While the Covid-19 vaccines currently available in the U.S have beenproved to be safe and effective, recent reports of rareadverse events, or side effects, have raised concerns On July 12, 2021, the Food and Drug Administration approved an update to the Johnson & Johnson Covid-19 vaccinefact sheetto include an increased risk of the rare nerve conditionGuillain-Barré syndrome This follows previous reports linking the J&J vaccine with arare blood clot
While reports like these can be scary, they’re a sign that the vaccine safety reporting system is working They also highlight how the relative risks of rare side effects like these need to be put into context As a pharmacist who has been managing operations for the University of Virginia Health System’s Covid-19 vaccine programme for the past seven months, I’ve seen how uncertainty and fear over potential side effects can drive vaccine hesitancy Understanding how information about adverse events is collected and what it means for vaccine safety may help people make informed decisions about their health
Tracking safety before, during and after approval
The FDA enforces rigorous testing and approval processes that manufacturers must follow before a new vaccine can be made available to the public Regardless of whether a vaccine is approved through thetypical FDA approval processor anEmergency Use Authorization (EUA), the steps required to test a new drug for safety and effectiveness are the same An EUA can get a vaccine to the public more quickly bystreamlining the regulatory process, but no shortcuts are taken Every step is taken to ensure the vaccine is both safe and effective
Vaccine clinical trials occur infour sequential phases In the first three phases, study investigators are the ones who identify, quantify and document safety issues Phase 1 typically introduces the vaccine to fewer than 100 people over several months under controlled conditions Typically, the majority of potential adverse events are identified in this stage
After the FDA reviews phase 1 data and deems the vaccine safe enough to be studied further, the vaccine moves on to phases 2 and 3, where it will be given to larger numbers of people over longer periods of time Here, investigators determine optimal dosage and screen for rare side effects If phase 2 and 3 data meets FDA approval standards, the vaccine will then move on to phase 4 and become available to the public The vaccine is observed over much larger populations and extended periods of time, and manufacturers are required to regularly check and report potential safety concerns to the FDA
What’s different about this final phase is that the public can also contribute to safety reporting TheVaccine Adverse Event Reporting System (VAERS)is a national safety monitoring system run by the FDA and Centers for Disease Control and Prevention While certain types of adverse events, such as injuries during vaccine administration and serious complications, aremandatory for health care providers to report, anyone can submit a report Recent adverse events associated with the COVID-19 vaccine, includingGuillain-Barréand thrombosis for Johnson & Johnson andmyocarditisfor Pfizer, were identified through VAERS
Serious adverse event risk from vaccines is small
A rare adverse event may take months or years to identify for a simple reason: It’s rare For some drugs that are less commonly used, new safety data takes longer to discover because a relatively small number of patients use the drug For example, though the shingles vaccine Shingrix was approved 2017, it wasn’t untilMarch 2021after over 3.7 million patients had gotten the shot that the FDA announced a potential increased risk of Guillain-Barré And it still hasn’t been confirmed that the Shringrix vaccine causes the nerve condition
For cases like the Covid-19 vaccine, however, millions of people will receive the drug shortly after it’s released to the public, and new issues or patterns often emerge more quickly This can lead to two problems First,not every reported adverse event is directly related to the vaccine For example, many of the tens of millions of people who have received the Pfizer vaccine have likely experienced a sunburn
People might report that they experienced a sunburn to VAERS, but the vaccine has no effect on your skin’s ability to protect against the sun.VAERS is very clearthat it “is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting.” Correlation does not imply causation Second, a plausibly identified adverse event does not necessarily make the vaccine unsafe According to CDC, there have been100 preliminary reportsof Guillain–Barré out of 12.5 million J&J doses, or 0.0008% of people who received the vaccine Administering one vaccine to a huge sample of people can make it easier to identify a possible connection between the shot and a side effect
But that doesn’t mean the risk of getting that side effect is very likely, or that it outweighs the benefit of getting vaccinated Source: Business Times
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Source: Businesstimes
