US distributes 800,000 doses of monkeypox vaccine

Alleviating shortages have hampered fight against monkeypox for weeks, Food and Drug Administration announced on Wednesday that it removed nearly 800,000 additional doses of the vaccine for use. The Biden administration said it would announce allocations to states and jurisdictions on Thursday.

The new doses of the drugs will significantly expand supply in the United States, but some experts question whether they will be enough to meet demand. Since May, the country has confirmed 3,600 cases, which is among the highest in the world, and the number is almost certainly an underestimate.

Stores of Jynneos, the monkeypox vaccine, have been limited since the start of the outbreak. The vaccine is manufactured by Bavarian Nordic, a small company in Denmark.

Although federal agencies helped develop Jynneos, the strategic national stockpile contained only a few thousand doses when the outbreak began, and the Biden administration has move slowly to achieve more.

US officials have now ordered nearly seven million doses, which will be delivered in batches over the coming months. To date, the administration has shipped about 320,000 doses to the states.

On Wednesday, the FDA said it completed an inspection of Bavarian Nordic’s manufacturing plant in Denmark earlier this month and had determined that the vaccine produced there met its standards.

With demand growing, the agency said it has “facilitate the transportation of the produced dose“Arrived in the United States, but declined to say whether the doses had arrived in the country.

Xavier Becerra, secretary of the Department of Health and Human Services, “Responding to the monkeypox outbreak aggressively is an important priority. said in a statement.

“HHS is working to make these doses available to states and jurisdictions as soon as possible to meet their needs and will announce allocations tomorrow,” he added.

Assuming doses are delivered quickly, they should alleviate at least some deficiencies. Tinglong Dai, a vaccine supply expert at Johns Hopkins University, said the current supply was “probably enough to meet the most pressing need”.

“I hope it alleviates the burning anxiety that thousands of people have experienced in recent weeks,” he added.

Bavarian Nordic has less than five million doses in hand, in addition to two million it is supplying to the United States by the end of the year. A manufacturing facility can make more than already close the door for expansion plans since last August.

But more doses of the vaccine will be needed, as some cities have expanded vaccination criteria against monkeypox to include sex workers, patients of sexual health clinics, doctors. Clinicians and other employees may be exposed to the virus in the workplace.

Men who have sex with men make up 99% of the cases to date. The US has identified 13 infected women, including a pregnant woman who gave birth to a healthy child and two small children.

But as awareness and access to testing grow, the number of people queuing up for a vaccine could also spike. “I’m afraid it’s too little” to meet that demand, Dr. Dai said of the new supply.

Activists said that the FDA did not promptly conduct inspections of the manufacturing facilities in Denmark and that it did not act sufficiently to explore other manufacturing options in the United States.

The agency has denied those allegations.

“There was no delay in inspecting the Nordic plant in Bavaria,” said Abigail Capobianco, an FDA spokesman.

But James Krellenstein, co-founder and chief executive officer of the advocacy group PrEP4All, noted that the European Medicines Agency inspected and approved the facility last year.

“We missed months of time when these drugs could be used to slow or stop this outbreak,” he said. “There is no scientific or medical reason to do so.”

Jynneos was supposed to be given two doses 28 days apart. Work to protect residents with meager supplyseveral jurisdictions – including Colorado, San Francisco, Washington DC, and New York City – decided to delay the second dose until supply opens up, a strategy that also applies in England and Canada.

Learn of the Bavarian Nordic suggests that a single injection of Jynneos induces an immune response comparable compared with the previous smallpox vaccine and should be protected, although immunity appears to begin to decline after two years.

“Some people may not be fully protected, but on balance this strategy makes sense when supply is limited,” Dr. Dai said. He also noted that Britain also postpones the second dose of the Covid vaccine during the pandemic, when supplies are low, and supplies them when more doses are available, he noted.

So far the FDA and the Centers for Disease Control and Prevention have been adamant about the two-dose regimen. “While the agency understands the desire to obtain as many doses as possible, the FDA advises against neglecting product labeling,” Ms. Capobianco said.

The United States is one of the few countries with a source of Jynneos. An older vaccine developed against smallpox is available worldwide but is too dangerous for people who are immunocompromised or those with certain skin diseases.

The United States has purchased large quantities of Jynneos material that could be converted into about 15 million finished doses in the next few weeks to months. The authorities should share some of that supply with the rest of the world, said Zain Rizvi, who researches drug accessibility at Public Citizen, an advocacy group.

“A global outbreak requires a global response,” said Mr. Rizvi. “The Biden administration should urgently convert its massive stockpile into vaccines and live up to its claim of being the world’s stockpile of vaccines.”