US shifts monkeypox vaccine strategy to expand supply

On Tuesday, federal health officials announced a new strategy to manage the monkeypox vaccine, which they said would increase the supply fivefold.


What You Should Know

  • The FDA has modified the emergency use authorization for the Jynneos vaccine to extend the supply fivefold.
  • Under the new strategy, healthcare workers can administer Jynneos monkeypox vaccine intradermally – between the layers of the skin – instead of injecting 0.5ml of the vaccine under the skin, giving five doses in one vial.
  • Bob Fenton, the White House’s monkeypox coordinator, said the plan would help the country “stay ahead of the virus” without compromising safety and effectiveness.
  • The Biden administration declared monkeypox a public health emergency last week to slow the growing outbreak, which has infected more than 8,900 Americans.

The FDA changed the emergency use authorization so that healthcare providers can inject just 0.1 mL of Jynneos monkeypox vaccine intradermally between the layers of the skin instead of injecting 0.5 mL of the vaccine under the skin. in a single vial.

“This is very good news in our fight against monkeypox,” Health and Human Services Secretary Xavier Becerra said at a briefing Tuesday. “Today’s action will strengthen and strengthen our response. It safely accelerates and increases our supply of effective vaccines by up to five times.”

CDC Director Dr. Rochelle Walensky said under the new plan, the 441,000 vaccine doses in the federal stockpile could be stretched to 2.2 million. Bob Fenton, the White House’s monkeypox coordinator, said in a briefing that 150,000 doses of the vaccine coming in September could be up to 750,000, which would vaccinate about 365,000 people with two vaccine doses per person.

Fenton called the new strategy a “game changer,” adding that the plan will help the country “stay ahead of the virus” without compromising safety and effectiveness.

“It’s safe, it’s effective, and it will greatly expand the amount of vaccine doses available to communities across the country,” he said.

FDA Commissioner Dr. Robert Califf highlighted data from a clinical study of Jynneos prior to its approval in 2019, evaluating intradermal versus subcutaneous administration of the vaccine.

“Individuals who received the vaccine intradermally received the vaccine in less volume – one fifth – than those who received it subcutaneously,” he said. “The results of this study demonstrated that intradermal administration elicited a similar immune response to subcutaneous administration. Many individuals in both groups responded similarly to the vaccines.”

Dr. Califf urged those who could get vaccinated with the Jynneos vaccine to “consider getting the first dose right away.”

This intradermal strategy is for adults only. The emergency authorization also allows children at high risk of mumps to receive the vaccine subcutaneously.

A very unusual move is to publicly admit that the United States does not have the funds to vaccinate everyone who wants to be protected against the rapidly spreading virus. That includes the 1.6 million to 1.7 million Americans who federal officials say are at highest risk of the disease, primarily men who are HIV-infected or at higher risk of contracting it. Vaccinating this group would require about three times more full doses than the roughly 1.1 million officials provided.

Some experts and advocates have warned that there is too little data to support the policy and worry that it could backfire if it makes the vaccine less effective.

“We have serious concerns about the limited amount of research that has been done on this dose and method of administration, and we fear that it will give people a false sense of confidence that they are protected,” said David Harvey of the National Coalition of CYB Directors, in a statement.

The Biden administration declared monkeypox a public health emergency last week to slow the growing outbreak, which has infected more than 8,900 Americans.

As of Monday, more than 600,000 doses of Jynneos had been shipped to states and jurisdictions across the country, according to HHS. So far, more than 1 million vaccines have been distributed to local and state health departments, and about 1.5 million people are eligible to receive the vaccine, the department says.

The Associated Press contributed to this report.

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