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Pfizer COVID Vaccine Safety Varies from Lot to Lot



By all accounts, Lauren Morgan Tweedale had a bubbly character. She was outgoing, beloved to sing karaoke, and to go to the gymnasium together with her buddies. Forty-seven years previous, Tweedale was additionally trim and wholesome. So it was an enormous shock to her household and mates when final 12 months, on the morning of April 6th, 2021, she was discovered unresponsive in her mattress.

The medical doctors informed the household that Tweedale died of a sudden cardiac event. Nonetheless, simply eight days earlier than she died, Tweedale had gotten her first dose of the Pfizer mRNA vaccine towards COVID-19.

“Like a well-oiled machine,” she posted privately on Fb, tagging the Oregon Conference Heart in Portland. “Nicely done, team!” The Epoch Instances additionally verified her vaccination card.

So far, properly over 300 million doses of the Pfizer vaccine have been administered in the US, in keeping with Statista.com. Whereas tens of millions of individuals have had these vaccines with solely short-term, gentle, and even no unintended effects in any respect, 1,255,353 reports of adversarial occasions have been regarding sufficient to be submitted to the American authorities’s information assortment system, as of April 29, and no less than 300,000 of those reactions look like extreme.

Tweedale’s sudden demise, together with 27,757 different deaths which are temporally related to the COVID vaccines, has additionally been reported to the Vaccine Adverse Events Reporting System. 

“The vaccine killed my wife’s best friend. She was the maid of honor at our wedding,” insisted Dan McDunn, a contractor, mountain bike coach, and father of three, when he spoke to The Epoch Instances. “This was not some random cardiac event.”

A Flurry of Sudden Deaths

Within the months after Tweedale died, McDunn and his spouse, Sabra, a registered nurse, began researching vaccine security.

But it surely wasn’t simply their finest buddy’s demise that had them so involved. In addition they turned conscious of what McDunn referred to as a “flurry of sudden deaths” amongst their mates.

One other dad McDunn is aware of, 39, bought up in the course of the night time to feed his new child and collapsed. Then his enterprise coach’s finest buddy additionally died, as did his eighth-grade crush’s husband, in addition to 4 highschool college students from his son’s college.

There isn’t a technique to know for sure if any of those sudden deaths are related to the COVID vaccines. However, McDunn mentioned, these deaths catapulted him into digging deeper to seek out out what occurred to Tweedale.

Not A Causal Relationship

The Vaccine Opposed Occasions Reporting System, VAERS, depends on medical professionals and the overall inhabitants to report their private experiences with vaccine unintended effects.

Earlier than getting access to it, customers are required to learn and comply with the CDC’s disclaimer: VAERS uncooked information doesn’t suggest or show a causal affiliation.

In different phrases, correlation doesn’t imply causation—a mantra that’s usually repeated by scientists and statisticians alike. Simply because two issues correlate to one another—say 5 folks named Jason who all drive the identical model of Hondas—doesn’t imply that one factor causes the opposite.

On the identical time, correlating information, particularly well being information, might help researchers suss out potential questions of safety with any given medicine or vaccine. 

In accordance with the CDC’s website: 

“VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.” [our emphasis.]

EN6201

Once you search each nationwide and worldwide databases, you rapidly see that almost all vaccine tons have possibly one or two adversarial occasions related to them. Normally these adversarial occasions are gentle: an upset abdomen or sore shoulder could also be reported, for instance.

Not so with Pfizer’s EN6201, the lot that Tweedale was given. When McDunn first beginning wanting into it, in early January, he discovered that the lot variety of Tweedale’s vaccine was related to 90 deaths in the US.

Since then, that quantity has grown. As of Could 9, 2022, when The Epoch Instances accessed it, Pfizer’s EN6201 was linked to 167 deaths and three,349 adversarial occasions. Once we performed a search a unique means, we discovered a good increased variety of deaths and unintended effects.

McDunn believes a single lot quantity related to practically 170 deaths ought to be trigger for concern. On the identical time, statistically talking, we would wish to know what number of doses of that lot have been given. 

