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The European Medicines Agency (ERA) has announced all the side effects of the three vaccines used in Europe.
A public debate took place today on the processes for approval and monitoring of the safety of COVID-19 vaccines in the EU. The online event was organized and hosted by the European Medicines Agency with the assistance of experts from the European Center for Disease Control (ECDC). Members of the team from the Science in the Crisis group participated: Dr. Momchil Baev and Simeon Petrov.
The main topics of discussion were vaccines – already approved and pending approval, their safety and efficacy, monitoring of side effects, review of preliminary data of the widespread use of vaccines in some countries such as Israel, testing of vaccines in children and adaptation of new doses of vaccines against variants of the coronavirus.
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It has been found that so far all approved vaccines have a positive benefit-risk balance, and to a large extent the differences in their efficacy data are due to the criteria and methodologies for conducting different clinical trials.
In terms of safety data and side effects, most of those observed and reported are of moderate to moderate intensity and are temporary.
In some rare cases (1/100 000) serious allergic reactions (anaphylaxis) have been observed and with an even lower frequency of manifestation they are called. thromboembolic events that have been observed in approximately 30 / 10,000,000 vaccinates.
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The Eudra Vigilance system for reporting adverse reactions within the European Union collects information submitted by EU citizens and healthcare professionals. Most of the reported adverse reactions and events are among those already mentioned in the Summary of Product Characteristics (SPC) of available vaccines. Many different institutions and circles, including citizens, are involved in the vaccine safety monitoring process.
From their introduction to date, statistics on vaccines approved by the EU show how many vaccines have been administered and what is the proportion of side effects for each one:
– At 42 million doses COMIRNATY (Pfizer / BioNTech) 94,303 cases of side effects have been reported. These are barely 0.22% side effects of all administered doses.
– At 2.6 million doses Modern Covid Vaccine – 4550. These are just 0.17% side effects of all administered doses.
– At 9.2 million doses ChAdOx1-S (AstraZeneca University / Oxford) – 28 042. These are just 0.3% side effects of all administered doses.
The three vaccines mentioned above were tested by the EAL for thromboembolic events and thrombocytopenia. Established analysis techniques are applied:
– Detailed clinical examination of cases registered by citizens and medical personnel
– Statistical methods for the identification of emergency values and models of the presence of secondary effects in the population.
– Comparison between EXPECTED and OBSERVED events and effects data
EAL is currently conducting an ongoing (ongoing) review of clinical trial data from various manufacturers. The EAL has reviewed the data for the Novavax vaccine since February 3, 2021, for the CureVac vaccine since February 12, and Sputnik V since March 4 of this year.
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