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Health & Fit AstraZeneca vaccine: EU regulators recommend authorization of Covid-19 shot

10:00  30 january  2021
10:00  30 january  2021 Source:   cnn.com

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The European Union's medicines regulator on Friday recommended authorizing the Oxford-AstraZeneca Covid-19 vaccine for use among its 27 member states, capping off a turbulent week which saw the bloc attack the drugmaker over delays to supply.

A laboratory technician supervises capped vials during filling and packaging tests for the large-scale production and supply of the University of Oxfords COVID-19 vaccine candidate, AZD1222, conducted on a high-performance aseptic vial filling line on September 11, 2020 at the Italian biologics manufacturing facility of multinational corporation Catalent in Anagni, southeast of Rome, during the COVID-19 infection, caused by the novel coronavirus. - Catalent Biologics manufacturing facility in Anagni, Italy will serve as the launch facility for the large-scale production and supply of the University of Oxfords Covid-19 vaccine candidate, AZD1222, providing large-scale vial filling and packaging to British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca. (Photo by Vincenzo PINTO / AFP) (Photo by VINCENZO PINTO/AFP via Getty Images) © Vincenzo Pinto/AFP/Getty Images A laboratory technician supervises capped vials during filling and packaging tests for the large-scale production and supply of the University of Oxfords COVID-19 vaccine candidate, AZD1222, conducted on a high-performance aseptic vial filling line on September 11, 2020 at the Italian biologics manufacturing facility of multinational corporation Catalent in Anagni, southeast of Rome, during the COVID-19 infection, caused by the novel coronavirus. - Catalent Biologics manufacturing facility in Anagni, Italy will serve as the launch facility for the large-scale production and supply of the University of Oxfords Covid-19 vaccine candidate, AZD1222, providing large-scale vial filling and packaging to British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca. (Photo by Vincenzo PINTO / AFP) (Photo by VINCENZO PINTO/AFP via Getty Images)

The long-awaited decision from the European Medicines Agency (EMA) came after several EU countries warned they were running out of vaccine doses, and as coronavirus deaths pile up across the continent.

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In a bid to tackle concerns over supply, the European Commission also adopted new measures Friday that could restrict the exporting of Covid-19 vaccines outside the bloc in some situations.

The EMA's authorization of the vaccine for use in all adults stands in contrast to an announcement by the German vaccine commission Thursday that it would not recommend the AstraZeneca vaccine for people aged 65 or over because of insufficient data.

In a statement, the EMA said most of the participants in AstraZeneca's clinical trials were between 18 and 55 years old, meaning there was limited data on how well the vaccine would work in older people.

"However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA's scientific experts considered that the vaccine can be used in older adults," it said. "More information is expected from ongoing studies, which include a higher proportion of elderly participants."

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The EMA authorization recommends giving the second dose within four and 12 weeks after the first.

The United Kingdom, which authorized AstraZeneca's vaccine on December 30, has been administering doses to people older than 65 for nearly a month. Health officials there have adopted a policy of extending the interval between the doses up to 12 weeks in order to give more people the protection of a first dose as soon as possible.

AstraZeneca CEO Pascal Soriot welcomed the EMA's decision. "Today's recommendation underscores the value of AstraZeneca's Covid-19 vaccine, which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalizations," he said.

The Oxford/AstraZeneca vaccine is the third to be given authorization for use in people aged 18 and over by the EMA. It is cheaper and easier to transport and store than the other two, produced by Pfizer/BioNTech and Moderna.

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Supply dispute

For the past week, the EU and AstraZeneca have been locked in an acrimonious dispute over vaccine supplies. A week ago, the British-Swedish pharmaceutical giant said it would not be able to deliver as many doses as the European Union expected because of production issues at a manufacturing site, upending the bloc's vaccination plans.

The disagreement is playing out against a dire backdrop. EU countries including Germany were already running low on vaccines even before the AstraZeneca vaccine was authorized Friday. The US drugmaker Pfizer had previously slowed EU deliveries of the vaccine it developed with BioNTech while a manufacturing facility was upgraded.

The European Commission -- which ordered 400 million AstraZeneca doses on behalf of EU member states and is poised to start rolling the first ones out across the bloc -- said the delay was unacceptable, and the drugmaker must find a way to increase supply.

