Nearly a year ago, Brian Wolin got involved because he wanted to help.
In the early days of the coronavirus pandemic, reports from inside hospitals were that health care workers were reusing N95s for days at a time. These masks are typically for one use.
A chiropractor for 22 years, Wolin partnered with his brother-in-law to form Protective Health Gear, a New Jersey company set on making N95 masks to help health care workers in the coronavirus pandemic.
Wolin never expected to have a surplus of N95s sitting in his warehouse, waiting for buyers in an ongoing pandemic.
He’s not alone. CNN found several small American N95 manufacturers are struggling to bridge the disconnect between N95 supply and demand.
For the past year, nothing has been in as short a supply and as high demand as the N95 respirator mask.
N95 masks are considered the gold standard in personal protective equipment because they block 95% of aerosols that may contain viruses like coronavirus. That level of protection was essential to frontline workers responding in high-risk transmission environments.
When the pandemic hit, the US Food and Drug Administration eased rules on standards for N95 respirators, and said frontline health care workers could use products approved by the National Institute for Occupational Safety and Health (NIOSH).
That regulatory change and calls from government officials to help inspired Brian Wolin to be one of those applicants. After months of thorough paperwork and rigorous testing of his N95 mask, his company Protective Health Gear was approved in August to make N95 masks that could go straight to health care workers in need.
Wolin hasn’t seen the frantic demand he expected or has seen in news reports. Demand for his N95 mask has been so low that his company, Protective Health Gear, is only making half of its full capacity of 100,000 masks a day.
“I thought the demand would be so overwhelming from everyone that we wouldn’t be able to even come close to providing what we needed,” Wolin told CNN Chief Medical Correspondent Dr. Sanjay Gupta in an interview. “We were very surprised to not have that.”
Demand has been so low that Protective Health Gear actually finds itself with a surplus of critically needed N95 masks piling up in its New Jersey warehouse – boxes and boxes of N95 masks just waiting for buyers.
Wolin has found it surprisingly difficult to connect with health care and government buyers to sell his NIOSH-approved N95 mask. He’s reached out to health care organizations, government agencies and has even met with New Jersey Governor Phil Murphy and Congressman Bill Pascrell, but nothing has come from those meetings.
“We listened to your calls for help. And we’re here to help. So please help us help you. And as I said, we’re ready to open any way possible that we can to produce as many that would possibly be needed,” Wolin told them.
There is still high demand for N95 masks across the country. At least 62% of health care facilities needed N95 masks last month according to Get Us PPE, a national organization working to get PPE to frontline workers.
Additional N95s are still critically needed even with the CDC’s authorization that the masks — which are typically single-use — can be reused. The CDC issued the guidance at the height of the pandemic when supplies were threatened. But CNN has learned that if the policy was reversed today, there would not be enough N95s to be used on a single-use basis.
Broken supply chain
According to a Biden administration official, an estimated 22 domestic N95 manufacturers have been granted NIOSH approval during the pandemic.
CNN spoke with seven of these new manufacturers. Six of the seven said they were having trouble connecting with health care and government buyers and actually had surpluses of N95 masks in their warehouses.
The official told CNN that domestic manufacturers are producing around 220 million N95 masks per month. Around 40 million are from new manufacturers per month.
All seven companies CNN spoke to said they were not operating at their maximum capacity to make the most N95 masks possible.
Administration officials noted the challenge in connecting these smaller manufacturers with buyers because a lot of the major hospital providers prefer to go through their existing contracts. Many of the small manufacturers didn’t have sales or distribution relationships as more established N95 manufacturers, so they’ve had a difficult time entering the market.
Several smaller N95 manufacturing companies also noted that their limited production ability disincentivizes hospital and government buyers that need to fill massive orders. Some companies may also be less inclined to order from a new company because they have already invested in having a certain mask product fit-tested to their employees — a time-consuming process that ensures optimal fit.
Los Angeles-based N95 manufacturer Aidway Personal Care Product told CNN that since getting approved in October, they’ve registered with every government agency, state and government contract websites. Their employees even knocked on doors of hospitals, clinics and health care facilities to try and get their product to the community, with little success. Aidway has donated most of its product to date.
“I have personally made phone calls and sent emails to people in our district or outside and in all of the municipalities around us in Los Angeles when, when it was the worst just a few weeks ago when ICU was at full capacity,” Aidway Client Relationship Director Aram Arutyunyan told CNN. “This is the most crucial time, and we were still unable to get through.”
Aidway has about 100,000 masks sitting in storage and the raw material to build 2 million more.
Demand has been so. Low the company has scaled down production and decided to focus on getting inventory to retail consumers.
But there’s a roadblock there, too. Platforms such as Amazon, Google and Facebook have restricted sales of N95s to preserve inventory for health care workers.
“By restricting our items from being sold, you’re basically in, in other words, pushing overseas products,” Arutyunyan said.
An Amazon spokesperson told CNN in an email: “We currently offer a significant number of N95 masks to consumers and will continue making more available, while also ensuring we have supply available for health care workers.”
Senior White House staff have reached out to Amazon about the sale of domestically made N95 masks on its website, administration officials and an Amazon spokesperson confirmed to CNN.
In the last two weeks alone, we onboarded multiple domestic, certified N95 mask manufacturers to increase selection for our customers. We continue to work with additional domestic manufacturers as their N95 masks receive NIOSH certification,” the Amazon spokesperson told CNN.
The Biden administration has reached out to at least 10 of the smaller and newer N95 manufacturers recently, an administration official told CNN this week.
Contracts with the federal government and these smaller companies also “are in the realm of possibility,” an administration official said, who cited ongoing conversations with a few of the companies. “There are opportunities and there will be more coming,” the official added.
ALG-Health in Ohio told CNN that a White House official did make an introduction to an Ohio-based health care company. But the Ohio company hasn’t responded, vice president of sales and marketing Brian Feeney told CNN Thursday via email.
CDC guidance on masks
With more transmissible coronavirus variants emerging, some scientists and health officials have called for the Biden administration and the CDC to recommend higher quality masks to protect the public.
CDC guidance remains that it “does not recommend the use of N95 respirators for protection against COVID-19 in non-health care settings because N95 respirators should be reserved for health care workers.”
In a letter last month experts and former Biden coronavirus advisers pushed the White House to more widely recommend use of N95 masks.
Brigham and Women’s Hospital and Harvard Medical School’s Dr. Abraar Karan, who has been advocating for public use of N95 masks, told CNN’s Gupta in an interview why N95s are critical at this stage of the pandemic.
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“If for four weeks the country essentially wore these masks in those risky settings like that indoors, what kind of difference do you think it would make?” Gupta asked.
“This would stop the epidemic,” Karan responded.