US plans to distribute vaccine immediately after regulators approve it

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AstraZeneca vaccine study remains paused in US

Reuters

AstraZeneca’s COVID-19 vaccine study remains paused in the US pending a regulatory review of an incident in which a UK participant became ill, federal officials said.

The British drugmaker and its partner, the University of Oxford, put research into the shot on hold last week after the volunteer suffered neurological symptoms. Trials resumed in the UK over the weekend, while researchers in South Africa also restarted tests, saying that an independent safety committee concluded that the event was unlikely to be related to the vaccination.

Temporary pauses in clinical trials aren’t unusual. However, the reported event has heightened worry that the global campaign to find a COVID-19 vaccine is moving too quickly. AstraZeneca is among several drugmakers who have agreed to work with and supply shots to Operation Warp Speed, the Trump administration’s effort to expedite the development of an inoculation.

Dr Anthony Fauci says the pause shows that vaccine trial safety protocols are robust. AP

Anthony Fauci, the top US infectious disease expert, told CNN it’s probably just a matter of time before they restart in the US Moncef Slaoui, who is leading the Warp Speed initiative, said the trial would resume when independent safety monitors and the Food and Drug Administration determine it’s safe.

“This pause while the adverse event is fully investigated means the science-based, data-driven process is working as it should,” he said in a statement.

US will distribute any COVID-19 vaccine within one day of approval

Reuters

The US government on Wednesday said it will start distributing a COVID-19 vaccine within one day of regulatory authorisation as it plans for the possibility that a limited number of vaccine doses may be available at the end of the year.

Officials from the Department of Health and Human Services and the Department of Defence on Wednesday held a call with reporters and then released documents on the distribution plans that it is sending to the states and local public health officials.

“Our goal at Operation Warp Speed, is that 24 hours after [regulatory authorisation] is issued, we have vaccine moving to administration sites,” one of the officials said.

The federal government will allocate vaccines for each state based on the critical populations recommended first for vaccination by the US Centres for Disease Control and Prevention.

The guidelines suggest that the government is likely to broadly follow guidelines generated by an independent expert panel tapped by US health officials to lay out which Americans to prioritise while vaccine supplies are limited.

The document, called the COVID-19 Vaccination Program Interim Playbook, said limited COVID-19 vaccine doses may be available by early November 2020 if one is authorised by then, but that supply may increase substantially in 2021.

Officials also said they were working to make sure there was no cost to patients for the vaccine.

Welcome to the blog

Welcome to the blog for Thursday 17 September. Here’s what’s happened tonight.

 AFR

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