coming in from China,” President Trump said.
FDA approves a CDC test for COVID-19. No other tests are approved.
The FDA approved the CDC test, making it the country’s only allowable test for the coronavirus. State health officials begin receiving the kits four days later.
By contrast, also on Feb. 4, also two weeks after South Korea reported its first coronavirus case, the government gives “emergency approval” for private company to manufacture the test kits.
The South Korea company already had lab work underway for the test kits, anticipating that the coronavirus would spill over from China.
And the CDC test is flawed.
New York City’s health department reports that there is a flaw in the test.
As they struggle to make the test kit work, public health labs report that eliminating one of the reagents would make the test useable. But under the FDA’s emergency rules, they could use the test only as it was approved. The flaw meant they could not use it at all.
There are 11 known cases of COVID in the US.
No word from the CDC on how to proceed with the faulty tests.
The FDA and CDC meet to discuss solutions, including eliminating the component of the test that was causing problems.
In the meantime, clinical labs across the country are working their way through the FDA’s paperwork for approval for their tests.
The Mayo Clinic appointed five people solely to fill out applications with the FDA, working 15-hour days for three weeks.
“It’s unlike anything we’ve ever done before,” said Matt Binnicker, a director of clinical virology at Mayo.
He said they decided to persist because, in a worst-case scenario, the public health labs alone could not test on the scale that would be needed. “The public health infrastructure is really not set up to handle a pandemic,” he said.
At the University of Washington, scientists spend more than 100 hours filling out forms and collecting information needed for the application. But when the material was finally submitted, an FDA official told him the agency could not accept it — because he had emailed it.
“I think it’s going to work out fine. I think when we get into April, in the warmer weather, that has a very negative effect on that and that type of a virus. So let’s see what happens, but I think it’s going to work out fine.”
There are 13 known cases in the US.
The Association of Public Health Laboratories formally ask the FDA to loosen the emergency rules.
“We are now many weeks into the response with still no diagnostic or surveillance test available outside the CDC for the vast majority of our member laboratories,” the association’s letter said. “While we understand that the EUA process is open to [public health labs], we believe a more expeditious route is needed at this time.”
The Coronavirus is very much under control in the USA. We are in contact with everyone and all relevant countries. CDC & World Health have been working hard and very smart. Stock Market starting to look very good to me!
— Donald J. Trump (@realDonaldTrump) February 24, 2020
At a White House news conference, commenting on the country’s first reported cases, Trump says, “We’re going to be pretty soon at only five people. And we could be at just one or two people over the next short period of time. So we’ve had very good luck.”
There was, at this time, 15 confirmed cases.
President Trump said, at a news conferences, “It’s going to disappear. One day it’s like a miracle–it will disappear.”
There are 16 confirmed cases, and almost no testing being done.
Labs and hospitals are approved to conduct their own tests.
Almost six weeks after the first case of coronavirus was confirmed in the country, laboratories and hospitals are finally allowed to conduct their own COVID-19 tests with the component (that was causing false results) eliminated. Although still limited, testing is now more widespread.
At a rally in South Carolina, Trump spoke to the audience about the new coronavirus, accusing Democrats of “politicizing” the virus, calling it their “new hoax” and claiming the U.S. was “totally prepared.”
The WHO reports 86,604 coronavirus cases worldwide.
President Trump claims that a vaccine will be readily available.
“We’re moving aggressively to accelerate the process of developing a vaccine,” says the President at a coronavirus roundtable meeting. “A lot of good things are happening and they’re happening very fast. I said, ‘Do me a favor, speed it up, speed it up.’ And they will — they’re working really hard and quick.” The president suggests the vaccine may be ready “over the next few months.”
At a campaign rally in North Carolina that evening, the president says to the crowd, “We had a great meeting today with a lot of the great companies and they’re going to have vaccines, I think relatively soon. And they’re going to have something that makes you better and that’s going to actually take place, we think, even sooner.”
In three days, the number of cases in the US jumps to 53.
President Trump falsely claims that any American who wants a COVID-19 test can get a test.
“Anybody that wants a test can get a test,” he says to reporters after a tour of the CDC in Atlanta. “That’s what the bottom line is.”
As of April 12, 2020, the CDC still says that it may “be difficult to find a place to get tested.”
The number of cases in the US is now at 214.
Trump tweets,“So last year 37,000 Americans died from the common Flu. It averages between 27,000 and 70,000 per year. Nothing is shut down, life & the economy go on. At this moment there are 546 confirmed cases of CoronaVirus, with 22 deaths. Think about that!”
The WHO reports 114,381 coronavirus cases worldwide.
There are 637 confirmed cases of coronavirus in the US.
Vice President Pence announces that over 1 million tests have been distributed and that 4 million would be distributed by the end of the week.
Note: As of April 12, the US had run only about 2 million tests, and states continue to report testing shortages.
“It hit the world. And we’re prepared, and we’re doing a great job with it. And it will go away. Just stay calm. It will go away,” President Trump says.
There are 937 confirmed cases in the US.
The World Health Organization (WHO) declares that COVID-19 is a global health pandemic.
President Trump addresses the nation with his declaration of an emergency. He announces new travel restrictions from Europe. The travel restrictions do not apply to the UK, even though the country has some of the highest number of cases in Europe. He also makes several misstatements about US policy that leads to confusion.
The President’s address marks a change in his focus on the outbreak, however.
Over the month of March there also is a change in the government’s reaction to the outbreak, including asking Americans to alter their behavior, activating the Defense Production Act, and approving commercial tests.
The number of confirmed cases jumps as testing increases.
On March 13, Trump declined to take responsibility for the delay in testing. “I don’t take responsibility at all,” Trump said.
There are 1,896 confirmed cases in the US.
Trump announces social distancing guidelines, to be in place for two weeks.
There are 4,226 confirmed cases in the US.
“America will again and soon be open for business … Parts of our country are very lightly affected.”
There are 44,183 confirmed cases in the US.
“The LameStream Media is the dominant force in trying to get me to keep our Country closed as long as possible in the hope that it will be detrimental to my election success. The real people want to get back to work ASAP. We will be stronger than ever before!”
The US leads the world in coronavirus cases. 21 states issue stay-at-home orders.
There are 85,386 confirmed cases in the US.
March 31 President Trump says the next two weeks for the US will be “very painful,” calling on “every American to be prepared for the days that lie ahead.”
There are 186,101 confirmed cases in the US.
There are 579,005 confirmed cases of COVID-19 in the US.