The security committee additionally ‘concluded that these events should be listed as very rare side effects of the vaccine’.
Eight circumstances of critical, uncommon blood clots related with low ranges of blood platelets, one of which was deadly, have been seen within the U.S. after administration of Johnson & Johnson COVID-19 vaccine. On April 20, European Medicines Agency’s security committee (PRAC) primarily based on these circumstances “concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen”. The security committee additionally “concluded that these events should be listed as very rare side effects of the vaccine”. As of 13 April 2021, over seven million folks had obtained the vaccine within the U.S.
In a press launch, the EMA mentioned that it discovered “possible link to very rare cases of unusual blood clots with low blood platelets” following administration of Johnson and Johnson vaccine.
On April 13, the U.S. referred to as for a pause in Johnson & Johnson vaccine use when six circumstances of a uncommon blood-clotting dysfunction had been seen within the vaccinated folks.
All the eight circumstances had been seen in these below 60 years of age inside three weeks after vaccination, the bulk being in girls. “Based on the currently available evidence, specific risk factors have not been confirmed,” the EMA mentioned in a launch.
Kai Kupferschmidt, a science journalist, tweeted saying that Sabine Straus, Chair of EMA, instructed the press that although the U.S. paused vaccination on April 13, circumstances can nonetheless happen for three weeks after immunisation. “So we still have to wait and see if there are more cases coming in, so it’s too early to say anything about the real occurrence of the cases,” Ms. Straus had apparently warned.
“At this moment, it’s not possible to identify clear risk factors for the occurrence of these very rare events, such as gender or age”, Ms. Straus instructed the press.
The security committee additionally famous that the blood clots occurred largely at uncommon websites equivalent to in veins within the mind (cerebral venous sinus thrombosis, CVST) and the stomach (splanchnic vein thrombosis) and in arteries, collectively with low ranges of blood platelets and typically bleeding. The circumstances reviewed had shut similarity to circumstances seen after administration of AstraZeneca vaccine.
The EMA confused that the reported “combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen [owned by Johnson and Johnson] in preventing COVID-19 outweigh the risks of side effects”.
The EMA listed out the signs to look out for inside three weeks after vaccination. These embody shortness of breath; chest ache; swelling within the leg; persistent belly ache; neurological signs, together with extreme or persistent complications or blurred imaginative and prescient; and pores and skin bruising past the location of injection.
The security committee emphasised the significance of immediate specialist medical therapy. “By recognising the signs of blood clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications,” the committee mentioned.
