A truck driver holds up an urgent medicines sign as he pulls his truck out of Pfizer Manufacturing in Puurs, Belgium. The European Medicines Agency approved a coronavirus vaccine on Monday. AP
A truck driver holds up an urgent medicines sign as he pulls his truck out of Pfizer Manufacturing in Puurs, Belgium. The European Medicines Agency approved a coronavirus vaccine on Monday. AP
A truck driver holds up an urgent medicines sign as he pulls his truck out of Pfizer Manufacturing in Puurs, Belgium. The European Medicines Agency approved a coronavirus vaccine on Monday. AP
A truck driver holds up an urgent medicines sign as he pulls his truck out of Pfizer Manufacturing in Puurs, Belgium. The European Medicines Agency approved a coronavirus vaccine on Monday. AP

Pfizer-BioNTech vaccine gets EU regulator approval


Paul Carey
  • English
  • Arabic

Inoculations against Covid-19 are due to start across the European Union within days after the European Medicines Agency gave approval to the Pfizer-BioNTech coronavirus vaccine.

After a closed-doors meeting on Monday, the EU drug regulator said it was recommending the drug be licensed for use in people over 16 years of age, with some exceptions. The pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

The head of the EU's medicines regulator said it appeared the Pfizer-BioNTech vaccine would protect against a new strain of the coronavirus found mainly in Britain.

"At this moment there is no evidence to suggest this vaccine will not work against the new variant," European Medicines Agency chief Emer Cooke said as she announced approval of the drug.

The decision comes weeks after the vaccine was first granted permission under emergency provisions in Britain and the US. "This is really a historic scientific achievement," Ms Cooke said. "It is a significant step forward in our fight against the pandemic."

The approval needed to be rubber-stamped by the EU’s executive branch on Monday evening.

European Commission President Ursula von der Leyen described it as "Europe's moment". She tweeted that the EMA’s approval was “a decisive moment in our efforts to deliver safe and effective vaccines to Europeans”.

“Now we will act fast. I expect a @EU—Commission decision by this evening,” she said. The EU’s executive arm was expected to require two or three days to approve the EMA’s decision.

Authorities in Germany and several other European countries said they hope to begin vaccinating people on December 27.

“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, the 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 to combat this devastating pandemic.

“We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light."

The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible. The EMA originally set December 29 as the date for its evaluation of the vaccine, but advanced the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.

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

Britain, Canada and the US authorised it to be used under to emergency provisions, meaning the drug is an unlicensed product but its temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide, according to Johns Hopkins University.

Switzerland became the first country on Saturday to authorise the Pfizer-BioNTech vaccine according to normal licensing procedure. EMA approval also follows 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.

In a statement last week that appeared to address concerns by some in Europe about the speed of the process, the agency said: “A vaccine’s benefits in protecting people against Covid-19 must be far greater than any side effect or potential 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 is ongoing because more information on whether the drug works in children is needed, in addition to its effects on pregnant women.

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

On the day Britain began its vaccination campaign, authorities told people with severe allergies not to get the inoculation after two people suffered serious allergic reactions, although it is unclear whether the reactions were caused by the immunisation.

The US Centres for Disease Control and Prevention said that as of Friday it had seen six cases of severe allergic reaction out of more than 250,000 administered doses of the BioNTech-Pfizer vaccine, including in one person with a history of vaccination reactions.

BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the bloc’s executive commission chose to buy 200 million, with an option for 100 million more.

The EMA plans to hold a meeting on January 12 to decide if the coronavirus vaccine made by Moderna should be licensed. It has reviews ongoing for a vaccine developed by the University of Oxford and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.

The five pillars of Islam

1. Fasting 

2. Prayer 

3. Hajj 

4. Shahada 

5. Zakat 

War 2

Director: Ayan Mukerji

Stars: Hrithik Roshan, NTR, Kiara Advani, Ashutosh Rana

Rating: 2/5

ENGLAND SQUAD

Team: 15 Mike Brown, 14 Anthony Watson, 13 Ben Te'o, 12 Owen Farrell, 11 Jonny May, 10 George Ford, 9 Ben Youngs, 1 Mako Vunipola, 2 Dylan Hartley, 3 Dan Cole, 4 Joe Launchbury, 5 Maro Itoje, 6 Courtney Lawes, 7 Chris Robshaw, 8 Sam Simmonds

Replacements 16 Jamie George, 17 Alec Hepburn, 18 Harry Williams, 19 George Kruis, 20 Sam Underhill, 21 Danny Care, 22 Jonathan Joseph, 23 Jack Nowell

if you go

The flights

Etihad, Emirates and Singapore Airlines fly direct from the UAE to Singapore from Dh2,265 return including taxes. The flight takes about 7 hours.

