WASHINGTON — After two months of a vaccine shortage that has undermined the response to the monkeypox outbreak, the Biden administration on Tuesday moved to stretch its limited supplies by allowing another injection method that will deliver one-fifth of the current dose. to use.
At the same time, promising news came out of Denmark, where the world’s sole producer of the main monkeypox vaccine, Jynneos, indicated that at least 200,000 doses previously thought to be expired could still be useful.
The developments suggest the United States may be able to vaccinate hundreds of thousands more people at risk for monkeypox by the end of the year than expected. That could significantly help curb an outbreak that has infected nearly 9,000 Americans since May, and which some experts fear could spread from high-risk groups to the wider population.
Injecting the vaccine between layers of the skin, rather than into the underlying fat, will be “a game changer when it comes to our response and our ability to stay ahead of the virus,” said Robert J. Fenton Jr., the new White. Home monkeypox response coordinator, at a news briefing. “It’s safe, it’s effective, and it will significantly scale up the number of vaccine doses available.”
Federal officials estimate that the government can vaccinate up to five times as many people using what is called an intradermal injection rather than the standard subcutaneous injection. The government issued a public health emergency declaration, the second in less than a week, allowing the Food and Drug Administration to approve the new regime.
The FDA also used its emergency powers to approve the monkeypox vaccine for people under the age of 18 at high risk of infection, citing an increase in potential exposure in that age group. Previously, doctors had to ask permission from the agency to vaccinate every child.
At least five children have been diagnosed with monkey pox and dozens more are being screened after an Illinois daycare worker was found to be infected last week.
The United States once had more than 20 million doses of Jynneos in its national supply. It still owns 16.5 million doses of bulk vaccine, stored in freezers at the headquarters of the manufacturer, Bavarian Nordic, outside Copenhagen.
But stock doses gradually declined over the past decade. After the outbreak began in mid-May, the government was slow to request that the bulk vaccine be made into vials, putting it in a row behind other countries that are also fighting monkeypox.
Now the Biden administration is trying to find a replacement company that can bottle and label the bulk vaccine faster than Bavarian Nordic. It is also working with Bavarian Nordic to test whether some of the expired doses in the stock remain potent even though the newest are already eight years old and at the end of their expected shelf life, according to company president Paul Chaplin.
What you need to know about the Monkeypox virus?
What you need to know about the Monkeypox virus?
What is monkey pox? Monkeypox is a virus similar to smallpox, but the symptoms are less severe. It was discovered in 1958, after outbreaks occurred in monkeys kept for research. The virus was mainly found in parts of Central and West Africa, but has recently spread to dozens of countries and infected tens of thousands of people, mostly men who have sex with men.
Since monkeypox emerged here in May, the federal government has shipped only 670,000 doses to local jurisdictions. Officials say they still have about half a million doses of the dual vaccine on their hands. Those shots are enough to cover only about a third of the 1.6 million to 1.7 million individuals the Centers for Disease Control and Prevention identified as high-risk. For the time being, the virus mainly spreads among men who have sex with men.
Changing the injection method appears to be the quickest solution to the shortfall, although some experts said they are concerned that the data showing it will work is essentially limited to one study published in 2015 that was sponsored. by the National Institutes of Health. Researchers compared the intradermal approach to the standard injection method and found that the intradermal injections produced a comparable level of neutralizing antibodies to one-fifth of the monkeypox vaccine. The intradermal injections also caused more redness, swelling and itching at the injection site.
During the briefing, Dr. Robert M. Califf, director of the FDA, who manage side effects. and dr. Peter Marks, who oversees the agency’s vaccine regulation, said a similar vaccine had been “administered intradermally to thousands of people” in Germany in the 1970s. The method is “not new at all,” he said.
Federal officials are eager for states and municipalities to adopt the new type of injection as soon as possible, even though vaccinators are more familiar with the standard approach. dr. Rochelle P. Walensky, director of the Centers for Disease Control and Prevention, said the agency offers training seminars and other information to educate vaccinators.
The federal government also hopes that with doses going further, jurisdictions will no longer give people just the first of two injections to maintain supply. “There is data that says this isn’t protective enough,” warned Dr. walensky. Research has shown that a single injection produces a much weaker immune response than two.
dr. Walensky also said vaccinated individuals should continue to “avoid close skin-to-skin contact, including intimate contact, with someone who has monkey pox, because we don’t yet know how well these vaccines work.”
The Jynneos vaccine was licensed by the FDA in 2019 for use against both monkeypox and smallpox without a large-scale clinical trial studying its effectiveness. dr. Califf said none was carried out because there were never enough cases in the United States. Studies showed that compared to a previously approved vaccine, Jynneos elicited a stronger immune response.
The intradermal method should reduce US demand for new doses, which would presumably mean less profit for Bavarian Nordic. In an interview Tuesday morning, Mr. Chaplin, the company’s CEO, said he hoped the federal government would monitor at least some of those who are being vaccinated intradermally to gather more safety data.
Since last Thursday, when federal officials first said they were considering the new method, the company has been “bombarded” with calls from state officials asking how it would work, including how many times a vial could be pierced and how long the vaccine would be potent. would remain if the vial seal was broken.
“We’re now trying to get a hold of the CDC and see what the official position will be because, frankly, we don’t know,” he said. “We don’t know how long you can keep the vial once you pierce it.”
Mr Chaplin also said the company is busy testing samples of older doses that had been in government national stockpiles for years, past their three-year expiration date. Up to a million doses manufactured in 2014 may still be usable, he suggested, but not for long.
“There’s not a lot of time to hang out before we use them,” he said. “We still have months, I’d say.”
Some activists expressed concern that the White House was embracing what they viewed as relatively risky solutions to the shortage, when it could use government authority under the Defense Production Act to force a U.S. company to sell the bulk vaccine it uses. to bottle and label.
“There are 15 million doses that they haven’t figured out how to bottle, and instead they’re following this very aggressive dose-saving strategy,” said James Krellenstein, a Brooklyn-based gay health activist who has been on the federal government’s agenda. urged health officials to expand access to the vaccine. He noted that the federal government has previously used the Defense Production Act to speed up aspects of Covid-19 vaccine production.
But vaccine manufacturing experts said it would take a U.S. company at least three months to get ready for the final stage of production, known as fill and finish, no matter how much pressure the White House exerted. Federal officials have spent weeks recruiting pharmaceutical companies looking for a company that will take on the work of taking on the bulk vaccine now stocked in Denmark.
Noah Weiland reporting contributed.