“You would need to know the size of each COVID vaccine lot to make a meaningful reactivity comparison between lots, but the size of lots is not publicly available,” identified Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, a non-profit group established in 1982 to advertise vaccine security by means of public training.


Fisher, who has been a vaccine security advocate for 40 years, informed The Epoch Instances that she is most involved about the truth that out of some 2,125,000 adversarial occasion studies filed with VAERS for all vaccines given to kids and adults since 1990, COVID-19 vaccines have generated over 1,255,000 of these studies, with about 730,000 associated to the Pfizer/BioNTech mRNA COVID vaccine.

“These are astonishing statistics and they confirm that the new COVID vaccines are highly reactive, regardless of how many VAERS reports are connected to different lots,” Loe wrote in an e mail. 

Pfizer, nonetheless, doesn’t consider there are questions of safety with their vaccine. 

“Regulatory authorities around the world have authorized the Pfizer-BioNTech COVID-19 vaccine and expert medical committees have and continue to review the data and recommended it,” Pfizer Media Relations wrote in a press release to The Epoch Instances.


“Every dose of the vaccine is manufactured under the strictest of control measures to ensure consistent identity, quality, purity and potency for optimal patient safety and efficacy. With more than one billion doses of the vaccine administered around the world, the safety profile for the vaccine for all authorized groups continues to be favorable.”

Vaccine Sizzling Lots

Vaccines are mass produced in batches. Every batch is labeled with so much quantity.

Generally, due to issues with the lot some batches of vaccines provoke extra reactions and extreme unintended effects than different batches. These points can happen throughout manufacturing, security inspection, and delivery and dealing with. 

Issues could embody contamination, inconsistent ingredient proportions, and insufficient temperature management throughout transportation. 

When issues like these have an effect on a batch of vaccines, they’re also known as “hot lots.”

Vaccine Lots Recalled 

In 2013, the pharmaceutical big Merck introduced a recall of 1 lot of its vaccine, Gardasil (developed to guard towards human papillomavirus) after the lot quantity— J007354—was discovered to include particles of glass.

Over 743,000 vials of that HPV vaccine, that had been distributed to services throughout the US between August 20, 2013 and October 9, 2013, had been recalled, as reported by CBS News.

That very same 12 months a study published in the peer-reviewed journal Pediatrics, discovered that security issues/unintended effects was one of many predominant causes mother and father selected to not give their kids this vaccine.

Different lot remembers embody a 2007-2008 recall of a number of numerous a Haemophilus influenzae sort b (Hib) vaccine and a hib/hepatitis B vaccine made by Merck after routine testing confirmed a attainable subject with sterility; in addition to a 2012 recall of roughly 39,000 doses of a measles, mumps, and rubella vaccine lot (Lot 0851AA of M-M-R II) that was shipped with out enough inner inspection.

Extra not too long ago, after discovering a vial to be contaminated with a “foreign body,” Moderna and ROVI Pharma Industrial Companies announced a recall of 764,900 doses of its European COVID-19 vaccine, Spikevax.

These had been distributed in Norway, Poland, Portugal, Spain and Sweden on January 13 and 14 of this 12 months. The recall of lot #000190A was introduced on April 8, 2022. 

Entire Cell Pertussis Vaccine Sizzling Lots Led to a Safer Vaccine

Up to now, figuring out issues with scorching tons have helped producers develop safer vaccines.

As Harris L. Coulter and Barbara Loe Fisher described of their 1991 book, “A Shot in the Dark: Why the P in the DPT vaccination may be hazardous to your child’s health,” the entire cell pertussis vaccine, which was really useful by the CDC for infants till 1996, was related to scorching tons that contained increased quantities of bioactive pertussis toxin and endotoxin. 

A clustering of 11 SIDS-diagnosed deaths in infants in Tennessee who had not too long ago obtained DPT vaccines in 1977 and 1978 caught the eye of the general public. 9 of the 11 infants had gotten DPT vaccine from the identical Wyeth lot. Statistical analyses revealed that the percentages of their DPT-associated deaths being a “coincidence” had been extraordinarily low. 

