Johnson & Johnson asked US drug regulators to clear its experimental Covid-19 vaccine for emergency use, setting up what is likely to be a fast-moving review process that could lead to millions more doses becoming available to step up a stumbling immunisation drive.
The drugmaker said on Thursday that it had filed an application for emergency-use authorisation with the US Food and Drug Administration (FDA). If cleared, the shot would give the US a third vaccine to try to halt a pandemic that has killed more than 450,000 people in the country. The process is likely to take weeks.
Paul Stoffels, the company's chief scientific officer, said that the company would be ready to begin shipping vaccines upon receiving authorisation.
"With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible," Mr Stoffels said.
Shares of the company gained 1.5 per cent in after-hours trading in New York. Over the past 12 months, the stock has advanced 6.85 per cent.
Vaccines from Moderna and partners Pfizer and BioNTech SE have already been given similar clearance and are the only two vaccines available to most Americans.
The Moderna and Pfizer-BioNTech vaccines, which in clinical studies were each found to be more than 90 per cent effective, should be given in two doses spaced several weeks apart, according to their authorisations.
Johnson & Johnson's vaccine was found to be 72 per cent effective in preventing moderate to severe Covid-19 after a single shot, and 66 per cent effective overall in a global trial. It was 100 per cent effective in preventing hospital admission and death.
Officials at the agency will now review the company’s trial data. The agency is also expected to convene a committee of outside experts to evaluate the trial findings.
The panel will then make a recommendation on whether the shot should be allowed on to the US market. The group’s findings are not binding on leadership, but it is unusual for the agency to reject their advice.
One question likely to be in focus as experts consider the vaccine’s potential authorisation is its effectiveness against new variants of the coronavirus. While Johnson & Johnson’s shot was 85 per cent effective across the board in preventing severe disease, there were indications it could be less potent against new viral mutations that have caused infections to rise in some countries.
In South Africa, where a variant called B.1.351 is circulating widely, the vaccine was only 57 per cent effective. And the shot was 66 per cent effective in Latin America, where another mutation caused cases to climb in Brazil. Both recently surfaced in the US, although there is not yet a clear indication that any are widespread.
The FDA said on Thursday that it has been communicating with drugmakers and developing guidelines for vaccine developers as they evaluate how their products will be affected by variants. The agency is “currently deliberating and discussing the types of data needed to support changes in the composition of the vaccine”, said acting agency commissioner Janet Woodcock.
US officials last week emphasised the shot's proficiency at preventing the worst forms of Covid-19.
“If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress and human suffering” of the pandemic, said Dr Anthony Fauci, the top US infectious disease official.
Johnson &Johnson previously indicated that it expected an emergency clearance as soon as March and that it would have millions of doses ready to ship upon receiving a nod from regulators. It vowed to deliver 100 million doses to the US by the end of June and maintains that it will be able to meet all other supply commitments.
Unresolved crisis
Russia and Ukraine have been locked in a bitter conflict since 2014, when Ukraine’s Kremlin-friendly president was ousted, Moscow annexed Crimea and then backed a separatist insurgency in the east.
Fighting between the Russia-backed rebels and Ukrainian forces has killed more than 14,000 people. In 2015, France and Germany helped broker a peace deal, known as the Minsk agreements, that ended large-scale hostilities but failed to bring a political settlement of the conflict.
The Kremlin has repeatedly accused Kiev of sabotaging the deal, and Ukrainian officials in recent weeks said that implementing it in full would hurt Ukraine.
