AstraZeneca

Italy and France to “Quickly Resume” AstraZeneca Rollout When EU Medicines Agency Gives Green Light

The leaders of Italy and France have made it clear that they will “quickly resume” their countries’ rollouts of the AstraZeneca Covid vaccine when the European Medicines Agency gives the green light, as it’s expected to on Thursday. MailOnline has the story.

The leaders of Italy and France today committed to “quickly” resume inoculations of the Oxford-AstraZeneca vaccine once the European regulator gives the all-clear. 

Italian PM Mario Draghi and French President Emmanuel Macron appeared to roll the pitch for an imminent climbdown.

On a call the two leaders agreed they were ready to resume using the jab “quickly” if the European Medicines Agency (EMA) gives the green light on Thursday.

Mario Draghi’s office said “the preliminary statement today from EMA was positive”. The EMA has found “no indication” that AstraZeneca’s Covid vaccine is the cause of reported blood clots.

A top European Commission official today urged EU governments to stop sitting on their vaccine stockpiles.

Stella Kyriakides, the Health Commissioner, said the bloc was in a “race against time” to roll out the vaccine or face several more spikes in infections.

The EU has already seen a disastrous rollout of the vaccine across the continent, with just 8% of adults receiving a jab compared to a third in the UK.

There have been supply problems with both the AstraZeneca and Pfizer jabs, but it was revealed earlier that several countries including Germany are sitting on stockpiles.

“Even with the immense and regrettable challenges around production capacity and deliveries, there are reports of unused reservoirs of vaccines across the EU,” said Kyriakides following talks with European health ministers. …

While Italy has used all of its Pfizer jabs, the country still has 250,000 AstraZeneca vaccines that it banned from going to Australia in storage.

According to the Times, there are some 14.2 million jabs (60%) delivered to EU governments that are yet to be used. 

It seems as though this saga is coming to an end. But might another now commence over Pfizer’s Covid vaccine, which has been linked to more blood clots than AstraZeneca’s in reports from the UK? That’s unlikely given that the Chief of Italy’s medicines regulator has claimed that bans across Europe of the AstraZeneca vaccine were the results of “political” choices.

Worth reading in full.

Lockdown Enthusiasts Belatedly Recognise Limitations of ‘Precautionary Principle’

“The EU, and often its member states, doggedly follows the ‘precautionary principle’,” writes Matthew Lesh in CapX, blaming this principle for the suspension of the rollout of the AstraZeneca vaccine in various EU countries. But hang on a minute. Is this the same Matthew Lesh who has been an enthusiastic cheer leader for the British lockdowns? He goes on to say about this rationale for erring on the side of caution: “To pass the precautionary principle challenge requires doing the impossible: proving something is completely safe. Based on this logic, if stairs or pools were invented today they would be forbidden because of the risks of falling and drowning.”

Well quite. In case it’s escaped your attention, Matthew, this is precisely the argument that lockdown sceptics have been making for the past year. It was the rigid application of the precautionary principle that led governments across the world to lock their citizens in their homes last year because the dangers posed by SARS-CoV-2 were still largely unknown. Or, more precisely, it was the combination of the precautionary principle and short-termism that led to the embrace of the lockdown policy, with the priority of political leaders being to prevent immediate harm befalling their populations even if the excessive precautions they took ended up causing far greater harm in the long-term. And this, surely, is exactly the combination that’s behind the AstraZeneca ban in continental Europe. Better to avoid the immediate political fallout caused by a handful of adverse events apparently caused by the vaccine than provide their populations with lasting protection from infection.

If people like Matthew Lesh can see how disastrous the application of this principle is to the vaccine rollout, how can they not see how disastrous it was when applied to managing the pandemic last year? And, of course, it isn’t just Matthew, but vast numbers of pro-vaxxers who were gripped by the same panic European leaders are now gripped by this time last year.

The senior financial journalist who’s been a longtime contributor to Lockdown Sceptics had this to say about the double-standards of the lockdown zealots.

It’s half amusing to see commentators decrying the Europeans for the the misuse of the ‘precautionary principle’ when suspending the Astra-Zeneca vaccination (e.g. Ambrose Evans-Pritchard writing in the Telegraph that the “French Precautionary Principle is literally killing Europe”. Also the Economist’s Health Correspondent said on BBC radio today that it is folly to apply the precautionary principle during a pandemic. But it is the same precautionary principle that was invoked 12 months ago to justify lockdowns in the first place – on the grounds that we didn’t know the covid infection fatality rate, its reproduction number and because hospitals might possibly be overwhelmed. The same precautionary principle was later invoked to justify two-metre social distancing, face masks, school closures, further lockdowns, etc. It seems that almost every day for 12 months we have had to endure some member of SAGE, notably Chris Whitty, appealing to the precautionary principle to justify some repressive measure unsupported by reliable data. Not only does the extreme risk aversion of the precautionary principle ignore costs (as LS has noted many times over the last year), but it returns to bite its advocates. One doesn’t know whether to laugh or cry.

