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Pfizer proposes expansion of late-stage coronavirus vaccine trial

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The Pfizer world headquarters stands in Midtown Manhattan in New York City.

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Pfizer and German biotech firm BioNTech announced Saturday that they have submitted a proposal to the U.S. Food and Drug Administration to expand the phase-three trial of its coronavirus vaccine to include up to 44,000 participants, a significant increase from its previous target of 30,000. 

The companies, which are developing the vaccine together, said in a statement that the trial is proceeding as planned and they expect to have enrolled 30,000 participants by next week. 

“The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data,” the companies said. 

Representatives of the Food and Drug Administration and of the Department of Health and Human Services did not immediately return CNBC’s request for comment.

Public health specialists have emphasized the need for participants in vaccine trials to reflect a diverse population, including the elderly, communities of color and people with underlying health conditions, all of whom have been disproportionately impacted by the virus. Including diverse participants helps ensure that the vaccine candidate is truly safe and effective across a variety of populations. 

Moderna, another company developing a Covid-19 vaccine, told CNBC earlier this month that they were slowing enrollment slightly in its trial to ensure it has sufficient representation of minorities most at risk for the disease.

Pfizer CEO Albert Bourla said earlier this month that the pharmaceutical company could have results from its late-stage trial as soon as October. On Saturday, the companies reiterated the possibility that they could have data reflecting whether the vaccine is effective or not by the end of October. However, it could take longer to collect enough data to determine whether the vaccine is safe, because it will take months of follow-up work to determine what kind of side effects, if any, the vaccine may cause.

“The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing,” the companies said. “As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.”

Through Operation Warp Speed, the Trump administration’s effort to quickly bring a Covid-19 vaccine and therapeutics to market, the U.S. has now invested more than $10 billion in six candidates, including Pfizer’s. The U.S. announced in July that it agreed to pay nearly $2 billion to Pfizer and BioNTech for at least 100 million doses. 

In July, Pfizer announced that early-stage clinical trial showed the vaccine produced some neutralizing antibodies, which researchers believe is necessary to build immunity to the virus. 

—CNBC’s Meg Tirrell contributed to this report.

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Covid-19 cases continue to mount around the country

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NBC’s Gabe Gutierrez reports on the growing number of Covid-19 cases in South Dakota and the difficulty the state is having in its attempts to deal with it.

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HSBC plans further cost cuts despite forecast-beating results | Business

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HSBC is planning further cost cuts, despite a sharp fall in provisions to cover bad debts linked to the Covid crisis and better-than-expected third-quarter profits.

The lender also signalled that it could start charging for bank accounts in markets such as the UK, where the service is currently free.

HSBC’s pre-tax profits fell to $3.1bn (£2.4bn) in the three months to September, down 36% from $4.8bn during the same period last year. However, that easily beat analysts’ forecasts of $2.1bn.

The performance of Europe’s largest bank was helped by lower-than-expected provisions to cover a potential surge in defaults linked to the economic fallout of the pandemic. HSBC put aside $785m in the third quarter, less than half the $2bn forecast by analysts.

It brings the bank’s total impairment charge to $7.6bn for the year to date, after setting aside $3bn and $3.8bn in the first and second quarters, respectively.

HSBC said it expected loan loss charges for the whole of 2020 to be at the lower end of the $8bn to $13bn range it outlined earlier this year.

“This latest guidance, which continues to be subject to a high degree of uncertainty due to Covid-19 and geopolitical tensions, assumes that the likelihood of further significant deterioration in the current economic outlook is low,” HSBC said.


However, HSBC again signalled it would be taking cost cuts further than originally planned. “Given the significant changes in the operating environment, we intend to accelerate the transformation of the group. We expect to reduce the group’s 2022 annual cost base beyond our original $31bn target, while sustaining investment in our focus areas.”

It comes just months after the bank said it would increase cost-cutting that was estimated to involve 35,000 job losses across its global business.


Meanwhile, its chief finance director, Ewen Stevenson, warned the bank could begin to charge for some services including current accounts in countries such as the UK, where basic accounts are usually free.

“We will have to look at charging for basic banking services in some markets, because a large number of our customers in this environment will be losing us money,” Stevenson told Reuters.


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Most UK bosses would back tougher employment laws to protect workers | Law

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Business leaders would support tougher employment laws and a higher minimum wage to protect workers from exploitation and poverty during the second wave of Covid-19, according to a report.

The Centre for Progressive Policy (CPP) said urgent legal reforms were needed in the jobs market to prevent extreme levels of financial insecurity, in-work poverty and worker exploitation during the coronavirus emergency.

The thinktank said the end of the UK government’s furlough scheme later this week would dramatically increase the risk of widespread unemployment this winter, undermining the bargaining power of workers and leaving the door open to a rise in insecure work.


Calling for a shake-up of the law to halt a sharp increase in worker poverty, the thinktank said the government should ban zero-hours contracts and boost the minimum wage from its current level of £8.72 for over-25s. It also said a legal pay floor should be introduced for self-employed workers to protect them from exploitation.

The intervention comes as unemployment is expected to more than double by the end of the year to hit 1980s levels, from a rate of 4% before the pandemic struck to 12%.

Although free-market economists have argued that looser labour laws were among reasons Britain recorded a lower unemployment rate after the 2008 financial crisis compared with many other EU nations, the CPP said tighter restrictions were needed to safeguard workers’ rights. It said they could also be used by Boris Johnson to show the government was serious about his promise to “build back better” and “level-up” Britain’s lopsided economy.

The CPP, which is funded by Lord David Sainsbury, said as many as one in five workers in the health and social care sector work on zero-hours contracts, and that insecure contracts were most heavily used in the north-east.

In a sign of the appetite for change, it said business leaders had become more receptive to tougher labour market laws since the onset of the Covid emergency as companies require state support and as more households come under financial pressure.

According to a survey of 600 company bosses, 64% would back tightening existing labour market regulations, including an increase in the minimum wage. It said 40% of employers felt more responsibility to offer secure job contracts to staff in response to Covid-19, while a quarter would support further restrictions or a ban on the use of zero-hour contracts.

With the government under mounting pressure to fund free school meals and to tackle child poverty, the CPP said there was clear evidence that tougher labour market laws could also be used to protect families from falling below the breadline.

Research from the Joseph Rowntree Foundation shows in-work poverty has been increasingly driven by the impoverishment of working parents. According to figures from Eurostat, the UK also has one of the highest levels of workers at risk of poverty in Europe, with British workers more than twice as likely to fall into poverty as those in Ireland and Belgium.

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Figures from the Office for National Statistics earlier this summer, revealed a rise in zero-hours contracts to the highest level on record. The number of people on zero-hours contracts increased by 156,000 in the three months to July, or by 17.4%, to 1.05 million.

Rosie Stock Jones, senior research analyst at the CPP, said: “Maintaining a system that legitimises the exploitation of society’s most important workers and contributes to rising levels of in-work poverty can no longer be acceptable. If the government truly wants to level up the country and empower more people to contribute to and benefit from increasing prosperity, they must deliver proper protections and improved conditions for our lowest paid workers.”


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