Bayer aims to deliver first doses of CureVac's COVID-19 shot in Q4

 German drugmaker Bayer said on Monday it aims to deliver the first doses of CureVac's COVID-19 vaccine from its factory in Wuppertal in Germany in the fourth quarter.

"We are very confident that we will even be able to deliver the first vaccines before the end of the year, if all goes well," Chief Executive Werner Baumann said during a visit to the plant by the premier of North Rhine-Westphalia Armin Laschet.

Head of pharma Stefan Oelrich said the company expects to start production in the fourth quarter.

German biotech company CureVac, which began late-stage testing of the vaccine in December and expects to announce interim results this quarter, signed up Bayer to help produce its shot earlier this month.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-aims-to-deliver-first-doses-of-CureVac-s-COVID-19-shot-in-Q4-32443771/

Covid-19 Vaccine Approval Process: Does It Take Too Long?

 The Food and Drug Administration will convene an independent panel of experts Feb. 26 to recommend whether the Johnson & Johnson Covid-19 vaccine should be authorized for use in the U.S.

The hearing comes 22 days after J&J submitted its application and supporting test data. That's on par with the timetable the FDA set for review of the vaccine from Pfizer Inc. and partner BioNTech SE, but nearly a week longer than the one for the vaccine from Moderna Inc. Both were approved in December.

Some readers have questioned the amount of time needed to convene these review panels amid a global crisis and the urgent need to get vaccines distributed. Here's a look at some of the issues involved:

How long does it take to review vaccine test data?

FDA officials say they need the time to review the vaccine test data submitted by the company and make sure the conclusions are accurate. As part of that review, FDA scientists scrutinize data from individual study volunteers, paying close attention to those who have had side effects and to differences between various demographic groups.

The time frame is still much shorter than the usual FDA review of proposed new drugs and vaccines, which normally takes months.

But the FDA took only about 2 1/2 weeks to review the Moderna data. Why three weeks for J&J?

The circumstances have changed considerably since Dec. 17, when the FDA advisory committee recommended an emergency authorization for the Moderna vaccine about 2 1/2 weeks after the company submitted data.

At that time, there weren't any known significant variants to the coronavirus. And both the Moderna and Pfizer vaccine approved earlier were home runs -- with effectiveness hovering around 95% -- and showed strikingly similar results across the board, regardless of race, age, sex and medical history.

The agency will also have to spend several days analyzing the J&J shot's effectiveness against variants identified in South Africa, the U.K. and elsewhere, and on varying effects in different groups of patients. The J&J data, in short, are nuanced.

"There is indeed a greater complexity here," said Peter Marks, director of the FDA biologics center.

What is this panel that will consider recommending approval of the J&J vaccine?

It is an independent committee of experts on vaccines, infectious diseases, pediatrics, epidemiology and other specialties that pertain. The committee advises the FDA on whether to authorize the use of the vaccine and in what groups of patients.

If the panel clears the vaccine for use, what happens next?

The FDA expects to act on the panel's recommendations within a day after the hearing. If the FDA authorizes use of the vaccine, vaccinations could begin in a matter of days.

I've heard the J&J vaccine isn't as effective as the others. Should I hold out for a Pfizer or Moderna vaccine?

Public health experts say no. To be sure, the Pfizer and Moderna vaccines reported stronger results. But in the world of vaccines, the J&J results -- 66% effective in its international study, and 72% effective in the U.S. portion of the study -- are considered good, and exceed the 50% standard the FDA set for vaccine efficacy.

The J&J shot showed efficacy of 57% even in South Africa where a resistant mutation of the coronavirus has spread.

And in preventing severe Covid illness -- involving respiratory failure, shock, organ failure or death -- the J&J shot was 85% effective. So in the very cases we're most worried about, those involving hospitalization and death, the J&J vaccine was strikingly effective.

The J&J vaccine also has some significant advantages. It requires just one shot, not two as required for the Pfizer and Moderna vaccines. And it can be stored at regular refrigerator temperatures for longer periods than the Pfizer and Moderna vaccines. That can be helpful in rural areas especially.

New variants of the coronavirus appear to be popping up on a regular basis. How effective will the vaccines be in preventing them?

The pharmaceutical companies say the vaccines can be tweaked to address new strains of the virus, and the FDA has said it would work to streamline the approval process for these updated vaccines, much in the way it does now for flu shots.

Pfizer and Moderna have found, at least in the lab, that their vaccines appear to cover the variant identified in South Africa. Their vaccines also showed good effects against the mutation that arose in England.

If new evidence shows variants to be more resistant to the vaccines, both Moderna and the Pfizer partnership are designing new vaccines that more specifically target the variant strains.

How does this vaccine fit into the bigger picture, including overcoming public resistance to a vaccine?

