Germany’s health ministry said Monday that the country may have to discard 3 million doses of expired COVID-19 vaccine by the end of June.
Ministry spokesman Hanno Kautz told reporters in Berlin that “not many doses” have been destroyed so far, though he couldn’t give an exact figure.
But Kautz said that “we have more vaccine available at the moment than is being used and than we can donate.” He added that the U.N.-backed program to distribute shots to poorer countries, COVAX, isn’t currently accepting donations.
“There is certainly a danger of vaccine being discarded,” Kautz said. However, he added that it recently emerged that the BioNTech-Pfizer vaccine can be stored for longer than previously thought, so German officials now believe that 3 million doses may have to be discarded or destroyed by the end of June — down from a previous estimate of 10 million.
Germany’s vaccination program has slowed considerably, with an average of only 33,000 shots administered per day over the past week — compared with over 1 million at times when the country’s booster campaign was in full swing in December.
Some 76% of the population has been fully vaccinated and 59% also have received a booster. Officials aren’t satisfied with the vaccination rate, particularly among older people, but the German parliament last week rejected a proposal to require all people 60 and over to get inoculated.
When the coronavirus pandemic first hit the U.S., sales of window coverings at Halcyon Shades quickly went dark. So the suburban St. Louis business did what hundreds of other small manufacturers did: It pivoted to make protective supplies, with help from an $870,000 government grant.
But things haven’t worked out as planned. The company quit making face shields because it wasn’t profitable. It still hasn’t sold a single N95 mask because of struggles to get equipment, materials and regulatory approval.
“So far, it has been a net drain of funds and resources and energy,” Halcyon Shades owner Jim Schmersahl said.
Many companies that began producing personal protective equipment with patriotic optimism have scaled back, shut down or given up, according to an Associated Press analysis based on numerous interviews with manufacturers. Some already have sold equipment they bought with state government grants.
As COVID-19 was stressing hospitals and shuttering businesses in 2020, elected officials touted the need to boost U.S. production of protective gear: “All this stuff should be made in the United States and not in China,” Florida Gov. Ron DeSantis said in remarks echoed by others.
Yet many manufacturers who answered the call have faced logistical hurdles, regulatory rejections, slumping demand and fierce competition from foreign suppliers. On April 1, Florida-based American Surgical Mask Co. became one of the latest to close.
“I’m just done with the fight,” CEO Matt Brandman told the AP.
After the initial scramble for PPE subsided, many industry newcomers faced difficulty selling products. Government agencies sometimes wanted huge quantities at tough-to-meet deadlines. Hospital systems tended to contract with established suppliers. Retail sales waned after every virus surge.
“At the end of the day, when everybody said they wanted American-made, nobody’s buying, not even the state,” said Tony Blogumas, vice president of Green Resources Consulting, a rural Missouri firm that received an $800,000 state grant but has sold only a few thousand masks. “We’re kind of upset about the whole situation.”
Missouri Gov. Mike Parson also is disappointed. His administration divided $20 million in federal COVID-19 relief funds among 48 businesses for the production of masks, gowns, sanitizer and other supplies. Parson hoped to seed a permanent field of manufacturers.
“I’m still a firm believer in that — that we need to be making PPE here in this state,” Parson said. “Unfortunately, a lot of entities went right back to where they were getting it before.”
The onset of the pandemic revealed that the U.S. was highly dependent on foreign countries for protective gear. When China limited exports because of its own battle against COVID-19, U.S. stockpiles plummeted. Prices skyrocketed as federal officials, governors and health care systems competed for supplies.
Though federal stockpiles have been replenished, shriveling domestic production has raised concerns that state governments, medical facilities and others could again get stuck scrambling for gear during a future pandemic.
The AP identified more than $125 million in grants to spur production of pandemic supplies made to over 300 business in 10 states — Alabama, Hawaii, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Missouri, New York and Ohio. It’s possible that grants were awarded in additional states, but there is no central clearinghouse to track them.
