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US signs off on 8 lakh doses of monkeypox vaccine

After weeks of delays, approximately 8,00,000 doses of the monkeypox vaccine will be available for distribution soon, according to US health officials on Wednesday.

The revelation comes amid mounting criticism that officials have been too tardy in delivering the vaccine, potentially missing a window of opportunity to manage what might soon become a well-established infectious illness.

Nearly two weeks ago, the Food and Drug Administration said it had finished the necessary inspections at Bavarian Nordic’s facility in Denmark, where the company fills vials of the vaccine. The FDA said via Twitter on Wednesday that the certification had been finalized. The doses are already in the U.S. “so that they would be ready to be distributed once the manufacturing changes were approved,” the agency said.

The United States has now sent over 310,000 doses of the two-shot Jynneos vaccine to state and local health authorities. However, clinics in San Francisco, New York, and other big cities report that they still do not have enough vaccines to fulfil demand.

According to the Centers for Disease Control and Prevention, there were over 4,600 recorded monkeypox cases in the United States as of late Wednesday. The Secretary of Health and Human Services stated Wednesday that further vaccination allocations would be announced on Thursday.

Officials at the San Francisco Department of Health welcomed the news, saying they need many thousands more vaccine doses than the 7,800 they have received to date. “Without enough vaccine supply, we would have trouble fulfilling our basic duty of keeping our communities safe,” the agency said in a statement.

Washington, D.C., officials said Wednesday they would join their counterparts in San Francisco, New York City and other cities who have stopped offering appointments for second vaccine doses due to short supplies. They said the single-dose strategy would allow them to “vaccinate more people at risk and slow the spread of monkeypox in the community more quickly.”

The monkeypox virus is mostly transmitted by skin-to-skin contact, but it can also be transmitted by touching linens used by someone infected. The great majority of cases documented have been in males who have intercourse with men, however health officials have emphasised that the virus may infect anybody.

Monkeypox patients may feel fever, body pains, chills, and weariness. Many people in the epidemic have acquired zit-like lesions all over their bodies.

The slow government reaction has been compared to the early days of the COVID-19 epidemic, although experts have pointed out that the United States had one significant advantage: more than 1 million doses of vaccine in the strategic national stockpile.

However, when the epidemic was initially recognised in May, US officials only had roughly 2,000 doses on hand. Due to shipping and regulatory delays, only a part of the remainder was deployed.

“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 earlier dosages were transported from a different facility in Denmark that already received FDA approval. Another 786,000 doses produced at a recently established Bavarian Nordic plant were awaiting U.S. certification, which was disclosed on Wednesday.

The FDA mandates inspections of all vaccine manufacturing sites to ensure product safety, sterility, and uniformity.

This month, US officials made purchases for 5 million additional doses, the most of which are not scheduled to arrive until next year.

Officials advise giving the injections to anyone who know or think they have been exposed to monkeypox in the past two weeks.

The Jynneos vaccine has never been extensively administered in response to an epidemic of this magnitude, and the government will monitor its effectiveness.

Medically Speaking Team

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