European Countries To Resume AstraZeneca Vaccine After EU Regulators Assure Safety
Several European countries have announced that they will resume the AstraZeneca vaccinations after the European Medicines Agency concluded that the anti-COVID vaccine is safe and effective. An extraordinary meeting of the EU medicines regulator on Thursday gave the go-ahead on the continued use of the COVID-19 vaccine.
After concluding its preliminary safety review, EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee, confirmed that the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects.
PRAC made it clear that the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it.
It also clarified that there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.
However, the committee noted that the vaccine may be linked to very rare cases of blood clots due to thrombocytopenia, i.e. low levels of blood platelets with or without bleeding, including rare cases of clots in the vessels draining blood from the brain.
Out of around 20 million people in the UK and EEA who received the vaccine, EMA had reviewed only 7 cases of blood clots in multiple blood vessels and 18 cases of CVST.
The number of thromboembolic events reported after vaccination was lower than that expected in the general population. This allows the PRAC to confirm that there is no increase in overall risk of blood clots. However, in younger patients there remain some concerns, related in particular to these rare cases, EMA said in a statement.
The EMA added that they could not rule out definitively a link between the vaccine and a “small number of cases of rare and unusual but very serious clotting disorders”.
“This is a safe and effective vaccine. Its benefits in protecting people from Covid-19 with the associated risks of death and hospitalization outweigh the possible risks,” Emer Cooke, the agency’s executive director, said at a news conference.
13 European countries had either temporarily halted AstraZeneca vaccine AZD1222 inoculations or delayed its roll out as a precaution following reports of patients developing blood clots after receiving AstraZeneca vaccine jabs.
This prompted the EMA to launch a safety review to see if there was a link between the vaccine and the blood clots.
The governments of France, Germany, Italy, Portugal, Lithuania and Latvia said they will resume using the Oxford-AstraZeneca vaccine Friday.
The Netherlands and Spain will start jabs again next week, while Denmark, Norway and Sweden announced they will not restart their roll outs of the AstraZeneca vaccine.
The World Health Organization called on countries to continue using the vaccine.
“As the European Medicines Agency has clearly stated today, the benefits of the vaccine in combating COVID-19 continue to outweigh the risks of side effects”, said Stella Kyriakides, Commissioner for Health and Food Safety. “It is an effective and safe vaccine that greatly contributes to the efforts to address the impact of COVID-19 and the very serious health risks of an infection,” she added.
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