Eli Lilly and Co said on Wednesday the U.S. government has purchased 650,000 additional doses of its COVID-19 antibody drug for $812.5 million.
The doses will be delivered through Jan. 31, with at least 350,000 delivered in December, the company said.
Moderna Inc’s COVID-19 vaccine could be approved for emergency use within 24 to 72 hours after the U.S. health regulator’s advisory committee meeting, Chief Executive Officer Stéphane Bancel said on Wednesday.
The Food and Drug Administration is scheduled to hold the meeting on Dec. 17 to discuss the company’s request for emergency use authorization for its vaccine.
Moderna currently has millions of doses of vaccines that can be shipped as soon as its request is granted, Bancel said, while speaking at the Piper Sandler healthcare conference.
Moderna, which is one of the front-runners in the race to develop a coronavirus vaccine, has applied for emergency authorizations both in the United States and the EU after full results from a late-stage study showed its vaccine was 94.1% effective with no serious safety concerns.
A shot developed by Pfizer Inc and BioNTech SE that was 95% effective in its pivotal trial is set to be reviewed by a panel of outside experts a week earlier. The FDA will decide on the authorizations after the advisers make their recommendations.
Bancel said Moderna was in a position to ramp up production quickly and would generate a lot of cash next year.
“We have the platform, and now is the time to scale,” he said.
Moderna shares were up 1% at $142.47. They have risen more than seven-fold this year, valuing the company at $55.80 billion as of Tuesday’s closing price.
AstraZeneca Plc will likely get results of its U.S. COVID-19 vaccine trial in late-January and could potentially file for an emergency authorization, the chief adviser for the U.S. government’s Operation Warp Speed program said on Wednesday.
The British drugmaker and Oxford University have already published interim efficacy results from their UK trial in November, but the results have raised questions among scientists.
The company said the vaccine could be 90% effective when given as a half dose followed by a full dose, based on a relatively small number of volunteers, while overall effectiveness was around 70%.
Speaking at a U.S. Department of Health and Human Services meeting, OWS chief adviser Moncef Slaoui said the large set of contrasting data coming out from the UK and Brazil trials may not be enough to ensure the vaccine receives the U.S. Food and Drug Administration’s emergency use authorization.
“Unless there is a very clear explanation based on facts and data of what’s behind those two numbers (on efficacy), it’s very likely that package would not be sufficient for (FDA) approval,” he said.
AstraZeneca resumed its U.S. trial in October after halting the study on Sept. 6 after a report of a serious neurological illness in a participant in the UK.
“I still expect that somewhere in January maybe, more towards the second half of January, data will become available and potentially an emergency use authorization could be filed,” Slaoui said, referring to the U.S. trial.
Federal Reserve officials saw “little or no growth” in four of their 12 regional districts and only modest growth in the others in recent weeks as a rapidly spreading health crisis and ongoing recession continued to devastate some U.S. businesses and families even as many others thrive.
In the U.S. central bank’s latest “Beige Book” compendium of anecdotes from businesses across the country, Fed officials seemed to signal that the winter slowdown they’ve feared would follow a new coronavirus outbreak is taking root.
Earlier on Wednesday, Fed Chair Jerome Powell repeated his plea for Congress to provide more aid to “get us through the winter” and support businesses and households until a vaccine allows for a broader resumption of commerce. Initial inoculations may begin in the United States this month.
Members of Congress and the Trump administration have resumed discussions over a possible aid package, but with no guarantee that a longstanding impasse will be broken during President Donald Trump’s final weeks in office.
Meanwhile, the pandemic is spreading at a rate of a million new cases a week and around 1,500 deaths a day.
In some places that has led officials to impose new restrictions on businesses and social gatherings. In others, households have pulled back on their own.
But overall it has left little capacity to fix problems that have plagued the economy since the onset of the pandemic last spring, with women sidelined from the workforce due to childcare concerns, leisure and hospitality firms semi-shuttered, and banks concerned their loans books may come under stress soon.
“This is one of the most troubling Beige Books we have seen in a long time,” Jefferies LLC economist Thomas Simon said.
The possibility of growing loan bank stress added a newly worrisome note: The comparative lack of loan defaults so far has prevented the recession from spawning a separate financial crisis.
But “banking contacts in numerous Districts reported some deterioration of loan portfolios, particularly for commercial lending into the retail and leisure and hospitality sectors,” Fed officials reported. “An increase in delinquencies in 2021 is more widely anticipated.”
Commercial real estate - especially in the office and retail sectors - was a weak spot across most districts. The Boston Fed reported that contacts there “estimated daytime office occupancy rates at around 20 percent - bad news for the shops and restaurants that relied on office workers’ business.”
The regional bank also said office tenants nearing the end of leases were renewing only for the short term and that some respondents noted an increase in available subleased space, signaling more trouble ahead in the sector.
