ACIP: LAIV OK to Use During 2018-19 Flu Season

Group Also Addresses Hepatitis A, B Vaccines

February 26, 2018, 03:59 pm Chris Crawford – During the Feb. 21-22 meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), the group voted 12-2 to recommend the inclusion of live attenuated influenza vaccine (LAIV; FluMist) among vaccines eligible for use during the upcoming flu season.

Specifically, for the 2018-19 influenza season, the ACIP recommended physicians administer any licensed, age-appropriate influenza vaccine, including LAIV, inactivated influenza vaccine and recombinant influenza vaccine. The committee also voted unanimously to include this recommendation for the Vaccines for Children program.

ACIP members also voted to, among other things, approve the use of a new recombinant hepatitis B vaccine (HBV), HEPLISAV-B, for patients ages 18 and older and approve use of hepatitis A vaccine for postexposure prophylaxis for all patients 12 months of age and older.

LAIV

The ACIP had recommended against the use of LAIV for the 2016-17 and 2017-18 flu seasons because the vaccine's H1N1 component wasn't protecting people against that influenza strain.

AAFP liaison to the ACIP Pamela Rockwell, D.O., of Ann Arbor, Mich., told AAFP News that's because FluMist manufacturer MedImmune, a subsidiary of AstraZeneca, has replaced the H1N1 component that seemed to be ineffective during previous flu seasons.

However, because LAIV has now been off the market for two seasons, no current effectiveness data are available, Rockwell noted. Effectiveness data won't be available until there is another H1N1-predominant flu season and enough people use the LAIV vaccine.

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"MedImmune changed up the H1N1 virus component, and all of the company's antibody research showed it's really effective to make good antibody response," she said. "This vaccine is better than no vaccine, for sure. And the hope is that kids who otherwise wouldn't be getting a flu vaccine because of the shot issue will be getting the intranasal vaccine."

During the meeting, the vaccine manufacturer presented a clinical study of 200 U.S. children ages 2-4 that evaluated the shedding and antibody response of the H1N1 strain in the latest version of the quadrivalent vaccine, finding that the vaccine's 2017-18 H1N1 post-pandemic strain (A/Slovenia) performed much better than the 2015-16 H1N1 post-pandemic strain (A/Bolivia).

The new H1N1 strain's antibody response was comparable to that seen with the highly effective H1N1 vaccine strain that was used before the 2009 influenza pandemic.

"This study validates the improvements we've made to our strain selection process and confirms an improved H1N1 LAIV strain was included in the 2017-18 formulation," said Gregory Keenan, vice president of U.S. Medical Affairs, AstraZeneca, in a Feb. 21 news release.

Rockwell said that although some physicians have already placed their flu vaccine orders for the coming season, they can still order FluMist to supplement their supply, if they so choose. In fact, said Rockwell, who sits on the vaccine committee at the University of Michigan, she recommended that her health care system do just that.

However, she cautioned, "You still have to remember because it's a live vaccine, you don't give LAIV to pregnant patients or to those who are immunocompromised."

Hepatitis B Vaccine

Last November, the FDA approved the HEPLISAV-B vaccine from Dynavax Technologies Corp. for protection against all known HBV subtypes in patients ages 18 and older. It's the only two-dose vaccine against hepatitis B infection, with doses administered one month apart; previously, HBV vaccines were available only as three-shot series.

At this meeting, the ACIP voted to recommend HEPLISAV-B for patients ages 18 and older.

Rockwell said the recombinant, adjuvanted vaccine appears to be very effective and is another option on the market, but the ACIP didn't give it a preferential recommendation.

"In the past, there was a high percentage of people who never completed the three-shot series to be fully immunized," she said. "So, the hope is the two-shot series will have a higher completion rate."

Hepatitis A Vaccine

In addition to the ACIP's recommendation to use the hepatitis A vaccine for postexposure prophylaxis for patients 12 months and older, the group offered additional disease-focused recommendations.

Specifically, said Rockwell, for patients 40 and older, physicians can give hepatitis A immunoglobulin (IG) based on their risk assessment.

"Previously, for people over age 40, IG was preferred. Vaccine could be used if IG wasn't available," she explained. "Now, vaccine is recommended, but then IG could be used, as well."

These recommendations are especially timely in light of current hepatitis A outbreaks in Michigan, California and Utah. 2017-18 data presented at the ACIP meeting showed Michigan alone accounted for 727 cases of hepatitis A infection, including 454 hospitalizations and 21 deaths.

Finally, the group voted to recommend that hepatitis A vaccine be administered to infants ages 6-11 months when they will be traveling outside the United States to areas where hepatitis A protection is recommended.

"This is new because normally, children don't get the hepatitis A vaccine until they turn 1," Rockwell said.

But, she noted: "If they get it earlier because they're traveling, it won't count toward the completion of their childhood vaccines. They'd need to repeat the vaccine later."

Additional Meeting Notes

Several other topics were taken up during the meeting, including the following:

Rates for influenza A strains circulating this season peaked the week ending Jan. 13, but influenza B strain rates continue to rise.
The anthrax work group presented scenarios and plans for broad vaccination and postexposure prophylaxis in case a state of emergency is accompanied by a vaccine supply shortage.
The pneumococcal work group reviewed the 13-valent pneumococcal conjugate vaccine effectiveness and found studies showed effectiveness rates in the mid-40s to mid-70s, Rockwell said.
The HPV work group reviewed the burden of HPV-related disease and found the nine-valent HPV vaccine to have no new safety concerns. The group also noted that oropharyngeal cancer is now the most common HPV-associated cancer and is rising in males.

Finally, the committee adopted a new Evidence-to-Recommendations Framework to support its decision-making.

Instead of the previous method of designating approved interventions as category A or B recommendations, which is based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, the ACIP will now say

We recommend against the intervention,
We recommend the intervention for individuals based on clinical decision-making or
We recommend the intervention.

Upcoming ACIP Meeting

Rockwell said that during the ACIP meeting in June, the Japanese encephalitis work group will present a review of ACIP recommendations on the vaccine from 2010 and review the GRADE analysis and cost-effectiveness of this immunization.

Also at the meeting, the mumps work group plans to define the at-risk group during an outbreak in response to the recent ACIP recommendation for a third dose of mumps-containing vaccine for patients at increased risk for acquiring the disease during an outbreak.

Finally, the meningitis B work group will review data on the two-year post-booster shot, present its GRADE analysis and address the timing of the first dose, between-dose intervals and at-risk populations.