FDA panel considers first-of-its-kind flu vaccine using mRNA technology
SO YOU MIGHT HAVE NOTICED IT AT WORK OR FROM YOUR CHILDREN AT SCHOOL. A SURGE IN THE NUMBER OF PEOPLE CALLING OUT SICK. BUT AS WE NEAR THE END OF FLU SEASON. WHAT’S CAUSING THIS DRIVE? WE’RE JOINED NOW BY DOCTOR PETER KANG, WHO IS THE ASSOCIATE MEDICAL DIRECTOR WITH UPMC GOHEALTH URGENT CARE. SO MUCH. THANK YOU FOR JOINING US, DOCTOR KANG. WELL, FIRST OF ALL, LET’S TALK ABOUT WHAT YOU’RE SEEING THERE IN URGENT CARE RIGHT NOW AND THE TYPES OF ILLNESSES YOU’RE SEEING. YEAH. THANK YOU FOR HAVING ME. SO IN URGENT CARE RIGHT NOW, SPECIFICALLY AT THE UPMC GOHEALTH URGENT CARE, WE’RE REALLY SEEING THREE MAJOR VIRUSES DRIVING A LOT OF RESPIRATORY VISITS. COVID 19, RSV AND INFLUENZA. YEAH. SO A LITTLE BIT OF EVERYTHING. SO IS IT TOO LATE FOR PEOPLE TO GO OUT AND GET A FLU SHOT RIGHT NOW? I MEAN, IT’S WEIRD TO THINK ABOUT THAT IN MARCH. USUALLY YOU THINK, OKAY, OCTOBER OR NOVEMBER. WHAT DO YOU RECOMMEND NOW? ABSOLUTELY NOT. IF YOU HAVE NOT RECEIVED YOUR 2020 FLU SHOT YET, I WOULD ENCOURAGE YOU TO GET YOUR 2020 FLU SHOT. IT IS THE MOST EFFECTIVE WAY TO PREVENT SEVERE CONSEQUENCES OF THE FLU. INTERESTINGLY, WHILE WE SAW A HUGE SPIKE IN INFLUENZA A DURING JANUARY, WE ARE SEEING A SLIGHT INCREASE OF INFLUENZA B CASES, WHICH IS DRIVING SOME VISITS TO THE CENTERS. I GUESS IT’S SORT OF ALWAYS AROUND, YOU KNOW, WHEN YOU THINK ABOUT IT IN THE WINTER MONTHS. BUT THE CDC SAYS FLU ACTIVITY IS STILL ELEVATED ACROSS THE NATION. DOCTOR KANG, EVEN THOUGH IT’S STARTING TO EASE A LITTLE BIT IN A LOT OF DIFFERENT PLACES, INCLUDING IN OUR STATE. BUT THAT DOESN’T MEAN THESE VIRUSES ARE GONE. SO HOW DO YOU EXPLAIN THE DIFFERENCE TO VIEWERS? WELL, ONE OF THE CHALLENGES I THINK WE’VE SEEN IS REALLY THE UNPREDICTABILITY OF WEATHER. WE’VE HAD SOME WARM DAYS, BUT WE ALSO HAVE SOME COLD DAYS. WHEN WE HAVE THOSE COLD DAYS, WE TEND TO CONGREGATE INSIDE TOGETHER. AND WHEN WE CONGREGATE INSIDE TOGETHER IN AN INDOOR ENVIRONMENT, THAT’S JUST A GREAT RECIPE TO SPREAD RESPIRATORY DISEASES. YEAH, LIKE INCUBATING IT ALL. SO WHEN SHOULD SOMEONE ACTUALLY GO TO THE DOCTOR VERSUS LIKE, HEY, I COULD JUST SLEEP AT HOME, HAVE MY FLUIDS AND REST? WHEN HOW DO YOU DIFFERENTIATE BETWEEN THE TWO? SO IF YOU’RE ONE OF TWO POPULATIONS, MEANING IF YOU’RE OTHERWISE HEALTHY, STAYING AT HOME AND RESTING IS PROBABLY YOUR BEST BET. BUT THEN IF YOU’RE NOT FEELING BETTER AFTER A WEEK, I DO ENCOURAGE YOU TO SEE THE DOCTOR. HOWEVER, IF YOU ARE UNDER THE AGE OF TWO OR IF YOU’RE ELDERLY, OR IF YOU HAVE A CONDITION THAT MAY COMPROMISE YOUR IMMUNE SYSTEM, YOU WANT TO SEE THE DOCTOR AS SOON AS POSSIBLE. BECAUSE WE DO HAVE EFFECTIVE MEDICATIONS WE CAN USE AGAINST INFLUENZA COVID 19, WHICH CAN REDUCE THE SEVERITY OF SYMPTOMS. AND IF YOU’RE ONE OF THOSE PATIENT POPULATIONS, YOU’RE GOING TO WANT TO SEEK TREATMENT AS QUICKLY AS POSSIBLE. YEAH, BUT THE KEY TO THAT, DOCTOR KANG, IS GETTING THAT ATTENTION RIGHT AWAY. DO YOU ADVISE, IF YOU’RE STARTING TO FEEL THESE SYMPTOMS, TO TAKE THOSE TESTS, YOU KNOW, THOSE AT HOME TESTS YOU CAN GET AT THE DRUGSTORE? ABSOLUTELY. YOU CAN GET THOSE TESTS AT ONE OF OUR URGENT CARE CENTERS OR EVEN AT YOUR PRIMARY CARE DOCTOR’S OFFICES, IF THAT’S NOT AVAILABLE TO YOU, THEN YES, THERE ARE SEVERAL OVER-THE-COUNTER TESTS YOU CAN GET THE STORE PHARMACY THAT CAN THAT CAN HELP. THEY CAN HELP YOU. YEAH. SO WHAT SHOULD █PEOPLEDO RIGHT NOW TO PROTECT THEMSELVES? I KNOW YOU HAVE TO WASH YOUR HANDS. ANY OTHER ADVICE? YOU KNOW, JUST THE GENERAL HYGIENE THAT WE ALWAYS RECOMMEND IS, YOU KNOW, WASHING YOUR HANDS, MAKING SURE YOU’RE WIPING DOWN HIGH CONTACT SURFACES AT WORK OR AT HOME, COVERING YOUR MOUTH WHEN YOU COUGH, AND JUST GENERALLY PRACTICING GOOD HAND HYGIENE. YOU KNOW, IT’S EASY TO GET LAX THIS TIME OF YEAR BECAUSE YOU THINK YOU’RE SORT OF OUT OF THE WOODS, BUT ALWAYS GOOD TO PAY ATTENTION TO THOSE WARNING SIGNS AND TO PROTECT YOURSELF IF YOU’RE SICK FROM OT
FDA panel considers first-of-its-kind flu vaccine using mRNA technology
