While many colleagues at Pfizer were working to develop and manufacture a COVID-19 vaccine, a team at Pfizer was hard at work monitoring the safety of the COVID-19 vaccine trial. And they did this while maintaining safety monitoring operations for more than 1,000 other products in the Pfizer portfolio.
Pharmacovigilance is the name for the scientific field in which scientists and healthcare professionals monitor safety issues related to drugs and vaccines. “Drug and vaccine safety is one of those topics that, if done well, is not necessarily at the forefront of ordinary people’s minds,” says Jamie Wilkins, head of the Center for Management Excellence global security risks at Pfizer.
Like the new vaccine was authorized and made accessible to people around the world, real-time monitoring would be essential, says Wilkins. And technology, particularly artificial intelligence, would be a crucial tool for processing large amounts of information around the clock for analysis by Pfizer scientists.
Fortunately, the foundations for this technology had been laid years before, allowing for rapid and responsive action.
“We were able to evolve the technology we already had to meet the demands of the pandemic. The groundwork was really crucial, as it allowed us to process a significant additional case volume,” says Wilkins, “and simultaneously helped us remain compliant with regulatory standards and continue to monitor the safety profiles of our other vaccines and medicines.
The science of medicine and vaccine safety
For Pfizer, the safety of drugs and vaccines is always a major concern. And since 2014, the company has been a pioneer in the use of artificial intelligence in pharmacovigilance and safety monitoring to help sort and categorize the “case reports” that people file when they experience what is called an “adverse event”, which could be an unexpected side effect in association with a Pfizer product. Because technology automates repetitive tasks, it can collect and analyze unlimited amounts of data, presenting it to trained experts for them to view and act on. Leveraging technology to automate this type of repetitive work frees up scientists and other team members so they can focus their attention on more sophisticated patient-centered tasks.
This was imperative when the pandemic hit, says Bhavin Patel, manager of case processing automation and intelligence at Pfizer Worldwide Safety. Statistically speaking, Patel says, due to the unprecedented volume of COVID-19 vaccinations, amounting to billions of people suddenly sharing information about their individual experiences, an increase in workload was to be expected. of his team.
Following emergency use authorizations and approvals, the vaccine became available to billions of people. Processing information received about any adverse event related to a vaccine or medicine, such as pain at the injection site, a headache following vaccination or taking a medicine, or a number other experiments, constitutes an important part of the pharmacovigilance process and regulatory control. requirement.
In fact, Patel and his team encourage people to report their experiences because it helps them better understand the potential side effects people might experience. “We want people to report events to us,” says Patel. “This helps us work with Pfizer scientists, physicians and other professionals to ensure that all prescribers, physicians, pharmacists and patients have accurate information about the benefits and risks of our medicines and vaccines. This allows them to make an informed decision about the best use of our medications for them.
Large-scale information collection
As the vaccine was rolled out, Patel’s team needed to find a way to best apply artificial intelligence so it could collect and analyze experiences with the vaccine, while simultaneously monitoring the rest of the global portfolio, which more than 1,000 drugs and vaccines, with more in development.
To prepare, Patel says his team looked to the past. “We tried to use the closest historical experience we had, which was the H1N1 pandemic. We looked at that, as well as the publications at the time, and anticipated what the increase in reporting would be,” he says. It quickly became clear, based on this modeling (along with real-time reporting), that hiring more employees to do the work was not feasible. “We couldn’t keep adding people to the problem,” he said.
“We have hired additional pharmacovigilance professionals. However, it quickly became clear that our experience during this pandemic was very different from that of the previous H1N1 pandemic, says Patel. “We could not continue to recruit staff to handle the growing workload. »
So employees in Pfizer’s Safety organization came up with creative solutions. “We started to think outside the box and ask ourselves, ‘How can we streamline processes to be more efficient?’ “How can we introduce new technologies? » “How can we train the people we have to take on a wider range of responsibilities in case processing? “, explains Patel. “The fact that we already had some tools gave us a great foundation. »
The team came up with nearly 120 ideas, and about half of them were given the green light for implementation. “We built agile, empowered teams that included subject matter experts from the security team as well as people from the digital and information management organization to ensure the effectiveness of technology and processes at the future,” says Patel.
Bringing new solutions to drug and vaccine safety to life
In about six months, many of these ideas were put into practice and have been instrumental in monitoring the safety of drugs and vaccines, Patel says.
He shares examples such as an online adverse event reporting portal called COVAES, available in multiple languages, 24/7, allowing patients to directly report their experiences with the vaccine. COVAES is accessible from www.pfizersafetyreporting.comand it asks questions tailored to each individual about their experience associated with vaccination.
“The goal is to collect complete and relevant information from people who receive the vaccine,” says Patel. Those who don’t want to use the portal can chat with Agent LEO, an AI solution that collects information from automated voice conversations. Additionally, the team designed a bot to fully automate the uploading, sorting and data entry of adverse event reports filed with the European Medicines Agency. Another technology solution provided significant efficiencies when reviewing medical journals for potential reports of adverse events related to Pfizer products.
By automating these tasks, this technology has saved countless hours, says Patel. “These are all things that need to be done, but they’re repetitive,” he says. “Using AI, we are able to reduce case processing time and manage a much higher volume of reports. Effective management of the large volume of reports allows scientists and safety professionals to have timely access to this data so they can communicate any important messages to patients, doctors and regulators.
Building for the future
Artificial intelligence is increasingly integrated into people’s daily lives as well as the way businesses operate in all areas, including healthcare and, in particular, drug and vaccine safety operations . As an example, Pfizer works with a data and analytics company that collects anonymized, anonymized, and secure health data from the electronic health records of approximately 80 million people in near real time.
Heather Rubino, head of safety monitoring research at Pfizer, says that by accessing this volume of information, the company can draw insights and monitor patient safety en masse. “Nearly a third of the U.S. population is covered by these systems, so we get a very good geographic representation of the people who consume our products, and that helps us measure the safety of our products across United States, in almost 100% of cases.” -in real time,” says Rubino. In the past, she adds, an analysis on this scale could have taken years. Now, she says, her team is able to gather information and act on it within months or even weeks.
Looking ahead, Rubino says Pfizer’s technology will continue to evolve, in preparation for the healthcare industry’s next challenge. Because, she says, there will always be a “next”.
“It is essential to build infrastructure and lay the foundations in times of calm, so that they are ready to be used in times of crisis,” she says. “Before you can get an ambulance to a hospital, you have to build roads.”