In interviews with the Times, FDA officials acknowledged that the monitoring system, dubbed BEST, is still in developmental stages. They expect it to start analyzing vaccine safety data sometime soon, but likely not until after the Biden administration hits its goal of vaccinating 100 million people, according to the report.
“It’s the right thing to do, but the fact of the matter is we don’t have enough information and we’re desperately in need of post-market information and monitoring,” said a high-ranking FDA official who asked to remain anonymous since he is not authorized to discuss the situation publicly.
Public health experts told the publication that funding shortages and “bureaucratic hurdles” were to blame for the slowdown of the new COVID-19 vaccine safety monitoring system, formally called the Biologics Evaluation Safety Initiative.
In the meantime, the government is using a 30-year-old safety monitoring system, known as the Vaccine Adverse Event Reporting System, or VAERS, the FDA shares with the CDC and a new smartphone app that people who get vaccinated can download and report any reactions they experience. The CDC also manages the Vaccine Safety Datalink, which is a collaboration between the agency and nine health systems that collects vaccine data and EHRs of about 12 million patients.
VAERS and the smartphone app so far have not received reports of any deaths conclusively linked to the vaccines, and it has seen reports of only few serious problems.
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