US needs big data registry to monitor COVID-19 vaccine outcomes, former FDA commissioners say  

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While COVID-19 vaccines being developed have generated promising results, the U.S. needs a distribution and monitoring system that allows Americans to be inoculated in a safe and timely manner to benefit from the new vaccine, according to former FDA commissioners Scott Gottlieb, MD, and Mark McClellan, MD, PhD.  

In a Nov. 29 op-ed for the Wall Street Journal, Drs. Gottlieb and McClellan highlighted systems such as the Vaccine Safety Datalink and the FDA's Sentinel and Biological Effectiveness and Safety initiatives, which compile research on previous vaccines' effectiveness and safety through collaborations among the FDA, CDC, Medicare, private health plans, large health systems and health tech companies. 

These monitoring efforts compile and analyze secure registries of vaccine use and health outcomes in large patient populations, Dr. Gottlieb and Dr. McClellan wrote. While Medicare is working with the FDA and CDC on a similar approach for studying COVID-19 vaccines in Medicare patients, a broader public-private collaboration may be even more useful, the co-authors added. 

The CDC is assembling a national COVID-19 registry to track vaccine use information and connect it with state vaccine registries. "Ideally, this registry would have mechanisms to pass along pertinent data to a patient’s doctor and health plan. Clinicians and plans would be better able to follow up on their patients, monitor for unusual adverse events, and reach out to those not vaccinated," Drs. Gottlieb and McClellan wrote. 

To better connect stakeholders, Drs. Gottlieb and McClellan suggested that the federal government set up secure data links for health plans and clinicians or use Medicare, which expects to receive claims paperwork including some information on everyone who receives a vaccination. Medicare could then pass this data along to health plans in Medicare Advantage, prescription drug plans and primary care providers. 

 

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