US regulator issues alert about Pfizer, Moderna jabs

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DAWN.com 26 June, 2021 - 08:51pm 27 views

FDA: Rare Heart Inflammation Warning For Pfizer, Moderna Covid-19 Coronavirus Vaccines

Forbes 26 June, 2021 - 04:41pm

This is not exactly an “oh, sheets” moment.

On June 25, the U.S. Food and Drug Administration (FDA) announced that their Facts Sheets for the Moderna and Pfizer/BioNTech Covid-19 vaccines now include info about “myocarditis” and “pericarditis.” Adding such words to the sheets was not really a surprise. After all, two days prior, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) had found a “likely association” between the vaccines and rare occurrences of myocarditis and pericarditis among younger people, according to Jemima McEvoy writing for Forbes. So now the FDA Fact Sheets say that the two mRNA vaccines may bring “increased risks of myocarditis and pericarditis, particularly following the second dose.”

It’s important to remember that myocarditis and pericarditis after the Covid-19 vaccines are still like barely cooked steak: very rare. As I wrote back on June 13 for Forbes, so far, there have been less 300 confirmed cases of myocarditis or pericarditis among over 150 million fully vaccinated people in the U.S. This would still be less than your odds of being killed by a cow, if you believe the one in 300,000 number in the photo accompanying the following tweet:

OK, maybe The Sun is not the best source for cow statistics. And of course, deaths by cow are complicated and depend heavily on what you did to the cow and whether the cow has nunchucks. Regardless, the point is that 300 out of 150 million or 0.0002% doesn’t seem to be a high risk.

Plus, having myocarditis or pericarditis is not necessarily as bad as being killed by a cow. Your “myocardium” is your heart muscle because “myo” stands for muscle and “cardium” stands for heart. Your “pericardium” is the membranous sac that surrounds your heart because “peri” means around. Adding an “itis” to the end of everything means inflammation. Thus, myocarditis is inflammation of your heart muscles. Pericarditis means that you have an inflamed sac, that is, the sac around your heart.

Inflammation, of course, is rarely a good thing. Typically, you don’t hope that one of your body parts will become inflamed as in “today would be a whole lot better if my butt cheeks were inflamed.” Nevertheless, to date, most of these rare cases of heart inlammation after Covid-19 vaccination have not been severe. “Most commonly there is some acute chest pain for several days and then symptoms will rapidly taper off,” explained Timothy Wong, MD, MS, Assistant Professor of Medicine at the University of Pittsburgh Medical Center (UPMC) and Director of the UPMC Heart and Vascular Institute Cardiovascular Magnetic Resonance Center. “Some of the patients have been prescribed anti-inflammatory medications, some have just used over-the-counter ones, and some have not used any medications to recover.”  

Wong also emphasized that in the cases that he has seen, “Even though there is inflammation, the heart function has remained OK. Measurements of the heart’s ability to pump blood like the ejection fraction were in the normal ranges.”

In addition to chest pain, other possible symptoms of myocarditis or pericarditis include shortness of breath or unusual heart rhythms. “If you have any such symptoms after getting the Covid-19 vaccine notify your doctor,” Wong advised. “It may not be the result of the vaccine and other things may be going on,” so it is important to “be aware of one’s self” and to have your doctor to assess your situation.

Currently, the FDA warnings cover only the Pfizer/BioNTech and Moderna Covid-19 mRNA vaccines. This doesn’t necessarily mean that such concerns are unique to the mRNA vaccines. Wong emphasized that by comparison, “there have been relatively fewer doses of the Johnson & Johnson vaccine administered.”

Keep in mind that “likely association” does not yet mean that a cause-and-effect relationship has been established. For example, if you were more likely to feel bloated after watching the TV show Keeping Up with the Kardashians, there could be a likely association between the two. That still wouldn’t mean that the TV show is causing the bloating. Maybe it’s the wheel of cheese that you always eat while watching the show. Similarly, researchers will still have to dig deeper to determine if other factors are at play. These rare conditions have seemed to occur more frequently among men in their teens and early 20s. Wong emphasized that it is “hard to tell the mechanism” until more studies are done and any speculation about the mechanism would still be no more than speculation. “Common causes of myocarditis and pericarditis is viral,” Wong explained. “Could there be some type of immune reaction to the vaccine that then cross-reacts with tissue in the heart?”

