Joe Fraiman, an emergency physician based in Louisiana, and lead author of a pivotal study that re-analysed the original mRNA vaccine trials, has recently called for the vaccines to be suspended.
Fraiman made the announcement in an online video that spread like wildfire across social media. I spoke with him recently to find out what troubled him the most about the vaccines.
“Since omicron, the benefits of the vaccine are greatly reduced. I have only admitted one person with covid-19 to the hospital in a year and my colleagues have had similar experiences,” said Fraiman, “So, if we’re giving the vaccine to people to prevent hospitalisations and death, then the impact of the vaccines is fairly insignificant.”
Fraiman joins a growing number of physicians and researchers questioning whether the benefits of the vaccines outweigh the harms.
Last year, Fraiman and his colleagues published their analysis in the journal Vaccine, and found the rate of serious adverse events with the mRNA vaccines was 1 in 800 – far greater than the rate of adverse events seen with traditional vaccines of 1 to 2 per million.
“I think the covid vaccines should be withdrawn,” said Fraiman. “I do not believe it’s wise to continue to administer them to people, until we have evidence that there is net benefit. And if it's only a net benefit in a certain group, then we should only give it to people in that group,” he added.
Soon after Fraiman’s analysis was published in Sept 2022, I spoke with him about a BMJ investigation I was conducting into the FDA’s post-marketing surveillance program.
I told him the FDA had detected a potential increase in four types of serious adverse events in elderly people who’d had Pfizer’s mRNA vaccine, but that the findings had not been announced to the public.
(The four serious adverse events were acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism.)
Fraiman was incredulous that the FDA had been sitting on those safety signals and had not alerted doctors or the public about the potential harms of the vaccines.
“They need to consider a person’s right to informed consent. As physicians, when we recommend medical therapies, we need to explain the full risks and benefits to the patient. This is not happening,” said Fraiman at the time.
Since then, the FDA published its analysis in the journal Vaccine and - of the four serious adverse events it had initially detected - only pulmonary embolism (blood clots in the lungs) continued to meet the agency’s statistical threshold for a signal (rate ratio = 1.54)
“That’s a 54% increase in pulmonary embolism!” remarked Fraiman, “Why haven’t we heard anything about this on the news. If, one year, the flu vaccine caused a 54% increase in pulmonary embolism, that would be on every headline across the world.”
The FDA still has not issued a press release, or notified doctors or changed the product label or consent forms.
Fraiman says the agency is too conflicted – the FDA approves the vaccines and therefore should not be in charge of monitoring vaccine safety.
“It's insane,” says Fraiman. “It’s a major conflict of interest to have the same people who approve the vaccines also in charge of doing safety surveillance on the vaccine they approved. Imagine having to report to the public a serious safety signal when your boss approved and recommended the vaccines in the first place”.
He added, “The safety of the public relies on FDA officials to indict themselves. The system needs to be fixed. We need to have a separate agency that does surveillance. I find it highly problematic.”
Fraiman has also been tracking the data on excess deaths (a measure of how many more deaths occurred than might have been expected) and says he’s seriously concerned.
“I don't see a strong effort by governments to try to figure out why we're seeing excess mortality across many countries,” said Fraiman.
“We're boosting millions of people and we have unexplained excess mortality. That doesn't mean that it's due to the vaccines, it just means that it's possible. And while that possibility exists, we should halt the vaccines and try to figure out the cause. It is irresponsible not to investigate,” he added.
In the UK for example, the BBC reported that excess deaths are at their worst in 50 years. Since the arrival of covid, there have been just over 30,000 excess deaths linked to heart disease, but no definitive studies have fingered the covid vaccines as the cause.
Fraiman points to a German autopsy study that linked sudden cardiac death with the vaccines, and recent CDC data which detected a possible link between Pfizer’s bivalent booster and stroke in people 65 and older.
“It’s becoming harder to ignore. Our study shows evidence of the mRNA vaccines causing serious adverse events, we have evidence that it's causing sudden cardiac death from autopsy studies and now we have surveillance data showing that there’s a 54% increased risk of pulmonary embolism,” said Fraiman.
“I no longer feel comfortable recommending the vaccines to anyone. I would not recommend this vaccine to my children, or to anyone in my family anymore, not even the booster for the elderly. I believe that we're playing with fire, and we don't understand what we're doing…there's too much uncertainty,” he added.
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Great interview Maryanne, you’re a voice of reason and sanity as always. And huge respect to Dr Fraiman for speaking out. His statements are evidence based and to me, highly persuasive
Thanks for the great interview. This is the money quote, "The safety of the public relies on FDA officials to indict themselves. The system needs to be fixed. We need to have a separate agency that does surveillance. I find it highly problematic." Really sums up the problem in a nutshell.