Getting a third vaccine on the market could reduce hospitalization rates and the need for intensive care, which had placed U.S. hospitals in a precarious situation.

Polls have shown many Americans -- including significant numbers of healthcare workers -- have been resistant to taking a vaccine. FDA officials say one reason they are vetting the results carefully is to ensure that the vaccine is safe and effective in all groups it is authorized for, so that any disappointing results don't dampen people's willingness to be vaccinated.

"That's not what you want as a public health professional," said the FDA's Dr. Marks.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Covid-19-Vaccine-Approval-Process-Does-It-Take-Too-Long-32443401/

India to ship COVID-19 vaccines to Canada as diplomatic tension ease

 India’s Serum Institute will ship COVID-19 vaccines to Canada within a month, its chief executive said on Monday, in a sign a diplomatic row triggered by Canadian Prime Minister Justin Trudeau’s comments on political protests in India was easing.

Trudeau said the months-long protests by farmers on the outskirts of Delhi were concerning, drawing a rebuke from the Indian government which said it was an internal matter.

Last week, however, Trudeau spoke to Indian counterpart Narendra Modi and they discussed the two countries’ commitment to democracy.

Modi also said India would do its best to supply COVID-19 vaccines sought by Canada.

On Monday Adar Poonawalla, the chief executive of Serum Institute of India (SII) - the world’s largest vaccine maker - reaffirmed that commitment.

“As we await regulatory approvals from Canada, I assure you, @SerumInstIndia will fly out #COVISHIELD to Canada in less than a month; I’m on it!” Poonawalla said in a Tweet, using the brand name under which Serum produces the shot developed by Oxford University and AstraZeneca Plc.

India’s SII has emerged as a key vaccine supplier amid the pandemic. Canada, like many other countries, is relying on foreign supplies because it is unable to produce the vaccine locally.

Experts and officials say India has been trying to use its vaccine dominance to shore up diplomatic support.

https://www.reuters.com/article/us-health-coronavirus-canada/india-to-ship-covid-19-vaccines-to-canada-as-diplomatic-tension-eases-idUSKBN2AF0KA

EU antitrust regulators to okay Siemens Healthineers' $16.4B Varian buy

 EU antitrust regulators are set to grant conditional clearance to German health group Siemens Healthineers’ $16.4-billion bid for U.S. peer Varian Medical Systems Inc, three people familiar with the matter said.

The EU green light will come after Siemens Healthineers last month offered concessions to address competition concerns about interoperability, the sources said. Such a measure enables computer systems and software to work with each other.

https://www.reuters.com/article/us-varian-med-syst-exclusive/exclusive-eu-antitrust-regulators-to-okay-siemens-healthineers-16-4-billion-varian-buy-sources-idUSKBN2AF10B

European Banks Use Pandemic to Clean House

 European banks are using the pandemic to make changes investors have wanted for years: slash jobs, shut branches and force customers online.

Germany's second-largest lender, Commerzbank AG, said Thursday that it would cut a third of its domestic staff and almost half of its bricks-and-mortar presence after pressure from U.S. shareholder Cerberus Capital Management. Bank mergers under way in Italy and Spain are expected to close thousands of overlapping branches. Business consulting firm Kearney predicts one-quarter of Europe's 165,000 bank branches will be gone in three years.

Banks are one of Europe's economic weak links, and they have been slow to change. Compared with U.S. peers, European banks struggle to make enough money to support lending growth. They came into the Covid-19 crisis still digesting a mountain of bad loans from the sovereign-debt crisis that started more than a decade ago.

The pandemic injected urgency into the situation. The European Central Bank has leaned on banks to reform and has paved the way for cost-saving mergers. National governments, long resistant to approving bank mergers that would result in job cuts, have changed their tune. Dreary stock-market valuations have spurred CEOs to act.

"The pandemic, to some extent, has been a catalyst for banks to bite the bullet and start addressing these weaknesses in a more radical way," Andrea Enria, head of banking supervision at the ECB, said recently.

European banks' costs are high compared to the revenue they generate. One area of low-hanging fruit is bank branches. Spain's top five banks closed 8% of their branches last year, and have vowed to shut more. Despite years of cuts, the country had one of the highest number of commercial bank branches per capita in the eurozone -- 49 for every 100,000 people in 2019 -- according to the International Monetary Fund, compared with 30 in the U.S.

Caixabank SA, which is buying smaller Bankia SA to scale up, said it would save EUR770 million a year, the equivalent of $930 million, a large part of which analysts expect to come from shutting as many as half of its 6,300 branches.

The hope is that the pandemic has taught customers how to live without frequent trips to bank branches, which are expensive to maintain and staff.

