EMA (European Medicines Agency) clears Astra-Oxford Vaccine
"The problems that have arisen in Austria in individuals after receiving AstraZeneca's corona vaccine were not caused by that vaccine"
-conclusion of European regulator for vaccines and medicines, EMA.
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"A 49-year-old woman in Austria died of severe blood clotting. Ten days earlier she had received the corona vaccine from AstraZeneca. A 35-year-old woman developed a pulmonary embolism from which she is now recovering"
"There were 2 more similar incidents. According to the EMA, this is not exceptional, it corresponds to the number of incidents among the general population. In Europe, 3 million people have been vaccinated with AstraZeneca, and 22 of them have had thrombosis or embolism"
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In summary, these were examples of AEFI (adverse effect following immunization) that were investigated by protocol and found to be negative.
In other words, the vaccine was not the cause of the events.
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The exact cause of these deaths is not known. But when events like this occur in someone who received vaccine, it gets the attention of the world.
Young deaths (non violent) occur from many reasons.
e.g. undetected cardiac illness, cerebral aneurysms, liver disease (see pic)
Italy is going through a COVID-19 surge now, which is bigger than April 2020. Silent or undiagnosed infections could result in deaths from vascular thrombosis that could be interpreted as sudden unexplained deaths. Such events occur even after recovery.
UK study shows GM-CSF is elevated early in those who will go on to get severe COVID-19. Other markers such as IL-2, IL-6 & D-Dimer also predict a severe course.
GM-CSF recruits monocytes and neutrophils into lungs, causing inflammation and damage.
The authors report that GM-CSF elevation is a feature of fatal COVID-19 (elevated 9.7 times), compared to fatal influenza (elevated only 1.4 times).
Older people and those with heart disease or diabetes had such elevations, but these conditions also correlate with age.
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Interpreting such findings is not easy and is prone to error. Immunology involves the simultaneous and sequential action of numerous players, many of whom have a positive and negative feedback role.
The GM-CSF is part of a chain of events in a dysregulated immune response.
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“The National Board of Health Denmark is now awaiting the EU drug authorities to investigate the possible connection between the COVID-19 vaccine from AstraZeneca and the serious cases of blood clots that have been reported”
“In six other European countries, the use of a specific batch of the AstraZeneca vaccine has currently been suspended pending investigations.
Unit Manager Tanja Erichsen encourages you to take it easy if you have been vaccinated with AstraZeneca's vaccine”
"I understand well if you are worried, but you must keep in mind that no connection has yet been established between the vaccines from AstraZeneca and the cases of blood clots. That is what we now want to investigate”
When an event occurs “following” vaccination it simply means it occurred in the days following the injection. It takes time for experts to investigate each event and determine the exact cause. The general public (& many healthcare professionals) do not know the difference.
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Deaths and illnesses occur in any population due to background rates.
But declaring that “AEFI occurred” unfortunately implies otherwise. Discretion must be followed while discussing this topic.
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Higher antibody level does not mean greater ability to neutralize the virus. This Italian paper finds that the strongest neutralization activity was shown by a patient who had the lowest antibody level detected by conventional serology assays.
Some basics:
Neutralization is the ability of the antibodies to inhibit growth of the virus. This is measured by looking at virus growth in lab cells, while bathed with serum containing antibodies - typically from those who are either recovered (convalescent) or vaccinated.
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Antibody titer, on the other hand, is measured by commercially available assays such as ELISA or CLIA .
Low levels might be marked as negative if below the detection limit of the assay. Manufacturer's claim of accuracy for these is often higher than real-life experience.
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Various antibody 'kits' check for different antibodies. Some vaccines only produce anti spike antibodies: kits that are designed for N antibodies will show a negative result. Besides, some kits may not pick up low levels of antibodies. Quality variation in kits is an issue.
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Is there s difference in antibodies generated by natural infection and vaccine?
Natural infection produces a wide range of antibodies, of whom kits check mostly N type. Vaccines of mRNA or adenovirus vector type generate only Spike antibodies.
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