The Food and Drug Administration (FDA) does not have a functional central system for monitoring the safety of coronavirus vaccines, officials admit
The Food and Drug Administration (FDA) does not have a functional central system for monitoring the safety of coronavirus vaccines, officials admitted to the New York Times.
More than 48 million doses of coronavirus vaccines have been given in the US, Bloomberg data shows.
Yet the safety of those shots is currently tracked by a cobbled together set of smaller, older monitoring networks.
And despite its promise of a state-of-the-art, comprehensive apparatus to track and analyze safety data on the shots, FDA officials told the Times its new BEST system is still being developed, and likely won’t be ready for weeks or months.
That said, both Pfizer’s and Moderna’s shots were deemed safe in massive 40,000-person trials, and so far concerning side effects have been rare with just 31 cases of anaphylaxis reported in the first weeks of rollout, among millions of shots given.
For now, an older system that tracks doctors’ reports of suspected side effects is being used, and just 9,000 reports of potential ‘adverse events’ have been submitted. About 10 percent were classified as potentially serious.
The FDA has not gotten its comprehensive new system for monitoring the safety of coronavirus vaccines up and running and is currently relying on a 30-year old system it shares with the CDC that is based on reports submitted by doctors and nurses. That system detected 21 severe allergic reactions to the Pfizer vaccine in the first weeks of rollout (pictured)
More than 1.6 million shots are being given a day in the US, which has administered more than 48 million doses to 10.5 percent of the US population
But, notably, anaphylaxis was not a significant issue flagged in trials.
Yet within the first days that Pfizer’s vaccine was given in the UK – which authorized it before the US did – reports of anaphylaxis, a life-threatening allergic reaction that can cause the throat to close, were reported.
Within 48 hours of the first shot being given, UK officials revealed that there had been to such reactions, so there was little delay before the world knew of the potential side effect.
Janet Woodcock took over as Acting Commissioner of the FDA once President Biden took office.
A similar pattern unfolded in the US, with two allergic reactions to Pfizer’s vaccine reported just days after rollout began.
But it underscores the need for a consistent and sweeping system to identify side effects in the much broader population that might not have occurred in the trials.
Centers for Disease Control and Prevention (CDC) reports have documented at least 21 cases of anaphylaxis after Pfizer’s shot, and 10 following Moderna’s, among the vaccinations given within two weeks of each being authorized.
But the FDA is meant to be monitoring these reactions through its Biologics Effectiveness and Safety (BEST) system.
The system was first launched in 2017 to improve upon its previous monitoring programs for vaccines and other biologic drugs and preventives.
In December, the FDA announced it would use BEST to monitor COVID-19 vaccine side effects.
Only about 9,000 reports of adverse events have been made, but the current system requires doctors and nurses to make voluntary reports, leaving the potential for side effects to be missed
And earlier this week, it said in a press release that the BEST system will be used for ‘active surveillance’ for several potential side effects of COVID-19 vaccines.
But it also noted that the system had been undergoing tests and, according to what officials told the New York Times, it still is.
When it’s up and running, the system will analyze data from millions of electronic health records a day, actively searching for potential side effects and patterns that suggest them, even if doctors and nurses don’t identify and report them as reactions.
In the meantime, side effect reports are coming into the FDA via a much less sophisticated process.
FDA co-runs the 30-year-old Vaccine Adverse Event Reporting System (VAERS) with the CDC. The system is a simple log for ‘passive surveillance’ via reports of side effects submitted by doctors and nurses.
So far, about 9,000 adverse events have been reported through VAERS and about 10 percent of been classified as serious.
The database also doesn’t reflect whether an analysis has deemed these effects definitively linked to the vaccines, but just logs reports of potential side effects.
CDC officials themselves are perplexed over the monitoring system fumbles.
‘It’s been a puzzle to me,’ an official, who asked not to be identified, told the Times.
‘FDA talks about this in a way that is really unclear as to what is up and ready to go and what isn’t.’
It’s unclear when the BEST system will truly be functional, though FDA officials estimated it could be weeks or months in interviews with the Times.