FDA Slow to Inspect Monkeypox Vaccine Facility: Article

An investigative article in New York Magazine says the lack of monkeypox vaccines in New York City, where cases have risen 370% in the last two weeks, is due in part to a slow FDA response to the need to inspect a vaccine manufacturing facility in Denmark.

“As monkeypox cases have ticked up nationwide, the White House and federal agencies have repeatedly assured the public that millions of vaccine doses will be distributed to at-risk populations before the end of the year,” the article says. “Yet since the World Health Organization announced the global monkeypox outbreak in May, only tens of thousands of shots have been administered in the U.S. The slow start is due, at least in part, to the fact that 1.1 million doses have been stored in a Denmark pharmaceutical facility while FDA has taken almost two months to approve their release here, according to people familiar with the situation.”

The article says public health experts say the lag time is indicative of the federal government’s lackadaisical approach to a growing public health emergency. “My impression is that there is very little coordination and leadership across the U.S. government about what’s going on here,” the article quotes a former senior U.S. official who has been in contact with the White House about the monkeypox response. “It feels to me like there’s nobody in charge of this. Who is driving this forward?”

The article says that in 2003 the U.S. government contracted with the Danish firm Bavarian Nordic to develop Jynneos, a monkeypox vaccine with fewer major side effects than other vaccines used against the disease. Since the beginning of this year, it says, Bavarian Nordic has sent 300,000 doses of Jynneos to the U.S., with two-thirds allocated to states and cities. The doses were produced by contractors in Denmark in facilities that had already been inspected by FDA. However, in 2020 Bavarian Nordic moved its vaccine production in-house and began building a new facility where it started manufacturing and stockpiling the 1.1 million doses owned by the U.S.

Before those doses could ship, the magazine says, the new facility needed to be inspected by FDA. The company had planned to submit documents to the agency in August and have an inspection later this year, but the timetable was moved up due to the current outbreak.

New York Magazine says an inspection is now underway and says “it’s unclear why FDA took so long to send inspectors to Denmark.”

Advocacy groups have complained that members of at-risk communities are being turned away from monkeypox vaccination “because these vaccines are not available in sufficient quantities in the U.S., but instead sitting in freezers in Denmark,” according to a letter to federal officials from PrEP4All and Partners in Health.

Stakeholders also reportedly are upset that FDA would not accept the results of an inspection performed last year by the European Medicines Agency that found the Bavarian Nordic facility complied with all FDA standards.

An agency spokesperson said FDA does not grant reciprocity for European Medicines Agency authorization of any vaccines for monkeypox or other diseases. “FDA expedited an inspection of a company manufacturing facility, as publicly reported,” the spokesperson said. “This inspection is necessary to ensure the vaccine meets FDA requirements, including for quality, which can impact its safety and performance. We do not expect any delay in vaccine availability due to this process.”