FDA advisory committee considers risk of heart inflammation from Moderna's COVID-19 vaccine



The U.S. Food and Drug Administration's vaccine advisory committee heard testimony Tuesday that Moderna's COVID-19 vaccine may carry a higher risk of heart inflammation in young men than the vaccine produced by Pfizer/BioNTech.

A panel of outside experts met Tuesday to consider whether the emergency use authorization for Moderna's mRNA vaccine should be expanded to include children ages 6 to 17 years old. The advisory committee will consider expert testimony from FDA scientists and then vote on whether Moderna's shot should be approved for children alongside Pfizer's COVID-19 vaccine.

Data presented to the committee by Dr. Tom Shimabukuro, a vaccine safety official at the U.S. Centers for Disease Control and Prevention, suggested that people ages 18 to 39 had a higher risk of myocarditis if they took the Moderna vaccine compared to those who had received the Pfizer shot.

But Shimabukuro cautioned that these findings were not consistent across U.S. databases, and he emphasized that heart inflammation remains a rare vaccine side effect.

According to the CDC, as of May 26, 2022, there have been 635 reports of myocarditis in children ages 5-17 who took the Pfizer vaccine. Putting that number in context, Shimabukuro said there have been nearly 55 million total Pfizer vaccine doses administered over the same period. Most of those that developed heart inflammation problems were adolescent boys who had received a second vaccine dose.

All children who reported having myocarditis recovered at least somewhat after it was diagnosed, and 80.1% of those diagnosed fully, or probably fully, recovered, according to a CDC survey of health care providers that treated them.

Comparing the Moderna vaccine to the Pfizer vaccine, Shimabukuro said there were slightly higher reporting rates of myocarditis for Moderna and that the reporting rate was higher in males.

Data from three U.S. vaccine safety databases showed the risk of myocarditis and pericarditis in young males aged 18-39 was 1.1 to 1.5 times higher after the Moderna shot, he said.

More CDC data on 18- to 39-year-olds showed 4.41 excess heart inflammation cases per 100,000 who took the Pfizer vaccine compared to 6.27 excess cases per 100,000 for Moderna. The Moderna vaccine is administered in higher doses than the Pfizer vaccine.

The FDA also reviewed Moderna's studies showing the efficacy of the vaccine in children 6 to 17. Officials said the vaccine was 93% effective among adolescents 12-17 and 77% effective in younger children. While these results met the agency's criteria for success, FDA officials warned that a booster shot will likely be needed for children, just like adults, because the vaccine's effectiveness wanes over time.

If the advisory committee votes to approve Moderna's vaccine for children, the question will go back to the FDA which must decide whether to take the committee's recommendation.

The committee will meet again Wednesday to consider whether the Pfizer and Moderna vaccines should be approved for use in infants under 5.

FDA limits authorized use of Johnson & Johnson vaccine over blood clot concerns



The U.S. Food and Drug administration announced limits on the authorized use of the Johnson & Johnson COVID-19 vaccine on Thursday, citing concerns over rare and potentially life-threatening blood clots that can be a side effect of the vaccine.

The authorized use of the vaccine is now limited to individuals 18 and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and to adults who choose to receive the Johnson & Johnson vaccine because they do not want to take another one.

According to the FDA, an analysis of reported vaccine side effects has determined there is a risk of thrombosis with thrombocytopenia syndrome (TTS), which causes blood clots in combination with low levels of blood platelets. Symptoms of the side effect can appear approximately one to two weeks after an individual receives the Johnson & Johnson vaccine, the FDA said.

But there are some people the FDA says should still be eligible to receive the Johnson & Johnson vaccine, such as those who have had a severe allergic reaction to the mRNA vaccines manufactured by Pfizer/BioNTech or Moderna, those who object to taking an mRNA vaccine, or those with limited access to mRNA COVID-19 vaccines.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA," he continued.

"The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information,” Marks said.

The Johnson & Johnson COVID-19 vaccine received FDA emergency use authorization on Feb. 27, 2021. Months later on April 13, 2021, the FDA and the CDC issued a call to "pause" the administration of the vaccine over concerns of blood clotting. At the time, the agency wanted to investigate six reported cases of TTS after nearly 7 million doses of Johnson & Johnson's single-dose vaccine had been administered. The pause was lifted on April 23, 2021, after the FDA and CDC conducted a safety evaluation.

