: As new coronavirus strains raise questions about mask quality, the N95 market in the U.S. is still facing supply issues

President Joe Biden’s executive order last week uses the Defense Production Act to speed up production of personal protective gear like N95 respirator masks, isolation gowns, and polymerase chain reaction (PCR) swabs used for diagnostic testing. 

The thinking in the U.S. around N95s is that they should be reserved for health care and other frontline workers who are at the highest risk of contracting the virus. The Centers for Disease Control and Prevention still says that N95s and medical-grade masks “should be conserved for health care personnel.”

But the emergence of new virus variants, including the B.1.1.7 out of the United Kingdom, the B.1.351 strain out of South Africa, and the P.1 from Brazil, has pushed medical experts to rethink what type of mask is safest right now. The CDC has said it expects the B.1.1.7 to be the most dominant strain of the virus in the U.S. by March.

“N95 masks are the most protective masks, followed by three-ply surgical masks, then fabric masks,” Dr. Tom Frieden, the former director of the CDC, tweeted Jan. 24. “A fabric mask is a lot better than no mask, but we may need to step up our mask game if contagious Covid variants start to spread widely.”

At least two of the new strains — the B.1.1.7, which has been detected in around 430 people in the U.S., and the B.1.351, which has been detected in two people in the U.S. — are thought to be more transmissible. What is more concerning is that the South African strain likely lessens the effectiveness of vaccines developed by BioNTech SE BNTX, +6.31% /Pfizer Inc. PFE, +0.11% and Moderna Inc. MRNA, +8.53% and of at least one antibody treatment, made by Regeneron Pharmaceuticals Inc. REGN, -0.48%.

Biden has also called for Americans to wear masks for 100 days and said masks are now required in federal buildings, in airports, and on planes, trains, and buses. Dr. Anthony Fauci, Biden’s chief medical adviser, this week said on the “Today” show that “if you have a physical covering with one layer, you put another layer on, it just makes common sense that it likely would be more effective.”

Countries in Europe are also implementing stricter mask rules. Austria, France, and Germany have all implemented or considered implementing requirements for more protective masks, including FFP2s (known as N95s in the U.S.), on public transport, in grocery stores, and when shopping. Austria is also making free FFP2s available to the homeless, low-income residents, and people older than 65.

“It is wise for the public to upgrade their cloth masks and use better quality masks,” said Ravina Kullar, an epidemiologist and adjunct faculty member at the University of California, Los Angeles. “And along the same lines, Dr. Fauci also recently stated that considering doubling up on your cloth mask as another recommendation.”

But even if most Americans were willing to buy and wear N95 respirator masks in daily life, it may be difficult to do so, given the ongoing supply chain issues.

“The pandemic has escalated demand for N95s to levels not seen before in the U.S.,” Chris Lavanchy, an engineering director for ECRI, a health care safety organization, said in an email. “That combined with international supply chain disruptions has contributed to the shortage. In addition, we have become dependent on other countries such as China to be the primary suppliers for both the raw materials for these masks as well as for the masks themselves, which has made it especially difficult for the U.S. to quickly ramp up production to meet the need.”

This is why Kimberly Clark Corp. KMB, -2.26% now makes its N95s in the U.S. — prior to 2020, they were produced on behalf of the company by external manufacturers. It also spent $30 million last year to beef up manufacturing capabilities and now has the ability to produce up to 30 million N95 respirators per month for non-medical use in the U.S., according to a company spokesperson. 

3M Co. MMM, -4.23% recently told investors it delivered approximately 1 billion respirators to the U.S. in 2020, while Honeywell International Inc. HON, -3.68% sold 225 million N95s and surgical masks to its U.S. customers in December. Honeywell does not sell N95s directly to the public, citing “unprecedented demand” for the respirators, but Kimberly-Clark now sells one non-medical use N95 respirator on Amazon.com.

The other issue has to do with stockpiling. Some government agencies and health care providers have since started to increase their stockpiles after extreme shortages were reported in the earliest days of the pandemic.

The Strategic National Stockpile, for example, had 107 million respirators, as of October, compared with only 12.6 million in December 2019, according to the Government Accountability Office. 

Premier Inc. PINC, -1.05%, which purchases medical supplies for hospitals, recently said that most American hospital systems it works with have a median of 150 days of N95s on hand, compared with 23 days back in April. And HCA Healthcare Inc. HCA, -0.81% said this month it’s part of a new joint venture that is manufacturing personal protective equipment, including masks, after the national hospital chain spent $196 million more than it expected on PPE in 2020.

Health care workers continue to say they are reusing PPE, including N95 masks, while caring for COVID-19 patients, according to media reports.

The N95 respirators are approved by the CDC’s National Institute for Occupational Safety and Health, and health care workers who use them are required to make sure they fit their faces. Over the summer, while campaigning, President Joe Biden said it was “unconscionable” that health care workers were rationing PPE.

“Every healthcare worker will have a reliable supply of properly fitted N95 mask,” Biden said.