A Food and Drug Administration panel has recommended the emergency-use approval of the Johnson & Johnson Covid-19 vaccine.
This paves the way for it to become the first single-dose vaccine approved for use in the US.
The vaccine advisory panel voted unanimously for the agency commissioner to issue emergency-use approval.
Its decision makes Johnson & Johnson the third approved vaccine in the US, following vaccines from Pfizer-BioNTech and Moderna, both approved last December.
Johnson & Johnson’s Covid-19 vaccine has the advantage of being a single-dose shot that can be stored in a regular refrigerator, whereas the other vaccines require two doses.
At first, Pfizer-BioNTech's vaccine appeared to require ultra-cold storage, but the FDA approved the company's claim that the vaccine did not actually need it.
The Johnson & Johnson vaccine was found to be 72 per cent effective in a US trial, but less so in South Africa and South America, with variants threatening the efficacy of vaccines.
FDA briefing documents also stated that the Johnson & Johnson vaccine was effective in reducing the risk of Covid-19, preventing asymptomatic infections and avoiding medical intervention.
No patient in the vaccine trial was admitted to hospital or died from Covid-19.
Bahrain was the first country to issue emergency approval of the vaccine.
The panel held a day-long meeting to review information, discuss concerns and address questions about the vaccine before it held its vote.
The FDA is not bound to follow what the panel recommends, but it often does.
Its commissioner could issue the emergency-use approval within the next few days.
President Joe Biden's administration has ordered 100 million doses from Johnson & Johnson.
The company says it is ready to send out 20 million in March, after it receives full approval, and projects it can send the remaining 80 million by June.
The US is dealing with the worst coronavirus outbreak in the world, with the highest death toll and the most recorded cases.
It passed 500,000 fatalities on Tuesday.
The vaccination programme is well under way in the US. The Centres for Disease Control and Prevention report more than 14 per cent of Americans have received one vaccine dose, while 6.8 per cent have been fully vaccinated.
Cases, deaths and hospital admissions had been on the decline from the worst surge in December and January until this week, when the downward trend appears to have stalled.
There is growing concern that with new highly transmissible variants spreading, there may be another small surge of cases.
The expectation is that the UK variant will become the dominant US coronavirus strain in March, while health authorities are monitoring ones detected in California and New York.
The rise of new variants is further emphasising the need for widespread vaccination.
Centres for Disease Control Director Rochelle Walensky said at the White House Covid-19 task force briefing Friday: "We may be done with the virus but clearly the virus is not done with us."
COMPANY PROFILE
Name: HyperSpace
Started: 2020
Founders: Alexander Heller, Rama Allen and Desi Gonzalez
Based: Dubai, UAE
Sector: Entertainment
Number of staff: 210
Investment raised: $75 million from investors including Galaxy Interactive, Riyadh Season, Sega Ventures and Apis Venture Partners
Where to donate in the UAE
The Emirates Charity Portal
You can donate to several registered charities through a “donation catalogue”. The use of the donation is quite specific, such as buying a fan for a poor family in Niger for Dh130.
The General Authority of Islamic Affairs & Endowments
The site has an e-donation service accepting debit card, credit card or e-Dirham, an electronic payment tool developed by the Ministry of Finance and First Abu Dhabi Bank.
Al Noor Special Needs Centre
You can donate online or order Smiles n’ Stuff products handcrafted by Al Noor students. The centre publishes a wish list of extras needed, starting at Dh500.
Beit Al Khair Society
Beit Al Khair Society has the motto “From – and to – the UAE,” with donations going towards the neediest in the country. Its website has a list of physical donation sites, but people can also contribute money by SMS, bank transfer and through the hotline 800-22554.
Dar Al Ber Society
Dar Al Ber Society, which has charity projects in 39 countries, accept cash payments, money transfers or SMS donations. Its donation hotline is 800-79.
Dubai Cares
Dubai Cares provides several options for individuals and companies to donate, including online, through banks, at retail outlets, via phone and by purchasing Dubai Cares branded merchandise. It is currently running a campaign called Bookings 2030, which allows people to help change the future of six underprivileged children and young people.
Emirates Airline Foundation
Those who travel on Emirates have undoubtedly seen the little donation envelopes in the seat pockets. But the foundation also accepts donations online and in the form of Skywards Miles. Donated miles are used to sponsor travel for doctors, surgeons, engineers and other professionals volunteering on humanitarian missions around the world.
Emirates Red Crescent
On the Emirates Red Crescent website you can choose between 35 different purposes for your donation, such as providing food for fasters, supporting debtors and contributing to a refugee women fund. It also has a list of bank accounts for each donation type.
Gulf for Good
Gulf for Good raises funds for partner charity projects through challenges, like climbing Kilimanjaro and cycling through Thailand. This year’s projects are in partnership with Street Child Nepal, Larchfield Kids, the Foundation for African Empowerment and SOS Children's Villages. Since 2001, the organisation has raised more than $3.5 million (Dh12.8m) in support of over 50 children’s charities.
Noor Dubai Foundation
Sheikh Mohammed bin Rashid Al Maktoum launched the Noor Dubai Foundation a decade ago with the aim of eliminating all forms of preventable blindness globally. You can donate Dh50 to support mobile eye camps by texting the word “Noor” to 4565 (Etisalat) or 4849 (du).
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
The National in Davos
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