Food Safety Authority announced on Wednesday, about 800,000 additional doses of the vaccine were approved for use. The Biden administration said it would announce the allocation of funds to states and jurisdictions on Thursday.
The new doses should greatly expand supply in the United States, but some experts question whether they will be enough to meet demand. The country has had 3,600 confirmed cases since May, one of the highest numbers in the world, and the figure is almost certainly an underestimate.
Stores of Jynneos, the monkeypox vaccine, have been restricted since the outbreak began. The vaccine is produced by a small company, Bavarian Nordic, in Denmark.
Although federal agencies helped develop Jynneos, there were only a few thousand doses in the national strategic stockpile at the start of the outbreak, and the Biden administration moving slowly in buying more.
US officials have already ordered nearly seven million doses, which will arrive in batches over the coming months. The administration has sent about 320,000 doses to the states so far.
On Wednesday, the FDA said it had completed a review of the Bavarian Nordic manufacturing plant in Denmark earlier this month and found that the vaccine being produced there met standards.
The Agency stated that, given the growing demandfacilitated the shipment of manufactured dosesto the United States, but declined to say if the doses had arrived in the country.
“An aggressive response to the monkeypox outbreak is a critical priority” – Xavier Becerra, Secretary of the Department of Health and Human Services, 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 the release tomorrow,” he added.
Assuming that the doses are distributed quickly, they should reduce at least part of the deficit. Stocks are currently “probably enough to meet the most pressing needs,” said Thinglong Dai, a vaccine supply expert at Johns Hopkins University.
What you need to know about the monkeypox virus
What is monkeypox? Monkeypox is a virus similar to smallpox, but the symptoms are less severe. It was discovered in 1958 after outbreaks occurred in monkeys kept for research. The virus has mostly been found in parts of Central and West Africa, but in recent weeks it has spread to dozens of countries and infected tens of thousands of people, mostly men who have sex with men. July 23 The World Health Organization has declared monkeypox a global health emergency..
“I hope this will lessen the burning anxiety that thousands of people have been experiencing in recent weeks,” he added.
Bavarian Scandinavian less than five million doses on hand, in addition to the two million he will deliver to the United States at the end of the year. A manufacturing plant that could produce more was shut up for a planned expansion from last August.
But additional doses of the vaccine will be needed as several cities expanded their monkeypox immunization criteria to include sex workers, sexual health clinic patients, clinicians and other employees who may be exposed to the virus at work.
Men who have sex with men account for 99 percent of cases so far. In the US, 13 infected women have been identified, including one pregnant woman who has since given birth to a healthy baby and two small children.
But as awareness and access to testing grows, the number of people on the waiting list for vaccinations could also increase. “I’m afraid that’s too little” to satisfy that requirement, Dr. White. Dai said about a new shipment.
The activists said that the FDA was unable to quickly inspect manufacturing facilities in Denmark and that it was not doing enough to explore other manufacturing options in the United States.
The agency denied these allegations.
“There were no delays in the inspection of the Bavarian Nordic plant,” said FDA spokesperson Abigail Capobianco.
But James Krellenstein, co-founder and managing director of advocacy group PrEP4All, noted that the European Medicines Agency reviewed and approved the institution last year.
“We have missed months of time in which these doses could have been used to slow or stop this outbreak,” he said. “There was no scientific or medical justification for this.”
It is suggested that Jynneos be given in two doses 28 days apart. The fight to protect the inhabitants scanning consumablessome jurisdictions, including Colorado, San Francisco, Washington, as well as New York – decided to delay second doses until the supply opens, this strategy is also used in Britannia and Canada.
Research from Bavarian Nordic suggest that one shot of Jynneos triggers an immune response comparable compared to the earlier smallpox vaccine and should be protective, although immunity appears to start to decline after two years.
“Some people may not be fully protected, but in general the strategy makes sense when supply is limited,” says Dr. Dai said. He noted that the UK also delayed second doses of the Covid vaccine early in the pandemic when supplies were low and offered them as soon as new doses become available.
So far, the FDA and the Centers for Disease Control and Prevention are pushing for a two-dose regimen. “While the agency understands the desire to get as many doses as possible, the FDA advises against backtracking on product labeling,” Ms said. Capobianco said.
The United States is one of the few countries where Jynneos is available. An older vaccine developed to fight smallpox is available worldwide but is too dangerous for people who are immunocompromised or have certain skin conditions.
The United States has purchased Jynneos bulk material, which can be converted into about 15 million finished doses over the next few weeks or months. The administration should share some of that supply with the rest of the world, said Zain Rizvi, who studies access to medicines with the advocacy group Public Citizen.
“A global outbreak requires a global response,” he said. Rizvi said. “The Biden administration must urgently convert its core stockpile into vaccines and justify its claim that it is the world’s vaccine arsenal.”