THE US Food and Drug Administration (FDA), quick to approve an experimental and untested Covid-19 ‘vaccine’, is now stalling over approval of a new device that could save the lives of people who go into anaphylactic shock.
Anaphylactic shock, or anaphylaxis, is an extreme immune system reaction to an allergy which leads to a massive release of chemicals around the body, principally histamine, in an effort to deal with an allergen. This reaction of the body is, in fact, an overreaction and the response leads to difficulties with breathing and sudden and dramatic drop in blood pressure (shock). If untreated it can be fatal.
One of the first lines of treatment for anaphylaxis is an EpiPen which can be carried by those who know they have allergies. It is a device containing the drug noradrenaline (called norepinephrine in the US) that counteracts the shock induced by anaphylaxis. However, an EpiPen requires the injection of noradrenaline intramuscularly. This is invasive and if the person is unable to administer the drug others can be reluctant, either not knowing how to use the device or being afraid to. Also, the drug has to get from the musculature to the bloodstream to be effective. This can take five to ten minutes during which time the person may die.
How much better if noradrenaline could be administered more directly into the bloodstream. Manufacturing a device to do this intravenously, far less expecting anyone other than a medic, nurse or paramedic to have the expertise to do this in an emergency, is a tall order. But drugs can be administered rapidly into the bloodstream nasally and a company, ARS Pharmaceuticals, has developed an injection-free device for administering noradrenaline nasally in the form of an epinephrine nasal spray.
What’s not to like, you may think. Well, the FDA don’t like it and have withheld approval pending further testing. The FDA objections are based on the need for further clinical data in people with anaphylaxis due to the fear that it may fail to work.
It is, surely, heartening that the FDA has the best interests of potential anaphylaxis sufferers at heart. If only they had had the same concern on 2021 when they approved the Pfizer Covid-19 vaccines. It has been exposed in these pages from the start of the Covid-19 vaccine rollout that these were ‘experimental’ medications and had not been tested adequately before approval. Well, they have been tested now and the outcome is clear: they were completely unnecessary; they do not work; and they are extremely dangerous leading to injury and death. They undoubtedly have played a large part in the level of excess deaths observed in recent years.
According to UK government figures, the overall fatality rate from Covid-19 (always a disputed figure due to the difficulty in distinguishing ‘with Covid’ from ‘from Covid’) is 0.1 per cent. The estimated fatality rate from anaphylaxis – made uncertain by the fact that many suspected cases are dead before being found – is between 0.7 and 2 per cent. Recent England hospital Covid-19 admissions are approximately 3,000 per month at the latest available figures. The annual rate of hospitalisation in England for anaphylaxis in 2022-23 was 26,000; at approximately 2,000 monthly, the same order of magnitude as the Covid-19 admissions.
Bearing in mind that it is not easy to distinguish Covid-19 from other respiratory infections but that anaphylaxis is unmistakable and more fatal and, assuming a similar situation in the US, the recent FDA decision regarding nasally administered noradrenaline for anaphylaxis in the light of their unseemly haste over Covid-19 vaccinations is hard to understand. Could political and financial pressured be involved? Surely not!