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

BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n149 (Published 15 January 2021) Cite this as: BMJ 2021;372:n149

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Rapid Response:

Accountability and FDA's response to BMJ

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...

Competing interests: No competing interests

23 April 2021
Alison B Fujito
violinist
Pittsburgh Symphony
Pittsburgh, Pennsylvania