The European Medicines Agency (EMA) again pointed out this Friday that the benefits of the vaccine AstraZeneca against Covid-19 are higher than the risks, after the analysis carried out by the body in relation to blood clots as a rare adverse effect. In addition, he recommended continuing to administer a second dose of the product, called Vaxzevria, between four and twelve weeks after giving the first injection.
“The benefits of Vaxzevria outweigh its risks in adults of all ages,” the agency recalled.
The Hague-based body explained that to help national authorities make decisions about how best to use the vaccine, its committee for human medicines (CHMP) has analyzed available data to analyze the risk of these very rare clots in the context of the benefits of the vaccine for different age groups and different infection scenarios.
“Vaxzevria is effective in preventing hospitalizations, intensive care unit (ICU) admissions and deaths from Covid-19,” the agency stated. The most common side effects are usually mild to moderate and improve within a few days. The most serious effects are very rare cases of unusual blood clots with low platelets, which the body estimated to occur in one in every 100,000 vaccinated people.
The medical committee has evaluated the benefits of the vaccine and the risk of unusual blood clots with low platelets in different age groups in the context of monthly infection rates: low infection scenario (55 per 100,000 people), medium (401 per 100,000 people) and high (886 per 100,000 people).
Conclusion, submits a report to the authorities in which you compare the different scenarios. Data show that the benefits of vaccination increase with age and levels of infection.
At a time of high contagion, the AstraZeneca vaccine causes a very high rate of prevented death cases for people over 80 years of age (733 cases per 100,000 inhabitants) compared to the infrequent affected by clots with low platelets (0.4 cases). Likewise, it shows the effectiveness in reducing infections and hospitalizations.
As the age of the people to whom it is administered is lowered, these benefits versus the risks are lower, but even so, the vaccine continues to be beneficial to avoid hospitalizations and admissions to the ICU in all age ranges due to Covid infection , since the probabilities are greater than that of thrombi.
“There is not enough data from across the EU to provide additional context on the benefits and risks with respect to sex,” the agency acknowledges for now. The benefit-risk balance of the vaccine “remains positive for adults of all age groups,” emphasizes the institution of The Hague.
Regarding the second dose with Vaxzevria, the EMA indicates that there has not been enough exposure and follow-up time to determine if the risk of blood clots with low platelets after a second injection will be different from the risk after the first.