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The covid AstraZeneca vaccine changes its name and becomes Vaxzevria. The drug leaflet, with the new name, appears on the website of Ema, the European pharmaceutical agency with information on side effects and also on the rare “combination of thrombosis and thrombocytopenia”. Very rare effect, but also recorded with the use of vaccines other than AstraZeneca.
The drug, a couple of weeks ago, was temporarily suspended by the EMA after some adverse events were reported. The green light was followed, in several countries, by specific provisions limiting the use of the vaccine to specific age groups. In Italy, the vaccine is also administered to people over 65 years of age.
The new brochure
In the ‘new’ Vaxzevria leaflet it is specified 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 leaflet states that “none of the components of this vaccine can cause the disease. The safety and efficacy of Vaxzevria in children and adolescents (under 18 years of age) have not yet been established. No data available “.
Thrombosis effect
A paragraph is devoted to “Thrombocytopenia and bleeding disorders.” “On very rare occasions a combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed after vaccination with Vaxzevria. This 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 55 years of age. However, this may reflect the increased use of the vaccine in this population. Some cases have had a fatal outcome ”, it reads.
In the document that accompanies the medicine there are some indications for patient, which should warn the doctor, nurse or pharmacist who performs the vaccination in some cases.
- If i had one reaction allergic after another vaccine injection or after the first dose of AstraZeneca serum.
- If it ever is Faint after an injection.
- If you have a major ongoing infection with temperature high above 38 ° C. Those with a fever with lower temperatures or colds can be vaccinated.
- If you have problems with bleeding or training of bruises, or assume a anticoagulant medicine.
- In case of immunodeficiency or therapy that weakens the system immune, such as corticosteroids, immunosuppressants, or anticancer drugs.
Side effects
Regarding ‘possible side effects’, the document published on the EMA website states that “the most frequently reported adverse reactions were:
- injection site sensitivity (63.7%),
- injection site pain (54.2%),
- headache (52.6%),
- tiredness (53.1%),
- myalgia (44.0%),
- malaise (44.2%),
- pyrexia (includes febrile state (33.6%) and fever> 38 ° C (7.9%)),
- chills (31.9%),
- arthralgia (26.4%) and
- nausea (21.9%).
Most of the adverse reactions were serious due to mild to moderate and usually it is resolved within days of vaccination. Compared with the first dose, the adverse reactions reported after the second dose were milder and less frequent. “
Effectiveness and protection
The duration of protection offered by the vaccine “is not known 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 subjects ”.
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