The Food and Drugs Authority (FDA) says there is currently no causal link between reports of blood clots and the AstraZeneca vaccines in the country.
According to the FDA, it constituted a Committee of Experts – the Joint COVID-19 Safety Review Committee (JCVSRC) on 26 February, to assess all reported adverse events regarding the use of the vaccines.
The FDA in a statement said the committee’s report “concluded that there is currently no causal link between the event [blood clots] and the vaccine, a position that was subsequently upheld by the European Medicines Agency and the World Health Organisation (WHO).”
It added “At its meeting held on 12 March 2021, the JCVSRC discussed reports received through the FDA’s robust safety monitoring system since vaccinations started. The most commonly reported adverse events are headaches, fever, chills, body pains, pain at the injection site, weakness, nausea, and dizziness.
“These adverse events are expected from the vaccination and in most cases, resolved within a day or two. Additionally, the JCVSRC discussed reports of blood clots in some countries in Europe following vaccination with the AstraZeneca COVID-19 vaccine, leading to the suspension of vaccination for further investigations,” the statement added.
The FDA said it will continue “to work with its Committee of Experts, other regulators globally and will use its established safety monitoring system to support the vaccine programme to ensure public health and safety.”
Fourteen European countries including 12 EU members have now suspended the use of the shots altogether – with Sweden joining the list today – while another five have black-listed specific batches and a handful of governments outside Europe have also pulled the emergency brake.
These countries say they were pausing the rollout following reports of blood clots in some recipients. Blood clots are solid clumps that form in the blood, which can be life-threatening if not treated quickly. The countries stressed that it was a precautionary measure.
The World Health Organisation (WHO) says there is no evidence of a link between blood clots and the AstraZeneca COVID-19 vaccines and has urged countries not to pause their vaccinations.
AstraZeneca says a review of 17 million people who received doses in Europe found there were 37 cases of people who had developed blood clots.
Experts say the number of blood clots reported in vaccinated people is no higher than that seen in the general population.
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