The tests so far prove that, despite the extremely rare cases of blood clot formation, the benefits of AstraZeneca's coronavirus vaccine still outweigh the risks of possible side effects, the European Medicines Agency (EMA) announced on Friday.
The Amsterdam-based agency, which plays the role of the European Union's drug supervisory authority, highlighted in its statement presenting the partial results of the ongoing investigation of the vaccine named Vaxzevria: the vaccine of the British-Swedish pharmaceutical manufacturer and the University of Oxford is an effective antidote against the coronavirus.
The benefits of Vaxzevria outweigh the risks for all age groups. The risk of possible side effects of the vaccine does not increase with age.
According to the available data, the vaccine is at least 80 percent effective, they said.
The EMA is conducting an extraordinary investigation because at the beginning of March and since then, several countries have announced that they will temporarily suspend the use of AstraZeneca's vaccine as a precaution, after several cases of blood clots forming in the bodies of those vaccinated were reported. Some countries have since lifted the restriction, while others have strengthened it.
In its announcement, the EU agency highlighted: the disease associated with the formation of blood clots, which is related to the low number of platelets, has occurred in some cases, at a very low rate so far, among those vaccinated with AstraZeneca's product.
According to estimates, such a side effect may occur in at most one case out of 100,000 vaccinated.
Those who notice symptoms should see a doctor immediately, they underlined.
They also said that the risk assessment committee still recommends that a booster shot of the vaccine be given between 4 and 12 weeks after the first dose.
The evaluation confirms that AstraZeneca's vaccine is safe and can effectively prevent the disease caused by the coronavirus, reducing the risk of hospitalization and death, they added.
The European Medicines Agency decided at the beginning of April that in the case of the Vaxzevria vaccine, the possible risk of blood clot formation should be listed as a "very rare side effect" of the vaccine.
The EU Medicines Agency is conducting an investigation into cases of blood clot formation and potential side effects of all vaccines approved for use in the EU so far, including vaccines from Pfizer/BioNtech, Moderna and Johnson & Johnson.
The EMA also informed that on Friday it adopted a recommendation to expand the production capacity of BioNTech and Pfizer and Moderna's vaccines against the coronavirus.
The decision allows Pfizer to step up the production process of its Comirnaty product developed jointly with biotech company BioNTech at its plant in Puurs, Belgium.
For Moderna's coronavirus vaccine, the EMA has recommended approval for the use of a new filling line at the company's site in Rovi, Spain. The commissioning of the new production line makes it possible to increase the production process of the preparation, they wrote.
The aim of expanding production processes is to increase production capacity and the supply of vaccines on the European Union market, they said.
Source and photo: MTI
