new guidance from the Food and Drug Administration could change who has access to co vaccines federal officials indicate they could require additional clinical trials before administering the shots to specific populations epidemiologist at Monontlair State University Stephanie Syla is with us now to explain the possible changes stephanie great to talk to you uh help us understand what's happening here with the FDA's new guidance and what it means for any individuals looking to get a COVID vaccine so I think we're all still trying to you know make sense of what the new guidance is typically the CDC issues the guidance not the FDA um but right now what the recommendation seems to be is that individuals who are 65 and older and those who are under 65 but who have um a list of these pre-existing conditions would still be able to get the vaccine um but for everybody else they may now be ineligible whether they want the vaccine or not stephanie we know it's been about four years since this vaccine was approved the FDA approved it on August 23rd 2021 are we seeing negative side effects in healthy individuals getting the vaccine enough to warrant this type of pause in my opinion no we we aren't there was a large metaanalysis of about a quarter million people um looking at randomized clinical trials that have been done um and the most common side effects were injection sight discomfort and some fatigue um of course there will be some individuals who have more severe side effects but in the overall vast majority of cases uh both from those clinical trials as well as um post-production data that's constantly being collected we're not seeing a lot of really negative side effects what does a clinical trial usually look like how long does it typically go when we're not in the kind of emergency case that we were in when this was first approved so I think that's going to depend on the type of study that's being done um it could be six months it could be a year and what I think most people need to realize is that clinical trials don't end once the drug or the vaccine goes to market there are phase four trials where any and all negative interactions or negative um effects of those drugs or vaccines can be reported and there was consistent um observational data that's being collected so just because the phase three formal part of those clinical trials ended doesn't mean we're not still collecting data on those vaccines is it typical then for clinical trials to continue on a vaccine even if they're uh able to still be accessed which in this case we know is there's going to be a pause likely right um I think that there are um a lot of times when those clinical trials are continued and I I don't think that there's any reason to not continue studying these vaccines especially if we can find a way to give an even more effective vaccine with even fewer side effects right that's that's part of the iterative nature of science um what I'm concerned about is making it unavailable to people who otherwise would want to have it in the meantime when there aren't a lot of data indicating significant negative side effects what can you tell us Stephanie about the number of young people healthy people right now who are going out and still getting COVID boosters um so we know that the COVID booster rates are incredibly low right now a lot of young people are not getting it um I know the FDA um one of the rationale they put out for this was that other countries are not are changing their guidelines they don't offer it to young people u but the reality is for example Canada recommends it for the same people who are over 65 people who have pre-existing conditions but it's still available to people 18 and up and so I think that that would be a better model um and I think that continuing to recommend it not require it because it's not required anywhere in New Jersey but to recommend it to keep the population safe as this virus can and likely will continue to mutate is really the best way forward very quickly we do know that an individual tested positive who was at the Shakira concert in New Jersey what does that mean for a possible outbreak here what should people know and be aware of and what should they do so I think for individuals who are at that concert unfortunately we don't know where that particular individual sat or the entrance of exits that they use um but if you have a fever runny nose watery eyes um it could just be allergies it could be the flu it could be a cold but if you notice about 3 to 5 days after that onset that you develop a rash that is most likely measles and you need to follow up with a medical professional um I would also encourage um people we know our vaccine rates for measles has dropped down post pandemic so if you are not vaccinated I highly recommend you do so it is a highly transmissible and very serious illness all right Stephanie SA epidemiologist at Monontlair State University thank you as always 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