All of this shouldn’t dissuade you from getting the Covid-19 vaccine, even if you are a teenager, according to Wong. “Covid-19 myocarditis is much more common and feared than Covid-19 vaccine myocarditis.” He emphasized that all of his family members who are currently eligible have already been vaccinated and that his toddler will be first in line to get it when possible.

In fact, on Wednesday after the ACIP announcement, the American Academy of Pediatrics (AAP) issued a statement that was co-signed by an alphabet soup of leading health organizations. The list consisted of organization such as the U.S. Department of Health and Human Services (HHS), CDC, American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American Heart Association, American Public Health Association (APHA), Infectious Diseases Society of America (IDSA), and National Association of County and City Health Officials (NACCHO). The statement included the following sentences: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.” The statement concluded by saying, “We recommend getting vaccinated right away if you haven’t yet. It is the best way to protect yourself, your loved ones, your community, and to return to a more normal lifestyle safely and quickly.”

In the following Good Morning America segment, Rochelle Walensky, MD, Director of the CDC, emphasized how the benefits of continuing to vaccinate 12 to 17 year olds far outweigh the heart inflammation risks:

Walensky explained that “if we have a group of 12 to 17-year-olds who we're working to vaccinate over the next four months and can vaccinate 1 million of them, which would be great strides, over the next four months we could expect 30 to 40 of these mild self-limited cases of myocarditis. And for that, if we were to vaccinate all 1 million we would avert 8,000 cases of Covid, 200 hospitalizations, 50 ICU stays and one death.”

So, basically don’t consider these changes in the FDA Fact Sheets to be a “sheet out of luck” situation. Myocarditis and pericarditis are still very rare possibilities after Covid-19 vaccination. The chances of getting such conditions from Covid-19 are still much higher if you remain unvaccinated. The FDA and CDC have to show that they are taking all possible side effects of the vaccines very seriously, regardless of how rare they may be. It’s always better to be pro-active and keep such Fact Sheets updated before the “sheets hit the fan” so to speak.

FDA adds warning about risk of rare heart inflammation to Pfizer, Moderna Covid vaccines

CNBC 26 June, 2021 - 08:57am

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.

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I’m no anti-vaxxer but there’s obvious corruption in how mRNA vaccine complications are downplayed compared to other jabs

RT 26 June, 2021 - 07:12am

is a Prague-based American journalist, columnist and political commentator. He has a syndicated column at CGTN and is a freelance reporter for international news agencies including Xinhua News Agency. Follow him on Twitter @BradBlank_

There have been instances like this before with the mRNA vaccines. Whereas blood clotting concerns have been the impetus for some countries to pull the Johnson & Johnson or AstraZeneca vaccines until a safety review could be undertaken, a study by Oxford University published on April 15 suggests that these complications actually have a higher incidence with the Pfizer and Moderna vaccines.

According to the study, the risk of portal vein thrombosis (a blood clot in the liver) appears to be 30 times higher with the mRNA vaccines made by Moderna and Pfizer than with AstraZeneca’s. As well, the risk of cerebral vein thrombosis (a blood clot in the brain) appears to be quite similar with both AstraZeneca (five in a million) and those mRNA vaccines (four in a million).  

This was pretty much ignored in the media and there’s been no public outrage about this. It begs the question in both of these cases, why? There could be many reasons but I think two reasons immediately come to mind that are obviously interlinked. 

First, the Moderna and Pfizer vaccines are the only two for-profit vaccines on the market. The already-massive drug company Pfizer raked in $900 million in the first quarter of this year. Big Pharma is a massive lobby in Washington and is also a huge patron of the news media, so it’s no wonder everyone’s hushing up about any potential dangers from these vaccines.

There’s simply too much at stake for the US and its ultra-wealthy ruling class to make a fuss about these particular vaccines even though they did the same thing with other vaccines that are being sold not-for-profit. 

