WASHINGTON, July 28 (BNA) After weeks of delay, nearly 800,000 doses of monkeypox vaccine will soon be available for distribution, US health regulators said Wednesday.
The announcement comes amid growing criticism that authorities have been too slow to deploy the vaccine, potentially losing the window to contain what could soon become an established infectious disease, the Associated Press reported.
Nearly two weeks ago, the Food and Drug Administration said it had completed necessary inspections at the northern Bavaria facility in Denmark, where the company fills vaccine vials. The US Food and Drug Administration said via Twitter on Wednesday that certification has been completed. The agency said the doses are already in the United States “so they will be ready for distribution once manufacturing changes are approved.”
The United States has already sent more than 310,000 doses of the dual-vaccine Jynneos vaccine to state and local health departments. But clinics in San Francisco, New York and other major cities say they still don’t have enough doses to meet demand.
More than 4,600 cases of monkeypox were reported in the United States as of late Wednesday, according to the Centers for Disease Control and Prevention. The head of the US Department of Health and Human Services said, Wednesday, that officials will announce more vaccine allocations on Thursday.
San Francisco Health Department officials welcomed the news, saying they need several thousand more doses of the vaccine than the 7,800 they have received so far. “Without an adequate supply of vaccines, we will have difficulty fulfilling our primary duty to keep our communities safe,” the agency said in a statement.
Officials in Washington, D.C., said Wednesday that they will join counterparts in San Francisco, New York and other cities that have stopped offering appointments for second doses of the vaccine due to a lack of 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 spread primarily through skin-to-skin contact, but it can also be transmitted through contact with linen used by an infected person. The vast majority of reported cases have been of men who have had sex with men, although health officials have emphasized that anyone can contract the virus.
People with monkeypox may have fever, body aches, chills, and fatigue. During outbreaks, many people have developed oily, oil-like bumps on many parts of the body.
The sluggish federal response has drawn comparisons to the early days of the COVID-19 outbreak, but experts note that the United States has one big advantage: More than a million doses of the vaccine are in the Strategic National Stockpile.
But it turns out that US officials only had about 2,000 doses on hand when the outbreak was first identified in May. Shipping and regulatory delays mean only part of the rest has been posted.
“There are not enough doses,” said Dr. Perry Halketes, a public health specialist at Rutgers University. “I think with some quicker action on the part of the federal government we may not be in the situation we are in right now.”
The previously shipped doses came from a separate facility in Denmark that had already received clearance from the Food and Drug Administration. Another 786,000 doses manufactured in a newly opened northern Bavaria facility await US certification announced Wednesday.
The US Food and Drug Administration (FDA) requires inspections of all vaccine plants to ensure safety, sterility, and consistency of production.
US officials announced orders this month for an additional 5 million doses, although most are not expected to arrive until next year.
Officials have recommended giving the injections to people who know or suspect they have been exposed to monkeypox in the past two weeks.
The Jynneos vaccine has not been widely used in response to an outbreak like this, and the government will track how well it works.
MI