The Coronavirus shows no signs of slowing down and is mutating with different strains. There can be millions of new infections caused by the Covid-19 virus in 2021 in the US, which can be prevented with timely vaccination efforts during Q1 and Q2 of this year. That is the equivalent of the total infections and deaths that the US experienced from the 1918 Spanish Flu.

Many scientists had warned of the possibility of a pandemic years ago and most agree that the COVID-19 outbreak is by no means an anomaly; there can be more deadly viruses cooking out there which can resist our drugs and spread uncontrollably.

So what can we do to be ready to deal with newer and more deadly strains in the future? The vaccination of 75% to 80% of the population is the most obvious solution. However, we need to continue to not just administer, but also monitor, COVID-19 vaccines’ immediate and long-term side effects.

The Challenges in Monitoring the Safety of COVID-19 Vaccines

While vaccines are essential, it’s equally important to monitor their safety. Due to the circumstances, there are a few unforeseen challenges that the current vaccination drive faces:

• Immense Scale of Distribution: Governments and health authorities worldwide are strongly advocating the quick distribution and administration of various COVID-19 vaccines. As a result, most of the human race–close to 7.5 billion people–will receive COVID-19 vaccines over the next 12 to 24 months.
• Not Enough Trial Data: Most of these vaccines have received Emergency Use Authorizations without going through normal vaccine trials. This type of fast-tracking means that at least some of the vaccines will likely have unsuspected dormant effects that might only become evident after several pharmacoepidemiological time-series analyses of data.
• The Sharing of Data: The biggest challenge is not the technology or the various models, but the access to COVID-19 vaccination data and records to which only state, and at times, federal agencies, may have access.

With the U.S. federal and state governments taking up the task of managing the vaccination program, multiple individual state immunization information systems have become the primary sources of vaccination data. This patient-level vaccination data then flows through the IZ Data Clearing House and COVID-19 Data Lake at the Centers for Disease Control and Prevention to Tiberius, the nerve center of the data infrastructure created by Operation Warp Speed to coordinate the distribution of COVID-19 vaccines across the country.

Connecting COVID-19 vaccination data to claims and electronic health records will enable pharmaceutical manufacturers to better understand the safety and effectiveness of their vaccines in real-world settings.

Why We Need to Actively Monitor the Safety of COVID-19 Vaccines

Active surveillance can be an important tool in the fight against the COVID-19 pandemic. Active surveillance uses real-world data – a patient’s longitudinal history of medications, diagnoses, procedures, labs, etc. – to identify potential adverse events that are associated with specific medications. Real-world data negates the influence of over- or under-reporting and provides consistent patient health information for all the patients included in the analysis.

Through the 2007 FDA Amendment Act passed by the U.S. Congress, the Sentinel Initiative was born. The Sentinel Operations Center has spearheaded several active safety monitoring models over the years, including the TreeScan model. These models have recently been embedded into Saama’s Active Safety Analytics for Pharma (ASAP) solution, which makes them accessible to the Pharma industry as well.

The use of the TreeScan methodology for safety signal detection has been extensively studied in many vaccines as part of the Sentinel Initiative. The mass administration of COVID-19 vaccines implies the exposure of vaccines to a very large population. Hence, adding active surveillance to normal drug safety efforts can increase the effectiveness of the process exponentially.

As a complement to traditional, passive safety surveillance techniques that rely on reports from patients and caregivers, active safety analytics gives pharmaceutical companies a powerful tool for monitoring the medium- and long-term safety of COVID-19 vaccines, as well as other drugs.