FDA shifts COVID-19 vaccine policy for healthy adults

FDA announces major policy shift on annual COVID-19 shots for healthy adults and children

HEALTH. ED TO YOU. LET’S PICK IT UP RIGHT THERE. MARIA. HERE TO DISCUSS SOME MORE. IS DOCTOR TODD AND FAMILIAR FACE HERE AT 430 ON NEWSCENTER 5. CHIEF OF INFECTIOUS DISEASES AT SOUTH SHORE HEALTH. HAPPY FRIDAY. IT’S GREAT TO SEE YOU. AS YOU KNOW, VACCINES HAVE BEEN A FREQUENT TARGET IN THE DEBATE ABOUT AUTISM. SO SO JUST TO JUST TO WE’LL BUILD A BASE. FIRST. TELL US AGAIN WHAT DOES WHAT DOES THE SCIENCE SHOW THE MMR VACCINE DOES NOT CAUSE AUTISM. UNFORTUNATELY, BACK IN 1998, THERE WAS A STUDY THAT WAS UNFORTUNATELY A FRAUDULENT STUDY THAT SHOWED THAT THERE WAS A LINK BETWEEN MMR AND AUTISM. THAT STUDY HAS BEEN RETRACTED AND BUT STILL, THERE’S A LOT OF SKEPTICISM. VACCINE SKEPTICISM WITH THE MMR AND WITH OTHER VACCINES BECAUSE OF THIS. BUT THE BOTTOM LINE, THE PROBLEM IS WE DO NEED TO FIND OUT THE CAUSE OF AUTISM. IT’S PROBABLY NOT ONE CAUSE. THERE’S PROBABLY GENETIC COMPONENTS. THERE MAY BE ENVIRONMENTAL COMPONENTS. I’M GLAD TO SEE THAT WE’RE GOING TO HAVE MORE RESEARCH, BUT WE HAVE TO GET BEYOND THE MMR VACCINE, WHICH HAS BEEN PROVEN IN THE UNITED STATES AND AROUND THE WORLD TO NOT BE LINKED TO AUTISM. AND, YOU KNOW, BUT MEASLES, MUMPS AND RUBELLA, IF YOU DON’T KNOW WHAT MMR STANDS FOR. SO WE’VE TALKED ABOUT THE MEASLES OUTBREAK AND WE JUST HAVE SOME NEW NUMBERS. LET’S PUT THEM UP ON THE SCREEN. BECAUSE, YOU KNOW, WE’RE A COUNTRY OF OF A LOT OF PEOPLE. BUT THERE ARE 712 CASES, WHICH ISN’T A LARGE NUMBER RIGHT, FOR THIS COUNTRY. BUT THERE ARE NOW 712 CONFIRMED IN 25 STATES. SO THAT’S HALF THE STATES IN THE UNION AND TWO DEATHS IN TEXAS. THEY’RE BOTH IN TEXAS. SO WHAT CAN YOU TELL US ABOUT THOSE PATIENTS? WELL, UNFORTUNATELY, THE THREE DEATHS WERE IN PATIENTS THAT WERE UNVACCINATED. AND, YOU KNOW, THE VACCINE, REMEMBER, A SINGLE DOSE, 93% EFFECTIVE, TWO DOSES, 97%. SO WHEN YOU LOOK AT THESE 700 PLUS CASES, ALMOST ALL OF THEM ARE IN UNVACCINATED CASES. THERE HAVE BEEN A HANDFUL OF PATIENTS THAT HAVE GOTTEN 1 OR 2 DOSES OF VACCINE. BUT REMEMBER, AGAIN, THIS IS WE’RE TALKING ABOUT A TINY PERCENTAGE OF THOSE WHO HAVE BEEN FULLY VACCINATED WHO HAVE GOTTEN THIS. SO SO THE VACCINE WORKS JUST OUT OF CURIOSITY, AS A FULLY VACCINATED PERSON EVER DIED FROM THE MEASLES, RIGHT. IT’S FASCINATING. THERE HAS NEVER BEEN A DEATH, AT LEAST THAT I CAN TELL. AND I’VE SORT OF SCOURGED THE MEDICAL LITERATURE THAT HAVE GOTTEN TWO DOSES OF OF THE MMR. NOW, THERE HAS BEEN AN IMMUNOCOMPROMISED PATIENT THAT GOT ONE DOSE OF THE VACCINE AND DIED. BUT REMEMBER, WE’VE ONLY SEEN A HANDFUL OF DEATHS IN THE PAST 20 YEARS. RIGHT, RIGHT. SO IT’S RARE, BUT THE VACCINE WORKS. BUT BEFORE I LET YOU GO, ONE LAST QUESTION ABOUT VACCINE. AND THIS IS COVID. SO, YOU KNOW, WE’VE TALKED ABOUT THAT AT NAUSEUM FOR THE LAST, WHAT, FIVE YEARS. PROTECTION WANES OVER TIME. OBVIOUSLY, LAST YEAR, THE CDC RECOMMENDED A SPRING BOOSTER FOR OLDER ADULTS. WHAT ABOUT THIS YEAR? THE RECOMMENDATION HAS STAYED. SO BASICALLY, IF YOU’RE ELDERLY, IF YOU’RE MODERATE TO SEVERE IMMUNOSUPPRESSION, YOU WANT TO GET A DOSE ESSENTIALLY IN THE SPRING AND A DOSE IN THE FALL. NOW AGAIN, WHY DO WE DO THAT? BECAUSE LIKE YOU SAID, IMMUNITY WANES. AND WE KNOW THAT THESE GROUPS HAVE A HIGHER RISK OF HOSPITALIZATION. AGAIN, I THINK IT’S IMPORTANT THAT WE CONTINUE TO STUDY THIS. I THINK MORE STUDY NEEDS TO BE DONE. BUT AT THIS POINT, THE CDC RECOMMENDS TWO DOSES FOR THOSE GROUPS. DEFINITION OF ELDERLY IS THEY’RE SAYING 65 AND OLDER.

