FDA eases shortages that have plagued monkeypox battle for weeks publication On Wednesday, it announced it had approved a booster dose of nearly 800,000 doses of the vaccine. The Biden administration said it would announce allocations to states and jurisdictions on Thursday.
The new dosage should significantly boost supply in the US, but some experts question whether it will be enough to meet demand.Since May, the country has reported 3,600 cases. We have confirmed, and this is one of the highest tallies in the world, and this figure is almost certainly underestimated.
Stores of Jynneos, a monkeypox vaccine, have been restricted since the outbreak began. The vaccine is manufactured by a small Danish company, Bavarian Nordic.
Federal agencies helped develop Gynneos, but strategic national stockpiles held only a few thousand doses when the outbreak began.
US officials have now ordered about 7 million doses, which are expected to arrive in batches over the next few months.
The FDA said Wednesday that it completed an inspection of the Bavarian Nordic manufacturing plant in Denmark earlier this month and determined that the vaccine produced there met its standards.
Given the growing need, the agency said:Facilitate shipping of manufactured doses‘ but did not disclose whether the dose reached the United States.
“Proactively responding to the monkeypox outbreak is a top priority,” said Secretary of Health and Human Services Xavier Becerra. said in a statement..
“HHS is working to make these doses available to states and jurisdictions as soon as possible, as needed, and will announce allocations tomorrow,” he added.
Assuming doses are distributed quickly, they should alleviate at least some of the shortage. enough to meet our needs,” he said.
What you need to know about the monkeypox virus
What is monkeypox? Monkeypox is a virus similar to smallpox, but less severe. It was discovered in 1958 after an outbreak in monkeys kept for research. The virus was primarily found in parts of Central and West Africa, but has spread to dozens of countries in recent weeks, infecting tens of thousands of people. On July 23, the World Health Organization declared monkeypox a global health emergency.
“I hope this will ease the burning anxiety that thousands of people have been experiencing in recent weeks,” he added.
Bavarian Nordic has less than 5 million doses on hand in addition to supplying the US with 2 million doses by the end of the year. Manufacturing facilities that can produce more shut Due to the expansion planned since last August.
But as some cities expand their vaccination standards against monkeypox to include sex workers, patients in sexual health clinics, clinicians, and other staff who may be exposed to the virus in the workplace. , more vaccinations will be required.
Men who have sex with men account for 99% of the cases so far. The United States has identified 13 infected women. one pregnant woman She later gave birth to a healthy baby and two young children.
But as awareness and access to testing increases, so too could the number of people queuing for a vaccine soar. The doctor spoke of the new supply.
activist said The FDA’s failure to act quickly to inspect its manufacturing facility in Denmark, and its failure to do enough to investigate other manufacturing options within the United States.
The agency has denied these accusations.
“There were no delays in the inspection of the Nordic factory in Bavaria,” said FDA spokeswoman Abigail Capobianco.
But James Clenstein, co-founder and managing director of advocacy group PrEP4All, said the European Medicines Agency inspected and approved the facility last year.
“We missed months that these doses could have been used to slow or stop this outbreak,” he said. “There is no scientific or medical justification for doing so.” did.”
Jynneos is to be administered in two doses 28 days apart.Efforts to Protect Residents lack of suppliesin some jurisdictions — including Colorado, San Francisco, Washington D.C., When New York City — Decided to postpone the second dose until supplies start. United Kingdom and Canada.
the study According to Bayern Nordic, Jynneos’ single shot has been suggested to trigger an immune response. similar Immunity appears to begin to decline after two years, but is similar to that of previous smallpox vaccines and should be protective.
“Some people may not be fully protected, but overall, when supplies are constrained, this strategy makes sense,” said Dr Dai. He noted that they postponed a second dose of the Covid vaccine early in the pandemic when supplies ran low, and provided them once more when they became available.
So far, the FDA and the Centers for Disease Control and Prevention have advocated a two-dose regimen. “Although we understand the agency’s desire to get as many doses as possible, the FDA advises against deviating from product labeling,” Capobianco said.
The United States is one of the few countries supplying Gineo. Older vaccines developed to combat smallpox are available worldwide, but are too dangerous for immunocompromised people and those with certain skin diseases.
The United States has purchased Jynneos bulk material that can be converted into approximately 15 million final doses in the coming weeks and months. The regime should share some of its supplies with the world, said Zain Rizvi, who studies access to medicines for the advocacy group Public Citizen.
“A global pandemic requires a global response,” Rizvi said. “The Biden administration should urgently convert its massive stockpile into vaccines and live up to its claims of being the world’s vaccine arsenal.”
