Johnson & Johnson’s one-shot coronavirus vaccine is safe and effective, the US Food and Drug Administration said on Wednesday.
The assessment paves the way for the drug’s emergency use in the US, and experts will meet on Friday to decide whether to approve it.
While it is not bound to follow the advice of its experts, the FDA usually does, and authorised vaccines from Pfizer-BioNTech and Moderna.
J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections.
It said that in preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group compared with two in the vaccine group, or 88 per cent efficacy.
While measuring asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe Covid-19, the reduction of asymptomatic cases implied the shot could also cut transmission of the disease.
J&J’s vaccine was, on average, 66 per cent effective in preventing Covid-19 against variants in a global trial involving about 44,000 people, the company said last month.
Its effectiveness varied from 72 per cent in the US to 66 per cent in South America to 57 per cent in South Africa, where a new, highly contagious variant was first identified.
The vaccine was effective in reducing the risk of Covid-19 and preventing PCR test-confirmed Covid-19 at least 14 days after vaccination, the FDA said in its briefing documents.
A fortnight after injection, only two vaccine recipients developed Covid-19 severe enough to need medical intervention, compared with 14 in the placebo group.
After 28 days, no vaccine recipients developed Covid severe enough to require medical intervention, whereas seven in the placebo group did.
Three vaccine recipients had severe side effects in the trial that were probably related to the vaccine.
But the FDA said its analysis did not raise any specific safety concern that would prevent authorisation for emergency use.
The most common adverse reactions were injection site pain at 48.6 per cent, headache at 39 per cent, fatigue at 38.2 per cent and myalgia, or muscle pain, at 33.2 per cent.
Other side effects included a fever in 9 per cent of participants and a high fever in 0.2 per cent of those who received the vaccine.
The regulator said one case of pericarditis, a heart condition, might have been caused by the vaccine.
It said cases of a rare disorder in which the immune system attacks the nerves, Guillain-Barre syndrome, were unlikely to be related to the shot, although data was insufficient to determine whether or not the vaccine had caused it.
J&J had not previously released details of its clinical trial data beyond efficacy rates.
More from Rashmee Roshan Lall
The bio
Favourite book: Peter Rabbit. I used to read it to my three children and still read it myself. If I am feeling down it brings back good memories.
Best thing about your job: Getting to help people. My mum always told me never to pass up an opportunity to do a good deed.
Best part of life in the UAE: The weather. The constant sunshine is amazing and there is always something to do, you have so many options when it comes to how to spend your day.
Favourite holiday destination: Malaysia. I went there for my honeymoon and ended up volunteering to teach local children for a few hours each day. It is such a special place and I plan to retire there one day.
MATCH INFO
Who: UAE v USA
What: first T20 international
When: Friday, 2pm
Where: ICC Academy in Dubai
UAE currency: the story behind the money in your pockets
UAE%20v%20West%20Indies
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Mercer, the investment consulting arm of US services company Marsh & McLennan, expects its wealth division to at least double its assets under management (AUM) in the Middle East as wealth in the region continues to grow despite economic headwinds, a company official said.
Mercer Wealth, which globally has $160 billion in AUM, plans to boost its AUM in the region to $2-$3bn in the next 2-3 years from the present $1bn, said Yasir AbuShaban, a Dubai-based principal with Mercer Wealth.
“Within the next two to three years, we are looking at reaching $2 to $3 billion as a conservative estimate and we do see an opportunity to do so,” said Mr AbuShaban.
Mercer does not directly make investments, but allocates clients’ money they have discretion to, to professional asset managers. They also provide advice to clients.
“We have buying power. We can negotiate on their (client’s) behalf with asset managers to provide them lower fees than they otherwise would have to get on their own,” he added.
Mercer Wealth’s clients include sovereign wealth funds, family offices, and insurance companies among others.
From its office in Dubai, Mercer also looks after Africa, India and Turkey, where they also see opportunity for growth.
Wealth creation in Middle East and Africa (MEA) grew 8.5 per cent to $8.1 trillion last year from $7.5tn in 2015, higher than last year’s global average of 6 per cent and the second-highest growth in a region after Asia-Pacific which grew 9.9 per cent, according to consultancy Boston Consulting Group (BCG). In the region, where wealth grew just 1.9 per cent in 2015 compared with 2014, a pickup in oil prices has helped in wealth generation.
BCG is forecasting MEA wealth will rise to $12tn by 2021, growing at an annual average of 8 per cent.
Drivers of wealth generation in the region will be split evenly between new wealth creation and growth of performance of existing assets, according to BCG.
Another general trend in the region is clients’ looking for a comprehensive approach to investing, according to Mr AbuShaban.
“Institutional investors or some of the families are seeing a slowdown in the available capital they have to invest and in that sense they are looking at optimizing the way they manage their portfolios and making sure they are not investing haphazardly and different parts of their investment are working together,” said Mr AbuShaban.
Some clients also have a higher appetite for risk, given the low interest-rate environment that does not provide enough yield for some institutional investors. These clients are keen to invest in illiquid assets, such as private equity and infrastructure.
“What we have seen is a desire for higher returns in what has been a low-return environment specifically in various fixed income or bonds,” he said.
“In this environment, we have seen a de facto increase in the risk that clients are taking in things like illiquid investments, private equity investments, infrastructure and private debt, those kind of investments were higher illiquidity results in incrementally higher returns.”
The Abu Dhabi Investment Authority, one of the largest sovereign wealth funds, said in its 2016 report that has gradually increased its exposure in direct private equity and private credit transactions, mainly in Asian markets and especially in China and India. The authority’s private equity department focused on structured equities owing to “their defensive characteristics.”
UAE currency: the story behind the money in your pockets