The hotel

Rooms at the M Social Singapore cost from SG $179 (Dh488) per night including taxes.

The tour

Makan Makan Walking group tours costs from SG $90 (Dh245) per person for about three hours. Tailor-made tours can be arranged. For details go to www.woknstroll.com.sg

Coming soon

Torno Subito by Massimo Bottura

When the W Dubai – The Palm hotel opens at the end of this year, one of the highlights will be Massimo Bottura’s new restaurant, Torno Subito, which promises “to take guests on a journey back to 1960s Italy”. It is the three Michelinstarred chef’s first venture in Dubai and should be every bit as ambitious as you would expect from the man whose restaurant in Italy, Osteria Francescana, was crowned number one in this year’s list of the World’s 50 Best Restaurants.

Akira Back Dubai

Another exciting opening at the W Dubai – The Palm hotel is South Korean chef Akira Back’s new restaurant, which will continue to showcase some of the finest Asian food in the world. Back, whose Seoul restaurant, Dosa, won a Michelin star last year, describes his menu as,  “an innovative Japanese cuisine prepared with a Korean accent”.

Dinner by Heston Blumenthal

The highly experimental chef, whose dishes are as much about spectacle as taste, opens his first restaurant in Dubai next year. Housed at The Royal Atlantis Resort & Residences, Dinner by Heston Blumenthal will feature contemporary twists on recipes that date back to the 1300s, including goats’ milk cheesecake. Always remember with a Blumenthal dish: nothing is quite as it seems. 

%3Cp%3EMATA%0D%3Cbr%3EArtist%3A%20M.I.A%0D%3Cbr%3ELabel%3A%20Island%0D%3Cbr%3ERating%3A%203.5%2F5%3C%2Fp%3E%0A
Company%20profile
%3Cp%3E%3Cstrong%3ECompany%20name%3A%20%3C%2Fstrong%3EHakbah%0D%3Cbr%3E%3Cstrong%3EStarted%3A%20%3C%2Fstrong%3E2018%0D%3Cbr%3E%3Cstrong%3EFounder%3A%20%3C%2Fstrong%3ENaif%20AbuSaida%0D%3Cbr%3E%3Cstrong%3EBased%3A%20%3C%2Fstrong%3ESaudi%20Arabia%0D%3Cbr%3E%3Cstrong%3ESector%3A%20%3C%2Fstrong%3EFinTech%0D%3Cbr%3E%3Cstrong%3ECurrent%20number%20of%20staff%3A%20%3C%2Fstrong%3E22%20%0D%3Cbr%3E%3Cstrong%3EInitial%20investment%3A%20%3C%2Fstrong%3E%24200%2C000%0D%3Cbr%3E%3Cstrong%3EInvestment%20stage%3A%20%3C%2Fstrong%3Epre-Series%20A%0D%3Cbr%3E%3Cstrong%3EInvestors%3A%20%3C%2Fstrong%3EGlobal%20Ventures%20and%20Aditum%20Investment%20Management%0D%3Cbr%3E%3Cbr%3E%3C%2Fp%3E%0A
UAE currency: the story behind the money in your pockets
The burning issue

The internal combustion engine is facing a watershed moment – major manufacturer Volvo is to stop producing petroleum-powered vehicles by 2021 and countries in Europe, including the UK, have vowed to ban their sale before 2040. The National takes a look at the story of one of the most successful technologies of the last 100 years and how it has impacted life in the UAE. 

Read part four: an affection for classic cars lives on

Read part three: the age of the electric vehicle begins

Read part two: how climate change drove the race for an alternative 

UAE currency: the story behind the money in your pockets
UAE currency: the story behind the money in your pockets
Francesco Totti's bio

Born September 27, 1976

Position Attacking midifelder

Clubs played for (1) - Roma

Total seasons 24

First season 1992/93

Last season 2016/17

Appearances 786

Goals 307

Titles (5) - Serie A 1; Italian Cup 2; Italian Supercup 2

The five pillars of Islam

1. Fasting

2. Prayer

3. Hajj

4. Shahada

5. Zakat 

The years Ramadan fell in May

1987

1954

1921

1888

PROVISIONAL FIXTURE LIST

Premier League

Wednesday, June 17 (Kick-offs uae times) Aston Villa v Sheffield United 9pm; Manchester City v Arsenal 11pm 

Friday, June 19 Norwich v Southampton 9pm; Tottenham v Manchester United 11pm  

Saturday, June 20 Watford v Leicester 3.30pm; Brighton v Arsenal 6pm; West Ham v Wolves 8.30pm; Bournemouth v Crystal Palace 10.45pm 

