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* Study finds TTS rate 8.1 per million after 1st dose
* Study finds TTS rate 2.3 per million after 2nd dose
* Results back 2nd dose, unless TTS after 1st - company
(Writes through with detail)
By Pushkala Aripaka
July 28 (Reuters) - AstraZeneca's COVID-19 vaccine carries a
small extra risk of rare blood clots with low platelets after
the first dose and no extra risk after the second, a study led
and funded by the drugmaker showed on Wednesday, after worries
over side-effects.
The study, published in the Lancet medical journal, found
that the estimated rate of thrombosis with thrombocytopenia
syndrome (TTS) after the first dose was 8.1 per million in those
inoculated, AstraZeneca said https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/vaxzevria-showed-no-increased-incidence-of-thrombosis-with-thrombocytopenia-after-second-dose.html.
After the second dose of the vaccine, branded Vaxzevria and
invented by Oxford University, the rate was 2.3 per million,
comparable to that seen in unvaccinated people, the
Anglo-Swedish company added.
AstraZeneca's shot has faced several setbacks, including
production delays, and rare cases of severe side-effects,
including TTS, which led to several countries restricting or
stopping use of the vaccine, probes by regulators and warning
labels.
The European Union's (EU) drugs regulator has been looking
into cases of TTS since March and has found a possible link to
Vaxzevria, and to Johnson & Johnson's single-dose
COVID-19 shot. It has, however, maintained that overall benefits
of both vaccines outweigh any risks posed by them.
Wednesday's findings evaluated cases reported as of April 30
that occurred within 14 days of receiving the first or second
dose, using AstraZeneca's global safety database, it said.
MEDIA ATTENTION
Public focus has been high on the vaccine as it had been
hailed as potentially the world's best weapon against the
pandemic because it is cheap and easily transportable.
The study said limitations of the analysis included reliance
on data provided by healthcare providers and those who got
vaccinated, which might lead to under-reporting of cases.
It added that "heightened media attention might have led to
event misclassification."
As of the cut-off date, 13 cases of TTS had been identified
globally after the second dose in people aged 45 years to 85
years, including eight women. Some 399 cases were reported after
the first, the study showed, while data used for the number of
doses administered was limited to the EU, European Economic
Area, and Britain.
"Unless TTS was identified after the first dose, these
results support the administration of the two-dose schedule of
Vaxzevria, as indicated, to help provide protection against
COVID-19 including against rising variants of concern,"
AstraZeneca senior executive Mene Pangalos said in a statement.
The EU drug regulator in May advised against a second
AstraZeneca shot for people reporting TTS after the first.
(Reporting by Pushkala Aripaka in Bengaluru Editing by
Uttaresh.V and Mark Potter)
