December 22, 2024
Study Finds Increasing Time Between COVID Vaccine Doses Reduces Risk Of Myocarditis, Yet Cardiologists Raise Concerns

Authored by Megan Redshaw via The Epoch Times (emphasis ours),

New research suggests increasing the interval between vaccine doses or using a single dose may significantly lower the risk of heart inflammation caused by mRNA COVID-19 vaccines. Yet some cardiologists are concerned about asymptotic myocarditis and say any risk of heart inflammation in a population group that’s not at risk of experiencing severe COVID-19 is too much.

(Lightspring/Shutterstock)

In a February peer-reviewed paper published in NPJ Vaccines, researchers in Hong Kong observed a significantly lower cumulative incidence of carditis, or heart inflammation, among adolescents who received their second vaccine dose more than 56 days after their first dose compared with those who received their second dose within 21 to 27 days. A second analysis showed that increasing the time between the first and second vaccine doses decreased the risk of heart inflammation by 66 percent. Researchers compared the risk of carditis between standard and extended interdose intervals in 12- to 17-year-olds who received two doses of Pfizer’s COVID-19 vaccine.

Among 143,636 adolescents who received at least one dose of Pfizer’s COVID-19 vaccine, 130,970 (91 percent) received a second dose. Approximately 43 percent of these adolescents received their second dose at an extended interval. During the study period, a total of 84 adolescents were hospitalized for conditions related to heart inflammation within 28 days of the second vaccine dose. After implementing exclusion criteria, 49 cases remained and were attributed to COVID-19 vaccination.

The incidence of heart inflammation was higher in males than females.

In a subgroup analysis among male adolescents, the incidence of carditis was significantly lower in the extended interval group compared with the standard group, with 22 versus 88 cases per million, respectively. In contrast, the incidence of heart inflammation was similar among females vaccinated at standard and extended dose intervals.

The researchers said their findings are consistent with other studies that show young males are at a higher risk of mRNA vaccine-related heart inflammation, although the absolute risk is low and that an interval between vaccine doses greater than 56 days could help reduce the risk of heart inflammation in adolescents.

Cardiologist: Vaccinating Healthy Adolescents Is ‘All Risk’

Pediatric cardiologist Dr. Kirk Milhoan told The Epoch Times that he doesn’t necessarily disagree with the study’s findings, but even a small risk of heart inflammation for adolescents who are not at risk from COVID-19 is too much.

Before we do any procedure like a medicine, vaccination, or surgery, I look to see if the benefit outweighs the risk or if there’s any benefit at all. A recent paper out of the Cleveland Clinic showed that with more vaccines comes an increased risk of experiencing COVID-19. Once data is available from a reputable study, we must then ask if there’s any benefit to vaccination for the majority of people,” he said.

Referencing the current Hong Kong study, Dr. Milhoan said researchers only looked at myocarditis among hospitalized patients, but he is concerned about people with silent myocarditis from the COVID-19 vaccine, which is why he checks troponin levels. Even a slightly elevated troponin level can be indicative of heart damage.

If you spread out the doses of the Pfizer product, which has a pseudo mRNA that may have asked the body to make a spike protein we now know is cardiotoxic and directly correlated with myocarditis, fewer people got hospitalized, but people still got hospitalized,” Dr. Milhoan said.

“If you get a large dose of toxin very close together, that’s probably harder on your body than if you spread it over time, but what I believe is that we don’t need the vaccine for this very, very healthy cohort that doesn’t have trouble with COVID. We’re basically giving them all risk even if it’s less risk with no benefit,” he added.

Heart Inflammation Is Higher Due to Asymptomatic Cases

Pfizer’s COVID-19 vaccine was first made available in Hong Kong in June 2021 with a recommended dose interval for adults and adolescents of 21 days. After a local pharmacovigilance study in January 2022 showed an increased risk of heart inflammation among adolescents who received two vaccine doses, the Department of Health in March 2022 recommended the interval between the first and second vaccine doses be increased to 56 days.

Although the Centers for Disease Control and Prevention (CDC) originally recommended a three-week interval between the first and second COVID-19 vaccine doses, it recommended the interval be increased in 2022 to eight weeks for Pfizer and Moderna to reduce the risk of heart inflammation.

In a Feb. 15 hearing by the Select Subcommittee on the Coronavirus Pandemic, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said myocarditis, or heart inflammation, is one of the “rare” adverse events the agency identified with COVID-19 vaccines, but with “mitigation strategies in place,” the occurrence has decreased.

“After the first COVID-19 vaccine where the primary series given two doses three or four weeks apart, there was a risk in the younger age range of males that was about 1 in 10,000 to 1 in 20,000 individuals got myocarditis. Now, with the spacing out of the vaccines, that risk is almost undetectable,” Dr. Marks told the committee.

There was a signal for myocarditis or pericarditis only after the primary vaccination series with the Pfizer mRNA vaccine in those 12 to 17 years of age, and that now that signal is not being seen more recently. So I think we’ve learned something with how to deploy the vaccines and I think that’s why the CDC ... has changed their recommendations for how they be used,” he added.

In an email to The Epoch Times, cardiologist Dr. Peter McCullough said he believes Dr. Marks and the FDA have failed to keep up with the evolving medical literature on COVID-19 and vaccine-induced myocarditis.

After reviewing multiple peer-reviewed publications on myocarditis, Dr. McCullough made the following conclusions:

1. Vaccine myocarditis occurs in about 2.5 percent of vaccine recipients per administration—and half of the cases are asymptomatic.

2. The incidence of myocarditis is heavily influenced by age and gender, with young men ages 18 to 24 being most at risk.