Sunday, June 21 Newcastle v Sheffield United 2pm; Aston Villa v Chelsea 7.30pm; Everton v Liverpool 10pm 

Monday, June 22 Manchester City v Burnley 11pm (Sky)

Tuesday, June 23 Southampton v Arsenal 9pm; Tottenham v West Ham 11.15pm 

Wednesday, June 24 Manchester United v Sheffield United 9pm; Newcastle v Aston Villa 9pm; Norwich v Everton 9pm; Liverpool v Crystal Palace 11.15pm

Thursday, June 25 Burnley v Watford 9pm; Leicester v Brighton 9pm; Chelsea v Manchester City 11.15pm; Wolves v Bournemouth 11.15pm

Sunday June 28 Aston Villa vs Wolves 3pm; Watford vs Southampton 7.30pm 

Monday June 29 Crystal Palace vs Burnley 11pm

Tuesday June 30 Brighton vs Manchester United 9pm; Sheffield United vs Tottenham 11.15pm 

Wednesday July 1 Bournemouth vs Newcastle 9pm; Everton vs Leicester 9pm; West Ham vs Chelsea 11.15pm

Thursday July 2 Arsenal vs Norwich 9pm; Manchester City vs Liverpool 11.15pm

 

Benefits of first-time home buyers' scheme
  • Priority access to new homes from participating developers
  • Discounts on sales price of off-plan units
  • Flexible payment plans from developers
  • Mortgages with better interest rates, faster approval times and reduced fees
  • DLD registration fee can be paid through banks or credit cards at zero interest rates
GAC GS8 Specs

Engine: 2.0-litre 4cyl turbo

Power: 248hp at 5,200rpm

Torque: 400Nm at 1,750-4,000rpm

Transmission: 8-speed auto

Fuel consumption: 9.1L/100km

On sale: Now

Price: From Dh149,900

The years Ramadan fell in May

1987

1954

1921

1888

The biog

Age: 59

From: Giza Governorate, Egypt

Family: A daughter, two sons and wife

Favourite tree: Ghaf

Runner up favourite tree: Frankincense 

Favourite place on Sir Bani Yas Island: “I love all of Sir Bani Yas. Every spot of Sir Bani Yas, I love it.”

WORLD CUP SEMI-FINALS

England v New Zealand

(Saturday, 12pm UAE)

Wales v South Africa

(Sunday, 12pm, UAE)

 

The burning issue

The internal combustion engine is facing a watershed moment – major manufacturer Volvo is to stop producing petroleum-powered vehicles by 2021 and countries in Europe, including the UK, have vowed to ban their sale before 2040. The National takes a look at the story of one of the most successful technologies of the last 100 years and how it has impacted life in the UAE.

Read part three: the age of the electric vehicle begins

Read part two: how climate change drove the race for an alternative 

Read part one: how cars came to the UAE

Infiniti QX80 specs

Engine: twin-turbocharged 3.5-liter V6

Power: 450hp

Torque: 700Nm

Price: From Dh450,000, Autograph model from Dh510,000

Available: Now

The specs

Engine: 2.3-litre, turbo four-cylinder

Transmission: 10-speed auto

Power: 300hp

Torque: 420Nm

Price: Dh189,900

On sale: now

MEYDAN CARD

6.30pm Al Maktoum Challenge Round-1 Group One (PA) US$65,000 (Dirt) 1,600m

7.05pm Handicap (TB) $175,000 (Turf) 1,200m

7.40pm UAE 2000 Guineas Trial Conditions (TB) $100,000 (D) 1,600m

8.15pm Singspiel Stakes Group Two (TB) $250,000 (T) 1,800m

8.50pm Handicap (TB) $135,000 (T) 1,600m

9.25pm Al Maktoum Challenge Round-1 Group Two (TB) $350,000 (D) 1,600m

10pm Dubai Trophy Conditions (TB) $100,000 (T) 1,200m

10.35pm Handicap (TB) $135,000 (T) 1,600m

The National selections:

6.30pm AF Alwajel

7.05pm Ekhtiyaar

7.40pm First View

8.15pm Benbatl

8.50pm Zakouski

9.25pm: Kimbear

10pm: Chasing Dreams

10.35pm: Good Fortune

While you're here

Company profile

Name: Oulo.com

Founder: Kamal Nazha

Based: Dubai

Founded: 2020

Number of employees: 5

Sector: Technology

Funding: $450,000

UAE currency: the story behind the money in your pockets
The specs
Engine: 4.0-litre flat-six
Power: 510hp at 9,000rpm
Torque: 450Nm at 6,100rpm
Transmission: 7-speed PDK auto or 6-speed manual
Fuel economy, combined: 13.8L/100km
On sale: Available to order now
Price: From Dh801,800