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VRBPAC recommends expanding EUAs to authorize Janssen and Moderna boosters

By Brian Buntz | October 15, 2021

COVID-19 vaccine

Image from Sam Moqadam on Unsplash

The U.S. appears to be on the verge of expanding the use of COVID-19 vaccine boosters after an advisory committee backed boosters for the Johnson & Johnson (NYSE:JNJ) and Moderna (NSDQ:MRNA) vaccines.

On Oct. 14 and 15, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) separately voted 19–0 to recommend boosters of both products.

VRBPAC recommended that recipients of the single-dose Janssen vaccine receive a booster at least two months after the initial dose.

The committee’s guidance for the two-dose mRNA vaccines from Moderna and Pfizer-BioNTech (NYSE: PFE/NSDQ:BNTX) was to allow boosters six months after completion of a primary series.

Several panelists balked at the word “booster” in reference to the Janssen vaccine, arguing that would be more accurate to start referring to it as a two-dose vaccine. The Janssen’s Ad26.COV2.S was “always a two-dose vaccine and it’s hard to recommend it as a single-dose vaccine,” said VRBPAC member Dr. Paul Offit.

VRBPAC member Dr. Archana Chatterjee said she had a similar perspective, but added “there’s so much confusion around these vaccines anyway that I thought introducing another term [‘additional dose’ versus ‘booster’] might be even more confusing.”

The VRBPAC has expressed reservations about the use of boosters in the broader public. Although members of the committee agreed the case for boosters was clear for the elderly, immunocompromised and those facing a high risk of occupational or institutional exposure, the panel was overall frustrated with the availability of relevant data concerning boosters.

Committee members were, however, more supportive of the use of a second dose of the Janssen vaccine, given a single dose of the vaccine does not tend to stimulate antibodies as well as two doses of the mRNA vaccines.

Chatterjee expressed skepticism that boosters would move the needle in fighting the pandemic, noting that the U.S. is “seeing cases going down”  without boosters. There may be little present need for boosters for those who are immune competent, she said.

“The disease primarily seems to be occurring, especially in its most severe forms, in those who are unvaccinated,” Chatterjee said in yesterday’s meeting.

Offit agreed. “The people who are in the ICU aren’t there because they haven’t gotten the third dose,” he said.

“I just worry that we haven’t clearly defined what the goal of this vaccine is,” Offit continued. “If the goal of the [COVID-19] vaccine is to prevent asymptomatic or mildly symptomatic infection, that is a goal for which we have set for no other vaccine,” he explained. “If we’re trying to prevent what is inevitable, which is the decline in neutralizing antibodies, and erosion of protection against mild or asymptomatic infection, that is a high bar to which we hold no other vaccine.”


Filed Under: Infectious Disease
Tagged With: booster, COVID-19 vaccine, COVID-19 vaccines, Janssen, Moderna, vaccine, Vaccines and Related Biological Products Advisory Committee, VRBPAC
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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