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COVID-19

AstraZeneca benefits outweigh risks, EMA says as EU orders 10 million more Pfizer doses

The EU's medicines regulator said Tuesday it was "firmly convinced" the benefits of AstraZeneca's vaccine outweigh potential risks, insisting there was no evidence linking it to blood clots after several nations suspended the shot over health fears. It came as Brussels sealed a deal for 10 million more Pfizer doses.

AstraZeneca benefits outweigh risks, EMA says as EU orders 10 million more Pfizer doses
This file illustration picture shows vials of the AstraZeneca Covid-19 vaccine and a figurine taken in a studio Paris on March 11, 2021. Joel Saget/AFP

The suspensions have provoked intense debate over whether it was prudent to put AstraZeneca inoculations on hold just as vaccination campaigns were beginning to gather pace in many countries.

Experts at both the World Health Organization and the European Medicines Agency met Tuesday to discuss the vaccine, with the European organisation expected to publish conclusions Thursday.

While millions of doses of the vaccine developed with Oxford University have been administered, small numbers of people have developed blood clots, prompting countries including the European Union’s three largest nations – Germany, France and Italy – to suspend injections.

But the EMA insisted that countries should continue using the vaccine.

“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 said Tuesday.

“At present there is no indication that vaccination has caused these conditions,” she added, echoing the WHO and drugmaker AstraZeneca itself.

Cooke noted however that the regulator was “looking at adverse events associated with all vaccines”.

France and Italy welcomed the news.

“Today’s preliminary statements from EMA are encouraging,” said a joint statement from French President Emmanuel Macron and Italian Prime Minister Mario Draghi.

French Prime Minister Jean Castex on Tuesday vowed he would be vaccinated “very quickly” with the AstraZeneca Covid-19 vaccine to give the public confidence in the jab if it is ruled as safe by the EU medicines agency.

In France, health authorities said Tuesday they are investigating a new coronavirus variant found in the western Brittany region. The variant appears to be more difficult for nasal tests to detect, however for now it does not appear to be more dangerous or contagious.

Covid, not jab, to blame?

In Britain, which has administered more than 11 million AstraZeneca doses, experts see no evidence of more frequent blood clots among the inoculated.

Prime Minister Boris Johnson wrote in The Times newspaper that the shot “is safe and works extremely well”.

French immunologist Alain Fischer, who heads a government vaccination advisory board, said a higher than normal number of pulmonary embolisms – blood clots in the lungs – had caused alarm at the weekend.

“There were a few very unusual and troubling cases which justify this pause and the analysis,” Fischer told France Inter radio.

But one British scientist has argued that Covid-19 itself – and not the vaccine – could be to blame, as it was known to cause such problems.

The “very likely explanation of at least some of the clotting disorders seen are a result of Covid-19 rather than the vaccine”, said Stephen Evans, professor of pharmaco-epidemiology at the London School of Hygiene & Tropical Medicine.

“Hence, even if there were a problem, acknowledged to be very rare with the AZ vaccine, the overall benefit would be so much greater than any speculative harm,” he added.

Coronavirus deaths across Europe meanwhile passed the 900,000 mark on Tuesday, making it the worst-hit global region in absolute terms, according to an AFP tally.

10 million Pfizer doses

More than 382 million doses of vaccine have been administered globally, the vast majority in wealthier countries while many poorer nations have yet to receive a single jab.

AstraZeneca’s shot, among the cheapest available, was billed as the vaccine of choice for poorer nations and the clot reports have had an impact beyond Europe.

Other countries that have halted or delayed the rollout include Indonesia, Venezuela, Denmark, Norway and the Netherlands – with Cyprus, Lithuania, Luxembourg and Sweden the latest to join the list.

The pandemic spurred unprecedented efforts to develop vaccines, with a number of successful options now available.

Rollouts have been hampered by export controls, bitter diplomatic disputes and production issues – in addition to the AstraZeneca suspension.

But on Tuesday Brussels sealed a deal to step up deliveries of 10 million doses of the Pfizer/BioNTech vaccine, now scheduled to arrive in the EU before July rather than in the third quarter.

And a new agreement for Germany’s IDT Biologika to help produce the single-shot Johnson & Johnson vaccine would offer Europe greater certainty, Germany’s economy minister said.

The developers of Russia’s successful Sputnik V vaccine also said they had reached production agreements in key European countries.

Member comments

  1. Unbelievable. The country has never been sicker, and what does the government do? Take AstraZeneca out of its arsenal to fight the virus. And NOT ONE WORD about what we, with jab #1, are supposed to do about jab #2. It’s insanity.

  2. It’s all political, there has been no mention of the deaths and blood clots that have happened with the Pfizer?

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HEALTH

EXPLAINED: The new rules around getting a sick note over the phone in Germany

Due to high Covid infection numbers throughout the summer, it’s now possible to get a sick note from a doctor over the phone again for some illnesses. Here’s what you need to know.

EXPLAINED: The new rules around getting a sick note over the phone in Germany

What’s happened?

In spring 2020, German authorities changed the law so that people with a mild upper respiratory tract illness, such as the common cold, were able to get an incapacity to work certificate or AU-Bescheinigung by simply calling and speaking to their GP.

The rule was extended several times and finally reversed on June 1st this year due to falling infection figures. Since then people have had to go back to the practice – or do a video call if the doctor’s office has that system in place – to get a sick note.

Now, due to a decision by the Joint Federal Committee, the regulation has been reintroduced and patients can call their GP again for a sick note.

Can I get a sick note over the phone for any illness?

No. As before, the regulation only applies to patients suffering from a mild upper respiratory tract illness. Though Covid has not explicitly been named in the announcement, it seems that it is intended to be covered by the regulation.

If the doctor is convinced that the patient is unfit for work after a telephone consultation, then they can issue a sick note for up to seven days.

READ ALSO: EXPLAINED: The changes around doctor’s notes in Germany you should know

If the symptoms persist after seven days, the certificate can be extended once more for another week.

Why now?

According to the Chairman of the G-BA, Josef Hecken, the regulation has been introduced now as a response to rising Covid numbers and in anticipation of the cold and flu season in the coming months: “We want to avoid full waiting rooms in doctors’ offices and the emergence of new infection chains,” he said.

The telephone sick leave rule is a simple, proven and uniform nationwide solution for that, he said. The rule is also necessary because video consultation hours are not yet available everywhere.

What else should I know?

The health insurer DAK is calling for telephone sick leave in the case of light respiratory diseases to be made possible on a permanent basis in Germany. DAK’s CEO Andreas Storm said that this should “not always be up for debate, because it has proven itself.” 

READ ALSO: Everything you need to know about making a doctor’s appointment in Germany

The social association VdK also welcomed the reintroduction of the rule. The VdK’s President Verena Bentele said that the regulation would help to protect high-risk groups in particular from potential infections.

What are the rules to know about sick notes in Germany?

Germany has a strict system in place. If you are sick, you need to give your employer a Krankmeldung (notification of sickness) before the start of work on the first day (of your illness).

However, you also need to hand in a Krankschreibung (doctor’s note) on the fourth day of your illness. Some employments contracts, however, require you to submit a sick not earlier than the fourth day so check with your boss or HR on that point. 

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