The monkeypox vaccine will soon be available for distribution after many weeks of delays, according to U.S. health regulators on Wednesday.
The revelation comes in the midst of mounting criticism that the government has been too slow to introduce the vaccine, thus squandering the opportunity to stop what may soon turn into a persistent infectious disease.
The Food and Drug Administration declared almost two weeks ago that the factory in Denmark where Bavarian Nordic fills vaccine vials had undergone all required inspections. On Wednesday, the FDA announced via Twitter that the certification was complete. The dosages have already arrived in the country, according to the agency, ‘so that they would be ready to be distributed whenever the manufacturing alterations were approved.’
More than 310,000 doses of the two-shot Jynneos vaccine have already been sent by the United States to state and local health departments. However, clinics in New York, San Francisco, and other significant cities claim they still lack enough injections to fulfil demand.
According to the Centers for Disease Control and Prevention, as of late Wednesday, there were more than 4,600 confirmed cases of monkeypox throughout the country. The U.S. Department of Health and Human Services chief stated on Wednesday that further vaccination allocations would be announced on Thursday.
San Francisco Department of Health officials welcomed the news and noted that they require many thousands more vaccination doses than the 7,800 they have so far. ‘Without enough vaccine supply, we would have trouble fulfilling our basic duty of keeping our communities safe,’ the agency said in a statement.
Officials in Washington, D.C., announced on Wednesday that they will follow the lead of their colleagues in San Francisco, New York City, and other locations by ceasing to schedule appointments for second doses of vaccines due to a lack of supply. They claimed that by using a single dose, they would be able to ‘vaccinate more persons and more quickly stop the spread of monkeypox in the community.’
In addition to skin-to-skin contact, the monkeypox virus can also be disseminated by coming into contact with linens that have been used by an infected person. Health experts have emphasised that anyone can contract the virus, despite the fact that the great majority of cases documented have been in men who have had sex with men.
Symptoms of monkeypox include fever, body pains, chills, and exhaustion. Many in the outbreak have developed zit-like bumps on many parts of the body.
Comparisons between the slow government reaction and the early stages of the COVID-19 outbreak have been made, although experts have noted that the United States had one significant advantage: more than 1 million doses of vaccine in the strategic national stockpile.
However, it turned out that when the outbreak was initially discovered in May, American authorities had only roughly 2,000 pills on hand. Only a percentage of the remaining units were deployed due to shipping and regulatory delays.
‘There’s not enough doses,’ said Dr. Perry Halkitis, a public health specialist at Rutgers University. ‘I think with some quicker action on the part of federal government we might not be in the situation we are now.’
The dosages that were previously sent were from a different facility in Denmark that had FDA clearance. Another 786,000 doses made at a newly opened Bavarian Nordic facility were awaiting the U.S. certification announced Wednesday.
All vaccine production facilities must undergo FDA-mandated inspections to ensure their sterility, uniformity, and safety.
5 million additional doses were ordered by the United States this month, although the majority of those are not anticipated to arrive until next year.
People who know or suspect they may have been exposed to monkeypox in the past two weeks are advised to receive the vaccinations.
The government will monitor how well the Jynneos vaccine is working because it has never been deployed extensively in response to an outbreak like this one.
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