It’s what they had long trained for—and hoped never to experience: a global COVID-19 pandemic that would cost millions of lives. When COVID-19 emerged on the world stage, Abt Global researchers tracked SARS-CoV-2 transmission for the Centers for Disease Control and Prevention (CDC) using, among other techniques, polymerase chain reaction (PCR) testing at a time when little was known about COVID-19. We used a network of prestigious clinical organizations established in 2013 to monitor novel flu viruses and eventually also tracked vaccine effectiveness.
Our rigorous data gathering produced a score of oft-cited journal articles that had a huge impact on national policy and science. More important, we assessed how COVID-19 operates in real world settings. And through regular testing of participants, we were able to track asymptomatic and mild cases that didn’t require a doctor’s visit and so weren’t necessarily entered in health records. Many studies rely on health records for data and miss what Abt detected.
On September 30, 2023, Abt ended its six COVID-19 studies, including Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) and Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT). The RECOVER study was the first to validate, in March 2021, the effectiveness of the mRNA vaccines in real-world conditions. The study received front-page media coverage in both the New York Times and Washington Post and more than 500 other news outlets. Ongoing research through the PROTECT study validated the effectiveness of the vaccines in children.
Waning Vaccine Effectiveness Against COVID-19 Omicron and Delta Variants
Both study platforms confirmed waning effects of vaccines over time and against the Delta and Omicron variant and measured real-world effectiveness of boosters. These findings were among the key data sources used by CDC’s Advisory Committee on Immunization Practices to inform vaccination recommendations. The findings also contributed to CDC guidance on vaccinations and boosters. The studies were the only CDC-funded large multi-site study in the U.S. that included weekly PCR testing for COVID-19, which is both accurate and reliable, regardless of whether participants had symptoms. This made our results among the few windows into COVID-19 infection incidence regardless of symptoms and acted as an early indicator for new waves and variants. CDC and the White House COVID-19 task force used these indicators to inform other guidance such as masking during the public health emergency.
Over the three years of the studies, the Abt team along with CDC and study partners published 20 research articles in major scientific journals, including the New England Journal of Medicine, which have jointly been cited 1,800 times, and analyses continue. While rapid interim data deliveries to the CDC occurred weekly during peak periods, in the last two weeks of September, Abt ultimately delivered final RECOVER and PROTECT datasets consisting of over 500,000 records and 429 million data points for use in ongoing and future analysis.
Background on the COVID-19 RECOVER and PROTECT Project
Abt led RECOVER study data collection under a contract with CDC since April 2020, shortly after SARS-CoV-2 began actively circulating in the U.S. RECOVER was originally designed to estimate the incidence of symptomatic and asymptomatic SARS-CoV-2 infection among health care workers in the U.S. and later included first responders and other essential and frontline workers. After emergency use authorization of Moderna and Pfizer-BioNTech COVID-19 vaccines in late 2020, study objectives expanded to include assessment of the effectiveness of COVID-19 vaccination. RECOVER evolved to provide scientific evidence to address new problems as they emerged during the pandemic, such as the impact and presentation of additional variants, antibody response to vaccine or natural infection, and long COVID. In April 2021, in anticipation of the pending availability of pediatric COVID-19 vaccines, RECOVER expanded to include PROTECT, which collected data from children aged 6 months to 18 years.
RECOVER and PROTECT Overview
RECOVER operated in six locations and enrolled 4,300 participants whose occupations placed them at high risk of exposure to COVID-19. PROTECT recruited nearly 1,000 pediatric participants. The studies collected survey data on participant demographics, medical history, and vaccination history at enrollment and throughout the study. Participants self-collected nasal respiratory specimens each week to be tested for SARS-CoV-2 infection and routinely provided blood, including after a SARS-CoV-2 infection or COVID-19 vaccination.
Given the prospective and longitudinal nature of RECOVER and PROTECT, the studies were was an important resource for the early evaluation of COVID-19 vaccine effectiveness and directly informed national public health policy during the public health emergency. They informed CDC guidance on masking and recommendations for primary and booster COVID-19 vaccine doses. Abt routinely delivered complete, processed data files to CDC within three days of data collection and on request we accelerated deliveries to within 24 hours in response to urgent policy needs. This enabled CDC to capture emerging trends in near-real time
RECOVER and PROTECT Published Studies
In addition to follow up articles in the Morbidity and Mortality Weekly Report and the New England Journal of Medicine about real-world vaccine effectiveness, some of the 20 RECOVER and PROTECT articles Abt has co-authored for scientific journals to date include:
- After the Delta variant began actively circulating in the U.S., RECOVER provided some of the first evidence of decreased vaccine effectiveness against the variant. Unpublished RECOVER data were presented publicly during the COVID-19 White House press briefing on August 18, 2021, with a follow-up rapid-release publication in the Morbidity and Mortality Weekly Report. We published more extensive longitudinal results on incidence of COVID-19 among vaccinated and unvaccinated participants pre- and post-Delta in Influenza and Other Respiratory Viruses, providing additional evidence on the continuing benefits of vaccination.
- Two separate PROTECT publications in the Morbidity and Mortality Weekly Report provided real-world vaccine effectiveness estimates for adolescents and children aged 5 and up. We again provided some of the first real-world evidence of vaccine effectiveness against infection, regardless of symptoms, for these populations. These articles also received substantial press coverage. More than 300 news organizations, including CBS and Forbes, quoted Abt Principal Investigator Lauren Olsho explaining the scientific contribution of PROTECT: “Other pediatric vaccine effectiveness studies relied on lab testing data or health records and generally captured only cases where a child had symptoms and received health care. With increased use of home rapid testing, studies like ours are needed to provide more comprehensive information on rates of infection and vaccine effectiveness.”
- A letter to the editor in the New England Journal of Medicine compared booster dose effectiveness during Delta and Omicron eras, documenting continued benefits of a third dose of mRNA vaccine despite reduced effectiveness against Omicron.
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