(The Hill) – The Biden administration on Tuesday announced a new strategy to expand the limited doses available of the Jynneos monkeypox vaccine by changing the way the vaccine is injected.
The new method would split the doses and use a fifth of the amount of vaccine per injection. The partial dose of the vaccine would be injected into the top layer of the skin, rather than the full dose into the underlying fat, which is how injections are usually given.
The strategy was first described last week by Food and Drug Administration (FDA) Commissioner Robert Califf, who said the intradermal injection method would allow officials to administer more vaccines without compromising the safety or efficacy of the vaccine.
“Over the past few weeks, the monkeypox virus has continued to spread at a rate that has made it clear that our current vaccine supply will not meet current demand,” Califf said in a statement Tuesday. “By increasing the number of doses available, more people wishing to be vaccinated against monkeypox will now be able to do so.”
In order to allow the FDA to authorize the new strategy, the Department of Health and Human Services first issued an order authorizing the agency to take emergency action based on currently available information about the virus. monkeypox.
The Biden administration is scrambling to try to control the monkeypox outbreak, which has become both a political and public health issue. More than 8,900 cases have been reported and experts believe this is likely an undercount.
The move is intended to alleviate a major shortage of Jynneos, the only FDA-approved monkeypox vaccine. The administration has hundreds of thousands of doses but will need millions more to vaccinate the 1.6 million gay and bisexual men officials say are most at risk of contracting the virus.
White House Monkeypox response coordinator Bob Fenton on Tuesday called the decision a “game changer.” He said the 400,000 vials currently in the National Strategic Stockpile now have the potential to supply up to 2 million doses.
“It’s safe, it’s effective and it will significantly increase the volume of vaccine doses available to communities across the country,” Fenton told reporters during a briefing.
The Biden administration has come under heavy criticism for its response to the outbreak. Critics say officials have been too slow to ship ready-to-use vaccine, and even slower to recognize the scale of the outbreak in order to get more ready-to-use vaccines.
The United States has already purchased much of the world’s supply of Jynneos, but much of it is stored frozen in bulk at the manufacturer in Denmark. It must go through a process called “fill and finish” to put the vaccine into usable vials to ship and then administer.
Intradermal injection is not a new method, but evidence of its effectiveness with Jynneos – and using a one-fifth normal-size dose – is limited at best. It is also a much more difficult method of vaccination and will likely require additional training.
Some outside experts said the strategy made sense, while others were unconvinced.
Monica Gandhi, an infectious disease expert and professor of medicine at UC San Francisco, said the idea of splitting the dose is a known strategy for extending the lifespan of vaccines. It has been studied with flu vaccines, rabies vaccines and some tuberculosis vaccines, she said.
“We are in this situation, at the moment, we are in a period of shortage. We have more people who need the vaccine than people who have it,” Gandhi said. “We have to figure out how to get people vaccinated.”
She added that US officials are likely realizing they made mistakes and are looking at all possible strategies to try to resolve the situation.
“We can’t we can’t go back in time. We just have to work with what we have until we can get more vaccines,” Gandhi said, adding that she would have advised the administration to implement the same strategy.
But some experts and advocates worry about the lack of data to support the new policy.
“We are very concerned about the limited amount of research that has been done on this dose and method of administration, and we fear it may give people a false sense of confidence that they are protected,” said David Harvey. , executive director of the National Coalition of STD directors said in a statement. “This approach raises red flag after red flag and appears to be rushed without data on efficacy, safety, or alternative dosing strategies.”
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