European Medicines Agency (EMA) - Garner Ted Armstrong Evangelistic Association

Several children jabbed with unapproved vaccine in Germany

DPA International — Mon, 20 Dec 2021 01:18:14 +0000

Berlin (dpa) – Several children in Germany were accidentally vaccinated with a coronavirus vaccine that had not yet been approved for their age group on Sunday, local officials said.

At a vaccination centre of the Olpe district in North Rhine-Westphalia, several children were injected with the Moderna vaccine. Only BioNTech has been approved for children so far.

“The parents of the affected children were immediately informed about the incident,” the district announced.

In a conversation with the medical director of the vaccination centre, the parents were informed that the approval for the Moderna vaccine for children was still pending at the European Medicines Agency.

At the time of leaving the vaccination centre, no abnormalities were observed in the children.

At the request of the parents, the incident was reported to police.

The number of children involved was not disclosed.

The vaccination centre is taking the employee’s mistake as an opportunity to review all procedures and child vaccinations.

“If further cases are discovered, the parents will be informed,” it said.

In November, the European Medicines Agency (EMA) gave the green light for the BioNTech vaccine for children from the age of 5. It was the first vaccine approved in the EU for children under 12.

Children receive only one-third of the adult dose.

Source: https://www.dpa-international.com/topic/several-children-jabbed-unapproved-vaccine-germany-urn%3Anewsml%3Adpa.com%3A20090101%3A211219-99-447078

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Vaccine deal on table as Britain and EU defuse tensions

John Dunne (@jhdunne) - Evening Standard — Sun, 28 Mar 2021 07:42:10 +0000

A vial of Oxford-AstraZeneca vaccine.

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A vial of Oxford-AstraZeneca vaccine. / PA

Britain is close to striking a vaccine deal with the European Union as soon as this weekend that will remove the threat of the bloc cutting off supplies, The Times has reported.

Under the agreement, the EU will remove its threat to ban the export of Pfizer-BioNTech vaccines to Britain.

In return, the UK government will agree to forgo some long-term supplies of the Oxford–AstraZeneca vaccine that had been due to be exported from Holland, the newspaper reported.

On Friday, the European Medicines Agency approved Halix production site in the Netherlands that makes the AstraZeneca vaccine and a facility in Marburg in Germany producing BioNTech/Pfizer shots.

The EU’s clearing of the vaccine site comes as the union is banking on them to boost deliveries in the second quarter and accelerate the slow pace of inoculations in the bloc.

Europe’s troubled vaccine rollout prompted the president of European Commission Ursula von der Leyen to block exports of the AstraZeneca jab.

She told Germany’s Funke Media Group in an interview published Saturday that the EU had the “possibility” to ban exports. “This is a message to AstraZeneca: You fulfill your part of the deal toward Europe before you start to deliver to other countries,” she said.

EU leaders claim Britain should share more, notably to help make up the shortfall in contracted deliveries of AstraZeneca shots.

But ministers have pointed out that the UK did a better job negotiating with manufacturers and arranging supply chains.

Brussels and London sought to cool tensions on Wednesday, declaring they were working “to create a win-win situation and expand vaccine supply for all our citizens”.

Source: https://www.standard.co.uk/news/uk/britain-eu-vaccines-b926593.html

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EU leaders’ vaccine sniping backfires

Steerpike - The Spectator — Tue, 02 Mar 2021 11:34:14 +0000

The eyes of the world have been on Britain’s vaccination programme in recent months, as the UK government embarked on a dramatic push to get our population inoculated by prioritizing first doses. During this time, the naysayers have been plentiful – with some UK commentators and plenty of politicians abroad keen to cast doubt over the strategy.

What everyone agreed was that time would tell. But now it appears we have promising results, with a new pre-print of a study published by Public Health England today. The study shows that just one dose of both the AstraZeneca and Pfizer vaccines has significantly reduced Covid-19 infections among those aged 70 and over. And, the study suggests that one dose of either vaccine is more than 80 percent effective at preventing hospitalizations among the over-80s, three to four weeks after the shot.

This is, of course, very welcome news for the many vulnerable people who have already received their first shot in Britain. But it may leave some leading EU figures with red faces this afternoon. Ever since Britain approved the Oxford vaccine and began its one-dose strategy, flying ahead of other EU countries, there have been howls of anguish from EU leaders who have sought to undermine Britain’s programme and cast doubt on the efficacy of the Oxford shot.

With the news that both the Pfizer and Oxford/ AstraZeneca vaccine appear to be effective after one dose, Mr. S thought it worthwhile to revisit some of those comments now…

Emmanuel Macron

At the end of January, French President Emmanuel Macron made some remarkable statements about the efficacy of the AstraZeneca vaccine. Speaking to reporters, Macron even suggested that the shot was ‘quasi-ineffective’ on the elderly:

“‘The real problem on AstraZeneca is that it doesn’t work the way we were expecting it to. We’re waiting for the EMA [European Medicines Agency] results, but today everything points to thinking it is quasi-ineffective on people older than 65, some say those 60 years or older.’

French ministers are said to believe Macron could have a second career as an epidemiologist. Mr. S would recommend that he doesn’t give up the day job…

Clement Beaune

Macron was not the only critic in the French government. At the beginning of February, the French Europe minister, Clement Beaune, suggested that Britain was taking ‘a lot of risks’ by having a 12-week gap between difference doses. The minister then suggested that French citizens would not stand for this kind of gamble, even if the method had been approved by scientists.