FDA announces major policy shift on annual COVID-19 shots for healthy adults and children

Annual COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift unveiled Tuesday by the Trump administration.Top officials for the Food and Drug Administration laid out new requirements for yearly updates to COVID shots, saying they'd continue to use a streamlined approach that would make vaccines available to adults 65 and older as well as children and younger adults with at least one health problem that puts them at higher risk.But the FDA framework urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. In a framework published Tuesday in the New England Journal of Medicine, agency officials said the approach still could keep annual vaccinations available for between 100 million and 200 million adults.The upcoming changes raise questions about people who may still want a fall COVID-19 shot but don't clearly fall into one of the categories.Video below: 5 years since COVID-19 declared a pandemic“Is the pharmacist going to determine if you're in a high-risk group?�� asked Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”The framework, published in the New England Journal of Medicine, is the culmination of a series of recent steps scrutinizing the use of COVID shots and raising major questions about the broader availability of vaccines under President Donald Trump.For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots when manufacturers provide evidence that they spark just as much immune protection as the previous year's version.But FDA's new guidance appears to be the end of that approach under Health Secretary Robert F. Kennedy, who has filled the FDA and other health agencies with outspoken critics of the government’s handling of COVID shots, particularly their recommendation for young, healthy adults and children.Tuesday’s update, written by FDA Commissioner Marty Makary and FDA vaccine chief Vinay Prasad, criticized the U.S.’s “one-size-fits-all�� approach and states that the U.S. has been “the most aggressive�� in recommending COVID boosters, when compared with European countries.“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,�� they wrote.Outside experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended for people at increased risk. An influential panel of advisers to the Centers for Disease Control and Prevention is set to debate that question next month.The FDA framework announced Tuesday appears to usurp that advisory panel's job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people.

WASHINGTON —

Annual COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift unveiled Tuesday by the Trump administration.

Top officials for the Food and Drug Administration laid out new requirements for yearly updates to COVID shots, saying they'd continue to use a streamlined approach that would make vaccines available to adults 65 and older as well as children and younger adults with at least one health problem that puts them at higher risk.

But the FDA framework urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. In a framework published Tuesday in the New England Journal of Medicine, agency officials said the approach still could keep annual vaccinations available for between 100 million and 200 million adults.

The upcoming changes raise questions about people who may still want a fall COVID-19 shot but don't clearly fall into one of the categories.

Video below: 5 years since COVID-19 declared a pandemic

“Is the pharmacist going to determine if you're in a high-risk group?�� asked Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.��

The framework, published in the New England Journal of Medicine, is the culmination of a series of recent steps scrutinizing the use of COVID shots and raising major questions about the broader availability of vaccines under President Donald Trump.

For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots when manufacturers provide evidence that they spark just as much immune protection as the previous year's version.

But FDA's new guidance appears to be the end of that approach under Health Secretary Robert F. Kennedy, who has filled the FDA and other health agencies with outspoken critics of the government’s handling of COVID shots, particularly their recommendation for young, healthy adults and children.

Tuesday’s update, written by FDA Commissioner Marty Makary and FDA vaccine chief Vinay Prasad, criticized the U.S.’s “one-size-fits-all�� approach and states that the U.S. has been “the most aggressive�� in recommending COVID boosters, when compared with European countries.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,�� they wrote.

Outside experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended for people at increased risk. An influential panel of advisers to the Centers for Disease Control and Prevention is set to debate that question next month.

The FDA framework announced Tuesday appears to usurp that advisory panel's job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people.

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FDA announces major policy shift on annual COVID-19 shots for healthy adults and children

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