U.S. health advisers are debating a new kind of flu vaccine Thursday, the first made with the same mRNA technology that was key to ending the COVID-19 pandemic.Video above: These are the three major viruses driving urgent care visits right nowModerna is seeking Food and Drug Administration approval of its new shot, dubbed mFlusiva, as an option for people 50 and older. The FDA advisory committee meeting is a step toward a final decision ahead of the winter flu season.Tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable. There are various types of flu vaccines already available in the U.S., including three specifically recommended for people 65 and older. But vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types — something experts say might help if the shape-shifting flu virus mutates in a way that requires suddenly brewing new doses to match.In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared to those given another routinely used vaccine brand. Ahead of the meeting, FDA published a favorable review of that data and reported no safety concerns.Moderna is seeking full approval for the vaccine’s use in the 50- to 64-year-old population — along with authorization for use in those 65 and older while it conducts additional testing.Earlier this year, Moderna’s data was at the center of a highly unusual public dispute as a then-top FDA official blocked the company’s application for its first-of-its-kind shot.The embattled vaccine chief at the time, Dr. Vinay Prasad, said the company should have compared its shot to a high-dose flu vaccine recommended for seniors rather than a standard-dose brand. It was a sign of FDA’s heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr.Moderna challenged that decision, noting that FDA staff had approved that main study’s design and citing a separate, smaller study comparing the mRNA shot with a high-dose vaccine for seniors. Days after the spat, the FDA accepted Moderna’s application.The expert panel also will assess that smaller study, which found Moderna’s shot generated flu-fighting antibodies similarly to a high-dose senior shot. The FDA’s initial review noted the new vaccine lacks data on very frail older adults and those with weak immune systems.
U.S. health advisers are debating a new kind of flu vaccine Thursday, the first made with the same mRNA technology that was key to ending the COVID-19 pandemic.
Video above: These are the three major viruses driving urgent care visits right now
Moderna is seeking Food and Drug Administration approval of its new shot, dubbed mFlusiva, as an option for people 50 and older. The FDA advisory committee meeting is a step toward a final decision ahead of the winter flu season.
Tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable. There are various types of flu vaccines already available in the U.S., including three specifically recommended for people 65 and older. But vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types — something experts say might help if the shape-shifting flu virus mutates in a way that requires suddenly brewing new doses to match.
In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared to those given another routinely used vaccine brand. Ahead of the meeting, FDA published a favorable review of that data and reported no safety concerns.
Moderna is seeking full approval for the vaccine’s use in the 50- to 64-year-old population — along with authorization for use in those 65 and older while it conducts additional testing.
Earlier this year, Moderna’s data was at the center of a highly unusual public dispute as a then-top FDA official blocked the company’s application for its first-of-its-kind shot.
The embattled vaccine chief at the time, Dr. Vinay Prasad, said the company should have compared its shot to a high-dose flu vaccine recommended for seniors rather than a standard-dose brand. It was a sign of FDA’s heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr.
Moderna challenged that decision, noting that FDA staff had approved that main study’s design and citing a separate, smaller study comparing the mRNA shot with a high-dose vaccine for seniors. Days after the spat, the FDA accepted Moderna’s application.
The expert panel also will assess that smaller study, which found Moderna’s shot generated flu-fighting antibodies similarly to a high-dose senior shot. The FDA’s initial review noted the new vaccine lacks data on very frail older adults and those with weak immune systems.
