WASHINGTON — The Biden administration took steps Tuesday to quintuple the available doses of monkeypox vaccine by authorizing its use intradermally in adults, while also authorizing usage of subcutaneous vaccine in children.
“Given the continued spread of the monkey pox virus for a price outpacing the option of our current vaccine supply, the agency began exploring viable scientific options that could enable greater usage of the available vaccine,” FDA Commissioner Robert Califf, MD, said on a call with reporters.
“After conversations in the last several days with key federal partners, the infectious disease community, and Bavarian Nordic, today the FDA has issued a crisis use authorization (EUA) allowing healthcare providers to utilize an alternative solution dosing regimen of the Jynneos vaccine,” he continued. “This can increase the final number of doses designed for use by around five-fold.”
“The EUA also permits usage of the vaccine and people younger than 18 years determined to be at risky of monkey pox infection,” Califf added. “In they, Jynneos is administered by subcutaneous injection.”
He noted that the agency and the CDC “could actually quickly adapt and address the requirements of a large number of young children carrying out a monkeypox exposure at a kid care facility in Illinois.”
Bob Fenton, the White House monkeypox response coordinator, called the announcement of intradermal work with a “game-changer” for the administration’s vaccine response.
“It’s safe, it’s effective, and it’ll significantly scale the quantity of vaccine doses designed for communities in the united states,” Fenton said, adding that as well as the 670,000 vials of the Jynneos vaccine which have recently been distributed, “we’ve 400,000 vials in the Strategic National Stockpile that [are] prepared to be ordered, when jurisdictions use 90% of these current supply. With today’s announcement, those 400,000 vials have the potential to supply around 2 million doses to Americans. We encourage jurisdictions to make use of the choice dosing method as fast as possible.”
Regarding the scientific basis for the two-dose intradermal vaccine regimen, Califf cited data from the 2015 clinical study of the Jynneos vaccine useful for its FDA approval in 2019.
The analysis “evaluated a two-dose series given intradermally in comparison to subcutaneously,” Califf explained. “Individuals who received the vaccine intradermally received a lesser volume — 1/5 — than individuals who received the vaccine subcutaneously. The outcomes of the study demonstrate that intradermal administration produces similar immune reaction to subcutaneous administration.” And even though the intradermal administration patients had mild to moderate unwanted effects, including redness, firmness, itchiness, and swelling at the injection site, “we were holding all manageable,” he said.
Despite the fact that the agency is granting a temporary unapproved usage of an approved product, “the FDA continues to be assuring high standards for safety and manufacturing quality,” Califf added.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said that giving the vaccine intradermally “is not very new … In Germany, this vaccine was presented with intradermally originally in order to replicate the initial version of a smallpox vaccine. It has been given to a large number of people intradermally.” For limiting used in children to a subcutaneous vaccine, Marks said that method “is really a a lot more facile method of getting those children vaccinated; it creates it easier for providers.”
CDC Director Rochelle Walensky, MD, MPH, gave a synopsis of the administration’s physician outreach on the intradermal usage of the vaccine. “Today, [the CDC] will post interim clinical considerations, distribute a clinician alert message, present this vaccine administration technique to the Association of State and Territorial Health Officials, conduct outreach to key clinician partners, and post an educational resource video with this new monkeypox vaccine administration strategy,” she said.
The CDC may also have its interim clinical considerations “to supply guidance for the usage of the Jynneos vaccine being an intradermal regimen for adults, along with the standard or subcutaneous regimen for children,” Walensky noted.
“CDC interim clinical considerations may also include a synopsis of both available vaccines, planning considerations for health departments, including health equity, vaccine administration schedule and dosing regimens, dosing intervals, contraindications and precautions, along with pre- and post-vaccination counseling,” she said. “CDC may also be conducting a number of webinars and training opportunities to teach clinicians on how best to appropriately administer the Jynneos vaccine.” Walensky also urged healthcare providers to join CDC health alerts and updates.
Throughout a question-and-answer session, Califf was asked whether there will be any ongoing evaluation of the vaccine’s safety and effectiveness. “I would like to point out there is absolutely no traditional assessment of the vaccine — it’s approved for emergency purposes in line with the immunological response, not on clinical outcomes, because there weren’t smallpox cases, and the monkeypox outbreaks before this weren’t large enough to essentially execute a clinical trial,” he said.
“Therefore the immunologic response with the intradermal approach is strictly exactly like with [subcutaneous vaccine],” Califf continued. “Nevertheless, in any case, you want to collect outcome data, once we do with all vaccines and I’d also explain that the NIH will undoubtedly be mounting a clinical trial and is working through the logistics of this now.” Because of its part, the CDC can be likely to collect data, Walensky said.
Some healthcare providers are worried that the data presented up to now is too scant for an EUA. “While we appreciate that the government is finally ready to look for answers to help rectify the shortage of vaccines, no effort to safeguard people’s health should come without proper homework and research,” David Harvey, executive director of the National Coalition of STD Directors, said in a statement.
“We’ve grave concerns concerning the limited level of research that is done with this dose and administration method, and we fear it’ll give people a false sense of confidence they are protected,” Harvey noted. “This process raises red flag after red flag, and is apparently rushed ahead without data on efficacy, safety, or alternative dosing strategies.”