Anna de Juan, a 60-year-old Bankia customer, used to go to a branch almost every day for at least an hour to make cash transfers and manage investment funds for a small asset-holding firm she works for. Since the pandemic, she has done almost everything online or over the phone.

"It has been a great change for me; I have saved time and energy," she said.

Branch foot traffic dropped 30% during the pandemic at Ireland's AIB Group PLC. That led to an unexpected benefit for the bank. Over-65s, who have been resistant to using online tools, are now the fastest-growing group on AIB's digital channels, said CEO Colin Hunt. He said branches can be an important "shop window." But it is merging some, cutting back on office space and eliminating 1,500 jobs to cut costs 10%.

So far, investors remain skeptical about whether the newfound resolve for cutting will be enough. European bank shares have languished for years. Europe's largest banks, despite having balance sheets on par with U.S. rivals, trade at a fraction of their market value.

At Commerzbank, years of slow progress on cost-cutting agitated its second-largest shareholder, Cerberus. Last summer it demanded a sharper turnaround, after which the bank's CEO and chairman resigned. The private-equity giant is sitting on a paper loss of over EUR300 million from its 2017 investment.

"If we want to make the bank future-proof, we need to carry out in-depth restructuring, and as quickly as possible," Manfred Knof, Commerzbank's CEO, said Thursday. The sharp cuts have been supported by the German government, the bank's largest shareholder, and have so far faced little resistance from unions.

A person familiar with Cerberus's thinking said the plan, which includes exiting international locations and unprofitable operations, is largely in line with what it has long called for.

In Italy, Intesa Sanpaolo SpA shed 10,000 jobs and hundreds of branches after it merged with a smaller rival last year. Chief Executive Carlo Messina said parts of the strategy were "reset due to the pandemic" as customers moved online, and the combined bank's annual cost savings rose 37% to EUR700 million.

Even still, Italy's largest bank by assets has more than 4,000 branches, on par with JPMorgan Chase & Co. and Bank of America Corp., despite operating in a smaller market. Intesa plans to keep at least 3,000 branches and turn them into advice centers to sell investments and insurance. It is also channeling customers who don't want to go online toward drugstores and espresso bars through a venture with a payments processor.

https://www.marketscreener.com/quote/stock/COMMERZBANK-AG-13057331/news/European-Banks-Use-Pandemic-to-Clean-House-32439756/

Covid-19 Vaccine Rollout Heads to Small Town

 Pat and John Thomas were watching the news one night last week when they saw that Walmart in Skowhegan, a central Maine town of 8,000 people was taking appointments for the Covid-19 vaccination. They had signed up for shots at a hospital about a month ago but still hadn't heard back. Ms. Thomas, a 74-year-old retiree, jumped on the computer.

On Friday the couple got the Skowhegan Walmart's first doses under a new federal government program that provides Covid-19 vaccines directly to retail pharmacies across the country.

"We'll be able to see our family and friends," said Ms. Thomas, a former assistant manager at a bank who has been married to her husband, a 78-year-old retired accountant, for 48 years. "It will just be nice to be able to visit and go somewhere when you're not afraid."

Walmart Inc., the U.S.'s largest retailer and private employer, is set to become one of the biggest distributors of the Covid-19 vaccine as the federal government enlists retail pharmacies to accelerate what has been a choppy rollout.

Last week, 21 retail chains and pharmacy networks started administering those doses, including CVS, Walgreens, Kroger and grocers in all 50 states. The government initially plans to give around a million doses a week directly to pharmacies. Around 200,000 of those are going to Walmart, a spokeswoman said.

That is in part because out of the roughly 5,000 U.S. stores under the company's Walmart and Sam's Club banners, about 4,000 are located in what the federal government defines as medically underserved areas.

"We have the most dispersed population of any state in the country," Maine Gov. Janet Mills said, as well as the oldest population of any state in the country.

Ms. Mills, a Democrat who took office in early 2019, said she chose to work only with Walmart to start because stores are well spread out and the chain was poised to roll out the vaccine quickly. "There are other chains, chain grocery stores and whatnot but they were not ready yet with respect to electronic medical records and being able to coordinate information with the state," said Ms. Mills.

At the Skowhegan Walmart on Friday, around two dozen people had vaccine appointments. Some said they couldn't wait to get their shots, while others said they were nervous about taking a new vaccine that was developed so quickly but feared Covid-19 even more.

"I'm on the fence," said Betty Kuhn, a 76-year-old who lives in Hartland, Maine, who came to the pharmacy counter to check that her Monday vaccine appointment was in the system. "But at my age, my family wants me to get it."

The vaccine started to arrive last Wednesday in refrigerated boxes that tell pharmacists if doses have been at the correct temperature during transit, said Robin Nicol, pharmacy manager at the store. The local news had already informed many that Walmart would be taking appointments. Walmart's booking website crashed in Maine and other locations across the country. A spokeswoman for the retailer said it is now running smoothly.

