Europe’s medicines regulator has found a “possible link” between the Covid-19 vaccine developed by Johnson & Johnson and rare blood clots in adults who received the shot in the US.
The European Medicines Agency said on Tuesday its safety committee concluded that a warning about unusual blood clots with low blood platelets should be added to the vaccine’s labels as a “very rare side effect”.
It said all reported blood clot cases occurred in adults aged under 60 – mostly women – within three weeks of vaccination.
All available evidence, including eight reports of cases in the US, were part of its assessment, it said.
The EMA said most blood clots had occurred in the brain and abdomen, but reiterated that the vaccine’s overall benefits outweigh the risks.
Concerns over J&J’s vaccine follow similar reports of blood clots in a minute number of people who received the AstraZeneca shot.
The ruling allows European governments to make their own decisions on whether to restrict use of the vaccine to a certain age or patient groups, as countries such as Germany and France have chosen to do with AstraZeneca.
Last week, J&J halted its European distribution of the vaccine after US officials recommended a pause when six blood clot cases were identified among about seven million people immunised with the shot.
The company advised European governments to store their doses until the EU drug regulator issued advice on their use.
Widespread use of the vaccine has not started yet on the continent, but EU officials had hoped the one-shot vaccine could be used to boost inoculation rates. The vaccine, which uses similar technology to AstraZeneca’s vaccine, does not need to be stored at ultra-low temperatures, unlike the Pfizer-BioNTech vaccine, and can therefore be delivered to remote communities.
The EU ordered 200 million doses of J&J’s Covid-19 vaccine for 2021.
The US medicines regulator is due to make its own ruling on Friday. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said the watchdog may still allow the use of the shot with some form of restriction or warning.
J&J said earlier on Tuesday it was “very confident” in its vaccine and hopeful for a quick resolution from regulators over its status.
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What: 11th edition of the Mubadala World Tennis Championship
When: December 27-29, 2018
Confirmed: men: Novak Djokovic, Rafael Nadal, Kevin Anderson, Dominic Thiem, Hyeon Chung, Karen Khachanov; women: Venus Williams
Tickets: www.ticketmaster.ae, Virgin megastores or call 800 86 823
Liverpool's all-time goalscorers
Ian Rush 346
Roger Hunt 285
Mohamed Salah 250
Gordon Hodgson 241
Billy Liddell 228
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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
Our family matters legal consultant
Name: Hassan Mohsen Elhais
Position: legal consultant with Al Rowaad Advocates and Legal Consultants.
When Umm Kulthum performed in Abu Dhabi
Known as The Lady of Arabic Song, Umm Kulthum performed in Abu Dhabi on November 28, 1971, as part of celebrations for the fifth anniversary of the accession of Sheikh Zayed bin Sultan Al Nahyan as Ruler of Abu Dhabi. A concert hall was constructed for the event on land that is now Al Nahyan Stadium, behind Al Wahda Mall. The audience were treated to many of Kulthum's most well-known songs as part of the sold-out show, including Aghadan Alqak and Enta Omri.
Sholto Byrnes on Myanmar politics
