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.

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The seven points are:

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Al Dhafra Street

Rabdan Street

Umm Yifina Street exit (inbound)

Ten tax points to be aware of in 2026

1. Domestic VAT refund amendments: request your refund within five years

If a business does not apply for the refund on time, they lose their credit.

2. E-invoicing in the UAE

Businesses should continue preparing for the implementation of e-invoicing in the UAE, with 2026 a preparation and transition period ahead of phased mandatory adoption. 

3. More tax audits

Tax authorities are increasingly using data already available across multiple filings to identify audit risks. 

4. More beneficial VAT and excise tax penalty regime

Tax disputes are expected to become more frequent and more structured, with clearer administrative objection and appeal processes. The UAE has adopted a new penalty regime for VAT and excise disputes, which now mirrors the penalty regime for corporate tax.

5. Greater emphasis on statutory audit

There is a greater need for the accuracy of financial statements. The International Financial Reporting Standards standards need to be strictly adhered to and, as a result, the quality of the audits will need to increase.

6. Further transfer pricing enforcement

Transfer pricing enforcement, which refers to the practice of establishing prices for internal transactions between related entities, is expected to broaden in scope. The UAE will shortly open the possibility to negotiate advance pricing agreements, or essentially rulings for transfer pricing purposes. 

7. Limited time periods for audits

Recent amendments also introduce a default five-year limitation period for tax audits and assessments, subject to specific statutory exceptions. While the standard audit and assessment period is five years, this may be extended to up to 15 years in cases involving fraud or tax evasion. 

8. Pillar 2 implementation 

Many multinational groups will begin to feel the practical effect of the Domestic Minimum Top-Up Tax (DMTT), the UAE's implementation of the OECD’s global minimum tax under Pillar 2. While the rules apply for financial years starting on or after January 1, 2025, it is 2026 that marks the transition to an operational phase.

9. Reduced compliance obligations for imported goods and services

Businesses that apply the reverse-charge mechanism for VAT purposes in the UAE may benefit from reduced compliance obligations. 

10. Substance and CbC reporting focus

Tax authorities are expected to continue strengthening the enforcement of economic substance and Country-by-Country (CbC) reporting frameworks. In the UAE, these regimes are increasingly being used as risk-assessment tools, providing tax authorities with a comprehensive view of multinational groups’ global footprints and enabling them to assess whether profits are aligned with real economic activity. 

Contributed by Thomas Vanhee and Hend Rashwan, Aurifer

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Dubai launched the pilot phase of its real estate tokenisation project last month.

The initiative focuses on converting real estate assets into digital tokens recorded on blockchain technology and helps in streamlining the process of buying, selling and investing, the Dubai Land Department said.

Dubai’s real estate tokenisation market is projected to reach Dh60 billion ($16.33 billion) by 2033, representing 7 per cent of the emirate’s total property transactions, according to the DLD.

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Engine 1,170cc air/oil-cooled flat twin four-stroke engine

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Date started: Okadoc, 2018

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Based: Dubai, UAE

Sector: Healthcare

Size: (employees/revenue) 40 staff; undisclosed revenues recording “double-digit” monthly growth

Funding stage: Series B fundraising round to conclude in February

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Start-up hopes to end Japan's love affair with cash

Across most of Asia, people pay for taxi rides, restaurant meals and merchandise with smartphone-readable barcodes — except in Japan, where cash still rules. Now, as the country’s biggest web companies race to dominate the payments market, one Tokyo-based startup says it has a fighting chance to win with its QR app.

Origami had a head start when it introduced a QR-code payment service in late 2015 and has since signed up fast-food chain KFC, Tokyo’s largest cab company Nihon Kotsu and convenience store operator Lawson. The company raised $66 million in September to expand nationwide and plans to more than double its staff of about 100 employees, says founder Yoshiki Yasui.

Origami is betting that stores, which until now relied on direct mail and email newsletters, will pay for the ability to reach customers on their smartphones. For example, a hair salon using Origami’s payment app would be able to send a message to past customers with a coupon for their next haircut.

Quick Response codes, the dotted squares that can be read by smartphone cameras, were invented in the 1990s by a unit of Toyota Motor to track automotive parts. But when the Japanese pioneered digital payments almost two decades ago with contactless cards for train fares, they chose the so-called near-field communications technology. The high cost of rolling out NFC payments, convenient ATMs and a culture where lost wallets are often returned have all been cited as reasons why cash remains king in the archipelago. In China, however, QR codes dominate.

Cashless payments, which includes credit cards, accounted for just 20 per cent of total consumer spending in Japan during 2016, compared with 60 per cent in China and 89 per cent in South Korea, according to a report by the Bank of Japan.

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