Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11
Executive Summary
CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.
In a win for data extrapolation, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to recommend use of Pfizer Inc./BioNTech SE’s COVID-19 vaccine booster in children ages 5-11 based on evidence that boosters increase protection in those 12 years and older.
At its 19 May meeting, ACIP voted 11 to 1 with one abstention for use of the booster in this age group. Helen Keip Talbot, Vanderbilt University, voted ‘no,’ citing concerns that only 29% of 5-11 year-olds are fully vaccinated with a primary series. Kevin Ault, University of Kansas Medical Center, abstained since he had been absent during the meeting.
The vote came two days after the US Food and Drug Administration amended the emergency use authorization for Pfizer/BioNTech’s vaccine to authorize a single booster for those 5-11 at least five months after completion of a primary series.
The committee was first asked to consider whether the recommendation state that this age group “should receive” the booster or “may receive” the booster. Members agreed that the recommendation should be definitive.
“My clinical experience from the clinical trenches is it’s confusing when we say ‘may,’” Camille Kotton, Massachusetts General Hospital and Harvard Medical School, said. “I think it’s important for our work today to provide the best clarity possible to understand the recommendations that we are making to avoid nuance.”
“We’ve seen presented today ... that a booster dose of an mRNA vaccine when it’s given to adults during the period of Omicron, provided measurable, detectable benefit across a wide range of health outcomes and that includes infection and emergency department visit, hospitalization and critical illness,” Matthew Daley, Kaiser Permanente Colorado and chair of ACIP’s Covid-19 Vaccines Work Group, said. “So that data poses to me the question, why would we think the same would not be true for children five to 11 years of age when they receive a lower dose from this vaccine?”
Timing Of Booster Dose
Talbot said she was hesitant to say that 5 to 11-year-olds should start getting a booster in June and then ask them to get another booster in September or October when they get a flu shot.
CDC’s Amanda Cohn, chief medical officer of the National Center for Immunization and Respiratory Diseases, told ACIP members that they should not rely on the availability of a booster dose in the fall for this age group.
“Even if there are booster doses in August or September for the general population, this is a different formulation and I don’t know that we can say with confidence that there will be a full booster dose available as early for these kids,” she said.
Committee chair Grace Lee, Stanford University School of Medicine, said that looking at the data she is starting to think that the COVID-19 vaccine should have been a three-dose vaccine, rather than a two-dose primary series and a booster.
“I don’t know what the future holds, but it is feeling like it is reasonable to think of this more in the framework of a flu vaccine, rather than to assume that we will have permanent immunity over time,” Lee stated.
Pfizer’s Data
The FDA authorized emergency use of Pfizer/BioNTech’s vaccine to include children 5 through 11 years of age in October 2021. CDC’s Sara Oliver reported that prior to authorization, there were 1.9 million cases of COVID-19 in this age group, 8,3000 hospitalizations, 3,070 cases of multisystem inflammatory syndrome in children (MIS-C), and 94 deaths.
Since authorization, there have been 2.9 million cases, 6,700 hospitalizations, 739 cases of MIS-C and 95 deaths. She noted that 90% of children hospitalized were unvaccinated and 93% of MIS-C cases were in those unvaccinated.
Chara Sabharwal, director, vaccine clinical research and development at Pfizer, presented safety and immunogenicity data from 401 children 5 to 11 years old who received a 10μ dose of the BNT 162b2 booster. She said the booster elicited robust neutralization titers against SARS-CoV-2 wild type and elicited neutralizing titers against SARS-CoV-2 Omicron in participants with and without evidence of prior infection.
Sabharwal said that overall the immune response associated with the booster given at least 6 months after the second dose is expected to confer protection against COVID-19, including that due to Omicron. She reported that safety data did not identify any new safety concerns. After the booster dose, 10 subjects (2.5%) had lymphadenopathy, which was mild overall and resolved within one week after onset.
Authorization In Children Under Five
CDC currently recommends booster doses of Pfizer/BioNTech’s COVID-19 vaccine in those 18 years and older and in those 12-17 years five months after receipt of the primary series dose.
The FDA authorized a second booster of the Pfizer/BioNTech and Moderna, Inc. mRNA vaccines for individuals 50 years and older and for immunocompromised individuals in March. (Also see "US FDA Bypasses Adcomm In Authorizing Second COVID Booster Because Decision ‘Straight-Forward’" - Pink Sheet, 29 Mar, 2022.)
At its previous meeting last month, ACIP discussed the approach to COVID-19 vaccine booster shots and agreed that the goal for future doses of vaccines should be to prevent severe disease and death rather than prevention of infection. (Also see "To Avoid ‘Booster Fatigue,’ Future COVID-19 Vaccine Doses Should Target Severe Disease" - Pink Sheet, 21 Apr, 2022.)
The FDA is next expected to act on applications for use of the mRNA vaccines in children under five. Pfizer has a rolling EUA application in children younger than five and Moderna has submitted an EUA request for those 6 months - ˂2 years and those 2-˂6 years.
During the open public comment session of the meeting, several speakers called on the FDA and ACIP to act quickly to make the vaccines available in younger children.
At the beginning of the meeting, FDA’s Doran Fink, deputy director, clinical, Division of Vaccines and Related Products Applications, noted that Moderna had recently completed its EUA application.
“We are working hard to review these data to bring to our Vaccines and Related Biological Products Advisory Committee as rapidly as we can,” he said. “We will also be requesting data to support that request for the Pfizer vaccine and once received, we will again move as rapidly as we can to bring those data to our advisory committee for discussion.”
The agency has tentatively scheduled VRBPAC to meet on 8, 21 and 22 June to discuss updates to Moderna and Pfizer/BioNTech’s vaccines to include younger populations. Center for Biologics Evaluation and Research Director Peter Marks noted earlier this month that the agency won’t wait until the end of June if it gets through its review sooner. (Also see "COVID-19 Vaccines In Five And Younger Could Get Earlier FDA Advisory Committee Review" - Pink Sheet, 10 May, 2022.)