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FDA provides warning of uncommon coronary heart irritation to Pfizer, Moderna vaccines

CDC group says there isn't enough data yet to recommend booster shots

Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021.

Dado Ruvic | Reuters

The U.S. Food and Drug Administration on Friday added a warning to patient and provider fact sheets for the Pfizer and Moderna Covid-19 vaccines to indicate a rare risk of heart inflammation.

For each vaccine, the fact sheets were revised to include a warning about myocarditis and pericarditis after the second dose and with the onset of symptoms within a few days after receiving the shot.

Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue surrounding the heart. Health officials said the benefits of receiving the vaccine still outweigh any risk.

“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Janet Woodcock, acting FDA commissioner, said in a statement.

“The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications,” she said.

The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday. 

There have been more than 1,200 cases of a myocarditis or pericarditis mostly in people 30 and under who received the shots, according to presentation slides from the CDC meeting.

About 300 million shots had been administered as of June 11, according to the CDC. There have been just 12.6 heart inflammation cases per million doses for both vaccines combined.

— CNBC’s Berkeley Lovelace Jr. contributed reporting

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CDC says there’s seemingly hyperlink between uncommon coronary heart irritation in younger folks after Covid shot

CDC says there's likely link between rare heart inflammation in young people after Covid shot

A CDC safety group said there was a “likely link” between rare heart inflammation in adolescents and young adults, mostly after they received their second Covid-19 vaccine, citing the latest available data.

There have been more than 1,200 cases of myocarditis or pericarditis, mostly in those under 30 who have the Covid- Vaccine received from Pfizer or Moderna have practices methods exercises.

Myocarditis is the inflammation of the heart muscle while pericarditis is the inflammation of the membrane that surrounds the heart.

“The clinical picture of myocarditis cases after vaccination was variable and most often appeared within a week of the second dose, with chest pain being the most common,” said Dr. Grace Lee, Chair of the Committee’s Security Group. CDC officials are collecting more data to fully understand the potential risks, how to deal with them and if there are any long-term issues, she said.

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The agency said 267 cases of myocarditis or pericarditis were reported after receiving one dose of the mRNA vaccines and 827 cases after two doses by June 11. There are 132 additional cases where the number of doses received is unknown, the CDC said.

The agency announced that around 300 million shots had been administered by June 11.

“This is still a rare occurrence,” said Dr. Tom Shimabukuro at the meeting. For both vaccines combined, there were 12.6 cases of heart inflammation per million doses. Cases were more common among Moderna vaccine recipients at 19.8 cases per million than eight cases per million at Pfizer, he said.

Men under 30 make up the bulk of cases, the CDC said, and most cases appear to be mild. Of the 295 people who developed the disease and were discharged, 79% made a full recovery, according to the presentation. Nine people were hospitalized, according to the agency, two of them in the intensive care unit.

CDC officials said the benefits of the Covid vaccine still outweigh the risks.

Cases in younger people are increasing as older people are vaccinated at higher rates. The US vaccinated 177.6 million people with at least one dose, according to the CDC, that’s about 53% of the population. Only 13.6% of 18- to 24-year-olds in the United States received at least one dose of vaccine, compared with 26% of people ages 50 to 64, the data shows.

While hospitalization rates have decreased in older age groups, they have barely moved in adolescents and young adults, said Dr. Megan Wallace from the CDC.

“Teenagers and young adults make up a larger proportion of the total cases, 33% of the cases reported in May were people ages 12-29, compared with 28% last December,” she said. Since the pandemic began, 2,767 people aged 12 to 29 have died of Covid, she said, noting that 316 of these deaths had occurred since April 1.

The CDC is coordinating its investigation with the Food and Drug Administration, which last month approved the Pfizer BioNTech vaccine for adolescents ages 12-15. Symptoms like chest pain and shortness of breath usually develop within a week of receiving the vaccination, with most developing within four days, the agency said.

This is a developing story. Please check again for updates.

CNBC’s Rich Mendez contributed to this article.

Correction: Most of the cases of people who had myocarditis occurred in people under the age of 30. In a previous version, the age was incorrectly stated. The number of cases per million doses administered was 12.6. In an earlier version, the number was incorrectly specified.

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Dr. Scott Gottlieb on uncommon coronary heart irritation in younger Covid vaccine recipients

Dr. Scott Gottlieb on rare heart inflammation in young Covid vaccine recipients

Rare instances of heart inflammation in young people after receiving their second Covid vaccine dose require further inquiry, Dr. Scott Gottlieb told CNBC on Friday.