Second, these vaccines, Pfizer in particular, are the cornerstone of the US-led global vaccination effort that has now pledged 1 billion doses to poor countries. If it were the case that these vaccines were pulled, countries might lose faith in them, pull them and then the US would lose some of the soft power it’s looking for through these donations. 

The US wants to use these vaccines to expand its global influence and prove that “democracy” (neoliberal capitalism) is the best socioeconomic system to spur innovation and provide basic necessities for people, which is clearly doomed to fail since the severity of the Covid-19 pandemic was driven by this system in the first place.

Put simply, the US wants to pull a “come-from-behind” victory on the pandemic and prove that its brand of for-profit medicine can address a global health emergency even though putting profits ahead of people is exactly why millions of people, including over 600,000 Americans, died from Covid-19. At the same time, Moderna and Pfizer are more than happy to lap up profits paid for mainly by Johnny Taxpayer. 

To be perfectly clear, I am not advocating against taking mRNA vaccines. These vaccines are shown to be highly effective against transmission, hospitalization and death, so of course you should take them. Any potential risks are far outweighed by potential complications from actually catching Covid-19, especially as more virulent variants, like the Delta or Gamma variants, become predominant in many parts of the world.

This is no doubt a solid reason why public health experts are not in an uproar about potential dangers from the mRNA vaccines, since they’re the most widely available in the United States and many other countries. This is especially true if you live in a country like the US, where now virtually every Covid-19 death is preventable with vaccination. With governments unlikely to reinstate social distancing measures when variant-driven cases swing up, getting inoculated is crucial to protecting your health. 

However, what I’m trying to say here is that when these arguments are only used to defend for-profit companies’ products, and thus help them profit even more, it reeks of corruption. This corruption becomes even more obvious when media outlets glorify Big Pharma, only to rediscover their critical faculties when they write about vaccines developed in countries like China, Russia, Iran or Cuba, as well as not-for-profit Western-developed vaccines like AstraZeneca or Johnson & Johnson. 

The fact is that the best vaccine is the one you have access to, therefore no vaccine should be getting biased coverage or attention from media outlets or government officials. 

The statements, views and opinions expressed in this column are solely those of the author and do not necessarily represent those of RT.

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The CDC Says 1 in 10 People Who Got Pfizer or Moderna Made This Mistake

Yahoo Lifestyle 26 June, 2021 - 06:44am

Per the CDC, about 88 percent of those who received one dose of the Pfizer or Moderna vaccine have completed their two-dose series as of June 16, according to data shared with CNN. This means that more than 1 in 10 people eligible to do so have not gotten their second shot. This number has grown, as just around 8 percent were missing their second dose as of March.

The New York Times reported that there are various reasons why people have missed their second dose. Some are reportedly nervous for worse side effects associated with the second shot, while others have said they felt protected enough with just the first jab.

According to the CDC, you should get the second dose of Pfizer 21 days after the first and the second dose of Moderna 26 days after the first. "You should get your second shot as close to the recommended three-week or four-week interval as possible," the CDC says. However, the agency also says that "your second dose may be given up to six weeks (42 days) after the first dose, if necessary."

As CNN reports, around 1.5 percent of people who got one shot are still in the "allowable interval" of 42 days, per the CDC. But nearly 11 percent of those eligible have exceeded that deadline. "There is currently limited information on the effectiveness of receiving your second shot earlier than recommended or later than six weeks after the first shot," the CDC explains.

Many experts say that making sure you get two doses is even more important as COVID variants, like the Delta variant, continue to spread. A recent study from Public Health England published June 22 found that Pfizer's vaccine was 88 percent effective against the Delta variant two weeks after the second dose, but only 33 percent effective after just one dose.

"I will say, as worrisome as this Delta strain is with regard to its hyper-transmissibility, our vaccines work," CDC director Rochelle Walensky, MD, said during a June 18 interview on Good Morning America. "So I would encourage all Americans, get your first shot and when you're due for your second, get your second shot and you'll be protected against this Delta variant."

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Travelers will have to upload their vaccination card to Hawaii's Safe Travels website and bring a hard copy.

The policy will be lifted on July 5.

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It's determined largely by vaccines, but also the venue, who's in your party, and the city you live in, experts explain.

The new policy will likely go into effect in phases later this summer.

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