3. COVID-19 vaccine-induced myocarditis is fatal in cases examined at autopsy.

Tyler Durden Tue, 02/27/2024 - 03:30

Authored by Megan Redshaw via The Epoch Times (emphasis ours),

New research suggests increasing the interval between vaccine doses or using a single dose may significantly lower the risk of heart inflammation caused by mRNA COVID-19 vaccines. Yet some cardiologists are concerned about asymptotic myocarditis and say any risk of heart inflammation in a population group that’s not at risk of experiencing severe COVID-19 is too much.

(Lightspring/Shutterstock)

In a February peer-reviewed paper published in NPJ Vaccines, researchers in Hong Kong observed a significantly lower cumulative incidence of carditis, or heart inflammation, among adolescents who received their second vaccine dose more than 56 days after their first dose compared with those who received their second dose within 21 to 27 days. A second analysis showed that increasing the time between the first and second vaccine doses decreased the risk of heart inflammation by 66 percent. Researchers compared the risk of carditis between standard and extended interdose intervals in 12- to 17-year-olds who received two doses of Pfizer’s COVID-19 vaccine.

Among 143,636 adolescents who received at least one dose of Pfizer’s COVID-19 vaccine, 130,970 (91 percent) received a second dose. Approximately 43 percent of these adolescents received their second dose at an extended interval. During the study period, a total of 84 adolescents were hospitalized for conditions related to heart inflammation within 28 days of the second vaccine dose. After implementing exclusion criteria, 49 cases remained and were attributed to COVID-19 vaccination.

The incidence of heart inflammation was higher in males than females.

In a subgroup analysis among male adolescents, the incidence of carditis was significantly lower in the extended interval group compared with the standard group, with 22 versus 88 cases per million, respectively. In contrast, the incidence of heart inflammation was similar among females vaccinated at standard and extended dose intervals.

The researchers said their findings are consistent with other studies that show young males are at a higher risk of mRNA vaccine-related heart inflammation, although the absolute risk is low and that an interval between vaccine doses greater than 56 days could help reduce the risk of heart inflammation in adolescents.

Cardiologist: Vaccinating Healthy Adolescents Is ‘All Risk’

Pediatric cardiologist Dr. Kirk Milhoan told The Epoch Times that he doesn’t necessarily disagree with the study’s findings, but even a small risk of heart inflammation for adolescents who are not at risk from COVID-19 is too much.

Before we do any procedure like a medicine, vaccination, or surgery, I look to see if the benefit outweighs the risk or if there’s any benefit at all. A recent paper out of the Cleveland Clinic showed that with more vaccines comes an increased risk of experiencing COVID-19. Once data is available from a reputable study, we must then ask if there’s any benefit to vaccination for the majority of people,” he said.

Referencing the current Hong Kong study, Dr. Milhoan said researchers only looked at myocarditis among hospitalized patients, but he is concerned about people with silent myocarditis from the COVID-19 vaccine, which is why he checks troponin levels. Even a slightly elevated troponin level can be indicative of heart damage.

If you spread out the doses of the Pfizer product, which has a pseudo mRNA that may have asked the body to make a spike protein we now know is cardiotoxic and directly correlated with myocarditis, fewer people got hospitalized, but people still got hospitalized,” Dr. Milhoan said.

“If you get a large dose of toxin very close together, that’s probably harder on your body than if you spread it over time, but what I believe is that we don’t need the vaccine for this very, very healthy cohort that doesn’t have trouble with COVID. We’re basically giving them all risk even if it’s less risk with no benefit,” he added.

Heart Inflammation Is Higher Due to Asymptomatic Cases

Pfizer’s COVID-19 vaccine was first made available in Hong Kong in June 2021 with a recommended dose interval for adults and adolescents of 21 days. After a local pharmacovigilance study in January 2022 showed an increased risk of heart inflammation among adolescents who received two vaccine doses, the Department of Health in March 2022 recommended the interval between the first and second vaccine doses be increased to 56 days.

Although the Centers for Disease Control and Prevention (CDC) originally recommended a three-week interval between the first and second COVID-19 vaccine doses, it recommended the interval be increased in 2022 to eight weeks for Pfizer and Moderna to reduce the risk of heart inflammation.

In a Feb. 15 hearing by the Select Subcommittee on the Coronavirus Pandemic, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said myocarditis, or heart inflammation, is one of the “rare” adverse events the agency identified with COVID-19 vaccines, but with “mitigation strategies in place,” the occurrence has decreased.

“After the first COVID-19 vaccine where the primary series given two doses three or four weeks apart, there was a risk in the younger age range of males that was about 1 in 10,000 to 1 in 20,000 individuals got myocarditis. Now, with the spacing out of the vaccines, that risk is almost undetectable,” Dr. Marks told the committee.

There was a signal for myocarditis or pericarditis only after the primary vaccination series with the Pfizer mRNA vaccine in those 12 to 17 years of age, and that now that signal is not being seen more recently. So I think we’ve learned something with how to deploy the vaccines and I think that’s why the CDC … has changed their recommendations for how they be used,” he added.

In an email to The Epoch Times, cardiologist Dr. Peter McCullough said he believes Dr. Marks and the FDA have failed to keep up with the evolving medical literature on COVID-19 and vaccine-induced myocarditis.

After reviewing multiple peer-reviewed publications on myocarditis, Dr. McCullough made the following conclusions:

1. Vaccine myocarditis occurs in about 2.5 percent of vaccine recipients per administration—and half of the cases are asymptomatic.

2. The incidence of myocarditis is heavily influenced by age and gender, with young men ages 18 to 24 being most at risk.

3. COVID-19 vaccine-induced myocarditis is fatal in cases examined at autopsy.

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