FDA’s Vaccine Committee Votes in Favour of Issuing EUA for Moderna’s COVID-19 Vaccine
By Denise Baez
NEW YORK -- December 17, 2020 -- The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of issuing an Emergency Use Authorization (EUA) to Moderna’s mRNA-1273 coronavirus disease 2019 (COVID-19) vaccine.
The vote was nearly unanimous, with 20 members voting “yes” for the EUA and 1 member abstaining from voting. No member voted against the EUA.
The final decision about whether to authorise the vaccine for emergency use will be made by FDA’s career officials, which is expected in the next few days.
The FDA’s VRBPAC convened today to determine whether the benefits of the mRNA-1273 vaccine outweigh the risks. The almost 8-hour deliberation covered efficacy and safety data, ethical issues, and adverse event monitoring. The FDA has been conducting a comprehensive review of the vaccine since the EUA submission was received on November 30, 2020.
Safety and efficacy data were from Study 301, a large, ongoing, randomised, blinded, placebo-controlled trial of more than 30,420 participants aged 18 to 95 years (79% white, 10% black). Of the participants, 25% were aged 65 years and older or aged 18 to 65 years with comorbid conditions. The vaccine is given as a 2-dose series, spaced 28 days apart (100 mcg each dose).
As of data cut-off, 100% of participants in the mRNA-1273 (n = 15,210) and placebo (n = 15,210) groups received their first dose and 97% and 96%, respectively received their second dose. In both groups, 88% have completed ≥28 days of follow-up since the second dose, and 62% of participants in the mRNA-1273 group and 61% in the placebo group have completed ≥56 days of follow-up since the second dose.
Primary efficacy analysis showed that vaccine efficacy after the second dose was 94.1%, with 11 confirmed cases of symptomatic or severe cases of COVID-19 in the mRNA-1273 group compared with 185 cases in the placebo group. There were 30 cases of severe COVID-19 in the placebo group and none in the mRNA-1273 group.
Most adverse events (AEs) were mild to moderate. Grade 3/4 AEs were rare. Within 7 days of dose 1, the most common AE was pain at the injection site. Within 7 days of dose 2, the most common AEs were fatigue and myalgia -- 10% of which was grade 3. There were lower rates of AEs in the older cohort after both doses.
There were 3 cases of Bell’s palsy in the vaccine group and 1 in the placebo group. Although there is no clear basis upon which to conclude a casual relationship at this time, the FDA is recommending further surveillance if the vaccine is authorised for widespread use.
Lymphadenopathy was more frequent in the vaccine group compared with the placebo group (1.1% vs 0.63%), and has been deemed possibly related to vaccination.
There were no anaphylactic or severe hypersensitivity reactions.
Study 301 will continue to provide safety and effectiveness data and will do so in a transparent way. The Data Safety Monitoring Board will continue to monitor safety.
Once clear benefit of the mRNA-1273 vaccine is that, in contrast to Pfizer’s BNT162b2 vaccine, it doesn’t need special temperature or freezer requirements. Moderna’s vaccine can be stored at 36 to 46 degrees Fahrenheit and can last nearly 30 days in refrigeration, and at room temperature for up to 12 hours.
mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilised spike (S) protein of severe acute respiratory syndrome coronavirus 2.
SOURCE: US Food and Drug Administration