Gothia Cup 2025
4,872 matches
1,942 teams
116 pitches
76 nations
26 UAE teams
15 Lebanese teams
2 Kuwaiti teams
Jeff Buckley: From Hallelujah To The Last Goodbye
By Dave Lory with Jim Irvin
Key facilities
- Olympic-size swimming pool with a split bulkhead for multi-use configurations, including water polo and 50m/25m training lanes
- Premier League-standard football pitch
- 400m Olympic running track
- NBA-spec basketball court with auditorium
- 600-seat auditorium
- Spaces for historical and cultural exploration
- An elevated football field that doubles as a helipad
- Specialist robotics and science laboratories
- AR and VR-enabled learning centres
- Disruption Lab and Research Centre for developing entrepreneurial skills
ACL Elite (West) - fixtures
Monday, Sept 30
Al Sadd v Esteghlal (8pm)
Persepolis v Pakhtakor (8pm)
Al Wasl v Al Ahli (8pm)
Al Nassr v Al Rayyan (10pm)
Tuesday, Oct 1
Al Hilal v Al Shorta (10pm)
Al Gharafa v Al Ain (10pm)
'Joker'
Directed by: Todd Phillips
Starring: Joaquin Phoenix
Rating: Five out of five stars
F1 The Movie
Starring: Brad Pitt, Damson Idris, Kerry Condon, Javier Bardem
Director: Joseph Kosinski
Rating: 4/5
PROFILE OF HALAN
Started: November 2017
Founders: Mounir Nakhla, Ahmed Mohsen and Mohamed Aboulnaga
Based: Cairo, Egypt
Sector: transport and logistics
Size: 150 employees
Investment: approximately $8 million
Investors include: Singapore’s Battery Road Digital Holdings, Egypt’s Algebra Ventures, Uber co-founder and former CTO Oscar Salazar
The specs
Engine: 4-litre twin-turbo V8
Transmission: eight-speed PDK
Power: 630bhp
Torque: 820Nm
Price: Dh683,200
On sale: now
Company%20profile
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%3Cp%3E%3Cstrong%3EEngine%3A%20%3C%2Fstrong%3E4.4-litre%2C%20twin-turbo%20V8%0D%3Cbr%3E%3Cstrong%3ETransmission%3A%20%3C%2Fstrong%3Eeight-speed%20auto%0D%3Cbr%3E%3Cstrong%3EPower%3A%20%3C%2Fstrong%3E617hp%0D%3Cbr%3E%3Cstrong%3ETorque%3A%20%3C%2Fstrong%3E750Nm%0D%3Cbr%3E%3Cstrong%3EPrice%3A%20%3C%2Fstrong%3Efrom%20Dh630%2C000%0D%3Cbr%3E%3Cstrong%3EOn%20sale%3A%20%3C%2Fstrong%3Enow%3C%2Fp%3E%0A
The specs
AT4 Ultimate, as tested
Engine: 6.2-litre V8
Power: 420hp
Torque: 623Nm
Transmission: 10-speed automatic
Price: From Dh330,800 (Elevation: Dh236,400; AT4: Dh286,800; Denali: Dh345,800)
On sale: Now
Jawan
%3Cp%3E%3Cstrong%3EDirector%3A%20%3C%2Fstrong%3EAtlee%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EStars%3A%3C%2Fstrong%3E%20Shah%20Rukh%20Khan%2C%20Nayanthara%2C%20Vijay%20Sethupathi%26nbsp%3B%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3ERating%3A%20%3C%2Fstrong%3E4%2F5%3C%2Fp%3E%0A
DUBAI CARNIVAL RESULTS
6.30pm Handicap US$135,000 (Turf) 2,410m
Winner Dubai Future, Harry Bentley (jockey), Saeed bin Suroor (trainer).
7.05pm UAE 1000 Guineas Listed $250,000 (Dirt) 1,600m
Winner Dubai Love, Patrick Cosgrave, Saeed bin Suroor.
7.40pm Dubai Dash Listed $175,000 (T) 1,000m
Winner: Equilateral, James Doyle, Charles Hills.
8.15pm Al Bastakiya Trial Conditions $100,000 (D) 1.900m
Winner Laser Show, Kevin Stott, Saeed bin Suroor.
8.50pm Al Fahidi Fort Group Two $250,000 (T) 1,400m
Winner Glorious Journey, James Doyle, Charlie Appleby.
9.25pm Handicap $135,000 (D) 2,000m
Winner George Villiers, Tadhg O’Shea, Satish Seemar.
What is a black hole?
1. Black holes are objects whose gravity is so strong not even light can escape their pull
2. They can be created when massive stars collapse under their own weight
3. Large black holes can also be formed when smaller ones collide and merge
4. The biggest black holes lurk at the centre of many galaxies, including our own
5. Astronomers believe that when the universe was very young, black holes affected how galaxies formed
FINAL SCORES
Fujairah 130 for 8 in 20 overs
(Sandy Sandeep 29, Hamdan Tahir 26 no, Umair Ali 2-15)
Sharjah 131 for 8 in 19.3 overs
(Kashif Daud 51, Umair Ali 20, Rohan Mustafa 2-17, Sabir Rao 2-26)
The Bio
Favourite Emirati dish: I have so many because it has a lot of herbs and vegetables. Harees (oats with chicken) is one of them
Favourite place to go to: Dubai Mall because it has lots of sports shops.
