AstraZeneca, what does Vaxzevria mean? The new brochure, the serious effects and the countries that reject it



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Perhaps many have thought of a particular strategy of AstraZeneca to change your name vaccine. It may be because that name, AstraZeneca, for many now creates uncertainty, if not fear, after thromboembolic cases (very rare but true) or even deaths after vaccination with Anglo-Swedish serum. “They have changed their name to get rid of the doubts,” someone thought, and there are many who have declined the invitation of their doctor to undergo vaccination with AstraZeneca.

AstraZeneca, Germany suspends the use of the vaccine for those under 60. The company changes its name (Vaxzevria) and brochure

But there is nothing obscure behind the vaccine name change, now officially renamed “VaxzevriaHowever, a name not very easy to pronounce. The explanation given by the manufacturer leaves no room for doubt and seems absolutely credible. “It is common to name a new drug. And it is a process that is carried out separately from the regulatory and regulatory approval of the drug itself – said AstraZeneca – The acronym “Covid-19 vaccine AstraZeneca” was not the name of the drug. Now it has a name that has been registered as a practice. ‘


THE NEW WARNINGS

Obviously, the change does not stop only in the name, approved by the EMA on March 25 at the request of the Anglo-Swedish pharmaceutical group. But the leaflet is also new and contains additional warnings and information on side effects and also the rare combination of thrombosis and thrombocytopenia. In fact, a special paragraph was dedicated to “Thrombocytopenia and bleeding disorders.”

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«Very rarely a combination of thrombosis and thrombocytopenia has been observed – read the package insert – in some cases accompanied by bleeding, after vaccination with Vaxzevria. This includes severe cases presenting as thrombosis venous, including unusual sites such as cerebral venous sinus thrombosis, mesenteric vein thrombosis, and arterial thrombosis, concomitant with thrombocytopenia. Most of these cases occurred within the first seven to fourteen days after vaccination and occurred in women under 55 years of age. However, this may reflect the increased use of the vaccine in this population. Some cases have been fatal». «Health professionals – the text continues – should pay attention to the signs and symptoms of thromboembolism and / or thrombocytopenia. Vaccinated persons should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain after vaccination. Also, anyone who experiences neurological symptoms, such as a severe or persistent headache or blurred vision after vaccination or bruising (petechiae) in a place other than vaccination after a few days, should see a doctor immediately.“The package insert states that” none of the components of this vaccine can cause disease. The safety and efficacy of Vaxzevria in children and adolescents (under 18 years of age) have not yet been established. No data available “.

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WHY LIE

In short, now there is total clarity, and perhaps the new triptych and less “triptych” than the previous one. And yes, because from this aspect the Bugiardino name derives, which has distant roots. Perhaps not everyone knows why the drug insert is called that. There is no doubt that this name wants to focus attention on the prerogatives of certain “instructions for use” that in the past tended to overlook the defects and unwanted effects of the drug to improve its merits and efficacy. Therefore, those that could be read were not real “lies”, but as a whole the brochure was a “pamphlet” that told little lies or, better, it omitted information that was important but could compromise the product. In recent years, thanks to legislative restrictions that have imposed stricter rules for the collection of prospectuses and also thanks to the greater attention of consumers in taking drugs, perhaps we have gotten to get all the important news about the drug. This is exactly what has happened now with the AstraZeneca vaccine.

DOSE AND DURATION OF PROTECTION

In the brochure of the “new” Vaxzevria yes It also specifies that the vaccination cycle consists of two separate doses of 0.5 ml each. The second dose should be given 4 to 12 weeks (28 to 84 days) after the first dose. No data are available on the interchangeability of Vaxzevria with other vaccines. Subjects who received the first dose of Vaxzevria must receive the second dose of Vaxzevria to complete the vaccination cycle. The drug is administered to adults over 18 years of age and stimulates the body’s natural defenses (the immune system) to produce antibodies and specialized white blood cells that act against the virus, thus providing protection against Covid-19. The duration of protection offered by the vaccine is unknown, as it is still being determined by ongoing clinical trials. Protection begins approximately 3 weeks after the first dose of Vaxzevria. People may not be fully protected for up to 15 days after the second dose is given. As with all vaccines, vaccination with Vaxzevria may not protect all vaccinated people.».

