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Moderna Booster - Printable Version

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Moderna Booster - M_T - 11-01-2021

FDA Advisory Committee Meeting Announcement 10/14-15/21

FDA Briefing Document
FDA Review Slides

Moderna Briefing Slides
(includes update on efficacy of original vaccine doses)

Moderna Briefing Document


RE: Moderna Booster - M_T - 12-20-2021

Dec. 20, 2021:  Moderna reported preliminary data about neutralization antibodies against Omicron with their EUA-approved booster (50ug), the full strength vaccination (100ug) as a 3rd shot, and some new formulations.


Quote:All groups had low neutralizing antibody levels in the Omicron PsVNT assay prior to boosting. At day 29 post boost, the authorized 50 µg booster of mRNA-1273 increased neutralizing geometric mean titers (GMT) against Omicron to 850, which is approximately 37-fold higher than pre-boost levels. At day 29 post boost, the 100 µg dose booster of mRNA-1273 increased neutralizing GMT to 2228, which is approximately 83-fold higher than pre-boost levels. The multivalent candidates boosted Omicron specific neutralizing antibody levels to similarly high levels at both the 50 µg and 100 µg levels. Based on the strength of neutralizing titers generated by mRNA-1273, the rapid pace of Omicron expansion, and the increased complexity of deploying a new vaccine, the Company will focus its near-term efforts to address Omicron on the mRNA-1273 booster.


My interpretation is that Moderna, without a booster has little protection against Omicron (neutralizing titer of 27).  With the EUA-approved booster, you will probably need another booster at maybe 6 months.  You've got better protection with a full 3rd dose (allowed for those with compromised immunity).


Quote:The Company also announced the safety and tolerability data from the Phase 2/3 study of the 100 µg booster dose of mRNA-1273 (N=305). A 100 µg booster dose of mRNA-1273 was generally safe and well tolerated. The frequency and nature of solicited systemic and local adverse events 7 days after receiving a booster were generally comparable to those seen after the two-dose primary series. There was a trend toward slightly more frequent adverse reactions following the 100 µg booster dose relative to the authorized 50 µg booster dose of mRNA-1273.


I don't know if that is enough testing to allow the FDA to approve full-strength boosters for Moderna for any further segment of the population (say, everyone 50+).