In November 2020, Alabama awarded one of the single largest grants — nearly $10.6 million from federal pandemic relief funds — to HomTex Inc. The company was to equip a new Selma facility to make 250 million surgical masks and 45 million N95 masks annually. The plant returned $1.8 million of the state grant and has yet to make anything due to a lack of customers.
“I can’t produce product that I can’t sell,” HomTex President Jeremy Wootten said.
Other companies also had trouble living up to political hype.
In October 2020, New York announced eight grants that then-Lt. Gov. Kathy Hochul, now the governor, said were “a model for how we build back better for the post-pandemic future.” Those included $800,000 for newly formed Altor Safety and $1 million for startup firm NYPPE.
But NYPPE’s equipment wasn’t ready until February 2021, by which time the market had changed, President Connor Knapp said.
So Knapp tapped the brakes on his plans. NYPPE still hasn’t sold any N95 masks because it lacks regulatory approval. It just recently scaled up production of surgical masks, after obtaining a U.S. Food and Drug Administration certification that came with its purchase of Altor Safety.
Some PPE manufacturers point to federal regulations as part of the reason for their struggles. Three-ply masks need FDA approval to be marketed for medical use — an important designation for building a long-term customer base.
That process can be time-consuming. Facing delays, Angstrom Manufacturing in Missouri ended up buying another business that already had FDA approval, President Chris Carron said. By then, it was fall 2021 — a year after it received a state grant.
Companies need approval from the National Institute for Occupational Safety and Health to market products as N95 respirators, which filter at least 95% of airborne particles.
During the first two years of the pandemic, NIOSH approved 30 new manufacturers — more than seven times the typical number during a similar pre-pandemic period, according to agency data. Some applications remain pending, while numerous others were denied.
Halcyon Shades’ N95 certification was rejected in October because its samples didn’t have head straps attached. While the company works on another application, its equipment sits idle inside the clear plastic-sheet walls of a “clean room” specially built to shield materials from airborne contaminants. Partially finished masks remain paused on a conveyor belt, waiting to be deposited into a cardboard box.
Without federal approval, “we’re just dead in the water,” said Schmersahl, the company owner.
Progress reports filed with the Missouri Department of Economic Development show that nearly all its PPE grant recipients faced challenges by July 2021, especially with sales.
Patriot Medical Devices, which received $750,000 from Missouri, hired nearly 100 people as it cranked out millions of masks during a COVID-19 surge in late 2020 and early 2021, CEO Rick Needham said. Fewer than 10 employees remain.
“We felt it was our patriotic duty to do something to help solve the problem,” Needham said. But, he added, “It’s frankly a little bit of a dysfunctional business model at this point.”
Ohio awarded $20.8 million to 73 businesses to manufacture pandemic-related supplies, according to state data. Of 60 businesses that complied with a recent reporting deadline, more than one-third no longer produced PPE by the end of 2021.
Cleveland Veteran Business Solutions, which received a $500,000 grant to get into the PPE business, made about 5 million surgical masks beginning in August 2020. It ultimately halted production in the face of cheaper imports and sold its machines this year, co-founder Taner Eren said.
“It was surprising and disappointing strategically that there wasn’t support for a local PPE manufacturing industry,” Eren said.
The business was among several dozen that banded together to form the American Mask Manufacturer’s Association with the goal of sustaining the industry. The group’s membership has dwindled as more and more go out of business.
Association organizers say the industry has reached a critical point. They want the federal government to treat PPE manufacturers like the nation’s defense industry — entering into long-term contracts to perpetually replenish a stockpile for future pandemics or emergencies.
“If the federal government doesn’t come in and help support the U.S. manufacturing base, it’s almost certainly going to go back to China, and we’ll be just as vulnerable as we were in early 2020 and 2019,” said Brent Dillie, the association chairman and co-founder of Premium-PPE, a Virginia manufacturer started during the pandemic that has shed about two-thirds of its roughly 300 employees.
Infrastructure legislation signed by President Joe Biden took a step toward bolstering domestic suppliers. Effective in February, it required new contracts for PPE purchased by the departments of Health and Human Services, Homeland Security and Veterans Affairs to run for at least two years and be awarded to U.S. producers — unless there’s not sufficient quantity and quality at market prices.
