AstraZeneca Resumes

AstraZeneca Resumes Its COVID-19 Vaccine Trials In The U.K. – NPR

Earlier in the week, AstraZeneca had paused worldwide studies of its candidate vaccine after one U.K. participant developed symptoms consistent with the spinal cord inflammation known as transverse myelitis.

Alastair Grant/AP

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Alastair Grant/AP

Earlier in the week, AstraZeneca had paused worldwide studies of its candidate vaccine after one U.K. participant developed symptoms consistent with the spinal cord inflammation known as transverse myelitis.

Alastair Grant/AP

Drugmaker AstraZeneca announced Saturday that its COVID-19 vaccine studies have resumed in the United Kingdom, though not yet in the United States. The vaccine trials had been placed on hold around the world earlier in the week after a U.K. participant in one of the studies developed a neurological illness.

The candidate vaccine was developed by the University of Oxford along with AstraZeneca. The goal of the large studies is to see whether the vaccine is capable of preventing COVID-19 and whether it is safe.

Although initial studies didn’t reveal serious side effects from the vaccine, rare complications of any vaccine, if there are any, may not turn up until it has been administered to thousands, or tens of thousands of people.

On Sunday, AstraZeneca says, all studies around the world of this particular candidate vaccine were paused after one volunteer in the U.K. developed symptoms consistent with transverse myelitis, an inflammation of the spinal cord that can cause paralysis.

According to a statement Saturday from the drug company, the studies were paused “to allow review of safety data by independent committees, and international regulators.”

The statement goes on to say that the committee has concluded its investigations and advised the Medicines Healthcare Products Regulatory Authority, the U.K. equivalent of the Food and Drug Administration, that trials in the U.K. are safe to resume.

In an email to NPR Saturday, an AstraZeneca spokesperson said, “The company will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume.”

AstraZeneca said it cannot disclose further medical information because it is the study sponsor, but added in its statement, “All trial investigators and participants will be updated with the relevant information, and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.”

The AstraZeneca/Oxford partnership is one of the vaccine development efforts against the coronavirus that is furthest along. The company recently began a phase 3 trial in the United States that aims to enroll 30,000 volunteers.

In late July, results of a preliminary safety and effectiveness study found that more than two-thirds of the people who received the experimental vaccine reported fatigue and headache after inoculation. Muscle aches and fever were also common. But the researchers said then that there were no “serious adverse reactions” among the more than 500 people vaccinated and that most of the effects were “mild or moderate in severity.”

In May, the Trump administration awarded the AstraZeneca effort up to $1.2 billion from the Biomedical Advanced Research and Development Authority as part of Operation Warp Speed, the administration’s push to have a widely available coronavirus vaccine by January.

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Batman Resumes

‘The Batman’ Resumes Production Without Robert Pattinson – Variety

Production on “The Batman” continues to be on pause after Robert Pattinson tested positive for COVID-19 this week, according to a source with knowledge of the situation.

Variety previously reported that shooting on the film had resumed without Pattinson, citing a story in the Daily Mail. However, studio insiders denied that report.

Crew members are still doing construction work on sets and props at Warner Bros. Studios in Leavesden, U.K., but people on the film team who were in contact with Pattinson are quarantining. The production is still doing contact tracing. It is unlikely that shooting will re-commence until the roughly two-week quarantine period ends.

It is also unclear if Pattinson has symptoms of the disease or if he is asymptomatic. Warner Bros., the studio behind the film, did not confirm that the star had tested positive and would only say that a member of the production had coronavirus.

Leading figures in the U.K. film production sector told Variety Friday that they continue to have absolute faith in the measures being taken to keep cast and crew safe from COVID-19 on British sets.

Meanwhile, the U.K. industry is confident that crews are observing COVID-19 protocols that were published by the British Film Commission at the end of May. “We know that productions in the U.K. are rigorously following BFC Guidance with robust health and safety procedures in place, including stringent testing regimes, which is why any case of coronavirus can be rapidly identified and appropriate self-isolating procedures implemented,” Adrian Wootton, chief executive of the British Film Commission and Film London, told Variety.

“We’re confident that with all measures in place, any production will resume filming as soon as it’s safe to do so. We also believe this will not impact production overall continuing in U.K., precisely because we have such robust health and safety measures operating, enabling our world-class film and high-end TV sector to get back up and running.”

“The behavior of U.K. cast and crew have been exemplary,” Lyndsay Duthie, CEO of the Production Guild of Great Britain, told Variety. “Wanting to return to work, everyone has embraced the comprehensive measures required of them and as a result many productions have been back on set and filming safely for weeks already. Where we have seen productions abroad where a cast or crew member has tested positive, precautions have been taken as required to enable them to start filming again as soon as they had the all clear.”

U.K. crew have also had access to free training modules offering practical advice on staying safe in the context of the pandemic provided by ScreenSkills, and some 20,000 people have already made use of this. “Productions have been taking this issue extremely seriously and we know everyone is working hard to prevent COVID-19 outbreaks during filming,” ScreenSkills CEO Seetha Kumar told Variety. “We collaborated with industry and health and safety experts to develop free online coronavirus basic awareness on production training to support the available guidance.”

In addition, the Production Guild is working on a bespoke program targeted at senior production staff who are taking on a COVID supervisor role, that will be announced next week. “This will be a definitive guide to standardize this new vital area on production to world-class standards,” said Duthie.

ScreenSkills is also running safe return to set seminars to share the experience of those already back in pre-production or production and are developing more advanced training. “None of this removes the threat of people falling ill but it acknowledges that everyone can play their part in trying to prevent outbreaks on set or location,” said Kumar.

There is also the question of crew morale being affected when a high-profile member of the team, like Pattinson, is diagnosed with the virus, so soon after resuming the stalled production. “Production teams are resilient as already proven and will always find innovative ways to keep moving forwards,” says Duthie. “I think it is more of a sense of frustration, when all have worked so hard to comply to comprehensive measures.”

Though it is not immediately clear what kind of insurance that “The Batman” has, COVID-19 is unlikely to be covered under any existing policies. “What we are seeing is that all insurers are making sure that there is specific wording to exclude COVID cover,” Kris Barnfather, senior account executive at Eggar Forrester Insurance, told Variety.

“The Batman” production does have recourse to the U.K. government $647 million film and TV insurance fund that was announced in July. The fund is available to all productions where at least 50% of the budget is spent in the U.K. Eligible productions will get compensation for costs caused by coronavirus delays up to a value of 20% of the production budget. Productions abandoned due to coronavirus will be covered up to 70% of the production budget. There is a total cap on claims per production of $6.65 million.

Brent Lang contributed to this report.

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