Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination

Dear Editor
Most but not all investigators are, I trust, honorable .
But I suggest that the English system of Coroner’s Inquest is worth utilising in every case when anyone suspects Covid was involved. Inquest . Not just “ Coroner’s Certificate without inquest”.

Dear Editor:

The FDA's recent response to BMJ Associate Editor Peter Doshi's questions [1] seems to show an awful lot of contradictions surrounding reported serious adverse events following Covid vaccination, as well as a curious lack of accountability.

In their response, they repeat the caveat that has become something of a mantra, "the VAERS system is not designed to determine causality of adverse events.” But then they state, "A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.” That would seem to imply that causality was ruled out -- by a system that was not actually set up to do that.

Of particular concern is the admission that the families of those who died were never asked for more information by the CDC, FDA, or VAERS staff. [1]

If the reaction under scrutiny involves clotting dysfunction, then personal and family medical history are crucial pieces of the puzzle. Did the women in question have a history of smoking, or of oral or implanted contraceptive use? Did they have family histories of clotting dysfunction, or of early strokes? What about vitamin D deficiency, which is, surprisingly, also associated with clotting disorders? [2]

People with such histories are certainly at increased risk of clots -- especially women on birth control pills —but are they also at increased risk of clots and/or clotting dysfunction specifically induced by Covid-19 vaccines? If this is a possibility, shouldn’t screenings and warnings be instituted?

While news reports focus solely on 6 deaths from an unusual combination of symptoms (clot + thrombocytopenia) following Johnson & Johnson's vaccine, VAERS holds upwards of 640 reports of serious clotting dysfunction events following Covid-19 vaccination -- and most of these reported adverse events followed Pfizer's and Moderna's vaccines.[3] [4] [5] [6] [7] (all links to VAERS reports)

The CDC states, "If scientists find a connection between a safety issue and a vaccine, FDA and the vaccine manufacturer will work toward an appropriate solution to address the specific safety concern." [8]. But who decides the criteria for a connection, and who decides what constitutes an appropriate solution?

If a public health initiative from a $14-billion partnership between industry and government [9] were to cause a safety issue, should those same partners be trusted to both identify the problem and decide its remedy?

1. https://www.bmj.com/content/372/bmj.n149/rapid-responses
2. Mohammed S. Mishra A, Ashraf MZ Emerging Role of Vitamin D and its Associated Molecules in Pathways Related to Pathogenesis of Thrombosis. Biomolecules. 2019;9(11):649. Published 2019 Oct 24. doi:10.3390/biom9110649

3. https://tinyurl.com/thrombosis-after-covid-shot
4. https://tinyurl.com/cerebrovascular-accidents
5. https://tinyurl.com/ischemia-after-covid-jab
6. https://tinyurl.com/there-are-even-more
7. https://tinyurl.com/thrombocytopenia
8. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vacc...
9. https://energycommerce.house.gov/newsroom/press-releases/pallone-on-comm...

Dear Editor

As the rollout of covid-19 vaccines continues, trustworthy and reliable pharmacovigilance systems are vital. In the 2009-2010 “swine flu” epidemic, initial concerns over febrile convulsions in young children[1] and narcolepsy in adolescents[2] following pandemic influenza vaccine receipt emerged from pharmacovigilance systems. And in the current covid-19 pandemic, reports of anaphylaxis,[3] blood clots,[4] and deaths[5] have all triggered regulatory investigations.

In the United States, the CDC and FDA jointly administer the Vaccine Adverse Event Reporting System (VAERS),[6] similar to the UK Yellow Card system. Unlike Yellow Card releases reports, the VAERS database is directly query-able, and allows access to the user-submitted adverse event narratives.[7]

The CDC webpage on "Selected Adverse Events Reported after COVID-19 Vaccination” currently discusses two types of adverse events: anaphylaxis and reports of death. Regarding deaths, the website states "CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.”[8]

I requested further details from FDA and CDC to better understand the process by which pharmacovigilance staff review VAERS reports, specifically of deaths post covid-19 vaccines. In the interest of readers, I share my questions - and FDA’s responses, sent March 23 - in full below.

Question 1. How many full-time equivalents (and what kind of e.g. physicians and pharmacists or physicians only?) CDC/FDA staff are assigned to reviewing case reports of deaths following covid-19 vaccines, that are submitted to VAERS?

FDA RESPONSE: Because both agencies draw upon available physicians depending on the number of reports received, we cannot provide a firm number as the number varies greatly based on workload. Both agencies assign an appropriate number of staff to ensure these reports are reviewed thoroughly.

Question 2. In what proportion of cases have CDC/FDA staff contacted families of the deceased for further details about VAERS reports?

FDA RESPONSE: A letter expressing condolences for the death of a family member and an explanation of what VAERS does is sent to all who report on the death of a family member. According to the reporter’s selected Communication Preference an electronic note may be sent. If no preference is specified by the time the letter is generated, a paper letter is sent. Condolence letters are only sent if the reporter is identified by visual review to be a relative.

Because the VAERS system is not designed to determine causality of adverse events, there is not a mechanism to follow-up with families for additional details. The determination of the cause of death is done by the certifying official who completes the death certificate or the pathologist who conducts the autopsy. While some reported adverse events may be caused by vaccination, others are not and may have occurred coincidentally..

Question 3. Are there standards for the proportion of families contacted? If so, what are they, and also how soon after the report is received or the event in question should a family be contacted?

FDA RESPONSE: [[see above]]
The letter/email is sent within a few weeks after receipt of the VAERS report.

Peter Doshi

References

[1] https://www.bmj.com/content/340/bmj.c2991
[2] https://www.bmj.com/content/362/bmj.k3948.full
[3] https://www.bmj.com/content/371/bmj.m4780
[4] https://www.bmj.com/content/373/bmj.n931
[5] https://www.bmj.com/content/372/bmj.n149
[6] https://vaers.hhs.gov/
[7] https://wonder.cdc.gov/vaers.html
[8] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events...

Dear Editor

mRNA vaccine against Covid-19 has been designed to trigger an immune response to one of the surface spike proteins of the virus that enables its entry into human cells. The vaccine induces local inflammatory reactions. Recently, in Norway, 23 fragile vaccinated elders died due to common adverse reactions such as, fever, nausea and diarrhea.

Since human mucosal tissues of the gut are involved in immune response to Covid virus, adverse reactions could be due to dysbiosis of the gut commensals that change with age and personalized nutrition.

The gut microbe composition of individuals with a high intake of protein and animal fat, like the western diet, is generally dominated by a Bacteroides driven enterotype, which is the largest phylum of the gut microbiome community. Some genera of Bacteroidetes stimulate macrophages and monocytes to secrete a complex array of pro-inflammatory cytokines such as IFNγ and TNFα, neurotoxins including surface lipopolysaccharides and toxic proteolytic peptides in the plasma. Secretion of these cytokines and toxins result in aberrant immune responses, involving elevated levels of circulating cytokines and immune-cell hyperactivation, thus contributing to abnormal inflammatory reactions due to cytokine storms.

Therefore, during vaccination, rectifying gut microbiome dysbiosis with prebiotic and probiotic oral supplementation might be a solution for the management of Covid-19 vaccine induced adverse reactions.