The health and veterans departments said they haven’t bought anything yet. Homeland Security hasn’t answered the AP’s questions. Documents show the government solicited bids due Dec. 6 for up to 381 million U.S.-made surgical masks over three years for its stockpile. No deal has been announced.
Other documents show the government is looking to contract with three major suppliers — 3M, Moldex, and Owens & Minor — for a total of $115 million in U.S-made N95 masks over three years. A justification document says noncompetitive contracts are necessary to preserve capacity for future coronavirus surges or emergencies.
The Biden administration also formed a task force of experts from federal agencies, health care providers, PPE manufacturers and distributors to develop a national strategy for ensuring a “resilient public health supply chain.” Its work is expected to extend for years.
Some manufacturers said they can’t wait long for a federal life preserver.
Dentec Safety Specialists is wrapping up a contract to supply 125,000 rubber reusable respirators and 500,000 filtration cartridges from its Kansas facility for the national stockpile, said President Claudio Dente. It needs more orders soon to prevent layoffs, he said.
“I thought that COVID would really change the mindset of the people, the governments and manufacturing,” Dente said. But he added: “The general marketplace is reverting back to their old ways — meaning looking to buy product from China.”
A COVID-19 patient was in respiratory distress. The Army nurse knew she had to act quickly.
It was the peak of this year’s omicron surge and an Army medical team was helping in a Michigan hospital. Regular patient beds were full. So was the intensive care. But the nurse heard of an open spot in an overflow treatment area, so she and another team member raced the gurney across the hospital to claim the space first, denting a wall in their rush.
When she saw the dent, Lt. Col. Suzanne Cobleigh, the leader of the Army team, knew the nurse had done her job. “She’s going to damage the wall on the way there because he’s going to get that bed,” Cobleigh said. “He’s going to get the treatment he needs. That was the mission.”
That nurse’s mission was to get urgent care for her patient. Now, the U.S. military mission is to use the experiences of Cobleigh’s team and other units pressed into service against the pandemic to prepare for the next crisis threatening a large population, whatever its nature.
Their experiences, said Gen. Glen VanHerck, will help shape the size and staffing of the military’s medical response so the Pentagon can provide the right types and numbers of forces needed for another pandemic, global crisis or conflict.
One of the key lessons learned was the value of small military teams over mass movements of personnel and facilities in a crisis like the one wrought by COVID-19.
In the early days of the pandemic, the Pentagon steamed hospital ships to New York City and Los Angeles, and set up massive hospital facilities in convention centers and parking lots, in response to pleas from state government leaders. The idea was to use them to treat non-COVID-19 patients, allowing hospitals to focus on the more acute pandemic cases. But while images of the military ships were powerful, too often many beds went unused. Fewer patients needed non-coronavirus care than expected, and hospitals were still overwhelmed by the pandemic.
A more agile approach emerged: having military medical personnel step in for exhausted hospital staff members or work alongside them or in additional treatment areas in unused spaces.
“It morphed over time,” VanHerck, who heads U.S. Northern Command and is responsible for homeland defense, said of the response.
Overall, about 24,000 U.S. troops were deployed for the pandemic, including nearly 6,000 medical personnel to hospitals and 5,000 to help administer vaccines. Many did multiple tours. That mission is over, at least for now.
Cobleigh and her team members were deployed to two hospitals in Grand Rapids from December to February, as part of the U.S. military’s effort to relieve civilian medical workers. And just last week the last military medical team that had been deployed for the pandemic finished its stint at the University of Utah Hospital and headed home.
VanHerck told The Associated Press his command is rewriting pandemic and infectious disease plans, and planning wargames and other exercises to determine if the U.S. has the right balance of military medical staff in the active duty and reserves.
During the pandemic, he said, the teams’ make-up and equipment needs evolved. Now, he’s put about 10 teams of physicians, nurses and other staff — or about 200 troops — on prepare-to-deploy orders through the end of May in case infections shoot up again. The size of the teams ranges from small to medium.
