Amidst Confusion, and Delayed Hepatitis B Vaccine Vote, CDC ACIP Votes to Restrict Measles Combination Vaccine

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) restricted the measles, mumps, rubella and the varicella (MMRV) vaccine and weighed changing the vaccine schedule for the hepatitis B vaccine from the first day of birth back to 30 days. However, a late day change prompted the committee to delay the vote until Friday. For the former, the committee recommended the combined MMRV vaccine not be given before the age of 4 years and that children in this age group should receive separate MMR and varicella vaccines. Their justification was given largely due to reducing the risk of febrile seizures.

The committee voted on the following:

1. For measles, mumps, rubella and varicella vaccines given before age 4 years, the combined MMRV vaccine is not recommended.

Children in this age group should receive separate measles, mumps, and rubella vaccine and varicella vaccine (MMR+V). The committee voted 8 to 2 in favor with 1 panelist abstaining.

2. Approve the updated Vaccine for Children (VFC) resolution for prevention measles, mumps, rubella and varicella. The committee had 1 yes vote, 9 no votes, and 3 abstain votes.

In the lead-up to the second vote, there was confusion on the language used in the recommendation. A no vote meant the vaccine would still be covered by VFC and no change to the policy. There was several back and forth discussions on what a yes or no vote meant.

"I am going to abstain as I don't know what I'm voting for," said ACIP panelist Cody Meissner, MD.

Prior to this recommendation in question #1, both separate MMR and varicella vaccines and the combined MMRV vaccine were available. The CDC previously recommended separate shots for the first dose for children between 12 and 47 months old. This approach is often preferred to reduce the risk of fever and seizures associated with the combination vaccine.

For the hepatitis B votes, the 2 questions that were on the docket but delayed were:

1. All pregnant women should be tested for hepatitis B infection.

2. The pediatric vaccine schedule should be updated to reflect the following change:

If a mother tests HBsAG-negative:

• The first dose of the Hepatitis B vaccine is not given until the child is at least one month old.
• Infants may receive a dose of Hepatitis B vaccine before one month according to individual based decision-making.

MMRV Vaccine Presentations

Arjun Srinivasan, deputy director for Program Improvement in the Division of Healthcare Quality Promotion, CDC, provided a review of the disease burden and then the licensure of the MMR vaccine and the reduction of disease of each of these with the introduction of this combination vaccination.

Srinivasan presented data on the MMRV vaccine, and stated this immunization has led to a 97% reduction of disease. Interestingly, the MMRV vaccine accounts for only 15% of first doses. Most infants are given the MMR vaccine for the first dose to prevent the risk of febrile seizures.

John R. Su, MD, PhD, MPH, medical officer, Immunization Safety Office, Division of Healthcare Quality Promotion, CDC presented past studies on the vaccines.

According to the presentation, the following was stated:

• “There is a small increased risk for febrile seizures after first dose of MMR
and MMRV vaccines
• The risk is slightly higher with MMRV combination vaccine after the first dose
• Studies have shown a small increased risk for febrile seizures during the 5- 12 days after a child has received their first vaccination with MMR vaccine
• Studies have not shown an increased risk for febrile seizures after the varicella vaccine
• There is no increased risk of febrile seizures after vaccination with MMRV vaccine in children aged 4 through 6 years”
  
  

The committee discussed the febrile seizure risks. Meissner noted all pediatricians deal with febrile seizures, and that seizures are "not associated with cognitive performance.” He later said in the comment portion that most seizures are not associated with vaccines.

Hepatitis B Vaccine Presentations

Adam Langer, DVM, MPH, DACVPM, associate director for Science, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC, discussed birth dose HBV vaccination. His presentation covered the burden of disease, including the number of people who have it, the health issues associated with it, and mortality rates. The US spends an estimated $1 billion annually on hepatitis hospitalizations.

Langer said the sooner the vaccine is given, the lesser the chances of a mother to child transmission. He also discussed the virus can remain viable for 7 days on environmental surfaces at room temperature and raised concerns around household transmission. He said adverse events are typically mild.

“The more we try to find a target group to vaccinate, the less successful they are,” Meissner said during a comment period when panelists were discussing if they should look to only vaccinate neonates who are born to mothers with hepatitis B and other high-risk groups.

“This is absolutely a safe vaccine,” he continued and questioned what the value would be to wait on the first immunization from newborns in the hospital to a later time.

CDC’s Su presented on adverse effects for the hepatitis B vaccine, and said no deaths occurred in a vaccine study with up to a 7 month follow-up.

Additionally, “the safety data available for hepatitis B vaccine administered at birth did not identify an increased risk for allergic reaction, all-cause mortality, expected, or unexpected deaths or deaths due to sudden infant death syndrome (SIDS), seizures or neurologic disease other than seizures.”

Impact of Today’s Vote

“The plain truth is that vaccines save lives. Before routine vaccination, 18,000 children contracted hepatitis B each year, which silently damages the liver and can cause cirrhosis, liver cancer and death. Millions of children got measles during years with outbreaks, thousands were permanently disabled from it, and hundreds died,” former CDC Director Tom Frieden, MD, MPH, wrote in a post on Linkedin this week.

Prior to vaccination, measles caused an estimated 400 to 500 people to die, 48,000 hospitalizations and 1,000 suffered encephalitis (swelling of the brain), annually, according to the CDC.

These vaccines work and the study data looking at them was again confirmed in the presentations today. In terms of what was achieved remains undetermined, but at one point during the MMRV vaccine discussion, Meissner said it was like Deja vu, and they had this discussion several years ago during another ACIP meeting.

Attendee Amy Middleman, MD, asked that with effective and safe HBV vaccines, what prompted this question of moving the immunization back to 30 days in the first place.

These comments point out the futility of this discussion around already well-established vaccines that are part of a successful public health policy.