Following the completion of an investigation of the overseas facility where the vaccine was produced, federal health officials said thousands more doses of the monkeypox vaccine will shortly start shipping to the United States.
The announcement from the Food and Drug Administration comes as discontent over the two-dose vaccine’s limited availability grows among the thousands of Americans waiting for a chance to receive the shot in New York City, California, and other states.
More than 1.1 million finished doses of the vaccine made in Denmark by Bavarian Nordic have been purchased by the U.S. government. However, the business stated earlier this week that before it could start transporting the majority of them to the U.S., it needed approval from an on-site FDA inspection.
Late on Wednesday, an FDA spokeswoman claimed that inspectors “expedited and finished an inspection of the company’s plant.”
In a statement sent through email, she stated, “We do not expect any delay in vaccine availability owing to this process.”
300,000 doses produced at a third-party facility that had previously undergone FDA inspection and were distributed by Bavarian Nordic.
State and local officials in the US claim that there is a gap between the limited vaccine supplies and the rising number of people seeking appointments, which is causing increased fear of the virus.
At this time, the demand is enormous, according to Dr. Mary Foote of the New York City health department. “We just want to be clear: We can administer the vaccine if we have it. Supply is currently the most important problem.
The system for arranging vaccination appointments in New York City broke earlier this week as a result of heavy online traffic.
132,000 doses of the vaccine have been sent by the US government to health authorities, including more than 21,000 doses for New York City and nearly 27,000 doses for California. Based on the number of cases in each region and the percentage of the population that is most in danger from the virus, federal officials are distributing the vaccines.
Health experts stress that anyone can contract the illness even though the majority of the nearly 1,000 cases documented in the U.S. have involved men who have had intercourse with other men.
Due to ongoing testing, the number of instances that have been documented at this time is probably an underestimate. U.S. officials claim they anticipate being able to handle 70,000 tests each week by the end of the month thanks to partnerships with several sizable commercial testing laboratories.
Patients with monkeypox typically only feel fever, body pains, chills, and exhaustion. Lesions on the hands and face that can spread to other regions of the body might also appear in people with more severe illnesses, along with rashes.
To ensure their safety, sterility, and consistency of production, the FDA mandates that all vaccine manufacturing facilities undergo previous inspections. After the monkeypox epidemic broke out in Europe in May, according to a company representative, Bavarian Nordic accelerated its plans to go through the examination. Initially, the business intended to deliver its paperwork to the FDA in August in preparation for an autumn inspection.
Jynneos from Bavarian Nordic is one of two vaccinations that can be administered in the United States to prevent monkeypox. The government has a lot more doses of the alternative vaccination, an earlier smallpox shot called ACAM2000 that is not advised for persons with HIV and is thought to have a higher risk of side effects. Therefore, the Jynneos vaccination has been the main tool that authorities have been employing to combat the outbreak.
The vaccination is advised for those who have already been exposed to the virus and their suspected contacts by the Centers for Disease Control and Prevention. That includes males who recently had sex with guys at events like parties or other get-togethers in areas where instances of monkeypox have been reported.
Based on their HIV status and other risk factors, the CDC predicts that 1.5 million American men are eligible for the vaccine.
Health professionals eventually hope to see a more extensive vaccination effort to preventively safeguard high-risk individuals.
Dr. Lilian Abbo, an infectious diseases specialist at the University of Miami, stated that there is not enough vaccine to immunize the entire population, but identifying higher-risk populations and giving them priority will be crucial to making efficient use of our resources.
More supplies, primarily from the Bavarian Nordic stockpile, have been pledged by White House officials. Recently, 2.5 million additional pills were ordered by the US for delivery later this year or early in 2019. And according to the business, it has enough bulk ingredients to produce an additional 15 million doses for the United States.
Activists in New York criticized the FDA last month for taking too long to evaluate the company’s facility and start sending the vaccines to the United States. The HIV non-profit PrEP4All underlined that European regulators had approved the plant last year in a letter to the White House.
The FDA said it performs its inspections of vaccination facilities “to guarantee uniformity in the inspection process” even though it depends on inspections by foreign agencies for some sites.