Johnson & Johnson has halted mass clinical trials of a potential COVID-19 vaccine after a participant fell ill.
Stat News reported the pause earlier in on Tuesday, citing a document sent to outside researchers running the 60,000-patient clinical trial.
“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” Johnson & Johnson told Stat News.
The patient’s illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company’s clinical and safety physicians, Johnson & Johnson said.
The document stated that a “pausing rule” had been met and the online system used to enrol patients in the study had been closed.
Trials of another major COVID vaccine hope, the Oxford University-AstraZeneca joint venture, were also halted in September after a participant experienced a serious adverse reaction.
A company spokesman said later a woman had developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.
Australia has ordered millions of doses of the AstraZeneca vaccine, which was expected to be rolled out in 2021, if trials proved successful.
Testing of the vaccine resumed days later in Britain, Brazil, South Africa and India. But the US trial is still on hold, pending a regulatory review.
Meanwhile, a 25-year-old man in the US with no known immune disorders or underlying conditions has been confirmed to have been infected with COVID-19 at least twice.
The Nevada man’s second infection was more severe than his first, leading to hospitalisation with oxygen support.
Researchers said it was the fifth documented reinfection worldwide. Others have been confirmed in Belgium, the Netherlands, Hong Kong, and Ecuador.
Melbourne eyes freedom as 14-day average increases
Victoria’s chief health officer Brett Sutton has defended the state’s still stringent virus measures as its posted double-digit infection numbers for the sixth day in a row.
There’s no question it’s frustrating. I’m frustrated. Everyone is frustrated,” he said.
With Melburnians in lockdown anxiously waiting to learn which rules will be wound back this week, Professor Sutton said the controversial rule banning travel further than five kilometres from home was being reviewed.
He said he would not be “pushing for anything” to change, but the rule was among the measures being considered.
“We are reflecting on all of those elements as we come to this weekend about what can reasonably change with what we’re facing at the moment. So yes, it’s up for serious consideration, as is everything,” he said.
Victoria had 12 new cases on Tuesday, with another death also confirmed. Its virus death toll has risen to 811, while the national figure is 899.
With Tuesday’s figures, Melbourne’s key 14-day rolling case average has risen to 10, and mystery cases for the fortnight are also up, to 13.
Regional figures remain steady, with the rolling average still 0.4 and no mystery infections.
Professor Sutton said Victoria’s situation could not be compared to NSW’s, despite similar numbers of new cases on Tuesday.
“The circumstances in NSW are very different. They have prospectively followed a small number of cases over recent months, where they’ve looked forward to the contacts that they have and managed them appropriately,” he said.
“What we had was 20,000 cases over over several weeks that have come down to a low level but the remaining chains of transmission in Victoria are some of the trickiest, I imagine, in the world.”
Premier Daniel Andrews has conceded Victoria’s roadmap out of lockdown is likely to be redrawn and restrictions may still be eased despite daily COVID-19 figures not meeting the original target.
“In recent weeks, where we’ve seen some outbreaks, those outbreaks have been handled very well, or we would not be reporting 12 cases a day, or an average of 10, we would be reporting a good number more than that,” he said.
“But these things do change. They evolve.”
Of Tuesday’s new cases, seven are connected to the Box Hill Hospital cluster, including four in one household.
Two have been linked to the Chadstone outbreak and two to aged care.
The final case is in Geelong and is considered a possible residual infection.
Locally acquired cases spike in NSW
NSW confirmed seven new locally transmitted coronavirus cases and six more infections in hotel quarantine on Tuesday.
Two of the new local cases are doctors from a medical clinic in Lakemba in south-western Sydney. Their infections are related to a previously reported case of unknown source.
The other five new local cases are members one household in south-western Sydney and have provided a previously missing link between two hospital outbreaks.
They have been connected to clusters at St Vincent’s Hospital and Liverpool Hospital.
Despite the increase in community transmission, NSW Premier Gladys Berejiklian announced the easing of restrictions on outdoor dining and events.
Ms Berejiklian said businesses using electronic QR codes to maintain customer records would be allowed one patron for every two square metres in outdoor areas.
“While we are concerned with the emerging clusters we do feel confident enough that from Friday, outdoor venues will be able to have two square metres outside, in preparation for summer,” she said.
Indoor restrictions will remain at four square metres.