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THE SIDE EFFECTS

As for the “possible side effects”, in the document published on the EMA website it is observed that «The most frequently reported adverse reactions were injection site pain (63.7%), injection site pain (54.2%), headache (52.6%), fatigue (53, 1%), myalgia (44.0%), malaise (44.2%), pyrexia (includes fever (33.6%) and fever> 38 ° C (7.9%)), chills (31.9 %), arthralgias (26.4%) and nausea (21.9%). Most adverse reactions were mild to moderate in severity and generally resolved within a few days of vaccination. Compared with the first dose, the adverse reactions reported after the second dose were milder and less frequent.». Most adverse reactions were mild to moderate in severity and generally resolved within a few days of vaccination. Compared with the first dose, the adverse reactions reported after the second dose were milder and less frequent. Below is a summary table of adverse reactions to the vaccine: those indicated as very common are headache, nausea, myalgias, antralgias, fatigue, fever, chills, pain and itching at the injection site; the most common are vomiting, diarrhea, fever of 38 ° and higher, erythema where the injection was given.

COUNTRIES THAT HAVE LIMITED IT

After the Paul Ehrlich Institut announced that in Germany, to date, there were 31 cases of cerebral thrombosis after the injection with the Oxford house serum, before the Land of Berlin decided to stop vaccines with AstraZeneca for women under 60 years of age; then, after several consultations, the Stiko (German Standing Vaccine Commission) decided by majority to recommend immunization with AstraZeneca only to people under 60 years of age. Angela Merkel justifies the change of new line for the administration of Astrazeneca, stating that this helps ensure confidence in Covid vaccines. “Confidence arises from the awareness that every suspicion, every case is taken into account,” said the chancellor after meeting with the prime ministers of the 16 federal states. “When it is my turn, I will also get vaccinated with AstraZeneca.”

And the British Government of Boris Johnson responds to German decision and it still being “100% confidence in efficacy” of the vaccine developed by the University of Oxford and manufactured by AstraZeneca. The Minister of Local Communities, Robert Jenrick, ruled out the need for a new review of the antidote as a consequence of the limitation imposed by Germany, excluding the use for children under 60 years, after rare cases of thrombosis whose cause-effect relationship is maintained. determined. «Our confidence – said Boris Johnson’s minister – has been corroborated study after study, including by recent research such as that of Public Health England that shows how the lives of thousands of people have been saved thanks to our vaccination program. Therefore, people must keep moving forward to get vaccinated under the UK dosing schedule, as the vaccine is safe and its distribution in the UK is saving many people’s lives every day. “

But in the meantime, Canada has been added to the list of countries that limit the use of the AtraZeneca vaccine, or rather Vaxzevria: discontinued administration for persons under 55 years of age following the recommendations for safety reasons of the National Advisory Committee on Immunization. “There is substantial uncertainty about the benefits of giving Astrazeneca to adults under 55 given the potential risks,” said Shelley Deeks, vice chair of the commission. Deeks recalled that the patients in Europe who developed the rare cases of blood clots were women under the age of 55 and the death rate among those who developed these clots is 40%. The Canadian health authorities have specified that they have not received any news of this type of side effects in Canada.

Vaccini Lazio, from April 1 reservations for over 66 and 67 years: how to do it and at what time

New increase in coronavirus infections in Japan, in the main urban centers but also in rural areas of the archipelago, a week after the end of the state of emergency. As of April 12, we will proceed with the immunization of citizens over 65 years of age, some 34 million people, and later patients with serious clinical pathologies. However, currently only the Pfizer vaccine has received the green light from the Ministry of Health, while Moderna and AstraZeneca are still awaiting approval. The minister in charge of the national vaccination plan, Taro Kono, foresees an acceleration in the administration of vaccines in May with the authorization of the AstraZeneca antidote. Unlike Pfizer, Kono explained, the 120 million doses
purchased will be produced in Japan, which will facilitate their distribution.



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