Earlier this week, Soriot told Italy's la Repubblica that at least 3 million doses would be shipped to Europe as soon as the vaccine was authorized, and that the goal was to deliver 17 million total doses by the end of February.

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During a briefing on Friday, he explained that delays and teething issues on some production sites were inevitable. "Manufacturing ... vaccines is extremely complicated, it's not like (making) orange juice."

He added that the company is "focused on supplying the European Union but at the end of the day everybody needs to recognize that it's a complicated process.

"The problem is what we've done nobody thought was possible nine months ago and now that it has been done, people take it for granted and they think it's simple, it is not simple, it is very complicated and some issues will happen," Soriot said.

The European Commission published on its website Friday the redacted contract signed with AstraZeneca for the purchase of its vaccine for all the EU member states.

The EU had asked AstraZeneca to publish the contract, signed on August 27, following the company's announcement of delays. The details of the vaccine delivery schedule have been redacted from the published document.

Vaccine export measures

The commission announced new restrictions Friday that made Covid-19 vaccines manufactured in the bloc subject to export authorization. It said the new mechanism would not affect humanitarian aid or COVAX, the global initiative aiming to distribute some 2 billion vaccines to poorer countries.

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Speaking in Brussels earlier on Friday, European Commission executive vice-president Valdis Dombrovski said that "the measure is time limited and specifically applies to those Covid-19 vaccines that were agreed by advance purchase agreements.

He added that "the protection and safety of our citizens is a priority and the challenges we now face left us with now other choice but to act."

"We are not in competition or in a race against any country," said European Health Commissioner Stella Kyriakides, speaking alongside Dombrovskis. "The only race we are in is against this virus, and this is what has been at the center of every single piece of work that we have been doing for almost a year."

As part of the export measures on vaccines, the EU stated that there was a risk of vaccines leaving the bloc via the Republic of Ireland, an EU member state, and entering Northern Ireland, which is part of the UK but has special status allowing trade on the island of Ireland.

In acknowledging this, the EU said that it was willing to use Article 16 of the Northern Ireland protocol -- an emergency measure that could be used by either the UK or the EU to retain stability on the island of Ireland.

If the EU invoked Article 16, that would mean it would restrict any effort to use Northern Ireland as a backdoor to circumvent export controls. But even raising the prospect of invoking Article 16 is extremely controversial.

It suggested that the EU would be willing to place restrictions on items moving between the two Irish nations, something all sides wanted to avoid during Brexit negotiations for fear of cross-border sectarian violence returning to the island.

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UK Prime Minister Boris Johnson expressed his "grave concerns about the potential impact" of such a move during a call with European Commission President Ursula Von Der Leyen on Friday evening, according to a 10 Downing Street spokesperson.

Then, in an apparent backtrack late Friday night, the commission issued a statement saying it will not trigger the Article 16 emergency Brexit clause.

"In the process of finalisation of this measure, the Commission will ensure that the Ireland / Northern Ireland Protocol is unaffected. The Commission is not triggering the safeguard clause," the Commision statement said.

However, the commission warned that "should transits of vaccines and active substances toward third countries be abused to circumvent the effects of the authorisation system, the EU will consider using all the instruments at its disposal."

In response to the sudden about face from Brussels, the Irish leader, Taoiseach Micheál Martin, said he "welcomed the decision by the EU not to invoke the safeguard clause of the Ireland/Northern Ireland Protocol."

"This is a positive development given the many challenges we face in tackling COVID-19," he added.

The Irish foreign minister, Simon Coveney, also welcomed the move and said lessons should be learned. "The Protocol is not something to be tampered with lightly, it's an essential, hard won compromise, protecting peace and trade for many," Coveney said on Twitter.

Concerns over expected shortages of the Moderna and Pfizer/BioNTech vaccines means some French regions, including Paris, will push back or cancel appointments for first injections, the French health ministry said in a press statement on Thursday.

In Spain, the regional government of Madrid stopped administering first doses of vaccine on Wednesday for the next two weeks to ensure there is enough to provide second doses for those who already got their first shots.

The death toll from Covid-19 is mounting, and the slow rollout of shots across the bloc is threatening a very fragile economic recovery from the pandemic. This week only 2 out of 100 people received jabs in the EU, compared to 7 out of 100 people in the US and 11 out of 100 in the UK, according to figures from Our World in Data.

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