Similarly, firms had become tentative about hiring because of the uncertain path of the pandemic.
Nearly all districts reported that employment was growing more slowly and that the recovery “remained incomplete.”
Businesses said it was harder to retain workers, especially women, because of challenges finding child care and dealing with school closures caused by the virus. Firms in several districts said they feared “employment levels would fall over the winter” before improving.
In Boston, “a supplier to commercial aviation announced major layoffs over the summer and has not had any reason to revise those plans either up or down,” local Fed officials noted.
Still the latest collection of Fed field reports, compiled on or before Nov. 20, included stories of other firms where managers struggled to find workers to help meet a boom in goods sales.
That divide, among regions and sectors that are doing well and those that are not, has become a hallmark of the current recession and presents the Fed with a difficult decision as it debates whether to provide more support for the economy at its Dec. 15-16 policy meeting.
The economy continues to recover from the deep blow it suffered at the start of the pandemic, and the prospect of a coming COVID-19 vaccine means the recovery could gain steam next year.
In the meantime, the country is 10 million jobs short of where it was in February. Job numbers for November will be released on Friday and are expected to show the pace of improvement is slowing, with some analysts now predicting an outright job loss.
U.S. regulations enacted after the financial crisis helped biotechnology companies raise the funds they needed to fight COVID-19 and will pave the way for further growth in the sector next year, the chief executive officer of investment bank Cowen Inc. said.
Dozens of biotechs including two leading the race for a coronavirus vaccine, are flourishing because the Jump-start Our Business Start-ups or JOBS Act has made it easier for small companies to raise financing.
Over the last 10 years, 415 biotechnology companies have listed their shares publicly, raising $200 billion through IPOs and follow-on fund raising, Cowen data show. Their continuing research allowed the companies to get 420 drugs approved during that time, the data show.
BioNtech, which listed its stock last year, and Moderna Therapeutics, which went public in 2018, have both asked U.S. and European regulators to approve their COVID-19 vaccines.
“Individuals and small businesses now have a smoother pathway to the capital markets thanks to more inclusionary rules and that has had a huge impact on many sectors but most prominently the biotech sector,” Jeffrey Solomon, Cowen’s CEO and chairman said at the Reuters Global Investment Outlook Summit. “Are we going to see more growth in the biotech sector next year? Yes.”
Cowen has helped a number of companies raise funds for researching therapeutics and creating tools and diagnostics.
Solomon said the companies Cowen has worked with have researchers working on therapies for cancer, aging, heart disease and mental health among others while also applying big data analytics and cloud computing.
Biotech investing has been lucrative for institutional investors and retail investors alike with health-care oriented hedge funds gaining an average 13% in the first 10 months of 2020 and retail funds like the Fidelity Select Biotechnology Portfolio gaining 31% in the first 11 months of 2020.
Solomon, who serves on the Securities and Exchange Commission’s Small Business Capital Formation Advisory Committee, said easier access to capital is just one theme of a handful he called instrumental.
He said he has been urging corporate chiefs to be more diverse in boardrooms and on the factory floors and embrace more sustainable production methods.
“CEOs are getting the message that your business model is predicated on embracing the changing demographics of the country. If you don’t do this, your business will be less relevant,” he said.
On Tuesday Nasadaq made a big push for diversity by saying it will require its listed companies to include women, racial minorities and LGBTQ individuals on their boards.
The pandemic has helped executives understand that what worked for decades might have to be thrown out the window. “Why wait, it is better to get out in front of new trends and adopt the mindset of stakeholder capitalism,” Solomon said.
Private U.S. companies have the right under the law to require employees to get vaccinated against COVID-19, but are unlikely to do so because of the risks of legal and cultural backlash, experts said.
Companies are still in the early stages of navigating access and distribution of vaccines against the disease caused by the novel coronavirus, but inoculation is considered the key to safely resume operations at crowded warehouses, factory lines and on sales floors.
“Companies have every good reason to get all of their employees vaccinated and also have an obligation to keep all employees and customers safe,” said Lawrence Gostin, a global health law professor at Georgetown University.
Gostin and five other health law experts said private companies in the United States have broad liberties to set health and safety standards, which would allow them to mandate vaccinations as a condition of employment with some exceptions.
The Equal Employment Opportunity Commission in May said employers were allowed to compel employees to get a coronavirus test before allowing them to return to work, a decision that some experts said might be extended to vaccine mandates.
But Robert Field, a law and public health professor at Drexel University, said companies considering mandates should wait for vaccines to undergo a full-fledged regulatory review process.
“Employers are on shakier grounds because of the emergency use authorization,” Field said, adding there was no precedent for vaccine mandates during that phase.
U.S. courts that have ruled on lawsuits by healthcare workers opposing employer-mandated flu vaccines have largely sided with hospitals as long as they provided reasonable exemption policies, court records showed.
