Two more coronavirus drugs trials have been halted because of patient safety concerns. Should we believe claims that such pauses are nothing out of the ordinary, or are scientists pushing too hard in the race to produce a vaccine?
What happened?
Pharmaceutical company Johnson & Johnson announced on Monday that it had suspended human trials of its coronavirus vaccine because of the “unexplained illness” of a participant. The Phase 3 trials were set up to assess the effectiveness and safety of the vaccine in humans and were expected to involve 60,000 participants in the US and elsewhere.
The following day, Eli Lilly said it was pausing its Phase 3 trial involving the anti-viral remdesivir and another drug. The action was reportedly taken out of “an abundance of caution” following a “potential safety concern”. As with the Johnson & Johnson trial, the precise details are unclear – as is the date when, if ever, the 10,000-participant trial will restart.
Hasn’t this happened before?
In September, trials of a coronavirus vaccine created by scientists at the University of Oxford and tested by AstraZeneca were halted after a participant developed an unexplained illness. It emerged that a healthy 37 year old woman developed transverse myelitis, causing inflammation of the spine – an extremely rare but recognised reaction to vaccination.
The huge international study restarted in mid-September, although it is still on hold in the US.
How serious are the incidents?
With no details about the precise causes, it is impossible to say. But it is likely that the incidents are demonstrations of a basic law of probability: that even extremely rare events will occur if given the opportunity.
All the trials involved tens of thousands of patients, raising the chances of at least a few rare side-effects being seen. Ironically, the fact that the trials have been halted is seen by clinical experts as proof that the testing methodology is working as it should, detecting even hints of potential problems and investigating them thoroughly before restarting the trials.
Can we trust drug companies ?
The share prices of Johnson & Johnson and Eli Lilly dipped a few per cent following the announcement, and they want the trials resumed as soon as possible. But the decision to do so is not in their hands.
Clinical trials are overseen by independent Data and Safety Monitoring Boards (DSMBs) whose decisions are made in meetings that exclude researchers and company officials. The decision to pause the Johnson & Johnson and Eli Lilly trials were made by their independent boards.
The pressure to develop a coronavirus vaccine raised concerns of researchers cutting corners. In response, Johnson & Johnson and AstraZeneca joined other vaccine makers in a pledge to apply for regulatory approval only after their vaccines passed all the standard phases of clinical trials.
Could trials be abandoned ?
Yes. The Eli Lilly trial involves a combination of drugs that has been used with few patients (although US President Trump appears to have been given the combination, alongside several other putative therapies, following his infection with coronavirus). The two components of the treatment – the anti-viral remdesivir and a so-called monoclonal antibody – are both at the cutting edge of scientific research. The Johnson & Johnson vaccine uses a modified human cold virus to trigger immunity, but it has been used for other diseases.
Even so, around one in six vaccines reaching the same stage of development fail.
Points to remember
- Debate the issue, don't attack the person
- Build the relationship and dialogue by seeking to find common ground
- Express passion for the issue but be aware of when you're losing control or when there's anger. If there is, pause and take some time out.
- Listen actively without interrupting
- Avoid assumptions, seek understanding, ask questions
Fixtures:
Wed Aug 29 – Malaysia v Hong Kong, Nepal v Oman, UAE v Singapore
Thu Aug 30 - UAE v Nepal, Hong Kong v Singapore, Malaysia v Oman
Sat Sep 1 - UAE v Hong Kong, Oman v Singapore, Malaysia v Nepal
Sun Sep 2 – Hong Kong v Oman, Malaysia v UAE, Nepal v Singapore
Tue Sep 4 - Malaysia v Singapore, UAE v Oman, Nepal v Hong Kong
Thu Sep 6 – Final
AVOID SCAMMERS: TIPS FROM EMIRATES NBD
1. Never respond to e-mails, calls or messages asking for account, card or internet banking details
2. Never store a card PIN (personal identification number) in your mobile or in your wallet
3. Ensure online shopping websites are secure and verified before providing card details
4. Change passwords periodically as a precautionary measure
5. Never share authentication data such as passwords, card PINs and OTPs (one-time passwords) with third parties
6. Track bank notifications regarding transaction discrepancies
7. Report lost or stolen debit and credit cards immediately
PREMIER LEAGUE FIXTURES
Saturday (UAE kick-off times)
Watford v Leicester City (3.30pm)
Brighton v Arsenal (6pm)
West Ham v Wolves (8.30pm)
Bournemouth v Crystal Palace (10.45pm)
Sunday
Newcastle United v Sheffield United (5pm)
Aston Villa v Chelsea (7.15pm)
Everton v Liverpool (10pm)
Monday
Manchester City v Burnley (11pm)
Ferrari 12Cilindri specs
Engine: naturally aspirated 6.5-liter V12
Power: 819hp
Torque: 678Nm at 7,250rpm
Price: From Dh1,700,000
Available: Now
Indian origin executives leading top technology firms
Sundar Pichai
Chief executive, Google and Alphabet
Satya Nadella
Chief executive, Microsoft
Ajaypal Singh Banga
President and chief executive, Mastercard
Shantanu Narayen
Chief executive, chairman, and president, Adobe
Indra Nooyi
Board of directors, Amazon and former chief executive, PepsiCo
THE BIO
Ms Davison came to Dubai from Kerala after her marriage in 1996 when she was 21-years-old
Since 2001, Ms Davison has worked at many affordable schools such as Our Own English High School in Sharjah, and The Apple International School and Amled School in Dubai
Favourite Book: The Alchemist
Favourite quote: Failing to prepare is preparing to fail
Favourite place to Travel to: Vienna
Favourite cuisine: Italian food
Favourite Movie : Scent of a Woman
The Sand Castle
Director: Matty Brown
Stars: Nadine Labaki, Ziad Bakri, Zain Al Rafeea, Riman Al Rafeea
Rating: 2.5/5
UAE currency: the story behind the money in your pockets
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).
