Monkeypox Vaccine Puts Bavarian Nordic on the Spot

As the only biotech with an approved vaccine for monkeypox, can Bavarian keep up with demand?

On July 23, WHO voted to declare monkeypox a "public health emergency of international concern," the highest level of warning given by the agency. The risk of monkeypox is moderate globally, but in Europe, it is considered high, WHO reports. The designation is meant to initiate an international response and allow funding for collaborations on sharing vaccines and treatments. It also increases the need for more vaccines that are provided solely by Danish biotech Bavarian Nordic, and it appears demand is outstripping supply.

So far this year, there have been more than 16,000 cases of monkeypox in more than 75 countries, and five deaths in Africa. There are 2,592 U.S. monkeypox cases in the U.S., with New York, California, and Illinois among the states hit hardest, according to the most recent data from the Centers for Disease Control and Prevention (CDC).

Raj Panjabi, director of the White House pandemic preparedness office, said the WHO declaration was a "call to action for the world community to stop the spread of this virus" and a "coordinated, international response is essential" to stop the spread of the disease and protect communities at the greatest risk of contracting it. Efforts have been made to expand testing and access to vaccines, but case numbers have escalated rapidly in recent weeks.

The disease has been spreading chiefly in men who have sex with men in the recent outbreak, outside of Africa, where it is endemic. Countries in Africa have experienced sporadic monkeypox outbreaks since the virus was discovered in 1970. In Nigeria, an outbreak has existed since 2017.

However, the CDC has reported identifying infections in a small number (at least eight) of cisgender women and the first documentation of two cases in children just this month.

The virus is not a sexually transmitted disease but most often spreads through prolonged physical contact. It can spread by handling clothes or bedding used by an infected person or through respiratory droplets.

The current global outbreak of monkeypox virus infection in humans suggests changes in biologic aspects of the virus, changes in human behavior, or both; such changes might be driven by waning smallpox immunity, relaxation of COVID-19 prevention measures, resumption of international travel, and sexual interactions associated with large gatherings, according to a study in the New England Journal of Medicine.

EC approval and WHO alarm boosts demand

On Monday, July 25, the European Commission (EC) approved Bavarian Nordic’s Imvanex vaccine to be marketed as protection against monkeypox. Bavarian reported that the EC approval was speedy, taking only one month when normally the process takes six to nine months. The shot had already been approved by EC for a vaccine against smallpox in 2013.

On the news of the EC approval, Bavarian stock rose as much as 10% in Copenhagen trading, Bloomberg reports. The approval not only raised Bavarian's stock but also others who are working on a monkeypox vaccine, according to Seeking Alpha. These past few months, the biotech has raised its 2022 financial forecast several times and its estimate for full-year revenue is now more than double what it predicted earlier in the year. “With the recent upgrades of our financial guidance we have significantly improved our cash position and we are now even approaching a break-even EBITDA for 2022,” Paul Chaplin, president and CEO of Bavarian Nordic said in a prepared statement.

Keeping up with demand

Bavarian Nordic is also in talks to potentially expand production capacity. Bavarian has annual production capacity of 30 million doses, including the monkeypox vaccine and other vaccines it makes. It can meet current demand in the tens of millions of doses for the monkeypox vaccine, Chaplin said in an interview with Reuters.

The federal government plans to release more than 1.6 million doses of the monkeypox vaccine Jynneos by the end of the year, but demand is so high that the 56,000 doses released in June have almost all been used.

According to the Center for Infectious Disease Research, the vaccines are in very limited supply, with people from all over the United States reporting waiting in long lines only to be turned away from clinics, and experts say sufficient doses of the two-dose Jynneos vaccine likely won't be available for months or even years.

Recent reports from the CDC, Oregon, San Francisco, New Hampshire, New York, Chicago, Los Angeles, New York City, Minnesota, Florida, and Virginia all say that demand outstrips availability of the vaccine.

Bavarian is working with an unnamed U.S.-based contract manufacturer to expand its production capacity. Chaplin said he hoped that process would be completed later this year, and added the company was in early talks with others, including contract manufacturers and other vaccine makers, in case a further expansion is needed.

Earlier this month, U.S. Biomedical Advanced Research and Development Authority (BARDA), ordered an additional 2.5 million doses of liquid-frozen Jynneos, a non-replicating smallpox vaccine and the only FDA-approved vaccine against monkeypox. The new order follows two previous orders from BARDA in June and July 2022 for 500,000 and 2.5 million doses respectively which, together with an order from BARDA in 2020 for 1.4 million doses, will bring the total deliveries in 2022 and 2023 to nearly 7 million doses.

“Expanding our manufacturing capabilities into the United States allows Bavarian Nordic to deliver more monkeypox vaccines to meet the immediate worldwide demand for Jynneos," Chapin said in a prepared statement.

The Centers for Disease Control and Prevention (CDC) and the California Department of Public Health (CDPH) recommend that individuals aged 18 or older who are at highest risk of monkeypox infection get the shots. Current limited vaccine is being prioritized for individuals who have or may have been exposed to the monkeypox virus, or who are at high risk for occupational exposure. The vaccines will be distributed through a tier system, prioritizing areas with a high number of confirmed cases.

The CDPH further recommends first vaccinating persons at risk in the community with non-healthcare related exposures, as opposed to vaccinating healthcare workers. In healthcare facilities, current infection control recommendations (including use of PPE) should be followed.