Today, December 17, 2020, the Vaccine and Related Biological Products Advisory Committee meeting discussed the Moderna vaccine. That vaccine is an mRNA vaccine, much the same as the Pfizer-BioNtech vaccine. To remind you, the mRNA vaccine:
- Does not replicate
- Does not enter or integrate into DNA
- And the Moderna vaccine does not contain any preservatives or adjuvants.
According to the data presented today, the efficacy is reported to be in the 94.5% range. In addition, the vaccine appears to reduce progression to severe disease for those patients that received the vaccine as there were no cases of severe disease in the vaccine group and thirty cases in the placebo group.
The safety profile was comparable to the previously EUA-authorized COVID vaccine. Of note, there were four cases of Bell’s Palsy, three of which occurred in the vaccine group and one in the placebo group and, while there were no anaphylactic reactions, there were a few cases of anaphylactoid reactions in both groups that consisted of rashes, etc. One of the reactions in the vaccine group occurred sixty-three days after the second dose and was deemed to not be vaccine-related. These issues are, of course, going to be dealt with in warnings and are consistent with the type of reactions seen with other vaccines as well as the experience seen in the EU as well as in the U.S. after the EUA was issued for the Pfizer vaccine.
Non-voting questions posed to the committee regarding the ongoing studies were ”In considering Moderna’s plans for unblinding and crossover of placebo recipients, please discuss the most critical data to further inform vaccine safety and effectiveness to support licensure that should be accrued in:
- Ongoing clinical trials with the Moderna COVID-19 vaccine
- Other studies (e.g., additional clinical trials or observational studies) with the Moderna COVID-19 vaccine”
The discussion centered around what and how the ongoing studies will be assessed and continued to address durability of immunity achieved with the vaccine’s effect as well as continued safety follow-up.
The Moderna vaccine was studied in patients eighteen years of age or older; thus, the question for the advisory committee is slightly different from that of the Pfizer-BioNTech vaccine in as much as there is no question regarding use in 16- and 17-year-olds and reads, “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” The committee vote was twenty yes, zero no, and one abstain.
This is further confirmation that the mRNA vaccines appear to be safe and effective. Of course, the committee makes a recommendation to the FDA, but the FDA is not bound by their decisions. Given the almost unanimous decisions, it is anticipated that the EUA will likely be issuedin a day or two and will provide another source of vaccine to address the pandemic.