Her motivation: My performance because I know that whatever I do, if I put the effort in, I’ll get results
During her free time: I like to drink coffee - a latte no sugar and no flavours. I do not like cold drinks
Pet peeve: That with every meal they give you a fries and Pepsi. That is so unhealthy
Advice to anyone who wants to be an ironman: Go for the goal. If you are consistent, you will get there. With the first one, it might not be what they want but they should start and just do it
Babumoshai Bandookbaaz
Director: Kushan Nandy
Starring: Nawazuddin Siddiqui, Bidita Bag, Jatin Goswami
Three stars
The biog
Marital status: Separated with two young daughters
Education: Master's degree from American Univeristy of Cairo
Favourite book: That Is How They Defeat Despair by Salwa Aladian
Favourite Motto: Their happiness is your happiness
Goal: For Nefsy to become his legacy long after he is gon
ABU DHABI ORDER OF PLAY
Starting at 10am:
Daria Kasatkina v Qiang Wang
Veronika Kudermetova v Annet Kontaveit (10)
Maria Sakkari (9) v Anastasia Potapova
Anastasia Pavlyuchenkova v Ons Jabeur (15)
Donna Vekic (16) v Bernarda Pera
Ekaterina Alexandrova v Zarina Diyas
THE SPECS
2020 Toyota Corolla Hybrid LE
Engine: 1.8 litre combined with 16-volt electric motors
Transmission: Automatic with manual shifting mode
Power: 121hp
Torque: 142Nm
Price: Dh95,900
Global Fungi Facts
• Scientists estimate there could be as many as 3 million fungal species globally
• Only about 160,000 have been officially described leaving around 90% undiscovered
• Fungi account for roughly 90% of Earth's unknown biodiversity
• Forest fungi help tackle climate change, absorbing up to 36% of global fossil fuel emissions annually and storing around 5 billion tonnes of carbon in the planet's topsoil
UAE currency: the story behind the money in your pockets
The biog
Family: He is the youngest of five brothers, of whom two are dentists.
Celebrities he worked on: Fabio Canavaro, Lojain Omran, RedOne, Saber Al Rabai.
Where he works: Liberty Dental Clinic
Pharaoh's curse
British aristocrat Lord Carnarvon, who funded the expedition to find the Tutankhamun tomb, died in a Cairo hotel four months after the crypt was opened.
He had been in poor health for many years after a car crash, and a mosquito bite made worse by a shaving cut led to blood poisoning and pneumonia.
Reports at the time said Lord Carnarvon suffered from “pain as the inflammation affected the nasal passages and eyes”.
Decades later, scientists contended he had died of aspergillosis after inhaling spores of the fungus aspergillus in the tomb, which can lie dormant for months. The fact several others who entered were also found dead withiin a short time led to the myth of the curse.
The specs
Engine: 2.0-litre 4-cyl
Power: 153hp at 6,000rpm
Torque: 200Nm at 4,000rpm
Transmission: 6-speed auto
Price: Dh99,000
On sale: now
RESULTS
6.30pm Handicap (TB) US$65,000 (Dirt) 1,400m
Winner Golden Goal, Pat Dobbs (jockey), Doug Watson (trainer)
7.05pm Dubai Racing Club Classic Listed Handicap (TB) $88,000 (Turf) 2,410m
Winner: Walton Street, William Buick, Charlie Appleby.
7.40pm Dubai Stakes Group 3 (TB) $130,000 (D) 1,200m
Winner Switzerland, Tadhg O’Shea, Satish Seemar
8.15pm Singspiel Stakes Group 3 (TB) $163,000 (T) 1,800m
Winner Lord Giltters, Adrie de Vries, David O’Meara
8.50pm Al Maktoum Challenge Round-1 (TB) $228,000 (D) 1,600m
Winner Military Law, Antonio Fresu, Musabah Al Muhairi.
9.25pm Al Fahidi Fort Group 2 (TB) $163,000 (T) 1,400m
Winner Land Of Legends, Frankie Dettori, Saeed bin Suroor
10pm Dubai Dash Listed Handicap (TB) $88,000 (T) 1,000m
Winner Equilateral, Frankie Dettori, Charles Hills.
The specs
Engine: 6.2-litre V8
Power: 502hp at 7,600rpm
Torque: 637Nm at 5,150rpm
Transmission: 8-speed dual-clutch auto
Price: from Dh317,671
On sale: now
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: 3.5-litre twin-turbo V6
Power: 380hp at 5,800rpm
Torque: 530Nm at 1,300-4,500rpm
Transmission: Eight-speed auto
Price: From Dh299,000 ($81,415)
On sale: Now
Race card
6.30pm: Handicap (TB) $68,000 (Dirt) 1,200m
7.05pm: Meydan Cup – Listed Handicap (TB) $88,000 (Turf) 2,810m
7.40pm: UAE 2000 Guineas – Group 3 (TB) $125,000 (D) 1,600m
8.15pm: Firebreak Stakes – Group 3 (TB) $130,000 (D) 1,600m
9.50pm: Meydan Classic – Conditions (TB) $$50,000 (T) 1,400m
9.25pm: Dubai Sprint – Listed Handicap (TB) $88,000 (T) 1,200m