In December, the CDC's Advisory Committee on Immunization Practices issued a "preferential recommendation" stating that unvaccinated adults should get one of the mRNA COVID-19 vaccines before they consider taking the Johnson & Johnson vaccine.

A fact sheet provided by the FDA says that TTS cases have been reported in males and females, in a wide range of individuals age 18 years and older. The highest reported rate of TTS was approximately 8 cases per 1,000,000 vaccine doses administered among females ages 30-29 years. The FDA says that approximately 15% of reported TTS cases have been fatal.

As of Friday, more than 18.7 million people have received the Johnson & Johnson COVID-19 vaccine, according to the U.S. Centers for Disease Control and Prevention. The FDA says it has confirmed 60 cases of TTS, including nine deaths. The FDA estimates the reporting rate of TTS is 3.23 cases per million vaccine doses administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

EU health agency to investigate whether mRNA vaccines affect women's menstrual cycles



European regulators are investigating reports of heavy menstrual bleeding and the absence of menstruation i women who have received an mRNA COVID-19 vaccine.

The European Medicines Agency's safety committee said Friday it is reviewing reports that the COVID-19 vaccines from Pfizer/BioNTech and Moderna are disrupting women's menstrual cycles, Reuters reported.

The agency said it is not yet clear whether there is a causal link between the disorders and the vaccines. Women's menstrual cycles can be affected by a range of underlying medical conditions, as well as from stress and tiredness, the EMA said. Though there are reports that women have had unusual menstrual cycles after being infected with COVID-19.

A recent study found that mRNA vaccines may be linked to small, temporary changes in a woman's menstrual cycle. Researchers at the Oregon Health & Science University in Portland found that those who received their first dose of a COVID-19 vaccine waited 0.71 days longer on average for their next menstrual cycle when compared to their cycles before vaccination.

The study also noted that unvaccinated women with normal menstrual cycle histories experienced a 0.07-day increase in cycle length on average, as TheBlaze previously reported. The study was funded by the National Institutes of Health, which collected data from nearly 4,000 users of a smartphone app that tracks menstrual cycles.

The EMA previously said in December that it has not established a link between changes in menstrual cycles and COVID-19 vaccines, after a study from Norway suggested some women experienced heavier periods following vaccination.

The EMA's Pharmacovigilance Risk Assessment Committee said it will review all available data to determine if there's a link between the COVID-19 vaccinations and unusual menstrual cycles, including reports from patients and doctors, clinical trials, and published studies.

The agency added that there is no evidence to suggest that COVID-19 vaccines affect fertility, in a response to rumors circulating social media that the vaccines have an impact on fertility.

A NIH-funded study published in January looked at more than 2,000 couples and found that COVID-19 vaccination did not impact the chances of conceiving a child in either men or women. However, couples had a slightly lower chance of conception if the male partner had been infected with the SARS-CoV-2 virus within 60 days before his partner's menstrual cycle, which suggested that COVID-19 may reduce male fertility.

“The findings provide reassurance that vaccination for couples seeking pregnancy does not appear to impair fertility,” said Diana Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development.

CDC considers adjusting COVID-19 vaccine schedules to lower risk of heart inflammation



The U.S. Centers for Disease Control and Prevention is considering changes to its COVID-19 vaccination schedule to reduce the risk of heart inflammation from mRNA vaccine shots.

During a meeting Friday, members of the CDC's Advisory Committee on Immunization Practices presented data that suggests there have been higher rates of myocarditis after receiving an mRNA COVID-19 vaccine, especially in young men. Advisory panel chairwoman Dr. Grace Lee said that a longer time period between vaccine doses could be safer and also improve the vaccine's effectiveness, according to the Washington Examiner.

“[The data is] ... fairly convincing that an extended interval is not only potentially safer from a myocarditis standpoint, but also potentially more effective,” Lee, a medical officer at the Lucile Packard Children’s Hospital at Stanford, said.

