FDA authorizes monkeypox vaccines for emergency use
The Food and Drug Administration (FDA) issued an emergency use authorization on Tuesday for the Jynneos monkeypox vaccine to allow intradermal injection for people 18 years and older who are at high risk for infection.
Why it matters: The alternative approach lets health care providers stretch out vaccine supplies, by administering one-fifth of the Jynneos shot into the skin rather than injecting a full dose into underlying fat.
- Facing vaccine shortages and almost 9,000 U.S. cases, the agency says the authorization will increase the number of available doses by up to five-fold while maintaining the same level of efficacy.
- The authorization also allows people younger than 18 who are at high risk of infection to access vaccines.
- People will still need to get two doses four weeks apart for full protection.
What they're saying: "In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand," FDA commissioner Robert M. Califf said in a statement.
- "The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so."
- Previous clinical studies have shown that intradermal administration produced a similar immune response to subcutaneous administration, according to the FDA.
The big picture: Tuesday's action comes shortly after Health and Human Services Secretary Xavier Becerra moved to allow the FDA to issue emergency use authorizations for monkeypox vaccines, which would help expand the availability of vaccines and give the agency greater flexibility in addressing the outbreak.
- The Biden administration declared monkeypox a public health emergency last week to "unlock additional tools that will help us contain and end this outbreak and to signal to the American people that we are taking our response to the next level," Becerra said in a statement Tuesday.
- The Centers for Disease Control and Prevention has issued updated guidance recommending that people limit their sexual partners while waiting to get vaccinated against monkeypox.