FDA updates COVID-19 vaccine warnings

FDA requires COVID-19 vaccine makers to warn about risk of heart inflammation

SEX ABUSE IN THE CATHOLIC CHURCH. RIGHT NOW WE TURN TO FIVE ON YOUR HEALTH TONIGHT, A MAJOR CHANGE FOR MILLIONS OF AMERICANS EXPECTING TO GET A COVID 19 BOOSTER. THIS FALL, THE FDA ANNOUNCES THAT IT WILL ONLY APPROVE SHOTS FOR SPECIFIC HIGH RISK GROUPS, AND THOSE INCLUDE. YOU’RE FAMILIAR WITH IT, RIGHT? ADULTS OVER THE AGE OF 65 AND PEOPLE WITH CERTAIN MEDICAL CONDITIONS. JOINING US RIGHT NOW IS DOCTOR TODD ELLERIN, CHIEF OF INFECTIOUS DISEASES. FAMILIAR FACE HERE AT CHANNEL 5 AT SOUTH SHORE HEALTH. SO LET’S START THERE. QUESTION ONE YOU’VE BEEN FOLLOWING THESE DEVELOPMENTS ALL DAY LONG, RIGHT? SO WHAT DO YOU THINK OF THE FDA’S DECISION? ALL RIGHT. WELL, WHAT’S IMPORTANT IS THAT THESE THIS CHANGE STILL ALLOWS THE HIGHEST RISK PATIENTS TO GET THE COVID VACCINE. YOU LISTED THE GROUPS, AND THAT’S THE MOST IMPORTANT THING, HIGHEST RISK PATIENTS, MOST VULNERABLE, WILL STILL BE RECOMMENDED TO GET THE VACCINE. NOW, WHAT’S REALLY CHANGED 180 DEGREES IS THE FACT THAT PREVIOUSLY, THE FDA RECOMMENDED SIX MONTHS AND OLDER, EVERYONE GET THE VACCINE AT LEAST ONCE. SO THIS WOULD BE A MAJOR CHANGE. I THINK WHAT THEY’RE ALSO SAYING IS THEY WANT TO SEE THE PHARMACEUTICAL COMPANIES STUDY IN THE OTHER GROUPS, LIKE THE 50 TO 64 AGE, OTHERWISE HEALTHY. LET’S DO A CONTROLLED TRIAL AND SEE IF IT’S STILL BENEFICIAL. YOU KNOW, SO I THINK THAT’S THAT’S THE CHANGE. DO YOU THINK IT SUGGESTS THAT THERE’S SOME KIND OF SAFETY ISSUE WITH THE COVID VACCINE AT ALL? THERE IS NO ISSUES IN SAFETY. THIS VACCINE HAS BEEN GIVEN TO BILLIONS OF PEOPLE AROUND THE WORLD, AND THERE’S NO SAFETY ISSUES. BUT AND WE ALSO KNOW THAT THE VACCINE HAS BEEN SHOWN TO DECREASE HOSPITALIZATION IN A WIDE RANGE OF ADULTS AND CHILDREN, DECREASED MORTALITY. BUT THERE’S BEEN HYBRID IMMUNITY NOW THAT WE’RE FIVE YEARS AFTER COVID HIT OUR SHORES, WE KNOW THAT MANY PEOPLE HAVE GOTTEN COVID MULTIPLE TIMES. THEY’VE GOTTEN THE VACCINE MULTIPLE TIMES. WHAT WE REALLY DON’T KNOW IS THE VACCINE STILL SIGNIFICANTLY EFFECTIVE IN PREVENTING SYMPTOMATIC ILLNESS AND HOSPITALIZATION IN THE OTHERWISE HEALTHY PERSON? THAT’S WHAT THE FDA WANTS TO SEE. SO LET ME GO 180 DEGREES OPPOSITE. IF WE’RE NOT CONCERNED ABOUT THE EFFICACY OF OF THE OF THE COVID VACCINE, IS IT A SUGGESTION THAT WE DON’T HAVE TO WORRY ABOUT COVID ANYMORE? WE STILL HAVE TO WORRY ABOUT COVID. I WILL JUST TELL YOU, IT’S SPIKING RIGHT NOW IN ASIA AND WE’RE GOING TO SEE IT AGAIN. YOU KNOW THAT COVID IS ABLE TO SURVIVE OUR SUMMERS. AND OF COURSE WE SEE IT IN THE WINTER. SO IT’S NOT SOMETHING THAT’S GOING AWAY. BUT THE QUESTION IS DO HEALTHY CHILDREN AND ADULTS NEED THE VACCINE EVERY YEAR? AND ONE THING I WANT TO REMIND YOU, THIS IS REALLY IMPORTANT. LAST YEAR, ONLY 10% OF KIDS UNDER THE AGE OF 12 ACTUALLY GOT THE BOOSTER, AND ONLY 50% OF OF THE HIGHEST RISK ADULTS OVER 65 GOT THE BOOSTER. SO WE’VE ALREADY SHOWN THAT WE’RE ABLE TO SURVIVE AND THRIVE EVEN WHEN MOST AMERICANS ARE NOT GETTING THE. IT’S NOT FAIR TO ASK YOU YES OR NO, BUT AS YOU SIT HERE RIGHT NOW, MEMORIAL DAY WEEKEND, ARE YOU STILL RECOMMENDING THE THE COVID BOOSTER? I STILL RECOMMEND THE COVID BOOSTER. THE QUESTION IS WHEN THE THE FDA HAS ALREADY TOLD US WHAT THEY’RE THINKING RIGHT NOW. I WANT TO SEE WHAT THE CDC SAYS. AND IF THEY’RE IF THEY’RE MIRRORING THE FDA’S RECOMMENDATION, THEN IT’S LIKELY THAT WE’LL NO LONGER BE RECOMMENDING THE VACCINE