The advisory cited studies from Canada and England that suggested a longer period between vaccine doses reduced the risk of myocarditis and pericarditis, two kinds of heart inflammation that can be rare side effects of mRNA vaccination.

“The longer interval resulted in lower myocarditis rates, whereas the shorter interval had higher myocarditis and pericarditis rates,” Dr. Bryna Warshawsky of the Public Health Agency of Canada said.

Current CDC guidelines state that the two-dose Pfizer-BioNTech mRNA vaccine shots should be given three weeks apart, while the Moderna vaccine doses have a four-week period between shots.

The panel recommended that the guidelines be changed to allow for eight weeks between vaccine doses. The CDC has not yet decided whether to adopt the recommendations.

Increasing the time between primary vaccine doses would mean it will take longer for people who receive an mRNA vaccine shot to be considered "fully vaccinated" against COVID-19. It would also mean vaccinated individuals may have to wait longer to get a booster dose.

The CDC also on Friday released new recommendations for individuals with compromised immune systems.

The agency said that immunocompromised people who've completed the primary COVID-19 vaccine schedule and who have taken one booster shot should wait at least three months before receiving a second booster dose.

This is a reduction in time between booster doses from the previous recommendation, which was to wait at least five months after the third COVID-19 shot before getting a fourth shot.

The new guidelines apply to people age 18 and older who have taken the Moderna vaccine, as well as those 12 and older who have had the Pfizer shot.

Immunocompromised individuals who were vaccinated with the Johnson & Johnson vaccine are recommended to get an mRNA vaccine dose at least 28 days after the first shot, followed by a third booster dose at least two months later.

LIVE: CDC Advisors Meet on Moderna COVID-19 Vaccine www.youtube.com

Canadian lawyer hospitalized for vaccine-related heart ailment: 'I accept my role as collateral damage of the vaccine rollout.' He even got a booster.



Based on what happened to Adam Goodman — a Toronto-based lawyer — after his second Pfizer shot, many might have assumed he'd never again go anywhere near a similar needle.

What happened to him?

Goodman said in a Monday op-ed for The Globe and Mail that at first, he thought he was merely experiencing "muscle pain" in his neck and then in his chest.

But a medical checkup revealed it actually was pericarditis — inflammation of the lining around the heart and "one of the two potential significant side effects associated with the mRNA vaccines," he said. The other significant side effect is myocarditis, which is inflammation of the heart itself, Goodman wrote.

"Because I thought I was experiencing muscle pain, I let the pericarditis go too long without treatment. As a result, I experienced a dangerous squeezing of the heart called tamponade," he added in his piece. "I spent five days in hospital recovering with the help of a crack team of cardiologists, nurses, and pharmacists at Toronto’s University Health Network and a heavy dose of anti-inflammatory drugs."

'The vaccines are our civic duty'

But despite his serious medical scare as a result of the vaccine, Goodman is still a fan of the shots.

"I accept my role as collateral damage of the vaccine rollout," he added in his op-ed. "Before the current Omicron wave, vaccines helped us get back to some degree of normality. They protect society and our public-health system. Previous generations were asked to undertake far greater risks for the protection of society, including being drafted for war. The vaccines are our civic duty."

As for vaccine opponents, Goodman declared that they use "absolutely false, conspiracy-theory laden arguments" and called them "clearly a lost cause, embracing an anti-science and anti-truth ideology with a fervor rarely seen since the advent of the Enlightenment."

He added that he believes "the positives of the vaccines greatly outweigh the negatives" and that his children are fully vaccinated. Plus, Goodman said he "received a booster shot a few days ago. So far, I’m feeling okay. Instead of an mRNA vaccine, I took the Johnson & Johnson shot, which is a viral-vector vaccine less associated with pericarditis."

He added in his op-ed that he hopes by telling his story of battling a serious vaccine side-effect that the "vaccine hesitant" might also get the shots.

How are readers reacting to Goodman's vaccine stance?

Goodman's op-ed so far has elicited a wide-range of reactions. Some commenters agree with him; some don't. And still others are engaging in debates with each other:

"Mass Formation Psychosis in action," one commenter wrote, after which another commenter linked to an article refuting "mass formation psychosis," which Dr. Robert Malone noted in his recent interview with podcaster Joe Rogan.

