Limited 'Booster' Vaccine Safety Data Presented to the U.S. FDA
The U.S. FDA published on October 13, 2021, a Briefing Document EUA amendment request for authorization for a booster dose for the Janssen COVID-19 Vaccine at least two months after a single-dose primary vaccination.
A section of the FDA Document focused on the safety of a 'booster' second dose says, 'The safety database to support the use of a booster dose comes primarily from study COV3009, with smaller contributions from studies COV1001, COV1002 and COV2001.'
'The total number of exposed subjects is 8,049.'
'The analyses of reactogenicity data during the seven days post-booster and the unsolicited AEs within 28 days post-booster do not appear significantly different from those for the single-dose primary vaccination and do not raise new safety concerns.'
'The limitations of these data include the length of the follow-up (median of 36 days of blinded follow-up post-dose 2 in study COV3009) and limited safety data are available for a booster dose administered six months after the primary dose (N=17).'
'While the overall size of the database (N=8049) may not be adequate to characterize infrequently occurring serious adverse events, the Sponsor has presented a plan (currently under review by FDA) to continue monitoring safety events following administration of a booster dose if authorization is granted.
The Vaccines and Related Biological Products Advisory Committee meeting to review this Document and others is scheduled for October 14 & 15, 2021.