However, the former Food and Drug Administration commissioner said the cases have mostly been mild and should not dissuade people from signing up for the two-shot regimens from Pfizer and Moderna.

“At this point, the risk/benefit still favors vaccination certainly in this age group,” Gottlieb, a Pfizer board member, said in an interview on “Squawk Box.” “That’s what CDC and FDA have also affirmed.”

A day earlier, the Centers for Disease Control and Prevention indicated it has seen a higher-than-projected number of cases of heart inflammation in 16-to-24-year-olds following their second Covid shot—  275 recorded occurrences compared with expectations of 10 to 102.

In people age 30 and below, there’s been 475 total reports of myocarditis or pericarditis, which according to the CDC involves inflammation of the heart muscle or the lining around it. Men make up the vast majority of reported instances of post-vaccine myocarditis or pericarditis.

Of the 270 people who developed the conditions and have been discharged from the hospital, 81% have fully recovered, according to CDC data. The remaining 19% either still have symptoms or their status is not known. Fifteen people are still hospitalized, the CDC said.

Symptoms, which include chest pain and shortness of breath, typically develop when a few days of receiving the vaccine, according to the CDC.

Gottlieb said many questions remain about the connection between the heart inflammation and the Covid vaccines from Pfizer and Moderna.

“I think at this point you need to assume there’s a causal relationship between the vaccine and these observations until you can prove otherwise,” said Gottlieb, who led the FDA from 2017 to 2019 in the Trump administration.

Gottlieb said what’s not known yet is whether there’s something specific about the vaccines that are causing heart inflammation. “We know the vaccine induces inflammatory response. That’s why you get a fever. That’s why you get injection-site pain because your immune system is stimulated.”

“Is this a more generalized inflammatory response from the vaccine that’s localizing in the heart in some patients?” Gottlieb asked. “Or is this something that’s more direct, where the vaccine itself is triggering some kind of very targeted immune reaction and it’s manifesting in this way? We don’t have the answers to these questions.”

It’s possible additional cases haven’t been recorded, Gottlieb said, but “we are probably capturing most of the severe cases.” He added, “When you look at the number of people who are having severe cases of pericarditis, it’s very small numbers right now.”

Roughly 141.5 million people in the U.S. have been fully vaccinated against Covid, according to CDC data. The vaccines have been critical in driving down the number of coronavirus cases in the U.S. to their lowest levels since early in the pandemic.

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C.D.C. Investigating Circumstances of Coronary heart Irritation Following Immunization

C.D.C. Investigating Cases of Heart Inflammation Following Immunization

Federal officials are reviewing nearly 800 cases of rare heart problems following immunization with the coronavirus vaccines made by Pfizer-BioNTech and Moderna, according to data presented at a vaccine safety meeting on Thursday.

Not all of the cases are likely to be verified or related to vaccines, and experts believe the benefits of immunization far outweigh the risk of these rare complications. But the reports have worried some researchers. More than half of the heart problems were reported in people ages 12 to 24, while the same age group accounted for only 9 percent of the millions of doses administered.

“We clearly have an imbalance there,” said Dr. Tom Shimabukuro, a vaccine expert at the Centers for Disease Control and Prevention who presented the data. Advisers to the agency will meet on June 18 to explore the potential links to the complications: myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the membrane surrounding the heart.

About two-thirds of the cases were in young males, with a median age of 30 years. The numbers are higher than would be expected for that age group, officials said, but have not yet been definitively linked to the vaccines.

As of May 31, 216 people had experienced myocarditis or pericarditis after one dose of either vaccine, and 573 after the second dose. Most cases have been mild, but 15 patients remain in hospitals. The second dose of the Pfizer-BioNTech vaccine was linked to about twice as many cases as the second dose of the vaccine made by Moderna.

There were 79 reported cases of the heart problems among those 16 or 17 years old, compared with a maximum of 19 cases expected for that group. And in the group of young people ages 18 to 24, there were 196 cases, compared with an expected maximum of 83.

But the true incidence may be lower, Dr. Shimabukuro said. Immunizations of younger teenagers began only last month, and data from that age group in particular are limited.

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Moderna says it hasn’t discovered a hyperlink between its shot and coronary heart irritation

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC

A healthcare worker stops during the coronavirus pandemic (COVID-19) in New York on Jan.

