Suspension of AstraZeneca shots is ‘political decision’: Italy’s medicines regulator head

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EMA chief Emer Cooke

The decision by Germany, France and Italy to suspend AstraZeneca’s COVID-19 shots after several countries reported possible serious side-effects is a “political one”, the director general of Italy’s medicines authority AIFA said on Tuesday.

“We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations… to put them on hold in order to carry out checks. The choice is a political one,” Nicola Magrini told daily la Repubblica in an interview.

Magrini said that the AstraZeneca vaccine was safe and that the benefit to risk ratio of the jab is “widely positive”. There have been eight deaths and four cases of serious side-effects following vaccinations in Italy, he added.

Aifa will take two to three days to collect all required data and once “doubts are cleared we can carry on at a faster speed than before,” Magrini said. ROME (REUTERS)

Playing Politics, putting lives at risk.

Germany on Monday halted the use of the AstraZeneca coronavirus vaccine, the Health Ministry announced in a statement, with Italy, France and Spain following suit later in the day. Several other EU countries have also stopped use of the vaccine because of the possibility of blood clots.

The German Health Ministry described the move as a “precaution” on the basis of advice from the national health regulator, the Paul Ehrlich Institute (PEI). According to the Health Ministry, the European Medicines Agency (EMA) will decide “whether and how the new information will affect the authorization of the vaccine” pending an investigation.

EU regulator ‘firmly convinced’ that benefits of AstraZeneca vaccine outweigh the risks

Meanwhile, the EU medical regulator says the AstraZeneca COVID vaccine does not cause blood clots

“We are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 with its associated risk of hospitalisation and death outweigh the risk of these side effects,” EMA chief Emer Cooke told an online press conference.

“At present there is no indication that vaccination has caused these conditions. They have not come up in the clinical trials and they are not listed as known or expected side effects,” Cooke added.

Clinical trials had shown “very small numbers of blood clot developments”, she added.

The EU regulatory body is “fully convinced” that the vaccine’s benefits outweigh possible risks. Global health experts have been under growing pressure to answer questions over the safety of AstraZeneca’s COVID-19 shot.

There is “no indication” that AstraZeneca vaccines are the cause of blood clots reported in some shot recipients, the European Medicines Agency’s (EMA) chief said on Tuesday.

The agency is “still firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risk of hospitalization and death outweigh the risk of these side effects,” Executive Director Emer Cooke added.

Cooke said that an EMA evaluation of individual incidents is ongoing. It is expected to complete a full review on Thursday.

What are the concerns about the vaccine?

There are fears about the safety of the vaccine in some countries after several cases of blood clots or brain hemorrhages in people after receiving the inoculation. A small number of deaths have been reported.

The WHO, AstraZeneca, and the EMA have all insisted the AstraZeneca shot is safe, and that there is no link between the vaccine and reported blood clots. They say clots are not occurring in greater numbers or frequency than normally in the general population.

German cases are growing ‘exponentially’ again. A leading expert has warned an easing of restrictions has led Germany to the brink of a third wave. Intensive care doctors warn that partial lockdown measures must be put back in place.

The number of coronavirus cases in Germany grew 20% in the past week, as lockdown restrictions are gradually eased, an expert at the Robert Koch Institute for infectious diseases (RKI) said Tuesday.

The figures were released as the country’s intensive care doctors warn of the need for an “immediate return” to partial lockdown to stave off a dangerous third wave of coronavirus cases.

France enters a third wave of the COVID-19 pandemic

French Prime Minister Jean Castex told Parliament on Tuesday that France had entered a third wave of the COVID-19 pandemic, as the seven-day average of new cases rose above 25,000 for the first time since Nov. 20.

French health authorities reported 29,975 new cases on Tuesday, a 4.5% jump versus last Tuesday’s total and the sharpest week-on-week rise in a month and a half.

France is grappling with a steady rise of new cases, leading to a heavy strain on the country’s hospital system, which prominent health experts say can be spared only by a new lockdown.

Like other EU countries, France has lagged far behind the United States or Britain in vaccinating its population.

What are the latest fears?

RKI epidemiologist Dirk Brockmann told German broadcaster ARD that the loosening of measures was particularly unhelpful given the exponential growth that has occurred with the British virus variant B117.

“We are exactly on the flank of the third wave. That can no longer be disputed. And, at this point, we have eased the restrictions and that is speeding up the exponential growth,” RKI epidemiologist Dirk Brockmann told German broadcaster ARD.

“It has been totally been irrational to loosen up here. It’s just fueling this exponential growth.”

“If you have been vaccinated with the AstraZeneca vaccine within the last 14 days and you experience signs of skin or mucosal bleeding, you should see a doctor,” the Danish Medicines Agency said Monday. “This could for example be easy bruising — except for at the injection site, which is normal — or small red spots on the skin or bleeding that does not stop as normal.”

For its part, the EMA said Monday that these temporary suspensions are “a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who had received the vaccine.”

Many thousands of people develop blood clots annually in the EU for different reasons, the EMA noted. The number of such events overall in vaccinated people doesn’t seem to be higher than that seen in the general population.

However, it said, its investigations are ongoing, and the agency will “continue to communicate further as appropriate.”

Speaking alongside Gentiloni on Monday evening, Paschal Donohoe, Ireland’s finance minister, said the suspensions were “the right decision.”

“I believe any short term effects on economic activity that could be caused by what I hope is a temporary suspension of the use of one vaccine, I believe will be offset by the great prize of retaining confidence in how safe our vaccines are and in an effective vaccination program in the weeks and months to come,” he said.

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