Visitors arrive to receive doses of the Pfizer-BioNTech Covid-19 vaccine at a centre in Wurzburg, Germany. Alex Kraus/Bloomberg
Visitors arrive to receive doses of the Pfizer-BioNTech Covid-19 vaccine at a centre in Wurzburg, Germany. Alex Kraus/Bloomberg
Visitors arrive to receive doses of the Pfizer-BioNTech Covid-19 vaccine at a centre in Wurzburg, Germany. Alex Kraus/Bloomberg
Visitors arrive to receive doses of the Pfizer-BioNTech Covid-19 vaccine at a centre in Wurzburg, Germany. Alex Kraus/Bloomberg

Urgent European warning on vaccine intervals as agency reviews Moderna approval


Nicky Harley
  • English
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Europe's medicine regulator has warned countries not to go it alone with single-dose injections as pressure builds on governments to speed up vaccination.

The European Medicines Agency said on Monday the maximum interval should be 42 days between the first and the second dose of the Pfizer-BioNtech vaccine.

Evidence of the vaccine's efficacy is based on a study where doses were administered 19 to 42 days apart, the agency said.

It said that full protection came seven days after the booster.

"Any change to this would require a variation to the marketing authorisation as well as more clinical data to support such a change, otherwise it would be considered as 'off-label use'," the agency said.

Europe is battling to catch up in the vaccine race as authorities face criticism for being slow.

Denmark became the latest country to follow a British initiative to stretch the interlude between doses to maximise the number of people receiving the initial injection.

Talks on approving the Moderna vaccine were brought forward to Monday.

The European Commission was forced to defend its strategy after being accused of failing to deliver enough doses.

Member states have complained that Europe’s Covid-19 response has been far too slow compared to those of Britain and the US.

They have pushed through emergency authorisation of two vaccines.

Last week, French President Emmanuel Macron said he would “not let an unjustified slowness take hold”.

The first doses of the AstraZeneca-University of Oxford vaccine were administered in England on Monday.

The UK has ordered about 100 million doses of that vaccine, enough to give 50 million people the two shots required, and last month Britain became the first country to use the Pfizer-BioNTech inoculation.

In Finland, health authorities were reportedly unhappy that about 40,000 doses were received in December, instead of the 300,000 expected.

European Commission spokesman Eric Mamer said the main problem with distribution “is an issue of production capacity, an issue that everybody is facing".

“We have actually signed contracts that would allow member states access to two billion doses, largely enough to vaccinate the whole of the EU population," Mr Mamer said.

As part of its strategy, the EU has sealed six vaccine contracts, with Moderna, AstraZeneca, Sanofi-GSK, Pfizer/BioNTech, Janssen Pharmaceutica and CureVac.

Only the Pfizer/BioNTech vaccine, which has to be stored at ultra-low temperatures, has been approved for use so far in the 27-nation EU.

The European Medicine Agency said its human medicine committee was meeting on Monday “to discuss the Moderna vaccine”.

The Agency in Amsterdam had been scheduled to discuss authorising the Pfizer-BioNTech vaccine for use on Wednesday.

“The meeting scheduled for Wednesday, January 6, is also still planned in case the committee does not reach a decision today,” the agency said.

Mr Mamer also clarified the role of the commission in securing contracts with drug makers.

He said the body did not buy doses of vaccines directly but “acted as an investor" to provide funding to pharmaceutical companies involved in their development.

The goal was to speed up research and production capacity, with each EU nation free to decide how many doses it would buy from the makers of its choice.

“Ultimately, these vaccines have to be produced, delivered, and some of the logistic chains involved are very sophisticated," Mr Mamer said.

Major deliveries of doses were anticipated by April, he said.

Asked why the European Commission did not buy more doses of the Pfizer-BioNTech vaccine, health policy spokesman Stefan de Keersmaecker said the “main philosophy was to diversify our portfolio, not to put all our eggs in one basket".

