Monkeypox vaccine: FDA approves change to vaccine administration to expand supply

Vaccines can now be administered to high-risk adults intradermally, meaning between layers of the skin, or under the skin, rather than subcutaneously, which was previously given up. This allows a healthcare provider to get her 5 doses out of her standard single-dose vial.

The new EUA also allows subcutaneous vaccination for those under the age of 18 who are at high risk of infection.

The move could boost the number of vaccines in the national stockpile from 441,000 to more than 2.2 million, officials said Tuesday.

However, as the outbreak continues to spread and demand for the vaccine remains high, EUA will not be a panacea. I assume there is.

Dr. Demetre Daskalakis, the White House’s assistant national response coordinator, said, “Before we run out of weapons, we’ll likely find that vaccines are in short supply.”

CDC report As of Tuesday night, there are 9,492 suspected or confirmed monkeypox cases in 49 states, Puerto Rico and the District of Columbia.

move as fast as possible

“In recent weeks, the monkeypox virus has continued to spread rapidly, making it clear that the current vaccine supply is not meeting current demand,” said FDA Commissioner Dr. Robert Calif. statement“The FDA quickly considered other scientifically sound options to make vaccines available to all affected individuals. More people who want to be vaccinated against smallpox will get the chance.”

“We encourage jurisdictions to take advantage of alternative dosing methods as soon as possible, and we will be your partner every step of this step,” he said in a briefing on Tuesday.

The move comes less than a week after the Biden administration declared monkeypox a public health emergency.

Earlier Tuesday, U.S. Department of Health and Human Services Secretary Xavier Becerra made a decision that paved the way for the FDA’s move.

“Last week we declared monkeypox a public health emergency. This unlocks additional tools to help contain and end this outbreak, taking our response to the next level. to let the American public know that they are,” Becerra said. statement“With today’s action, the FDA will increase the availability of vaccines that prevent monkeypox and may provide additional additional assurances that vaccines will continue to meet high standards of safety, efficacy and manufacturing quality.” You can exercise your authority.”

Prevention remains important

CDC has launched an outreach program to ease the transition to the new strategy and is expanding its efforts to educate and inform public health officials and healthcare providers. Vaccine equity is an important part of this message, as is training and outreach on how to use special needles for intradermal vaccination.

Officials also stressed that people should continue to take steps to protect themselves from the monkeypox virus even after being vaccinated. This includes avoiding skin-to-skin contact with and limiting the number of sex partners.

“Truly, monkeypox prevention is multi-domain,” said Daskalakis. “And as people grapple with getting vaccinated, we really want to give people options and give them clear guidance on what to do between the first and second shots. We also recognize that after a second dose it will take time to achieve adequate protection.”

Jynneos is given in two doses at least four weeks apart. Officials said Tuesday that those who received the first dose subcutaneously can receive a second dose intradermally.

research continues

The use of small amounts by intradermal injection has been done in flu and rabies vaccines, said epidemiologist Dr. Jay Varma. told CNN on mail. Intradermal injections are also used for skin testing for tuberculosis.

“The skin has special cells that are very good at helping vaccines stimulate the body’s immune system,” he writes.

These cells, called dendritic cells, are highly capable of generating an immune response, said Dr. Danielle Griffin, an infectious disease expert at Columbia University.

“They live in the skin and are good at teaching the immune system what it needs to respond to,” he said.

A 2015 study found similar immune responses when the vaccine was administered intradermally at a dose five times lower than that administered subcutaneously. Side effects such as redness, itching, and swelling were more common with the intradermal method, but it was less painful.

Jinneos has also been found to be safe and effective in people with weakened immune systems, the Caliph said on Tuesday.

However, existing research on vaccines focuses on the recipient’s immune response rather than whether it actually prevents monkeypox cases.

“There is no traditional evaluation of this vaccine…because there have been no cases of smallpox and previous monkeypox outbreaks were not large enough to actually conduct clinical trials,” the FDA biologics said. Director of the Center, Dr. Peter Marks, said. He said evaluation and research, Tuesday. “As with all vaccines, we hope to collect outcome data. I would also like to point out that the NIH has initiated a clinical trial and is currently working on its logistics.”

According to the FDA, the move to allow vaccination for children is based on findings about its use in adults and data on childhood smallpox vaccination.

There are two reasons why the FDA does not allow intradermal vaccination in children. “Second, as a practitioner – I know I’m not a pediatrician; I sometimes treat pediatric patients – we had to administer this vaccine to the youngest children. Injecting a baby can actually be a little more difficult.”

CNN’s Jeremy Diamond, Brenda Goodman and Virginia Langmaid contributed to this report.

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