On Wednesday, the FDA announced clearing 800,000 monkeypox vaccines for use. The Biden administration said it would announce allocations for states and jurisdictions on Thursday. The new doses will significantly expand the supply in the U.S. However, experts question whether these new monkeypox vaccines will be enough to meet the demand.
There have been 3,600 cases since May. Unfortunately, the U.S. only had about a few thousand doses when the outbreak began. American officials have ordered nearly seven million doses of Jynneos, which will arrive in batches over the following months. So far, 320,000 doses have shipped to the states.
Monkeypox Vaccine Distribution
In addition, the FDA completed its inspection of Bavarian Nordic’s manufacturing plants in Denmark earlier this month. The agency determined that the vaccine produced there met its standards. Given the rising need, the agency said it had “facilitated the shipment of manufactured doses” to the United States. Still, it declined to say whether the doses had arrived in the country. “Aggressively responding to the monkeypox outbreak is a critical priority,” Xavier Becerra, secretary of the Department of Health and Human Services, said in a statement. “H.H.S. is working to make these doses available to states and jurisdictions as soon as possible to fulfill their needs and will announce allocations tomorrow,” he added.
If the doses are administered quickly, it should lessen some shortages. The supply now is “probably sufficient to meet the most pressing need,” said Tinglong Dai, an expert in vaccine supply at Johns Hopkins University. “I hope it alleviates the burning anxiety thousands of people have been experiencing in recent weeks,” he added.
Currently, Bavarian Nordic has less than five million doses on hand. That doesn’t include the two million doses it’s supplying to the U.S. at the end of the year. Since last August, the manufacturing facility that could make more has been shut down for planned expansion. More vaccine doses will be needed. Several cities have expanded their criteria for immunization against monkeypox to include the following:
- sex workers
- patients of sexual health clinics
- other staff members potentially exposed to the virus at work
How Jynneos Works
Jynneos is supposed to be given in two doses, delivered 28 days apart. Some jurisdictions decided to defer second doses until the supply opens up. Studies suggest that one dose of Jynneos produces an immune response comparable to that of the earlier smallpox vaccine and should provide protection. The immunity seems to start to decline after two years.
“Some people may not be fully protected, but on balance, the strategy makes sense when supply is constrained,” Dr. Dai said. He noted that Britain also deferred second doses of the Covid vaccines early in the pandemic, when supplies were low, and offered them once more doses became available.
For now, the FDA and the Centers for Disease Control and Prevention are insisting on a two-dose regimen. “While the agency understands the desire to get out as many doses as possible, FDA advises against departing from the product labeling,” Ms. Capobianco said. The United States is among the few countries to have a supply of Jynneos. An older vaccine developed to combat smallpox is available worldwide but is too dangerous for immunocompromised people or those with certain skin conditions. The United States has purchased bulk material of Jynneos that can be converted into some 15 million finished doses over the next few weeks to months.