Mr de Keersmaecker said the contract with Moderna was for an initial purchase of 80 million doses on behalf of all EU nations, but the commission intends to double that when the vaccine is approved.

It has an option for another 100 million Pfizer-BioNTech doses that will bring the total to 300 million, he said.

Last week, the agency said EU approval of the AstraZeneca-Oxford vaccine in the next month was unlikely.

Wayne Rooney's career

Everton (2002-2004)

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  • Goals: 17
     

Manchester United (2004-2017)

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England (2003-)

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At Everton Appearances: 77; Goals: 17

At Manchester United Appearances: 559; Goals: 253

Company Profile

Company name: Fine Diner

Started: March, 2020

Co-founders: Sami Elayan, Saed Elayan and Zaid Azzouka

Based: Dubai

Industry: Technology and food delivery

Initial investment: Dh75,000

Investor: Dtec Startupbootcamp

Future plan: Looking to raise $400,000

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Tokenisation refers to the issuance of a blockchain token, which represents a virtually tradable real, tangible asset. A tokenised asset is easily transferable, offers good liquidity, returns and is easily traded on the secondary markets. 

UAE currency: the story behind the money in your pockets
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Who was Alfred Nobel?

The Nobel Prize was created by wealthy Swedish chemist and entrepreneur Alfred Nobel.

  • In his will he dictated that the bulk of his estate should be used to fund "prizes to those who, during the preceding year, have conferred the greatest benefit to humankind".
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Engine: 2.0-litre 4-cyl, 48V hybrid

Transmission: eight-speed automatic

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AWARDS
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Directed by: Michael Fimognari

Starring: Lana Condor and Noah Centineo

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The specs

Engine: 3.8-litre, twin-turbo V8

Transmission: eight-speed automatic

Power: 582bhp

Torque: 730Nm

Price: Dh649,000

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The specs

Engine: 2.0-litre four-cylinder turbo

Power: 178hp at 5,500rpm

Torque: 280Nm at 1,350-4,200rpm

Transmission: seven-speed dual-clutch auto

Price: from Dh209,000 

On sale: now

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Founder: Ahmed Wadi

Launched: 2016

Employees: 76

Financing stage: Series A ($4 million)

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Most wins by a jockey: Jerry Bailey(4)

Most wins by an owner: Godolphin(9)

Most wins by a horse: Godolphin’s Thunder Snow(2)

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Defenders: Trent Alexander-Arnold, Conor Coady, Marc Guehi, Reece James, Harry Maguire, Tyrone Mings, Luke Shaw, John Stones, Ben White

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Oct 8: Malaysia (h)
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The Specs

Engine 3.8-litre, twin-turbo V8

Transmission: eight-speed automatic

Power: 582bhp (542bhp in GTS model)

Torque: 730Nm

Price: Dh649,000 (Dh549,000 for GTS) 

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Rating: 1/5

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Anthony Anderson, Black-ish
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Ted Danson, The Good Place
Michael Douglas, The Kominsky Method
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Christina Applegate, Dead to Me
Rachel Brosnahan, The Marvelous Mrs. Maisel
Linda Cardellini, Dead to Me
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Tracee Ellis Ross, Black-ish

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The Daily Show with Trevor Noah
Full Frontal with Samantha Bee
Jimmy Kimmel Live
Last Week Tonight with John Oliver
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Jennifer Aniston, The Morning Show
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Cate Blanchett, Mrs. America
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Watchmen

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Curb Your Enthusiasm
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The Kominsky Method
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Schitt’s Creek
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Better Call Saul
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Killing Eve
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Arsenal win 5-4 on penalties

Man of the Match: Ainsley Maitland-Niles (Arsenal)

Red flags
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THE SPECS

Engine: 1.6-litre turbo

Transmission: six-speed automatic

Power: 165hp

Torque: 240Nm

Price: From Dh89,000 (Enjoy), Dh99,900 (Innovation)

On sale: Now