NC Companies Respond to Monkeypox Outbreak

At least two North Carolina bioscience companies are playing important roles in the monkeypox outbreak.

Burlington-based Labcorp will begin offering a diagnostic test for the viral infection, and Bavarian Nordic, a Danish company with a U.S. subsidiary in Morrisville, will provide the only monkeypox vaccine approved by the U.S. Food and Drug Administration.

Labcorp’s testing

Labcorp will begin testing for monkeypox using the U.S. Centers for Disease Control and Prevention’s (CDC) orthopoxvirus test, which detects all non-smallpox-related orthopoxviruses, including monkeypox. Labcorp is the first national laboratory to offer this polymerase chain reaction (PCR) test, which it verified for the CDC.

“Labcorp appreciates the opportunity to support the CDC in its efforts to keep the public safe and manage the monkeypox outbreak,” said Brian Caveney, M.D., JD, chief medical officer and president of Labcorp Diagnostics. “We will initially perform all monkeypox testing in our main North Carolina lab and have the capacity to expand to other locations nationwide should the need arise.”
 
Labcorp will conduct the testing in Burlington at its largest U.S. laboratory, which employs about 650 people. 

The company will accept specimens from its customers, as well as overflow from public laboratories. Eventually, Labcorp will be able to increase capacity up to 10,000 tests per week, nearly double the current capacity of 6,000 tests provided through CDC’s Laboratory Response Network, a national system of laboratories established in 1999 to respond to biological and chemical threats and other public health emergencies.

"The ability of commercial labs to test for monkeypox is a key pillar in our comprehensive strategy to combat this disease," said CDC Director Rochelle Walensky. "This will not only increase testing capacity but will make it more convenient for providers and patients to access tests by using existing provider-to-lab relationships."

Anyone who suspects they may have a monkeypox infection can visit their health-care provider for sample collection and to initiate the testing process. Providers can order the test from Labcorp just as they normally would order other tests on the company’s menu. 

Bavarian Nordic’s vaccine

Bavarian Nordic’s Jynneos is a vaccine for non-replicating smallpox, a virus similar enough to the monkeypox virus for the vaccine to be at least 85% effective in preventing monkeypox. The U.S. government has ordered a total of 4.4 million doses of the vaccine for delivery this year and next year. 

“The monkeypox outbreak continues to develop at an unprecedented rate, and we applaud the U.S. government’s decision to prioritize the supply of our vaccine to enable broader access for those at risk of infections,” said Paul Chaplin, president and chief executive officer of Bavarian Nordic. 

The two-dose vaccine is produced at the company’s manufacturing facility in Kvistgaard, Denmark, but the North Carolina office supported its clinical development, according to a company spokesperson.

The federal government has allocated North Carolina 444 doses of Jynneos. Those doses have been allocated to seven local health departments to ensure access across the state. As additional doses become available, more locations will be added, according to the N.C. Department of Health and Human Services.

The local health departments first receiving doses are those in Buncombe, Durham, Forsyth, Mecklenburg, New Hanover, Pitt and Wake counties. 
 
Because of limited supply, vaccination is currently only being offered to individuals with known or suspected exposure to monkeypox.

Bavarian Nordic’s Morrisville site was established in February 2017. It houses U.S. commercial and support functions and a development team that includes clinical operations, regulatory affairs, clinical safety/pharmacovigilance and biometrics.

About half of the publicly held company’s 40 U.S. employees work in North Carolina.

‘Evolving health threat’

The World Health Organization (WHO) has declared monkeypox an "evolving health threat” as the number of cases rises.

More than 6,000 cases have been detected in 58 countries, but that total may be low due to a lack of testing, according to WHO. About 600 cases have been confirmed to date in the United States, including three in North Carolina.

Symptoms include fever, muscle pain, swollen lymph nodes and a rash that forms blisters. Cases may be severe, especially in children, pregnant women or people with compromised suppressed immune systems.

According to the CDC, the virus can spread person to person through:

• direct contact with the infectious rash, scabs or body fluids;
• respiratory secretions during prolonged, face-to-face contact, or during intimate physical contact, such as kissing, cuddling or sex;
• touching items (such as clothing or linens) that previously touched the infectious rash or body fluids.

Monkeypox has no known cure.