Ursula von der Leyen

The European Commission President, Ursula von der Leyen, was not much more helpful. Despite essentially going to war with AstraZeneca to gain more of its vaccine doses, von der Leyen suggested at the beginning of February that Britain had compromised on ‘safety and efficacy’ by approving the vaccine so early. The fact that the European Medicines Agency (EMA) reached exactly the same conclusions as Britain’s healthcare regulator appeared to have passed the bureaucrat by entirely…

Handelsblatt

You could say that the true sniping against the Oxford/AstraZeneca vaccine was kicked off by the German financial newspaper, Handelsblatt, who claimed in a story in January that the shot was only 8 percent effective on the over-65s. The story did not appear to have aged well.

The Robert Koch Institute

Handelsblatt’s somewhat dubious reporting appeared to influence German scientists as well. In January, the European Medicines Agency approved the Oxford vaccine for use on all ages. The German government’s vaccine committee, however, pointedly refused to allow the vaccine to be given to the over-65s, citing insufficient data.

In the end, almost half of the EU’s members have restricted the use of the AstraZeneca vaccine and doses are being wasted across the continent as Europeans refuse to receive the Oxford jab. Now that we have data showing the efficacy of the shot, including on the elderly, that decision seems certain to have been proven unwise.

Source: https://www.spectator.co.uk/article/eu-leaders-vaccine-sniping-backfires

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European Union Greenlights BioNTech-Pfizer COVID-19 Vaccine After Agency Gives Safety Approval

Aleksandar Furtula and Frank Jordans - AP — Tue, 22 Dec 2020 06:51:05 +0000

A person enters the European Medicines Agency in Amsterdam, Netherlands, Dec. 21, 2020, where the EMA’s human medicines committee is holding an exceptional meeting to conclude the evaluation of the Pfizer-BioNTech COVID-19 vaccine. -AP

(AMSTERDAM) — The European Union on Monday gave official approval for the coronavirus vaccine developed by BioNTech and Pfizer to be used across the 27-nation bloc, raising hopes that countries can begin administering the first shots to their citizens shortly after Christmas.

The EU’s executive commission gave the green light just hours after the European Medicines Agency said the vaccine meets safety and quality standards. Brussels had been expected to take two or three days to endorse the market authorization move.

“As we have promised, this vaccine will be available for all EU countries at the same time, on the same conditions,” said European Commission President Ursula von der Leyen. “This is a very good way to end this difficult year, and to finally start turning the page on COVID-19.”

Deliveries of the vaccine had been penciled in to start this coming Saturday, with inoculations beginning across the EU between Dec. 27-29, she said.

The same vaccine was authorized in Britain and the United States weeks ago, prompting pressure from EU governments for EMA to speed up its approval process as virus cases surged again across the continent.

EMA originally set Dec. 29 as the date for evaluating the vaccine but moved up the meeting to Monday after calls from the German government and others for the agency to move more quickly.

Harald Enzmann, the head of EMA’s expert committee, dismissed any suggestion that political influence had affected the decision.

“The focus was exclusively on the science,” he told reporters. “That was a scientific assessment, full stop.”

The Amsterdam-based EMA is responsible for approving all new drugs and vaccines across the 27 EU member states, Iceland, Liechtenstein, and Norway. It is roughly equivalent to the U.S. Food and Drug Administration.

The vaccine has already been given some form of regulatory authorization in at least 15 countries.

Britain, Canada, and the U.S. authorized the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide, according to a tally by Johns Hopkins University.

Switzerland became the first country Saturday to authorize the vaccine according to the normal licensing procedure. EMA’s conditional market authorization also followed the regular process, only on an accelerated schedule and under the condition that the pharmaceutical companies submit follow-up data on their vaccine for the next year.

While many have clamored for the vaccine’s authorization, there have also been concerns, in Europe and elsewhere, about the speed with which the shot was developed. Normally, vaccines take years to develop and approve, not months.

In a statement last week that appeared to address those concerns, the agency stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the risks.

Scientists are still waiting for more long-term follow-up data to see how long immunity from the vaccine lasts and if there are any rare or serious side effects. Final testing of the vaccine is still ongoing, and more information on whether the shot works in children is needed. EMA experts also said that data on pregnant women is limited, and physicians should decide on a case-by-case basis.

The vaccine is not made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.

On the day Britain began its vaccination campaign, authorities warned people with severe allergies not to get the shot after two people suffered serious allergic reactions; it’s unclear if the reactions were caused by the vaccine.

The U.S. Centers for Disease Control and Prevention said that as of Friday there had been six cases of severe allergic reaction in the U.S. out of more than a quarter-million shots of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.

Adding to an already grisly toll were concerns over a newly identified strain that appears to spread more easily. But experts expressed confidence that the new vaccine would still be effective against it.

“At the moment, we can say that there is no evidence to suggest that the vaccine will not work against the new variant of the coronavirus,” Emer Cooke, the head of the drug regulator, said after a closed-door meeting in which experts unanimously recommended the shot for people over 16.

But she added that protective measures such as wearing masks, washing hands, and social distancing would likely be needed for some time.

“Vaccines alone will not be the silver bullet that will allow us to return to normal life,” said Cooke. “But the authorization of this first vaccine is definitely a major step in the right direction and an indication that 2021 can be brighter than 2020.”

The EU has ordered 300 million doses of the BioNTech-Pfizer vaccine; two are needed for each person, meaning other shots will be required to immunize all of the bloc’s nearly 450 million inhabitants.

The EMA plans to hold a meeting on Jan. 6 to decide if another vaccine made by Moderna should be licensed. It has reviews ongoing for a shot developed by Oxford University and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.

“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, the Germany-based company’s chief executive, and co-founder. “Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic.”

___

Jordans reported from Berlin. Associated Press writers Maria Cheng in Toronto and Lorne Cook in Brussels contributed to this report.

Source: https://time.com/5923862/biontech-pfizer-covid-19-vaccine-european-union/

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