Dr. Kencee Graves, inpatient chief medical officer at the University of Utah Hospital, said the facility finally decided to seek help this year because it was postponing surgeries to care for all the COVID-19 patients and closing off beds because of staff shortages.
Some patients had surgery postponed more than once, Graves said, because of critically ill patients or critical needs by others. “So before the military came, we were looking at a surgical backlog of hundreds of cases and we were low on staff. We had fatigued staff.”
Her mantra became, “All I can do is show up and hope it’s helpful.” She added, “And I just did that day after day after day for two years.”
Then in came a 25-member Navy medical team.
“A number of staff were overwhelmed,” said Cdr. Arriel Atienza, chief medical officer for the Navy team. “They were burnt out. They couldn’t call in sick. We’re able to fill some gaps and needed shifts that would otherwise have remained unmanned, and the patient load would have been very demanding for the existing staff to match.”
Atienza, a family physician who’s been in the military for 21 years, spent the Christmas holiday deployed to a hospital in New Mexico, then went to Salt Lake City in March. Over time, he said, the military “has evolved from things like pop-up hospitals” and now knows how to integrate seamlessly into local health facilities in just a couple days.
That integration helped the hospital staff recover and catch up.
“We have gotten through about a quarter of our surgical backlog,” Graves said. ”We did not call a backup physician this month for the hospital team … that’s the first time that’s happened in several months. And then we haven’t called a patient and asked them to reschedule their surgery for the majority of the last few weeks.”
VanHerck said the pandemic also underscored the need to review the nation’s supply chain to ensure that the right equipment and medications were being stockpiled, or to see if they were coming from foreign distributors.
“If we’re relying on getting those from a foreign manufacturer and supplier, then that may be something that is a national security vulnerability that we have to address,” he said.
VanHerck said the U.S. is also working to better analyze trends in order to predict the needs for personnel, equipment and protective gear. Military and other government experts watched the progress of COVID-19 infections moving across the country and used that data to predict where the next outbreak might be so that staff could be prepared to go there.
The need for mental health care for the military personnel also became apparent. Team members coming off difficult shifts often needed someone to talk to.
Cobleigh said military medical personnel were not accustomed to caring for so many people with multiple health problems, as are more apt to be found in a civilian population than in military ranks. “The level of sickness and death in the civilian sector was scores more than what anyone had experienced back in the Army,” said Cobleigh, who is stationed now at Fort Riley, Kansas, but will soon move to Aberdeen Proving Ground in Maryland.
She said she found that her staff needed her and wanted to “talk through their stresses and strains before they’d go back on shift.”
For the civilian hospitals, the lesson was knowing when to call for help.
“It was the bridge to help us get out of omicron and in a position where we can take good care of our patients,” Graves said. “I am not sure how we would have done that without them.”
The manufacturing hub of Guangzhou closed itself to most arrivals Monday as China battles a major COVID-19 surge in its big eastern cities.
Shanghai has taken the brunt of the surge, with another 26,087 cases announced on Monday, only 914 of which showed symptoms. The city of 26 million is under a tight lockdown, with many residents confined to their homes for up to three weeks.
No such lockdown has yet been announced for Guangzhou, a metropolis of 18 million northwest of Hong Kong that is home to many top companies and China’s busiest airport. Just 27 cases were reported in the city on Monday.
However, primary and middle schools have been switched to online after an initial 23 local infections were detected last week. An exhibition center was being converted into a makeshift hospital after authorities said earlier they would begin citywide mass testing.
Only citizens with a “definite need” to leave Guangzhou can do so, and only if they test negative for the virus within 48 hours of departure, city spokesperson Chen Bin said in a social media announcement.
China has stuck to its “zero-COVID” strategy of handling outbreaks with strict isolation and mass testing, despite complaints in Shanghai over shortages of food and medical services.
China’s government and the entirely state-controlled media are growing increasingly defensive about complaints over the COVID-19 prevention measures, censoring content online and rebuking foreign critics.