FDA requires COVID-19 vaccine makers to warn about risk of heart inflammation

The U.S. Food and Drug Administration will now require COVID-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.The vaccines�� previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the U.S. Centers for Disease Control and Prevention website says is rare but possible after vaccination. The new labels will expand that warning to certain age groups.Research has shown that the mRNA COVID-19 vaccines are safe and effective.The CDC last month told its independent vaccine advisers that research showed COVID-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and “there is no increased risk observed with the doses administered in subsequent years,�� the agency said.In the case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly.The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer’s; the new warnings for both vaccines will be for males age 16 to 25.In letters to Pfizer and Moderna that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and/or pericarditis per million vaccine doses given to people ages 6 months through 64 years.Cases were more common among males ages 16 through 25 within seven days of vaccination, but they were still rare, with about 38 cases of myocarditis and/or pericarditis per million doses among this group.A spokesperson for the U.S. Department of Health and Human Services said Wednesday that the move was intended to increase “radical transparency.�� Neither Pfizer nor Moderna responded to requests for comment.The vaccines were developed during the first Trump administration and underwent what the CDC says was “the most intensive safety analysis in U.S. history,�� and the agency continues to monitor vaccine administration data for effectiveness and any potential problems.U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has falsely claimed that the COVID-19 vaccine was “the deadliest vaccine ever made.”In a U.S. Senate Homeland Security and Governmental Affairs subcommittee hearing on Wednesday, Sen. Ron Johnson, R-Wisconsin, claimed that the Biden administration downplayed the risks of the vaccine and delayed getting information about those risks to the public.One witness, Hawaii Gov. Josh Green, a family physician, said in his testimony the U.S. vaccine safety monitoring systems worked “exactly as intended�� by detecting rare cases of myocarditis.“The data were made public, warnings were updated, and clinical guidance was revised accordingly,�� Green said. “Despite this, some continue to promote misleading interpretations, unverified claims or anecdotes to suggest that vaccines are broadly unsafe.”The FDA has taken recent steps to limit COVID-19 vaccines for certain groups.On Tuesday, the FDA said it would change the type of evidence it will accept from vaccine manufacturers to approve updated COVID shots, which may limit who is eligible for updated shots. The vaccines are expected to be available in the fall, but only for adults 65 and older and people with underlying conditions that put them at a higher risk for severe COVID-19 infection.In an editorial published in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, said there’s not enough evidence that healthy children and adults get clinically meaningful benefit from regular COVID-19 shots, and officials want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups.On Thursday, the FDA’s vaccine advisers �� the Vaccines and Related Biological Products Advisory Committee �� will meet to discuss the coronavirus strain selection for this fall’s COVID-19 vaccines.

WASHINGTON —

The vaccines�� previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the U.S. Centers for Disease Control and Prevention website but possible after vaccination. The new labels will expand that warning to certain age groups.

has shown that the mRNA COVID-19 vaccines are safe and effective.

The CDC last month that research showed COVID-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and “there is no increased risk observed with the doses administered in subsequent years,�� the agency said.

In the case that someone did develop heart inflammation after vaccination, the CDC , acute myocarditis typically resolves quickly.

The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer’s; the new warnings for both vaccines will be for males age 16 to 25.

In letters to and that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and/or pericarditis per million vaccine doses given to people ages 6 months through 64 years.

Cases were more common among males ages 16 through 25 within seven days of vaccination, but they were still rare, with about 38 cases of myocarditis and/or pericarditis per million doses among this group.

A spokesperson for the U.S. Department of Health and Human Services said Wednesday that the move was intended to increase “radical transparency.�� Neither Pfizer nor Moderna responded to requests for comment.

The vaccines were developed during the first Trump administration and underwent what was “the most intensive safety analysis in U.S. history,�� and the agency continues to monitor vaccine administration data for effectiveness and any potential problems.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has falsely claimed that the COVID-19 vaccine was “the deadliest vaccine ever made.��

In a U.S. Senate Homeland Security and Governmental Affairs subcommittee on Wednesday, Sen. Ron Johnson, R-Wisconsin, claimed that the Biden administration downplayed the risks of the vaccine and delayed getting information about those risks to the public.

One witness, Hawaii Gov. Josh Green, a family physician, said in his the U.S. vaccine safety monitoring systems worked “exactly as intended�� by detecting rare cases of myocarditis.

“The data were made public, warnings were updated, and clinical guidance was revised accordingly,�� Green said. “Despite this, some continue to promote misleading interpretations, unverified claims or anecdotes to suggest that vaccines are broadly unsafe.��

The FDA has taken recent steps to limit COVID-19 vaccines for certain groups.

the FDA said it would change the type of evidence it will accept from vaccine manufacturers to approve updated COVID shots, which may limit who is eligible for updated shots. The vaccines are expected to be available in the fall, but only for adults 65 and older and people with underlying conditions that put them at a higher risk for severe COVID-19 infection.

In an in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, said there’s not enough evidence that healthy children and adults get clinically meaningful benefit from regular COVID-19 shots, and officials want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups.

On the FDA’s vaccine advisers �� the Vaccines and Related Biological Products Advisory Committee �� will meet to discuss the coronavirus strain selection for this fall’s COVID-19 vaccines.

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FDA requires COVID-19 vaccine makers to warn about risk of heart inflammation

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