Insights into the review of reports of blood clots and AstraZeneca's vaccine?

Explainer: How worried should we be about reports of blood clots and AstraZeneca's vaccine? Europe's drug watchdog is reviewing a small number of reports of bleeding, blood clots and low platelet counts in people who have received AstraZeneca's coronavirus vaccine. Ludwig Burger, Matthias Blamont U.S.

FRANKFURT/PARIS (Reuters) - Europe’s drug watchdog is reviewing a small number of reports of bleeding, blood clots and low platelet counts in people who have received AstraZeneca’s coronavirus vaccine.

The European Medicines Agency (EMA) has said it has so far found no causal link between the vaccine and the incidents. The World Health Organization has also said there was no proven link and people should not panic.

At least 13 EU member states including Germany, France, Italy have suspended use of the shot pending the outcome of EMA’s probe.

Here’s what we know so far:

The EMA is investigating reports of 30 cases of unusual blood disorders out of 5 million people who got the AstraZeneca vaccine in the EU.

The EMA’s focus and primary concern is on cases of blood clots in the head, a rare condition that’s difficult to treat called cerebral venous thrombosis (CVT).

In Germany, seven people aged 20 to 50 have been diagnosed with CVT up to 16 days after vaccination as per Monday, according to the national vaccine authority Paul Ehrlich Institute (PEI). Based on the known rate of CVT in the general population, the PEI would have expected one case in 1.6 million.

Britain has administered more than 11 million doses of the AstraZeneca vaccine and reports of blood clots were no greater than would have occurred naturally. The UK’s medicine regulator has urged Britons to keep on getting their vaccines, including the AstraZeneca shot.

EMA’s head of safety monitoring, Peter Arlett, added the rarity of CVT meant the watchdog would have to rely more heavily on case-by-case analysis rather than on the sparse statistical data.

A spokeswomen for Germany’s vaccine authority, which is part of the investigation, said EMA would not rule on causality.

Instead, EMA will assess the likelihood of an increased risk of the condition and weigh that against the benefits of fighting COVID-19 and providing relief for health systems....