Foreign Ministry spokesperson Zhao Lijian on Sunday said China had “lodged solemn representations with the U.S.” after the State Department advised Americans to reconsider traveling to China due to “arbitrary enforcement” of local laws and COVID-19 restrictions, particularly in Hong Kong, Jilin province and Shanghai. U.S. officials cited a risk of “parents and children being separated.”
China was “strongly dissatisfied with and firmly opposed to the U.S. side’s groundless accusation against China’s epidemic response,” Zhao said.
Despite that, and indications the hardline policy is being dictated by head of the ruling Communist Party Xi Jinping, China has rejected any notion that its response is political in nature. Xi has demanded social stability above all else in the runup to a key party congress later this year at which he is expected to bestow on himself an unprecedented third-term as party leader.
The English-language China Daily acknowledged that Shanghai’s measures are “far from perfect,” and pointed to the firing last week of three local officials for failing in their duties. But it said that shouldn’t become an “excuse to politicize the event and blame China.”
Despite the large number of cases, no new deaths have been reported in the Shanghai wave, possibly because the omicron variant is less deadly than older variants.
City authorities also say they have secured daily supplies for residents, following complaints about deliveries of food and other necessities.
Residents have resorted to group buying of groceries because they are not allowed to leave their buildings, with only partial success in obtaining needed items.
The capital Beijing has seen relatively few restrictions, although the Erjiefang neighborhood including the famed 798 art district has been cordoned off and classified as high risk after eight infections were reported there over the past two weeks.
China is facing one of its worst local outbreaks since the pandemic began. China is still mostly closed to international travel, even as most of the world has sought ways to live with the virus.
Total Doses Distributed = 711,815,445. Total Doses Administered = 565,598,011. Number of People Receiving 1 or More Doses = 256,213,167. Number of People Fully Vaccinated = 218,377,792.
Shanghai on Sunday discharged over 11,000 recovered COVID-19 patients and health authorities emphasized that they must be allowed to return home despite the lockdown that has severely restricted movement in China’s largest city.
“We hope their family and community will not worry about them or discriminate against them,” said Wu Jinglei, director of the Shanghai Health Commission.
The city of 26 million people reported 1,006 confirmed infections and nearly 24,000 asymptomatic cases in the last 24 hours. Shanghai has been under lockdown since March 28, and authorities said Saturday that the strict measures would be lifted in areas with no new cases in the last 14 days following another round of mass testing.
The United States on Saturday advised its citizens to reconsider traveling to China due to “arbitrary enforcement” of local laws and COVID-19 restrictions, particularly in Hong Kong, Jilin province and Shanghai. U.S. officials cited a risk of “parents and children being separated.”
Foreign Ministry spokesperson Zhao Lijian said in response that China was “strongly dissatisfied with and firmly opposed to the U.S. side’s groundless accusation against China’s epidemic response.”
“It should be pointed out that China’s anti-epidemic policies are science-based and effective, and we are fully confident that Shanghai and other places in China will prevail over the new wave of the epidemic,” said Zhao.
Meanwhile, Shanghai authorities said that they have secured daily supplies for residents from online platforms, according to state-owned newspaper Global Times, following complaints about deliveries of food and other basic necessities as the lockdown enters its third week.
Residents have resorted to group buying of groceries because they are not allowed to leave their buildings. Posts circulating on social media platforms such as Weibo also show that some residents have not been able to have their food orders delivered, while others posted online that they’re running out of food.
Some people said that as soon as you go to the grocery shopping app, a day’s orders are already filled.
According to the Global Times, platforms such as JD.com as well as Alibaba’s Ele.me delivery apps are working with authorities to ensure that everyone has access to vegetables, fruits and other produce.
Shanghai highlights the soaring human and economic cost of China’s “zero-COVID” strategy that aims to isolate every infected person.
Separately, Erjiefang, an area in capital Beijing, was classified as high-risk on Saturday after eight local COVID-19 infections were reported there over the past two weeks.
China is facing one of its worst local outbreaks since the pandemic began. China is still closed to international travel, even as most of the world has sought ways to live with the virus.