Last week, Maine received about 4,800 doses from the federal government that went only to Walmart. That worked out to around 200 doses in each of Walmart's 24 stores in the state with pharmacies, enough for a few dozen vaccine appointments each day per store. "Demand is massive," Mr. Nicol said. When the website crashed, interested patients called or came to the store to ask about availability, he said.

The store did a trial run the day before the official launch, calling 10 patients in for vaccinations from the store's "waste protocol list," which the store maintains in case any doses are left over, Mr. Nicol said.

The Skowhegan pharmacy serves a steady stream of customers, some driving as much as 90 minutes from the more remote north for prescriptions or other services, store workers said.

"I live at the top of a mountain so I come when I'm absolutely out of everything and I get one of everything," said Gloria Guerette, a 78-year-old piling her cart with cooking oil, meat and frozen vegetables. She said she hasn't tried to get a vaccine appointment yet, because they require two shots. "I hope I can get one shot so I only have to travel once," she said.

"We have areas of our county that would be designated as frontier really, " said Matt L'Italien, director of Somerset Public Health, a community health group at Redington-Fairview General Hospital in Skowhegan. "There is not enough access to primary-care physicians, dentists, all those services," he said.

After the state moved on from vaccinating front-line healthcare workers to citizens 70 and older, supply at Redington-Fairview became constrained, said Lisa Caswell, director of pharmacy at the hospital. More than 5,000 people have preregistered on the hospital's website since Jan. 20, she said, and more than 1,000 have called to join the wait list. The hospital had 300 first doses to give out last week, 200 this week, said Ms. Caswell.

Dawn Wing, a 70-year-old from nearby Madison, came to the Skowhegan Walmart pharmacy counter Friday to try to score an appointment, after she called three regional hospitals and tried to book online at Walmart's website with no luck. "I have high blood pressure issues and my husband has had colon cancer," she said. "I'm ready to pull my hair out."

Each Maine Walmart store is preparing to administer about 400 doses a week starting a month from now to provide second doses as federal supplies increase, said Chad Tozier, health and wellness director for an 11-store region, including Skowhegan. Walmart plans to host clinics, moving shelves of products to make room for more appointments and the waiting areas required so pharmacists can monitor patients for allergic reactions, he said. For now, patients sit behind a movable blue 5-foot barrier near the pharmacy to get the vaccine.

The government gives Walmart and other retail pharmacies the vaccine free and there is no charge to shoppers. Walmart can earn a small fee from insurance companies when patients are covered, but is largely shouldering the cost to administer the vaccine, said Lisa Smith, senior director of health and wellness at Walmart.

Walmart is likely to benefit in other ways. Many of the people getting the vaccine at the Skowhegan store Friday didn't previously have patient profiles in Walmart's system, said Mr. Tozier. "We are making relationships with new patients," he said.

Ann Jackson and her husband, Norman Jackson, 73 and 76 years old respectively, arrived for their vaccine appointment midmorning after waiting for weeks to get an appointment at the local hospital, said Ms. Jackson. Later, she added chips, bananas and T-shirts to her cart. "You never want to waste the trip to Walmart," she said.

https://www.marketscreener.com/quote/stock/WALMART-INC-4841/news/Walmart-Covid-19-Vaccine-Rollout-Heads-to-Small-Towns-32439754/

Airport COVID-19 Safety Measures Still Need Work

 Safety measures taken by U.S. airports have lowered travelers' risks of getting the new coronavirus, but more needs to be done, a new report claims.

"To be clear, we are not saying that it is safe to fly," but precautions taken by airports "do significantly reduce the risk of contracting the virus," for those who must fly, Leonard Marcus, founding codirector of the National Preparedness Leadership Initiative, said in a news briefing Thursday, The Washington Post reported. The initiative is a joint program of the Harvard T.H. Chan School of Public Health and the Kennedy School of Government.

Wendy Purcell, Ph.D., a research associate in the department of environmental health at the Harvard Chan School, cited one airport that installed two miles of clear physical barriers, 500 hand sanitizing stations, and 5,000 floor decals to remind travelers of the importance of social distancing. Others, in conjunction with airlines, have adopted technology that enables people to check in for a flight, check their luggage, and obtain a boarding pass with almost no human contact, she added.

The researchers suggested that airports consider limiting eating and drinking in spaces where large numbers of travelers gather. If such a ban is not possible, steps should be taken to improve air circulation, the study said. The Harvard team said challenges still faced by airports include improving ventilation systems and making operational changes to handle more people once there is increased demand for air travel.

https://consumer.healthday.com/airport-covid-19-safety-measures-still-need-work-2650518509.html