LAST-16 EUROPA LEAGUE FIXTURES
Wednesday (Kick-offs UAE)
FC Copenhagen (0) v Istanbul Basaksehir (1) 8.55pm
Shakhtar Donetsk (2) v Wolfsburg (1) 8.55pm
Inter Milan v Getafe (one leg only) 11pm
Manchester United (5) v LASK (0) 11pm
Thursday
Bayer Leverkusen (3) v Rangers (1) 8.55pm
Sevilla v Roma (one leg only) 8.55pm
FC Basel (3) v Eintracht Frankfurt (0) 11pm
Wolves (1) Olympiakos (1) 11pm
Tips for used car buyers
- Choose cars with GCC specifications
- Get a service history for cars less than five years old
- Don’t go cheap on the inspection
- Check for oil leaks
- Do a Google search on the standard problems for your car model
- Do your due diligence. Get a transfer of ownership done at an official RTA centre
- Check the vehicle’s condition. You don’t want to buy a car that’s a good deal but ends up costing you Dh10,000 in repairs every month
- Validate warranty and service contracts with the relevant agency and and make sure they are valid when ownership is transferred
- If you are planning to sell the car soon, buy one with a good resale value. The two most popular cars in the UAE are black or white in colour and other colours are harder to sell
Tarek Kabrit, chief executive of Seez, and Imad Hammad, chief executive and co-founder of CarSwitch.com
WRESTLING HIGHLIGHTS
Killing of Qassem Suleimani
RESULTS
5pm: Rated Conditions (PA) Dh85,000 (Turf) 1,600m
Winner: AF Mouthirah, Tadhg O’Shea (jockey), Ernst Oertel (trainer)
5.30pm: Maiden (PA) Dh80,000 (T) 1,400m
Winner: AF Alajaj, Tadhg O’Shea, Ernst Oertel
6pm: Wathba Stallions Cup Handicap (PA) Dh70,000 (T) 1,400m
Winner: Hawafez, Connor Beasley, Abubakar Daud
6.30pm: Maiden (PA) Dh80,000 (T) 2,200m
Winner: Tair, Fabrice Veron, Eric Lemartinel
7pm: Handicap (PA) Dh80,000 (T) 2,200m
Winner: Wakeel W’Rsan, Richard Mullen, Jaci Wickham
7.30pm: Handicap (PA) Dh100,000 (T) 2,400m
Winner: Son Of Normandy, Fernando Jara, Ahmad bin Harmash
What can you do?
Document everything immediately; including dates, times, locations and witnesses
Seek professional advice from a legal expert
You can report an incident to HR or an immediate supervisor
You can use the Ministry of Human Resources and Emiratisation’s dedicated hotline
In criminal cases, you can contact the police for additional support
BMW M5 specs
Engine: 4.4-litre twin-turbo V-8 petrol enging with additional electric motor
Power: 727hp
Torque: 1,000Nm
Transmission: 8-speed auto
Fuel consumption: 10.6L/100km
On sale: Now
Price: From Dh650,000
The specs
Engine: 6.2-litre supercharged V8
Power: 712hp at 6,100rpm
Torque: 881Nm at 4,800rpm
Transmission: 8-speed auto
Fuel consumption: 19.6 l/100km
Price: Dh380,000
On sale: now
Zayed Sustainability Prize
COMPANY%20PROFILE
%3Cp%3E%3Cstrong%3ECompany%20name%3A%3C%2Fstrong%3E%20HyperPay%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EStarted%3A%3C%2Fstrong%3E%202014%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EFounder%3A%3C%2Fstrong%3E%20Muhannad%20Ebwini%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EBased%3A%3C%2Fstrong%3E%20Riyadh%2C%20Saudi%20Arabia%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EIndustry%3A%3C%2Fstrong%3E%20FinTech%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EFunding%20size%3A%3C%2Fstrong%3E%20%2455m%3C%2Fp%3E%0A%3Cp%3E%3Cstrong%3EInvestors%3A%3C%2Fstrong%3E%20AB%20Ventures%2C%20Amwal%20Capital%2C%20INet%2C%20Mada%20VC%2C%20Mastercard%2C%20SVC%3C%2Fp%3E%0A
The biog
Favourite hobby: taking his rescue dog, Sally, for long walks.
Favourite book: anything by Stephen King, although he said the films rarely match the quality of the books
Favourite film: The Shawshank Redemption stands out as his favourite movie, a classic King novella
Favourite music: “I have a wide and varied music taste, so it would be unfair to pick a single song from blues to rock as a favourite"
Top 5 concerns globally:
1. Unemployment
2. Spread of infectious diseases
3. Fiscal crises
4. Cyber attacks
5. Profound social instability
Top 5 concerns in the Mena region
1. Energy price shock
2. Fiscal crises
3. Spread of infectious diseases
4. Unmanageable inflation
5. Cyber attacks
Source: World Economic Foundation
Labour dispute
The insured employee may still file an ILOE claim even if a labour dispute is ongoing post termination, but the insurer may suspend or reject payment, until the courts resolve the dispute, especially if the reason for termination is contested. The outcome of the labour court proceedings can directly affect eligibility.
- Abdullah Ishnaneh, Partner, BSA Law