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Moderna has not found a link between its Covid-19 vaccine and the rare heart inflammation cases reported in young people who received the vaccination, the company said on Friday.

The Massachusetts-based biotech said it reached the conclusion after “carefully reviewing the safety data previously available for the Moderna COVID-19 vaccine for cases of myocarditis and / or pericarditis”.

“The company will continue to monitor these reports closely and is actively working with public health and regulators to further evaluate this issue,” said a statement.

A spokesman for the Centers for Disease Control and Prevention did not immediately respond to a request for comment.

A CDC advisory body is organizing on 18.

A CDC official said Thursday that by May 31, the agency had received reports of 275 cases of myocarditis or pericarditis in this age group, up from the 10 to 102 expected cases. The condition includes inflammation of the heart muscle or the lining around it.

“We clearly have an imbalance,” said Dr. Tom Shimabukuro of the CDC’s Immunization Safety Office on Thursday at a meeting of the FDA’s Advisory Committee on Vaccines and Related Biological Products. The group met to discuss safety issues related to the use of Covid-19 vaccines in children 6 months and older.

The CDC’s vaccine safety group said last month it is studying heart infections in “relatively few” people who have received Covid vaccinations. Officials say they still don’t know if the condition is really related to the vaccines.

Some of the reported cases could be something other than myocarditis or pericarditis upon further investigation, Shimabukuro said Thursday.

Men make up the majority of reported cases and most cases appear to be mild, officials say. Of the 270 people who developed the disease and were discharged, 81% made a full recovery, according to a CDC presentation at Thursday’s meeting. By May 31, 15 people had been hospitalized, three of them in intensive care, the agency said.

Although no link has been found between the vaccines and the disease, health experts say side effects occur rarely once a vaccine or drug is administered to the general population. The US has distributed millions of Covid vaccines which have helped contain new cases and hospital stays across the country.

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CDC says coronary heart irritation in 16- to 24-year-olds increased than anticipated after second shot

CDC says heart inflammation in 16- to 24-year-olds higher than expected after second shot

A young man in West Virginia receives the vaccine while overlooking the West Virginia Capitol Building at Riggleman Hall.

Stephen Zenner | LightRakete | Getty Images

There have been a higher than expected number of cases of heart inflammation in 16- to 24-year-olds after receiving their second dose of Covid-19 vaccine from Pfizer or Moderna, the Centers for Disease Control and Prevention shared on Thursday Relying on preliminary data from its vaccine safety monitoring system.

The CDC has received reports of 275 cases in this age group as of May 31, the agency said in a presentation prepared for a meeting of the Food and Drug Administration advisory panel on Thursday. Scientists expected between 10 and 102 cases of myocarditis, or pericarditis – in which the heart muscle or the lining of the heart becomes inflamed, according to the CDC.

“We clearly have an imbalance,” said Dr. Tom Shimabukuro of the CDC’s Immunization Safety Office on Thursday on the FDA Advisory Committee on Vaccines and Related Biological Products to discuss safety issues related to the use of Covid-19 vaccines in children 6 months and older.

Although rare, a total of 475 cases of myocarditis or pericarditis have been reported in people aged 30 years and younger, according to the CDC. Most of the patients hospitalized, or 81% of them, had fully recovered from their symptoms, the agency said. May there are still 15 people in the hospital, three of them in the intensive care unit.

The majority of cases appear to occur in men, and the median time to onset of symptoms is two to three days, according to the CDC.

Some of the reported cases could be something other than myocarditis or pericarditis upon further investigation, Shimabukuro said.

The CDC’s Vaccine Safety Group announced last month that it is examining heart infections in “relatively few” people who have received Covid vaccinations.

The cases mostly affected adolescents and young adults and usually occurred within four days of the vaccination, the CDC said at the time. The condition has been seen more often in men and most cases appear to be mild, the agency said, although officials are following up on patients.

The CDC is coordinating its investigation with the FDA, which last month approved the Pfizer BioNTech vaccine for adolescents ages 12-15.

“We still don’t know if this is really related to the vaccine,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, during a virtual question-and-answer event on May 27th. He added that the “handful” of reported cases were “very mild, lasting a day or two,” and usually occurred after a second dose.

Health experts say finding rare side effects once a vaccine or drug is administered to the general population, and if myocarditis is found to be related to the Covid vaccine, the risk is negligible compared to the risks of infection with Covid-19.