European Medicines Agency Says “No Indication” AstraZeneca Jab Is Cause of Blood Clots

The EU’s medicines agency has responded to concerns over the Oxford-AstraZeneca Covid vaccine, saying there is “no indication” that the vaccine is the cause of reported blood clots. Sky News has the story.

The European Union’s medicines agency has said there is “no indication” that AstraZeneca’s coronavirus vaccine is the cause of reported blood clots.

The European Medicines Agency (EMA) has been carrying out a case-by-case evaluation of incidents and was expected to complete a review on Thursday, said Executive Director Emer Cooke.

The regulator said it was “firmly convinced” the vaccine’s benefits outweighed the risk of side effects.

The WHO has urged countries to continue using the jab as global medical experts meet to discuss reports of blood clots.

UK leaders and medical professionals have joined in their defence of the Oxford-AstraZeneca vaccine after some European countries – including Germany, Italy, Spain, the Netherlands, France and Sweden – paused its use due to concerns over possible adverse side effects. …

Now, France has said it expects inoculations there to resume after the agency meets and issues its recommendations. …

The EMA has said “many thousands of people” develop blood clots every year in the EU and “the number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population”. …

Dr Soumya Swaminathan, WHO’s Chief Scientist, [also] told a media briefing “we do not want people to panic”, as she said no association has been found so far between blood clots and Covid vaccines.

Worth reading in full.

France and Germany Suspend Rollouts of Oxford-AstraZeneca Vaccine Amid Blood Clot Concerns

Germany and France are the latest countries to put their rollouts of the Oxford-AstraZeneca Covid vaccine on hold because of fears over blood clotting. Boris Johnson, Britain’s medicines regulator and AstraZeneca itself have all defended the vaccine as safe to use. Sky News has the story on Germany’s suspension.

Germany is suspending use of the Oxford-AstraZeneca coronavirus vaccine in order to investigate reports of blood clots.

The country’s Health Ministry said the measure was a “precaution”. …

In a statement, the German health ministry said the reported blood clots involved cerebral veins, but did not specify where or when the incidents happened.

It said its decision to suspend the vaccine was taken on the advice of national regulator, the Paul Ehrlich Institute.

The ministry said the EMA would decide “whether and how the new information will affect the authorisation of the vaccine”.

The Telegraph has the following on France:

Emmanuel Macron said that French authorities have decided to suspend shots at least until Tuesday afternoon, when the European Medicines Agency will issue its recommendation over the vaccine.

Yesterday, Ireland and the Netherlands followed the example of other EU countries – including Norway and Denmark – in halting their AstraZeneca vaccine rollouts amid reports of “bleeding, blood clots and a low count of blood platelets” in health workers who had recently received the vaccine. One particular batch of AstraZeneca vaccines (which is implicated in reports of a death) was sent to 17 countries.

The greater the concern over the vaccine, the greater the defence from others. On March 14th, AstraZeneca addressed safety concerns in a statement.

A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with Covid Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. …

Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.

Responding to Germany’s suspension of the jab’s rollout, Boris Johnson said the vaccine is “both safe and effective”:

“[The UK has] one of the toughest and most experienced regulators in the world.

“They see no reason at all to discontinue the vaccination programme… they believe that they are effective, highly effective in driving down not just hospitalisations but also serious disease and mortality. We continue to be very confident about the programme.”

Representatives of Britain’s Medicines and Healthcare products Regulatory Agency added that the evidence “does not suggest” the jab causes clots.

We are closely reviewing reports but given the large number of doses administered, and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause.

Worth reading in full.

Stop Press: Professor Anthony Harden, the Deputy Chair of the Joint Committee on Vaccination and Immunisation (JCVI), has hit back at claims that the vaccine increases risk of blood clotting, saying: “We’ve given 11 million doses here and there’s no evidence of increased risk of blood clots.” The JCVI can now be added to the list of organisations that have dismissed concerns about the AstraZeneca vaccine which includes the World Health Organisation (WHO), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA).