Another commenter actually managed a balanced take: "I think the stance that antivaxers are anti-science is naive. There are plenty of scientists and doctors who question the vaccines (for the record I'm pro-vaccine) and the anti-vax people do engage in scientific thinking. The issue is more epistemological and has more to do with trust than being 'anti-science.' If we are going to convince anyone we need to be more nuanced with our thinking and less lazy otherwise our efforts will be easily ignored. You have to dig in a little to the content they are consuming to see their side accurately. Is this dangerous? Probably, but not looking at an argument from just one perspective is truly anti-science."

FDA to announce new warning on Johnson & Johnson vaccine, linking it to rare neurological condition



The Food and Drug Administration will soon announce a new warning about the Johnson & Johnson coronavirus vaccine, linking the shot to increased risk of a rare neurological condition known as Guillain-Barré syndrome, which can cause permanent nerve damage.

Both the Washington Post and the New York Times reported Monday that about 100 suspected cases of Guillain-Barré syndrome have been detected among recipients of Johnson & Johnson's COVID-19 vaccine. The cases were reported about two weeks after vaccination and were mostly among men age 50 and older, according to the Centers for Disease Control and Prevention's preliminary findings.

For context, the CDC says 12.8 million doses of Johnson & Johnson's vaccine have been administered. The risk of developing the disease is low, but still the data indicates it is three to five times higher for those who received the Johnson & Johnson vaccine than the general population. So far, there is no evidence linking the Pfizer-BioNTech and Moderna vaccines to Guillain-Barré cases.

Guillain-Barré syndrome is a rare neurological disorder in which the body's immune system attacks part of its peripheral nervous system by mistake. The causes of the condition are still unknown, but according to the National Institute of Neurological Disorders and Stroke, when an immune attack is initiated to fight an infection, some chemicals on infecting bacteria and viruses resemble those on nerve cells. The body's immune cells might become confused and attack the nerve cells in addition to the infection.

Symptoms can range from mild cases of weakness to severe cases of paralysis. Each year, an estimated 3,000 to 6,000 people will develop the disease in the United States. Most people recover, even from the severe cases, but rarely some may have permanent nerve damage, which could lead to weakness. People over age 50 are at the greatest risk.

The Biden administration is expected to make an announcement about the new warning as early as Tuesday. Officials will emphasize that the benefits of vaccination against COVID-19 strongly outweigh the risk and that the Johnson & Johnson vaccine is safe for the vast majority of people.

Still, the new warning is unlikely to instill public confidence in a vaccine that has already faced intense public scrutiny. The benefit of the Johnson & Johnson vaccine compared to its competitors from Pfizer and Moderna is that it only requires one dose, not two, meaning more people could be vaccinated against COIVD-19 quickly with widespread use. However, confidence in Johnson & Johnson's vaccine plummeted last April after the FDA and CDC called for an immediate pause in its use because of concerns about six women who developed blood clotting issues after taking the vaccine. The suspension was lifted after government agencies conducted an extensive safety review, though a warning label was added to the vaccine.

The mRNA vaccines are not without their own side effects. Late last month, the FDA added a warning to the Pfizer and Moderna coronavirus vaccines about an increased risk of heart inflammation following vaccination mostly found in young adult males.

Vaccine hesitancy prevented the Biden administration from meeting its goal of having 70% of U.S. adults vaccinated by the Fourth of July. Currently, about 47% of adults in the U.S. are fully vaccinated. Public health experts say 70%-90% of adults need to be vaccinated to beat the pandemic.

President Joe Biden said last week that his administration will start a door-to-door effort to encourage more Americans to get vaccinated.

"Now we need to go to community by community, neighborhood by neighborhood, and often times door to door— literally knocking on doors to get help to the remaining people, protected from the virus," Biden said.

The CDC and the Department of Health and Human Services, as well as various other public health organizations, continue to strongly recommend that everyone 12 and older get vaccinated because the risks of disease and death from COVID-19 are far greater than potential side effects from the vaccines.