Throughout 2021, federal agencies created new solutions to mitigate unique health and IT challenges brought on by COVID-19. With silver linings to the pandemic in sight, current efforts include managing resources and getting the nation moving forward.
“Even though we’re not where we need to be yet, we are not back at the starting line when it comes to COVID-19. We have safe and effective vaccines ... we have new, lifesaving therapeutics, we have additional resources Congress passed in the American Rescue Plan, which can help increase our testing capacity, tech workers and give schools the support they need to stay safely open,” Sen. Murray said during a Jan. 11 Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing to examine emerging COVID-19 variants.
COVID-19 Reporting and Tracking
Data and IT modernization exist at the heart of government’s pandemic response. Not only has telehealth seen a drastic increase in utilization, with the Department of Veterans Affairs reporting 14.7 million telehealth visits in November 2021 alone, but also data modernization and digital services are proving to be valuable tools long term in helping to track and report cases.
“What we really need to do is scale up our data modernization efforts and do it not just for COVID, and not just for other respiratory diseases ... but for all diseases,” CDC director Rochelle Walensky said during the HELP hearing.
Over the past year, health agencies like the National Institutes of Health, Food and Drug Administration and Centers for Disease Control and Prevention created HHS Protect, a secure data-sharing platform to guide the government's COVID-19 pandemic response.
“The ecosystem has matured more, the data sharing has matured more, and we’ve built up a lot of infrastructure and responsiveness to adapt to a rapidly moving virus and pandemic and all of its major impacts on our society,” HHS Chief Data Scientist and Senior Advisor to the Assistant Secretary of Health Kristen Honey said earlier last year.
As health agencies look to better leverage data to inform and improve decision-making, leaders are also developing new digital services like exposure notification apps and digital vaccine credentials to standardize virus reporting.
In the U.S., because vaccination and testing are not centralized and vary across states and territories, there is significant fragmentation, noted Hayden Huang, GAO’s assistant director for science, technology assessment, and analytics. There also needs to be clearer standards on what information is tracked and processed, especially with the rise of emerging variants and cases of COVID-19.
“Our bottom-line message for both technologies ... is that they offer a lot of promise that facilitate various types of responses to the ongoing pandemic, as well as potentially for future pandemics, if the proper framework could be put into place,” Huang said.
Access to COVID-19 Testing
As part of President Biden’s plan to mitigate COVID-19, the administration has worked to increase the number of drive-through testing sites and invest in next-generation testing, like at-home and instant tests, to scale up testing capacity.
To support these priorities, HHS launched new initiatives and programs to ramp up testing services and availability. As of Dec. 28, 2021, FDA reported that it has authorized 419 tests and sample collection devices under emergency use authorizations (EUAs).
The Rapid Acceleration of Diagnostics (RADx) Program, a federal initiative led by NIH, has been at the forefront of COVID-19 testing. The program’s primary goal is to help expand the number of tests and types of tests available during the pandemic. RADx has created innovative solutions to rapidly scale-up testing across the country and enhance access to those most in need.
"I believe the RADx Program ... is really cutting-edge,” FDA’s acting commissioner Janet Woodcock said during the January HELP hearing. “They have sort of a shark tank approach. They’re really looking for innovation. They provide assistance to developers, and I really believe that’s promising — that we will come up with additional technologies that are easier to manufacture, easier for people to use and cheaper.”
FDA has recently granted EUAs to a new handful of at-home COVID-19 tests, amid nationwide reports of shortages and rising case rates as a result of the Omicron variant. The authorization comes after the launch of the Independent Test Assessment Program (ITAP), funded by $70 million from the American Rescue Plan, to boost regulatory review and availability of high-quality, accurate and reliable over-the-counter COVID-19 tests to the public.
"This program is incredibly beneficial to increasing access to rapid tests by quickly and consistently gathering the critical data companies need to request EUA and subsequently enter the U.S. market once authorized," said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.
Eligibility for COVID-19 Vaccines, Boosters
Since the first COVID-19 vaccine's approval in August 2021, FDA and CDC officials have been building out long-term vaccination strategies to limit infection rates and reduce the rate of virus spread. As new COVID-19 variants emerge, FDA has been conducting laboratory and field studies to analyze how the current generation of vaccines are faring with new mutations and variants.
“We want to make sure that we’re doing the right thing here in protecting our population. We don’t want to see people starting to get sick again from COVID-19 after a number of months,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), said during a September 2021 virtual event. “Variant[s] may need a very robust antibody response to protect against it.”
Together, FDA and CDC approved booster doses for all three available vaccines, as well as authorized doses for some children. To make these recommendations, data has been instrumental across the agencies.
“This pandemic is dynamic and evolving, with new data continuously emerging about vaccine safety and effectiveness. As we obtain more data about the safety and effectiveness of COVID19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Woodcock said during the HELP hearing.
What to Expect in 2022
Vaccines, testing and hospital support have been cornerstones of the administration’s plan to further tackle the pandemic. Leaders across HHS are looking to how they can scale up capacities to effectively combat the virus.
“Our vaccines are the most powerful tools we have — they work to protect people from serious illness and death, and boosters provide people optimal protection,” the administration said in a press statement.
During the HELP hearing, NIH’s National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci explained the agency is conducting early stage research on pan-coronavirus vaccines designed to provide broad protective immunity against multiple coronaviruses, especially SARS-CoV-2 and other viruses with pandemic potential.
“Looking ahead in the context of the inevitable, continual emergence of new variants, the importance of developing a pan-coronavirus vaccine, namely one that would be effective against all SARS-CoV-2 variants and ultimately against all coronaviruses becomes even more apparent,” Fauci said.
Fauci reported that he and his colleagues have made “significant progress in that direction,” including identifying antibodies that neutralize multiple different coronaviruses and issuing new awards to fund research on pan-coronavirus vaccines.
Biden also announced several steps to ensure health systems have the personnel and supplies needed to combat Omicron hospitalizations. As part of this effort, the administration reported that it will deploy additional medical personnel, expand hospital capacity and provide critical supplies to ensure hospitals are able to provide for the rising demand.
As part of its effort to expand testing and vaccine availability, the administration will stand up additional testing and vaccination sites, distribute free rapid tests and leverage the Defense Production Act (DPA) and other authorities to rapidly scale up testing availability.
“In the last few weeks, for two tests, we were able to unlock supplies and manufacturing capacity. We continue to invest in rapid, over-the-counter tests, which are in high demand, and in the fall, we invested $3 billion to increase manufacturing lines, staffing ... as a result, we went from 46 million over-the-counter tests available in October to over 300 million that are available now,” Assistant Secretary for Preparedness and Response (ASPR) Dawn O'Connell said during the HELP hearing.
One of these efforts included collaborating with the U.S. Digital Service and the U.S. Postal Service to develop a portal for the public to order up to four at-home rapid-test kits per household. The tests are currently en route.
Ultimately, the administration plans to purchase and distribute 1 billion at-home rapid tests.
"We didn't start from scratch," a White House senior administration official said on a call with reporters last month. "The Postal Service is an important partner here. They already have a website that does sell to the public and has for quite some time."