Astrazeneca vaccine: novelty, efficacy and warnings of Vaxzevria
The Astrazeneca vaccine changes its name and contraindications. Here is the new vaccine leaflet now called Vaxzevria
Change the identity card of Astrazeneca's Covid-19 vaccine.
The drug, first baptized with the generic name "Covid-19 AstraZeneca vaccine", will be called "Vaxzevria" and can lead, as adverse reactions, to thrombosis and thrombocytopenia. All the details.
THE CHANGE OF NAME
Let's start with the name. The medication anti-Covid 19 Astrazeneca is called Vaxzevria. The name change was approved by the European Medicines Agency on 25 March following a request from the Anglo-Swedish pharmaceutical group.
CONTRAINDICATIONS
The part of the contraindications also changes. The new leaflet , under the title "Special warnings and precautions for use", states that the drug can cause "thrombosis and thrombocytopenia, in some cases accompanied by bleeding".
“This – adds the EMA – includes severe cases presenting as venous thrombosis, 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 the age of 55. However, this may reflect the increased use of the vaccine in this population. Some cases have had a fatal outcome ”.
DIRECTIONS TO DOCTORS
And this is what the EMA recommends to "health professionals" to "pay attention to the signs and symptoms of thromboembolism and / or thrombocytopenia. Vaccinated individuals 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. In addition, anyone who experiences neurological symptoms including severe or persistent headache or blurred vision after vaccination or bruising (petechiae) in a site other than that of vaccination after a few days, should immediately consult a doctor.
EFFECTIVENESS
The effectiveness of the drug always remains below the 60% threshold. The vaccine is 59.5% effective, based on "a pooled analysis of two ongoing randomized, blinded, controlled clinical trials: a Phase II / III study, COV002, in adults aged ≥18. years (including the elderly) in the UK, and a phase III study, COV003, in adults aged ≥18 years (including the elderly) in Brazil ”.
GERMANY BANS VACCINE TO UNDER 60
News on the Astrazeneca front also comes from Germany.
Berlin, writes Repubblica , has banned the administration of the drug to anyone under 60 years old. The decision, made by the independent panel of vaccine experts Stiko, came after the Robert Koch-Institut announced that 31 cases (out of approximately 2.7 million vaccinated with AstraZeneca) of rare blood thrombi had been recorded as of 29 March. . All cases, except for two, involved women between the ages of 20 and 63.
ASTRAZENECA: SIDE EFFECTS IN LINE WITH OTHER VACCINES
But Astrazeneca, despite the announced data and the news of the leaflet, continues to reassure. “We need to take data and science into account: this is a first important element to restore trust. The other is that more and more people are also getting vaccinated in Italy with AstaZeneca. People will remember being vaccinated and it is important to restore confidence and curb the perhaps somewhat elevated emotionality that has existed in recent weeks ", commented the CEO of Astrazeneca in Italy, Lorenzo Wittum, speaking to webinar organized by the American Chamber of Commerce in Italy.
The drug's side effects "align with the side effects of all vaccines," Wittum added.
EMA: BENEFITS GREATER THAN RISKS
And even the EMA, despite the update of the leaflet, does not change the opinion on the vaccine. "As communicated on March 18, the EMA believes that the benefits in preventing Covid-19, with the associated risk of hospitalization and death, outweigh the risks of side effects," explains the drug agency.
“At present the review did not identify any specific risks such as age, gender or previous episodes of clotting problems for these very rare events. A causal link with the vaccine is not proven but it is possible and further analysis is in progress ”. This is what we read in a note from the EMA which explains that a group of experts gathered on Monday 29 March to provide their contribution to the ongoing evaluation.
EXPERTS AT WORK
The same agency, in these hours, has met the health safety committee to analyze the very rare cases of unusual blood clots associated with a low number of platelets, in people vaccinated with the AstraZeneca Covid-19 vaccine. They are, explains the same agency, independent external experts with a range of medical specialties, including haematologists, neurologists and epidemiologists.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-astrazeneca-novita-efficacia-e-avvertenze/ on Wed, 31 Mar 2021 13:48:00 +0000.