More Countries Halt Rollout of AstraZeneca Vaccine

Ireland and the Netherlands have joined the list of countries that have suspended the use of AstraZeneca’s Covid vaccine because of fears over blood clotting. The Dutch Government has announced a suspension until at least March 29th. Both countries have paused their rollout efforts due to reports of “bleeding, blood clots and a low count of blood platelets” in health workers who had recently received the vaccine.

The Republic of Ireland’s Deputy Chief Medical Officer acknowledged in a statement that “it has not been concluded that there is any link between the Covid vaccine AstraZeneca and these cases [of clotting]”.

However, acting on the precautionary principal, and pending receipt of further information, the NIAC (National Immunisation Advisory Committee) has recommended the temporary deferral of the Covid vaccine AstraZeneca vaccination programme in Ireland.

The NIAC is due to meet again this morning. A further statement will follow thereafter.

AstraZeneca addressed these safety concerns in a statement issued at 6pm last night.

A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with Covid Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. …

Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.

One particular batch of AstraZeneca vaccines (which is involved in reports of a death) was sent to 17 countries, an increasing number of which are putting the rollout of this vaccine on hold.

Stop Press: Health officials in Northern Ireland have announced that they will continue to use the Oxford-AstraZeneca vaccine after its suspension in the Republic of Ireland.

Three Norwegian Health Workers in Hospital with “Unusual” Symptoms After Receiving AstraZeneca Jab

Concerns about the Oxford-AstraZeneca Covid vaccine have intensified following reports of three Norwegian health workers suffering from blood clots and a low count of blood platelets after receiving the jab. Reuters has the story.

Three health workers in Norway who recently received the AstraZeneca vaccine against Covid are being treated in hospital for bleeding, blood clots and a low count of blood platelets, Norwegian health authorities said on Saturday.

Norway halted on Thursday the rollout of that vaccine, following a similar move by Denmark. Iceland later followed suit.

“We do not know if the cases are linked to the vaccine,” Sigurd Hortemo, a senior doctor at the Norwegian Medicines Agency told a news conference held jointly with the Norwegian Institute of Public Health.

All three individuals were under the age of 50.

The European medicine regulator EMA would investigate the three incidents, Hortemo added.

“They have very unusual symptoms: bleeding, blood clots and a low count of blood platelets,” Steinar Madsen, Medical Director at the Norwegian Medicines Agency told broadcaster NRK.

“They are quite sick…We take this very seriously,” he said, adding authorities had received notification of the cases on Saturday.

AstraZeneca was not immediately available for comment.

A number of European countries have halted the rollout of the AstraZeneca Covid vaccine following reports of negative side effects relating to blood clots. AstraZeneca has highlighted that there have been “no confirmed serious adverse events associated with the vaccine”, but is supportive of ongoing investigations.

Worth reading in full.

Stop Press: Ireland has temporarily halted its use of the Oxford-AstraZeneca jab following the above reports of blood clots in vaccinated people.

Denmark Suspends Use of AstraZeneca Vaccine Over Blood Clot Fears

Denmark has halted the rollout of the AstraZeneca Covid vaccine following reports of negative side effects relating to blood clots. The Telegraph has the story.

Denmark has temporarily suspended AstraZeneca Covid vaccine shots after reports of cases of blood clots forming, including one in Denmark, Danish authorities said on Thursday.

They did not say how many reports of blood clots there had been, but Austria has stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.

They said six other European countries had halted the use of a vaccine batch from AstraZeneca.

“Both we and the Danish Medicines Agency have to respond to reports of possible serious side-effects, both from Denmark and other European countries,” the director of the Danish Health Authority, Soren Brostrom, said in a statement.

The vaccine would be suspended for 14 days, the health agency said. It did not give details of the Danish blood clot patient.

AstraZeneca has defended its shot, highlighting that there have been “no confirmed serious adverse events associated with the vaccine”, but is fully supportive of Denmark’s investigation.

Worth reading in full.

Stop Press: There have been no registered cases of blood clots related to AstraZeneca’s Covid vaccine in Spain, according to the country’s Health Secretary, which will continue to use the shots.

Stop Press 2: Norway and Iceland have also stopped giving the AstraZeneca jab and a number of other countries, including Italy, have temporarily stopped using two different batches of the AstraZeneca vaccine, after reports in Italy of a “serious adverse event” linked to one batch and the death in Austria related to another batch. The Telegraph has more.

Stop Press 3: Romanian authorities have temporarily stopped vaccinating people with one batch of AstraZeneca’s vaccine as an “extreme precaution” while deaths in Italy are investigated, but are continuing to use other doses from the company. Channel News Asia has more.