ATLANTA -- The CDC's Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend vaccination against Ebola for certain healthcare personnel and laboratory workers, including but not limited to those responding to outbreaks, at a meeting here.
In a 14-0 vote, pre-exposure vaccination with rVSVΔG-EBOV-GP vaccine was recommended for adults ages 18 or older who are at potential risk of exposure to Zaire Ebolavirus who are responding to an outbreak of Ebola; work as healthcare personnel at federally-designated Ebola Treatment Centers in the U.S.; and those working as laboratorians or other staff at U.S. biosafety-level 4 facilities.
This vaccine was approved by the FDA in December 2019 as Ervebo, a single-dose live attenuated vaccine indicated for adults age 18 and older to protect against Zaire Ebolavirus infection.
The ACIP's Ebola working group said these recommendations were population-based and would not involve shared clinical decision-making, adding the vaccine was not "mandatory" and it would be up to organizations to decide whether it was recommended or not.
"We would give a lot of guidance about how the decision was to be made," said ACIP committee member Sharon Frey, MD, of Saint Louis University Medical School in Saint Louis, but said it was ultimately "up to the organizations to decide the risk for their particular employees."
There was a brief discussion about vaccine side effects, which included arthralgia and arthritis, although working group members acknowledged there are generally more side effects with a live attenuated vaccine versus a subunit vaccine. Ultimately, the benefits outweighed the risks, they said.
A representative from vaccine manufacturer Merck cited data from "the largest U.S. based study," which found 3.7% of subjects developed arthritis, with a median onset of 11 days following vaccination. All events resolved within 6 months, and there were none after 2 years.
In addition, 10% to 50% of participants in the vaccine group reported arthralgia, but it was generally resolved by day 14.
The FDA liaison representative also noted there was "no signal to suggest cardiac toxicity."
Initially, the recommendation included wording about "healthy, non-pregnant, non-lactating adults," as this vaccine is a live virus vaccine, and live virus vaccines are not recommended for pregnant women.
But that also drew discussion, with the committee arguing this wording takes away a woman's choice to decide whether getting the vaccine is worth the risk.
"If it's high risk enough, it could be done. The way it's stated here, she's not going to get it even if she wants it," said ACIP member Pablo Sanchez, MD, of The Research Institute at Nationwide Children's Hospital in Columbus, Ohio.
Liaison member Linda O'Neal Eckert, MD, on behalf of the American College of Obstetricians and Gynecologists, agreed, adding the wording should "give pregnant women a choice."
Following the vote, ACIP committee member Kevin Ault, MD, of the University of Kansas Medical Center in Kansas City, Kansas, added comments to the record about language surrounding vaccines and pregnant women.
"We had a task force to talk about language in pregnancy," Ault stated. He said they "decided we were going to state the data we had, and tell people what we know and don't know, and that applies to this vaccine as well."
As always, all ACIP recommendations are not considered final until they are published in the Morbidity and Mortality Weekly Report.