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July 28 (Reuters) – AstraZeneca’s COVID-19 vaccine carries a small additional risk of rare blood clots with a low platelet count after the first dose and no additional risk after the second, a study led and funded by the drug manufacturer, after concerns about side effects.
The study, published in the medical journal Lancet, found that the estimated rate of thrombosis with thrombocytopenia syndrome (TTS) after the first dose was 8.1 per million in those inoculated, said AstraZeneca (AZN.L) .
After the second dose of the vaccine, branded Vaxzevria and invented by the University of Oxford, the rate was 2.3 per million, comparable to that seen in unvaccinated people, added the Anglo-Swedish company.
AstraZeneca’s firing has seen several setbacks, including production delays and rare cases of serious side effects, most notably TTS, which have led several countries to restrict or stop the use of the vaccine, probes by regulators. and warning labels. Read more
The European Union (EU) medicines regulator has been examining cases of TTS since March and has found a possible link to Vaxzevria and to the single-dose COVID-19 vaccine from Johnson & Johnson (JNJ.N). He maintained, however, that the overall benefits of both vaccines outweigh the risks they pose. Read more
Wednesday’s results assessed cases reported as of April 30 that occurred within 14 days of receiving the first or second dose, using AstraZeneca’s global safety database, he said. declared.
MEDIA ATTENTION
Public attention has been raised on the vaccine as it has been hailed as potentially the world’s best weapon against the pandemic, as it is cheap and easily transportable.
The study indicated that the limitations of the analysis included reliance on data provided by health care providers and those who were vaccinated, which could lead to underreporting of cases.
He added that “increased media attention may have led to misclassification of events.”
By the deadline, 13 cases of TTS had been identified worldwide after the second dose in people aged 45 to 85, including eight women. According to the study, some 399 cases were reported after the first, while the data used for the number of doses administered was limited to the EU, the European Economic Area and Great Britain.
“Unless TTS was identified after the first dose, these results support the two-dose schedule administration of Vaxzevria, as indicated, to help provide protection against COVID-19, including increase in worrisome variants, “said Mene Pangalos, senior executive at AstraZeneca. A declaration.
The European medicines regulator in May advised against a second shot of AstraZeneca for people reporting TTS after the first. Read more
Reporting by Pushkala Aripaka in Bengaluru Editing by Uttaresh.V and Mark Potter
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