Biden administration authorizes intradermal monkeypox vaccine

WASHINGTON — The Biden administration took steps Tuesday to authorize the intradermal monkeypox vaccine for adults, increasing the available dose by five times, while also authorizing subcutaneous use in children.

“Given the continued spread of monkeypox virus faster than our current vaccine supply, the agency began to explore viable scientific options for greater access to currently available vaccines,” FDA Commissioner Robert Califf, MD, said in a call with reporters. The Emergency Use Authorization (EUA) allows healthcare providers to use alternative dosing regimens for the Jynneos vaccine,” he continued. “This would increase the total number of doses available by up to five-fold. “

“The EUA also allows for the use of vaccines and determines that individuals under the age of 18 are at high risk of contracting monkeypox,” Califf added. “In these individuals, Jynneos was administered by subcutaneous injection. medicine.

He noted that the agency and the CDC “were able to quickly adapt and address the needs of dozens of monkeypox children exposed at a child care facility in Illinois.”

White House monkeypox response coordinator Bob Fenton called the announcement of intradermal injections a “game changer” for the government’s vaccine response.

“It’s safe, effective and will significantly expand the vaccine dose available to communities across the country,” Fenton said, adding that in addition to the 670,000 vials of Jynneos vaccine already distributed, “we have 400,000 vials in the strategic national stockpile ready to order when jurisdictions use their current supplies 90% of the time. According to today’s announcement, the 400,000 vials have the potential to deliver as many as 2 million doses to Americans. We encourage jurisdictions to consider alternative drug delivery methods as soon as possible. “

Regarding the scientific basis for the two-dose intradermal vaccine regimen, Califf cites data from a 2015 clinical study for the Jynneos vaccine. It was FDA approved in 2019.

The study “evaluated a two-dose series given intradermally compared to subcutaneously,” Califf explained. “Individuals vaccinated intradermally received lower doses than those vaccinated subcutaneously. – 1/5. The results of this study showed that intradermal vaccination produced a similar immune response to subcutaneous vaccination. Although patients who received intradermal injections had mild to moderate side effects, including redness, firmness, itching and swelling at the injection site, “these were manageable,” he said.

Even though the agency is approving the temporary unapproved use of an approved product, “FDA is still ensuring high standards of safety and manufacturing quality,” Califf added.

Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, said intradermal vaccines “are nothing new… In Germany, this vaccine was originally administered intradermally to replicate the original version of the smallpox vaccine. . Intradermal injections are given to thousands of people. As for limiting the use of subcutaneous vaccines in children, Marks said the approach “is an easier way to get these children vaccinated; it makes it easier for providers.”

CDC Director Rochelle Walensky, MD, MPH, outlines the government’s physician advocacy for intradermal vaccines. “Today, [CDC] will release Interim clinical considerations, disseminate clinician alerts, brief associations of state and territorial health officials on this vaccine administration strategy, conduct outreach with key clinician partners, and publish a video about this new educational resource on the monkeypox vaccination strategy”, She said. As a standard or subcutaneous regimen in children,” Walensky noted.

“CDC interim clinical considerations will also include an overview of the two available vaccines, health sector planning considerations, including health equity, vaccine dosing schedules and regimens, dosing intervals , contraindications and precautions, and pre- and post-vaccination counselling,” she said. “CDC will also host a series of webinars and training opportunities to educate clinicians on how to properly administer the Jynneos vaccine.” Walensky also urged healthcare providers to sign up for CDC health alerts and updates.

During the Q&A session, Califf was asked if there would be any ongoing assessment of the safety and security of the vaccine. potency. “I would like to point out that there is no traditional assessment of this vaccine – it is approved for emergency purposes based on immune response rather than clinical results, because there have been no cases of smallpox and prior monkeypox outbreaks have not been large enough to actually conduct clinical trials ,”He says.

“Therefore, the immune response of the intradermal approach is exactly the same as [subcutaneous vaccine],” Califf continued. “Nevertheless, in either case, we want to collect outcome data, as we do with all vaccines, and I would also point out that the NIH is going to have a clinical trial and it’s going through the logistics right now,” Walensky said. , in the case of the CDC, which also plans to collect data.

Some healthcare providers are concerned that the evidence presented so far is too little for EUA. “While we appreciate the federal government’s eventual willingness to find solutions to help address vaccine shortages, no effort to protect people’s health should emerge without proper due diligence and research,” said David Harvey, executive director of the National STD Alliance. directors, said in a statement. Confidence in their protection,” Harvey noted. “This approach raises red flags after red flags and appears to be rushed forward without data on efficacy, safety, or alternative drug delivery strategies.” ”

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  Joyce Frieden oversees MedPage Today’s Washington coverage, including coverage on Congress, the White House, the Supreme Court, healthcare industry associations, and federal agencies. She has 35 years of experience in healthcare policy. Follow