The US Food and Drug Administration and the Centres for Disease Control and Prevention called for a pause in the use of Johnson & Johnson’s single-dose Covid-19 vaccine.
Six women in the US between the ages of 18 and 48 developed a disorder involving blood clots about two weeks after they were immunised.
One of the women died and a second woman was admitted to hospital.
“Out of an abundance of caution, we’re recommending a pause in the use of the Johnson & Johnson Covid-19 vaccine due to reports of six cases of a rare and severe type of blood clot following vaccine administration,” acting FDA commissioner Janet Woodcock said.
“We’re recommending this pause while we work together to fully understand these events and also so we can get information out to healthcare providers and vaccine recipients.
"Right now, I'd like to stress these events appear to be extremely rare. However, Covid vaccine safety is a top priority for the federal government and we take all reports of adverse events following vaccination very seriously."
Dr Woodcock said the FDA expected the Johnson & Johnson vaccine pause to last "for a matter of days".
Anne Schuchat, the CDC's principal deputy director, said the pause was intended to better equip US healthcare providers to diagnose and treat severe blood clots, which are different from the standard flulike symptoms that some people experience after receiving their Covid vaccine.
Dr Schuchat said people who received the Johnson & Johnson vaccine more than a month ago were at "very low" risk of developing blood clots.
But patients who had the shot within the past two weeks should contact their healthcare providers if they develop symptoms that include severe headaches, abdominal pain, leg pain or shortness of breath.
“While these events are very rare, we’re recommending a pause in the use of the [Johnson & Johnson] Covid-19 vaccine in order to prepare the healthcare system to recognise and treat patients appropriately and to report severe events they may be seeing in people who’ve received the [Johnson & Johnson] vaccine,” Dr Schuchat said.
“The pause will also allow the CDC’s expert committee to review the situation.”
The CDC's advisory committee on immunisation practices will convene to review the initial data on the blood clots.
“This will allow careful deliberation about what we know so far about these events and consider next steps given the current context of the Covid-19 pandemic in the United States and our broader immunisation efforts,” Dr Schuchat said.
Seven million people in the US have received the Johnson & Johnson vaccine. About nine million more doses have been shipped across the country.
Although the new guidelines will be enforced at all federal vaccination sites, the FDA and CDC expect state officials to enact the rules as well.
The CDC said most US vaccinations involved the two-dose Pfizer-BioNTech or Moderna shots, which account for a combined 23 million doses.
The extent to which the pause will affect vaccine administration is unknown.
“It’s too early for us to know the impact on the supply longer term,” Dr Schuchat said.
But Jeff Zients, the White House response co-ordinator for the Johnson & Johnson vaccine, said the pause would not have any major effect on distribution.
“This announcement will not have a significant impact on our vaccination programme,” he said.
“The [Johnson & Johnson] vaccine makes up less than five per cent of the more than 190 million recorded shots in arms in the United States to date.”
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Four reasons global stock markets are falling right now
There are many factors worrying investors right now and triggering a rush out of stock markets. Here are four of the biggest:
1. Rising US interest rates
The US Federal Reserve has increased interest rates three times this year in a bid to prevent its buoyant economy from overheating. They now stand at between 2 and 2.25 per cent and markets are pencilling in three more rises next year.
Kim Catechis, manager of the Legg Mason Martin Currie Global Emerging Markets Fund, says US inflation is rising and the Fed will continue to raise rates in 2019. “With inflationary pressures growing, an increasing number of corporates are guiding profitability expectations downwards for 2018 and 2019, citing the negative impact of rising costs.”
At the same time as rates are rising, central bankers in the US and Europe have been ending quantitative easing, bringing the era of cheap money to an end.
2. Stronger dollar
High US rates have driven up the value of the dollar and bond yields, and this is putting pressure on emerging market countries that took advantage of low interest rates to run up trillions in dollar-denominated debt. They have also suffered capital outflows as international investors have switched to the US, driving markets lower. Omar Negyal, portfolio manager of the JP Morgan Global Emerging Markets Income Trust, says this looks like a buying opportunity. “Despite short-term volatility we remain positive about long-term prospects and profitability for emerging markets.”
3. Global trade war
Ritu Vohora, investment director at fund manager M&G, says markets fear that US President Donald Trump’s spat with China will escalate into a full-blown global trade war, with both sides suffering. “The US economy is robust enough to absorb higher input costs now, but this may not be the case as tariffs escalate. However, with a host of factors hitting investor sentiment, this is becoming a stock picker’s market.”
4. Eurozone uncertainty
Europe faces two challenges right now in the shape of Brexit and the new populist government in eurozone member Italy.
Chris Beauchamp, chief market analyst at IG, which has offices in Dubai, says the stand-off between between Rome and Brussels threatens to become much more serious. "As with Brexit, neither side appears willing to step back from the edge, threatening more trouble down the line.”
The European economy may also be slowing, Mr Beauchamp warns. “A four-year low in eurozone manufacturing confidence highlights the fact that producers see a bumpy road ahead, with US-EU trade talks remaining a major question-mark for exporters.”