Wyeth withdrew the DPT lot in query from the market.

On the identical time, the corporate additionally stopped future delivery of vaccines from a single lot to the identical geographical location. Dad and mom of vaccine-injured kids felt Wyeth did this to make it harder to establish and hint scorching tons.

Fisher informed The Epoch instances that, like with COVID-19 vaccines, the place of vaccine producers and public well being officers on the time was that the DPT vaccines had been “safe and effective.” In actual fact, well being authorities dismissed the intense accidents and deaths kids skilled after vaccination as unrelated.

Nonetheless, largely due to newspaper articles and investigative reporters highlighting mother and father’ ongoing security issues, the entire cell vaccine was changed with a purified much less reactive acellular pertussis vaccine.

That is the DTaP vaccine (to guard towards diphtheria, tetanus, and pertussis) that the CDC currently recommends for infants at 2 months, 4 months, and 6 months of age, after which once more for toddlers between 15 and 18 months of age, and for college kids between 4 and 6 years.

After the change from a complete cell vaccine to an acellular vaccine, the new lot subject disappeared. 

Inconsistent Vials

Whereas scorching tons are an issue, scientists have additionally discovered that particular person vaccine vials generally have inconsistencies that may compromise each security and efficacy.

A July 2021 study, performed by a group of British scientists led by Christopher Exley, Ph.D., previously of Keele College, examined the aluminum content material in 13 completely different childhood vaccines.

They discovered that six of the vaccines contained considerably increased quantities of aluminum than the producer claimed, and 4 of the vaccines contained considerably smaller quantities. In actual fact, the examine confirmed, solely three of the 13 vaccines contained an quantity of aluminum inside 10 % of the producers’ listed contents.

Since there could also be variation from vial to vial, a group of Maryland-based scientists really useful that particular person vials should be investigated within the occasion of unhealthy outcomes. Writing within the peer-reviewed journal Vaccine, they explained: “All vials are not the same: Potential role of vaccine quality in vaccine adverse reactions. We suggest taking the quality of individual vaccine vials into account in an adverse reaction investigation, i.e., a serious adverse reaction, anaphylaxis or other types, might be caused by one defective vial out of many good-quality vials.” 

Barbara Loe Fisher, the vaccine security advocate, thinks it’s crucial that we examine the potential of COVID vaccine scorching tons and different questions of safety.

Based mostly on medical trials, “the majority of adults and children who get the COVID vaccine experience some kind of reaction, and many of those reactions at least temporarily interfere with normal activity,” she informed The Epoch Instances. “Other more serious reactions lead to chronic heart, brain, immune system and other disorders, or end in death.”

The McDunns are actually caring for Lauren Morgan Tweedale’s orphaned 16-year-old daughter, together with their very own three sons. 

“It requires some connection to a bad injury or a death in order to be willing to admit there’s a problem,” McDunn, whose spouse has determined to not get any extra COVID-19 vaccines, mentioned. 

“And even when people have a close contact with an injury or death, they’re still not connecting the dots. I don’t know why. I don’t know how the public health system has done such a wonderful job of demonizing people who are sounding the alarm, either,” McDunn added. “It’s incredible.”

How you can Search Vaccine Lot Numbers on VAERS

  1. Go to surprise.cdc.gov
  2. Click on on A-Z Index after which “V”
  3. Click on on Vaccine Opposed Occasions Reporting
  4. Comply with the Disclaimer
  5. Choose VAERS information search
  6. Scroll right down to merchandise 3
  7. Enter lot # in “Vaccine lot,” a discipline on the righthand aspect of merchandise 3
  8. Press Enter
  9. A desk will seem with an entire record of adversarial occasions related to the vaccine lot quantity

 

Views expressed on this article are the opinions of the creator and don’t essentially replicate the views of The Epoch Instances.



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