In Europe, companies face a patchwork of national vaccine regulation, with some countries mandating childhood vaccines, but European employers overall are unlikely to be able to mandate vaccination for staff, experts said.
In France, which in 2018 began mandating some childhood vaccines, some vaccinations are obligatory for professionals in the social and healthcare industry. President Emmanuel Macron has said a coronavirus vaccine will not be mandatory.
In Germany currently, only measles vaccines are mandatory for some employees and companies have no sufficient legal basis to order COVID-19 vaccination, said Pauline Moritz, a Frankfurt-based employment law attorney.
And in the UK, the government has no legal power to compel vaccination and employers attempting to mandate vaccines would likely confront human rights concerns, employment lawyers at Morgan Lewis wrote in a blog post. bit.ly/3lDbG9W
U.S. agencies to date have not weighed in on COVID-19 vaccine mandates, but the Occupational Safety and Health Administration (OSHA) in the past has said employers have the right to mandate vaccines.
OSHA referred a request for comment to the U.S. Department of Health and Human Services, which did not respond.
U.S. companies so far are shying away from discussing vaccine mandates, ahead of formal approval for a vaccine by the U.S. Food and Drug Administration.
Ford Motor Co, which has ordered a dozen ultra-cold freezers to distribute vaccines to employees, said they would be made available on a voluntary basis.
A spokeswoman for Kellogg Co said the company was working with a medical expert and industry trade associations to make vaccines available to employees on a voluntary basis, in compliance with local and regional regulations.
“Companies could theoretically issue a mandate, but in the current political climate it is very unlikely they will do so,” said Peter Meyers, a law professor at George Washington University Law School. “Americans tend to shy away from mandates.”
Surveys have shown many Americans have safety concerns about a COVID vaccine, with nearly half of the 10,000 respondents polled in a September Pew research survey saying they would definitely or probably not get the vaccine.
Some experts said any vaccine mandates would prompt litigation. Cases alleging infringement on religious freedom could make it to a more conservative U.S. Supreme Court.
Vaccine mandates are common in the U.S. healthcare industry, where many hospitals require staff to take annual flu shots and all U.S. states mandate vaccines for school children.
Employees and parents can object to vaccines largely on two grounds: medical conditions that contraindicate vaccination or - depending on the U.S. state - religious or personal believes.
Some union contracts with individual employers, particularly in the healthcare industry, also prevent mandatory vaccines.
If an employee rejects vaccination on religious grounds, an employer has to make a reasonable effort to accommodate the worker, such as offering a transfer to a different department with fewer personal interactions or mandating masks, said Dorit Rubinstein Reiss, a law professor at UC Hastings.
So far two companies, Pfizer Inc and Moderna Inc, have asked the U.S. Food and Drug Administration for emergency use authorization of their vaccine candidates.
The chief adviser of the U.S. government’s COVID-19 vaccine program said on Tuesday that 20 million people could be vaccinated by the end of 2020, and that by the middle of 2021 most Americans will have access to highly effective vaccines.
The European Union criticised Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday, saying its own procedure was more thorough, after Britain became the first western country to endorse a COVID-19 shot.
The move to grant emergency authorisation to the Pfizer/BioNTech vaccine has been seen by many as a political coup for UK Prime Minister Boris Johnson, who has led his country out of the EU and faced criticism for his handling of the pandemic.
The decision was made under an ultra-fast, emergency approval process, which allowed the British drugs regulator to temporarily authorise the vaccine only 10 days after it began examining data from large-scale trials.
In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.
The agency said on Tuesday it would decide by Dec. 29 whether to provisionally authorise the vaccine from U.S. drugmaker Pfizer Inc and its German partner BioNTech SE .
A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.
Pfizer UK Country Manager Ben Osborn said, “We have provided complete data packages, the unblinded data, to both regulators. I think what you’re seeing is just the difference in the underlying process and timelines, as opposed to any difference in data submission.”
June Raine, the head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), said, “The way in which the MHRA has worked is equivalent to all international standards.
“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” she added.
The EMA started a rolling review of preliminary data from Pfizer trials on Oct. 6, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data.
The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA.
“The idea is not to be first but to have a safe and effective vaccine,” Germany’s Health Minister Jens Spahn told a news conference.
Asked about the emergency procedure used by Britain, he said EU countries had opted for a more thorough procedure to boost confidence in vaccines.
“If you evaluate only the partial data as they are doing they also take a minimum of risk,” the EMA’s former head Guido Rasi told an Italian radio.
“Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first,” he added.
‘PROBLEMATIC’
EU lawmakers were even more explicit in their criticism of Britain’s move.
“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.
“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU Parliament.
Under EU rules, the Pfizer vaccine must be authorised by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use.
Britain is still subject to EU rules until it fully leaves the bloc at the end of the year.
“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the Parliament.
“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”
