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FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval

FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
HEALTH. ED TO YOU. LET鈥橲 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鈥橲 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鈥橪L 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 THAT STUDY HAS BEEN RETRACTED AND BUT STILL, THERE鈥橲 A LOT OF SKEPTICISM.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鈥橲 PROBABLY NOT ONE CAUSE. THERE鈥橲 PROBABLY GENETIC COMPONENTS. THERE MAY BE ENVIRONMENTAL COMPONENTS. I鈥橫 GLAD TO SEE THAT WE鈥橰E 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鈥橳 KNOW WHAT MMR STANDS FOR. SO WE鈥橵E TALKED ABOUT THE MEASLES OUTBREAK AND WE JUST HAVE SOME NEW NUMBERS. LET鈥橲 PUT THEM UP ON THE SCREEN. BECAUSE, YOU KNOW, WE鈥橰E A COUNTRY OF OF A LOT OF PEOPLE. BUT THERE ARE 712 CASES, WHICH ISN鈥橳 A LARGE NUMBER RIGHT, FOR THIS COUNTRY. BUT THERE ARE NOW 712 CONFIRMED IN 25 STATES. SO THAT鈥橲 HALF THE STATES IN THE UNION AND TWO DEATHS IN TEXAS. THEY鈥橰E 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鈥橰E 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鈥橲 FASCINATING. THERE HAS NEVER BEEN A DEATH, AT LEAST THAT I CAN TELL. AND I鈥橵E 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鈥橵E ONLY SEEN A HANDFUL OF DEATHS IN THE PAST 20 YEARS. RIGHT, RIGHT. SO IT鈥橲 RARE, BUT THE VACCINE WORKS. BUT BEFORE I LET YOU GO, ONE LAST QUESTION ABOUT VACCINE. AND THIS IS COVID. SO, YOU KNOW, WE鈥橵E 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鈥橰E ELDERLY, IF YOU鈥橰E 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鈥橲 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鈥橰E SAYING 65 AND OLDER.
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FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The U.S. Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its COVID-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN.The terms need to be negotiated before Novavax's vaccine could be granted full approval, the source said, declining to be named because they weren't authorized to speak on behalf of the FDA.Novavax had anticipated full approval of its vaccine by April 1, but the FDA delayed the decision because it sought more data, a source told CNN at the time."We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency," Novavax said in a statement Friday. "PMCs are not unusual with many approved drugs / biologics having at least one PMC or requirement. We continue to believe that our application is approvable, and we look forward to our continued engagement with the FDA about their request for a PMC and to moving to approval as soon as possible."A spokesperson for the U.S. Department of Health and Human Services, the FDA's parent agency, said Friday that it "remains committed to our promise: ensuring products are safe for the American people and grounded in gold-standard science."The Novavax COVID-19 vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from Pfizer/BioNTech and Moderna, has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against COVID-19 to receive full FDA approval, which could provide additional reassurance to people seeking the shot.The missed deadline came at the same time the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was forced out. In his resignation letter, Marks cited "efforts being advanced by some on the adverse health effects of vaccination" that he called "concerning."

The U.S. Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its COVID-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN.

The terms need to be negotiated before Novavax's vaccine could be granted full approval, the source said, declining to be named because they weren't authorized to speak on behalf of the FDA.

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Novavax had anticipated full approval of its vaccine by April 1, but the FDA delayed the decision because it sought more data, a source told CNN at the time.

"We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency," Novavax said in a statement Friday. "PMCs are not unusual with many approved drugs / biologics having at least one PMC or requirement. We continue to believe that our application is approvable, and we look forward to our continued engagement with the FDA about their request for a PMC and to moving to approval as soon as possible."

A spokesperson for the U.S. Department of Health and Human Services, the FDA's parent agency, said Friday that it "remains committed to our promise: ensuring products are safe for the American people and grounded in gold-standard science."

The Novavax COVID-19 vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from and , has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against COVID-19 to receive full FDA approval, which could provide additional reassurance to people seeking the shot.

The missed deadline came at the same time the FDA Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was . In his resignation letter, Marks cited "efforts being advanced by some on the adverse health effects of vaccination" that he called "concerning."