Bavarian Nordic's monkeypox vaccine supply quintupled in US thanks to FDA 'dose-sparing' switch

When it comes to U.S. supply of Bavarian Nordic’s monkeypox vaccine Jynneos, the numbers don’t look good. Fortunately, however, the U.S. Food and Drug Administration has found a way to quintuple the nation’s stock for the year, courtesy of a strategy known as “dose-sparing.”

The FDA will extend supplies of BN’s monkeypox vaccine by clearing the administration of a smaller dose, the FDA said Tuesday. The strategy will still see patients get two injections four weeks apart, but each shot will be just one-fifth of a typical Jynneos dose. Further, the lower-dose vaccine will be injected right under the skin, rather than into the layer of fat beneath the skin where the full dose is introduced.

The FDA notes there aren’t any data to show a single dose of Jynneos offers long-lasting protection. Conversely, a 2015 clinical study found that patients given a lower intradermal dose of the vaccine charted a similar response to those who received the shot subcutaneously.

Currently, the U.S. expects to get its hands on 1.9 million Jynneos doses by year-end. Meanwhile, the Centers for Disease Control and Prevention last week estimated that between 1.6 million to 1.7 million men with HIV or who are at risk of HIV infection must get vaccinated to contain the monkeypox outbreak, which is now competing with COVID-19 as an official public-health emergency.

Prior to the FDA’s dose-sparing switch, that 1.9 million-dose stock wouldn’t have been sufficient to complete a full two-dose vaccination course for all the roughly 1.65 million men urged to get the vaccine by the CDC.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” FDA commissioner Robert Califf, M.D., said in a statement. 

Back to Bavarian Nordic itself, the company’s manufacturing capacity and its ability to meet this year’s monkeypox vaccine demand remain murky. The fact that the U.S. has dibs on much of the global supply at this point also threatens a repeat of the vaccine equity shortfalls seen during the COVID-19 pandemic, Health Policy Watch warned last month.

The problem is further exacerbated by the fact that Bavarian Nordic’s European manufacturing plant is shuttered until late 2022, making it unclear how much of the world can access the shot, barring donations from a few high-income countries that have stockpiled the vaccine.

Even then, the U.S.’ Jynneos reserves aren’t what they used to be, as some 20 million doses have languished over the years in the Strategic National Stockpile, The New York Times recently reported.

Bavarian Nordic planned its plant shutdown prior to the monkeypox outbreak. With the project, the company aims to create new production lines for BN’s GSK-acquired rabies and tick-borne encephalitis shots, Rabipur and Encepur, respectively.

“The exterior work has largely been completed and interior construction work, including commissioning of new manufacturing equipment has begun,” BN said in May. “Meanwhile, training of personnel to support the new processes is ongoing.”

Once the plant re-opens, Bavarian Nordic will start producing new monkeypox vaccine doses beginning early next year, global health sources in Geneva told Health Policy Watch.

Aside from the FDA’s dose-sparing strategy, Bavarian Nordic is reportedly in talks to expand vaccine production, too, according to Reuters.

Currently, the company can supply Jynneos in the tens of millions of doses, the company’s chief executive Paul Chaplin told the news service. But BN is tapping an unnamed U.S. contract manufacturer to expand capacity, Reuters said.

Bavarian’s helmsman said he hoped the process would wrap up later this year, noting his company is also in early talks with others, including contract manufacturers and other vaccine players, to secure further expansion if needed.