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#GlobalCoronavirusResponse - EU sends assistance to tackle pandemic in #Kenya, #Bangladesh, #Ecuador and #ElSalvador

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This week, the EU continues its global deliveries of medical supplies and personal protective equipment. Through the EU Civil Protection Mechanism, in response to a request from Kenya, Slovakia has sent 20,000 protective face masks, 50,000 coronavirus test kits, hand disinfectant and laboratory supplies to the country. On its return to Europe the Slovak flight will repatriate EU citizens stranded in Kenya due to the coronavirus pandemic. Furthermore, France is sending medical supplies and equipment to Bangladesh, Ecuador and El Salvador this week via the Mechanism. 

“To limit the spread of the coronavirus we have to act together, globally. I am proud to see Slovakia provide vital protective and medical equipment to Kenya and France's offer for assistance to Bangladesh, Ecuador and El Salvador, with EU support. The EU's global response is helping tackle the pandemic on multiple fronts,” said Crisis Management Commissioner Janez Lenarčič. Protective equipment such as masks, but also test kits and other material, have proven vital to slow down the spread of the coronavirus.  Any country in the world can call on the EU Civil Protection Mechanism for help. During this ongoing pandemic, the Mechanism has co-ordinated the delivery of assistance to 24 countries, including seven EU member states, on top of bilateral offers.

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Brexit Britain just approved a European vaccine, German health minister says

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Celebrating Britain’s swift approval of BioNtech and Pfizer’s coronavirus vaccine as a benefit of Brexit is misplaced since the vaccine was itself a product of the European Union that Britain has left, German Health Minister Jens Spahn (pictured) said, writes Thomas Escritt.

Spahn told journalists that while Britain had been the first to approve the vaccine, he was optimistic that the European Medicines Agency would soon follow. The time difference was due to Britain and the US having conducted an emergency approval process, while the EU was using a regular process.

“But a few remarks on Brexit to my British friends: Biontech is a European development, from the EU. The fact that this EU product is so good that Britain approved it so quickly shows that in this crisis European and international cooperation are best,” he said.

Some have suggested that Britain having its own medicines approval meant it could move more nimbly than the EU’s bloc-wide agency.

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EU criticizes 'hasty' UK approval of COVID-19 vaccine

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The European Union criticized Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday (2 December), saying its own procedure was more thorough, after Britain became the first western country to endorse a COVID-19 shot, writes .

The move to grant emergency authorization to the Pfizer/BioNTech vaccine has been seen by many as a political coup for UK Prime Minister Boris Johnson, who has led his country out of the EU and faced criticism for his handling of the pandemic.

The decision was made under an ultra-fast, emergency approval process, which allowed the British drugs regulator to temporarily authorise the vaccine only ten days after it began examining data from large-scale trials.

In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.

The agency said on Tuesday it would decide by Dec. 29 whether to provisionally authorise the vaccine from U.S. drugmaker Pfizer and its German partner BioNTech.

A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.

June Raine, the head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), defended its decision.

“The way in which the MHRA has worked is equivalent to all international standards,” she said.

“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” she added.

The EMA started a rolling review of preliminary data from Pfizer trials on 6 October, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data.

The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA.

“The idea is not to be first but to have a safe and effective vaccine,” Germany’s Health Minister Jens Spahn told a news conference.

Asked about the emergency procedure used by Britain, he said EU countries had opted for a more thorough procedure to boost confidence in vaccines.

“If you evaluate only the partial data as they are doing they also take a minimum of risk,” the EMA’s former head Guido Rasi told an Italian radio.

“Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first,” he added.

EU lawmakers were even more explicit in their criticism of Britain’s move.

“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.

“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorization of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU Parliament.

Under EU rules, the Pfizer vaccine must be authorized by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use.

Britain is still subject to EU rules until it fully leaves the bloc at the end of the year.

“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the Parliament.

“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”

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President von der Leyen at the EU Health Summit

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On 1 December, European Commission President Ursula von der Leyen gave a speech at the virtually held EU Health Summit. In her address, the president emphasized the need for a common and global response to defeat the virus: “The challenge of this pandemic is unprecedented in modern times. We now know that defeating this virus is possible. But no country and no government can defeat the virus alone. This is true, first of all, at the global level. Secondly, inside Europe. And thirdly, between the public and the private sectors. The EU has taken the lead to convene a global response to COVID-19.” 

President von der Leyen also recalled the “unprecedented co-operation on health issues” in the European Union during the past months, putting us on the path to establishing a European Health Union. This will improve EU-wide preparedness and responsiveness, give more responsibilities and resources to the European Centre for Disease Prevention and Control and to the European Medicines Agency, and allow for close co-operation with the private sector in medicines development and supply.

“Governments alone cannot end this pandemic. That's why the Commission presented last week its Pharmaceutical Strategy. It is about creating win-win situations with the private sector. But we also want to put patients at the centre of medicines development and supply. Europe can take the lead in supplying ground-breaking medicines that are also affordable and widely available”, she said.

Finally, President von der Leyen repeated the mantra that “vaccines don't save lives, vaccinations do”, and that that “development of vaccines has been a remarkable team effort”, but that to deliver them to everyone in the world, we will need an even greater effort: “Vaccination is about self-protection and solidarity.”

Read the full speech here.

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