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AstraZeneca chief says COVID vaccine on track for year end | United Kingdom News

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AstraZeneca CEO dismisses reports of delays with COVID-19 vaccine, says large-scale vaccinations could be possible by December.

AstraZeneca Plc’s coronavirus shot could be ready for large-scale vaccinations as early as this year, Chief Executive Officer Pascal Soriot said, dismissing reports of delays and production snags.

The U.K. drugmaker is poised to unveil vaccine test results by year-end even after trials were slightly delayed over the summer as infection rates slowed in the northern hemisphere. A recent resurgence has allowed scientists to gather the clinical data they need, according to Soriot. Astra and the University of Oxford are keeping the vaccine in a frozen bulk state to preserve its shelf life while they await final test results.

“At the end of the day, we don’t yet know if the vaccine works,” Soriot said in a Bloomberg Television interview, adding that many questions remain, such as whether it will show results for everyone and for how long. “We would hope that large-scale vaccinations would be possible starting in January next year — possibly even December.”

Soriot’s remarks come a day after Kate Bingham, chair of the U.K. Vaccine Taskforce, said only 4 million doses of the shot would be available by the end of the year, far fewer than the 30 million that were due to be ready by September. AstraZeneca said it’s confident it can begin supplying hundreds of millions of doses on a “rolling basis” once a shot is cleared.

The U.K. drugmaker has been at the forefront of efforts to fight the pandemic, and its experimental shot could be one of the first to be approved globally if successful. Astra and drugmakers Pfizer Inc. and Moderna Inc. are all seeking to deliver crucial test results on a vaccine in the coming weeks, with emergency clearance possible before the end of the year.

Soriot said the world needs several vaccines and that Astra studies conducted in the U.K. and Brazil kept progressing well even as the U.S. one suffered a halt. It’s possible the U.S. Food and Drug Administration will want to wait for the results of the local trial before reviewing the product, he said.

The FDA “may want to wait for the results of the U.S. study or they may review our international program and give us an emergency approval on that basis,” Soriot said. “It will be up to regulators in individual countries to decide.”

Vaccine Timeline

Astra has said it will sell the vaccine at cost during the pandemic at a price tag of between $4 to $5, depending on local manufacturing charges. The company said recently it would add as much as 20% to cover manufacturing costs to avoid any material impact on its finances. Astra is incurring a bill in excess of $1 billion globally for expenses including clinical development, Soriot said.

The Astra-Oxford candidate has produced a robust immune response in older adults and the elderly, those at highest risk of severe illness. Astra and Oxford have enrolled about 23,000 volunteers in vaccine trials globally, with plans to reach 50,000 once the U.S. arm has completed recruitment.

A U.K. government spokesperson said Thursday that “a vaccine will only be deployed once proven to be safe and effective” and that the National Health Service was ready to start the vaccination program.

Pandemic Disruption

Pfizer, which is developing its vaccine with Germany’s BioNTech SE, has said it may release initial late-stage trial data this month. The company is also waiting to hit a safety milestone, two months of data on half of participants, which it expects by the third week of November. Assuming both sets of results are positive, it would apply for emergency use authorization in the U.S. shortly thereafter.

Astra on Thursday reported third-quarter profit that fell short of analysts’ estimates as the pandemic inflated costs and discouraged some doctors’ visits and diagnoses. Other drugmakers such as Switzerland’s Novartis AG and Denmark’s Novo Nordisk A/S also cited similar disruptions.

“Believe it or not, people are having heart attacks and they don’t go to the hospital because they are scared,” Soriot said on a conference call, also citing delays in cancer diagnoses and treatment. Injectable products are more affected by such slowdowns, he said.

Astra shares were little changed in London trading.

(Updates first and third paragraphs with CEO coments)
–With assistance from Naomi Kresge, Francine Lacqua and Tom Keene.



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US says it has jabbed 82 million people, topping the world | Coronavirus pandemic News

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But coronavirus rates have plateaued over the past week, raising concern over yet another surge in cases and deaths.

The United States has administered 82 million coronavirus vaccine shots, White House officials announced on Friday, more than any other country in the world.

During a coronavirus task force news conference, health officials said 55 percent of Americans aged 65 and older have now received at least one shot, up from 8 percent just six weeks ago.

“Altogether we’ve administered more than 82 million shots, more than any country in the world,” said Andy Slavitt, White House senior adviser for the COVID-19 response team.

But the US has also suffered more deaths than any other country in the world – more than 518,000 Americans have lost their lives to the disease.

President Joe Biden has set a goal of 100 million vaccines administered during his first 100 days in office [File: Evan Vucci/AP Photo]

US President Joe Biden who took office in January has promised to make tackling the pandemic a top priority for his administration and has set a target to vaccinate 100 million Americans by early May – to coincide with his 100 days in office. He has said the country is well under way to meeting that goal.

Officials say 450 vaccination sites have been set up around the country which has sped up the effort and they have plans to open up more sites as vaccine supplies increase over the next weeks.

In an effort to further boost the campaign, last week the US gave emergency approval to use a third vaccine produced by drugmaker Johnson & Johnson. Biden has also announced that the US will manufacture the J&J vaccine, a shot that requires only one dose, further speeding up the effort.

But even with the vaccination campaign well under way, officials said deaths and infection rates have plateaued in recent days, indicating that the nation could be at risk of yet another surge.

CDC Director Rochelle Walensky said amid the rapid spread of new variants across the country, Americans need to ‘double down’ on protection measures of wearing masks, maintaining social distance and frequent hand washing [File: Kevin Lamarque/Reuters]

Director of the Centers for Disease Control and Prevention (CDC), Rochelle Walensky, said over the past week, there have been daily 60,000-70,000 new coronavirus cases, and 1,900 Americans have been dying every day.

“The current numbers remain concerning,” Walensky said, “cases and deaths are still too high, and have now plateaued for more than week.”

Amid the rapid spread of new variants, which have been detected in 48 US states, she urged Americans need to “double down” on protection measures of wearing masks, maintaining social distance and frequent hand washing.

“I know that the idea of relaxing mask wearing and getting back to every day activities is appealing,” she said, “but we’re not there yet.”

Several states have in recent days announced the easing of coronavirus restrictions on businesses and have lifted statewide mandates to wear masks. Health officials have responded with concern and urged Americans to continue to wear masks and follow precautions set under federal guidelines.

Biden blasted the decisions by state governors on Thursday, calling it “a big mistake” and “the last thing we need is Neanderthal thinking.”

Anthony Fauci, the nation’s top infectious disease doctor said the current numbers are an indication of a likely fourth surge in cases.

“When you have that much viral activity in a plateau it almost invariably means that you are at risk for another spike,” he said.

During the briefing on Friday, officials also announced that the CDC is working on publishing guidance for fully vaccinated individuals, indicating which activities they may or may not be able to resume.



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