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Moderna prepares to submit RSV vaccine for FDA approval

BREAKTHROUGH FOR US TO HAVE A VACCINE AVAILABLE. >> MODERNA RELEASED FOR PRELIMINARY RESULTS OF THEIR VACCINE FOR RSV SHOWING IT IS MORE THAN 80% EFFECTIVE AT PREVENTING SERIOUS DISEASE IN PEOPLE OVER 60. AND IS PREPARING TO SUBMIT TO THE FDA FOR APPROVAL. THIS FOLLOWS SUBMISSIONS FROM PFIZER AND GLAXOSMITHKLINE LATE LAST YEAR. >> THE PFIZER VACCINE, THEY ALSO RELEASED RESULTS ON GIVING THAT SAME VACCINE TO PREGNANT WOMEN. AND THEN WHAT HAPPENS IS THE WOMAN, THE ANTIBODIES THAT THE WOMAN MAKES GET PASSED THROUGH THE PLACENTA INTO THE BABY. THEY SHOWED VERY GOOD PROTECTION IN THE FIRST THREE MONTHS OF LIFE. >> BABIES A YOUNG KIDS ARE ONE OF THE HIGH-RISK GROUPS FOR DEVELOPING COMPLICATIONS AND DYING FROM RSV. CLINICAL TRIALS ARE UNDERWAY ON A VACCINE FOR THEM. THESE WOULD BE THE FIRST RSV VACCINES APPROVED, A FEAT BECAUSE RESEARCHERS HAVE BEEN WORKING ON THEM SINCE THE 1960’S. MODERNA’S VERSION USES A MRNA TECHNOLOGY MADE FAMOUS BY THE COVID SHOT. >> THE REASON WHY THEY CAN MOVE SO QUICKLY ON THE COVID VACCINE WAS BECAUSE THEY HAD ALREADY BEEN STUDYING THIS VACCINE, THIS RSV VACCINE WE ARE LEARNING ABOUT NOW AND THEY USED THAT SAME TECHNOLOGY AND A LOT OF THE TRICKS THEY HAD FOUND FROM THAT TO DEVELOP THE COVID VACCINE. DR. CAMPBELL CAUTIONS THESE RESULTS ARE PRELIMINARY AND ARE NOT PEER REVIEW. SO, WHILE PROMISING, HE IS WAITING FOR FULL DETAILS. >> DOESN’T TAKE AWAY FROM THAT THIS IS REALLY EXCITING NEWS. BUT I AND I THINK EVERYONE SHOULD BE WAITING TO SEE WHAT THE FINAL, ALL THE DATA SHOW. FOR THIS VACCINE AND THE OTHER RSV VACCINES. >> DR. CAMPBELL SAYS RESEARCHERS ARE HOPEFUL THAT SOME OF THESE VACCINES WILL BE READY IN TIME FOR THIS YEAR’S RSV. SEASON THIS FALL.

Researchers on cusp of rolling out new vaccine for RSV

Study: Moderna RSV vaccine more than 80% effective at preventing RSV in older adults


Researchers are on the cusp of rolling out a new vaccine to combat the respiratory syncytial virus amid an increase in cases in recent months.RSV has become the second leading cause of hospitalization, and tens of thousands of people a year die from it. Children under 2 and adults older than 60 are most at risk for serious disease, and a vaccine has been elusive -- until now."It will be a huge, huge breakthrough for us to have an RSV vaccine available," said Dr. James Campbell, professor of pediatrics and the University of Maryland School of Medicine.RELATED: Sinai pediatrician describes ICU availability amid increase in RSV casesModerna released preliminary results of their vaccine for RSV that shows it's more than 80% effective at preventing serious disease in people older than 60. The company is preparing to submit the vaccine to the Food and Drug Administration for approval, which follows submissions from Pfizer and GlaxoSmithKline late last year."The Pfizer vaccine, they also relayed results on giving that same vaccine to pregnant women, and then what happens is the antibodies the woman makes, gets passed through the placenta into the baby, and they showed very good protection in the first three months of life," Campbell said.Clinical trials are underway on a vaccine for babies and young children, who are among the high-risk groups for developing complications and dying from RSV.RELATED: Maryland hospitals concerned over surge of children with RSVThese would be the first RSV vaccines approved, which would be a feat because researchers have been working on them since the 1960s. Moderna's version uses the mRNA technology made famous by its COVID-19 vaccine."The reason why they could move so quickly on the COVID vaccine was because they had already been studying this RSV vaccine that we're just learning about now, and they used that same technology, and a lot of the tricks they found from that, in order to develop the COVID vaccine," Campbell said.RSV video playlist below:Campbell cautioned the results in the RSV vaccine study are preliminary and are not yet peer-reviewed, so while promising, he's waiting for the full details."That doesn't take away that this is really exciting news, but I think everyone should be waiting to see what the final, all the data show for this vaccine and the other RSV vaccines," Campbell said.Campbell said researchers are hopeful that some of these vaccines will be approved in time for RSV season in the fall.LINK: Maryland Department of Health website for RSV

Researchers are on the cusp of rolling out a new vaccine to combat the respiratory syncytial virus amid an increase in cases in recent months.

RSV has become the second leading cause of hospitalization, and tens of thousands of people a year die from it. Children under 2 and adults older than 60 are most at risk for serious disease, and a vaccine has been elusive -- until now.

"It will be a huge, huge breakthrough for us to have an RSV vaccine available," said Dr. James Campbell, professor of pediatrics and the University of Maryland School of Medicine.

RELATED: Sinai pediatrician describes ICU availability amid increase in RSV cases

Moderna released preliminary results of their vaccine for RSV that shows it's more than 80% effective at preventing serious disease in people older than 60. The company is preparing to submit the vaccine to the Food and Drug Administration for approval, which follows submissions from Pfizer and GlaxoSmithKline late last year.

"The Pfizer vaccine, they also relayed results on giving that same vaccine to pregnant women, and then what happens is the antibodies the woman makes, gets passed through the placenta into the baby, and they showed very good protection in the first three months of life," Campbell said.

Clinical trials are underway on a vaccine for babies and young children, who are among the high-risk groups for developing complications and dying from RSV.

RELATED: Maryland hospitals concerned over surge of children with RSV

These would be the first RSV vaccines approved, which would be a feat because researchers have been working on them since the 1960s. Moderna's version uses the mRNA technology made famous by its COVID-19 vaccine.

"The reason why they could move so quickly on the COVID vaccine was because they had already been studying this RSV vaccine that we're just learning about now, and they used that same technology, and a lot of the tricks they found from that, in order to develop the COVID vaccine," Campbell said.

RSV video playlist below:

Campbell cautioned the results in the RSV vaccine study are preliminary and are not yet peer-reviewed, so while promising, he's waiting for the full details.

"That doesn't take away that this is really exciting news, but I think everyone should be waiting to see what the final, all the data show for this vaccine and the other RSV vaccines," Campbell said.

Campbell said researchers are hopeful that some of these vaccines will be approved in time for RSV season in the fall.

LINK: Maryland Department of Health website for RSV


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