Initial U.S. Approval: 2022
SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age…Â Information is not yet available about potential long-term sequelae.
Upon issuance of the Emergency Use Authorization (December 18, 2020) for Moderna COVID-19 Vaccine (SPIKEVAX), participants were unblinded in a phased manner over a period of months to offer placebo participants SPIKEVAX. The median duration of follow up for safety after the second injection during the blinded phase was 4 months.
Participants were monitored for unsolicited adverse events for 28 days following each dose… unsolicited adverse events that occurred within 28 days following any vaccination were reported by 31.3%… who received SPIKEVAX and 28.6%… who received placebo.
[R]eports of facial paralysis (including Bell’s palsy)… herpes zoster…
There were three serious adverse events of angioedema/facial swelling in the vaccine group in recipients with a history of injection of dermatological fillers. The onset of swelling was reported 1-2 days after the second dose and was likely related to vaccination.
Emergency Use Authorization [Postmarketing] Experience
– myocarditis, pericarditis
– anaphylaxis
– syncope
Available data on SPIKEVAX administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
It is not known whether SPIKEVAX is excreted in human milk. Data are not available to assess the effects of SPIKEVAX on the breastfed infant or on milk production/excretion.
SPIKEVAX contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.
Each 0.5 mL dose of SPIKEVAX also contains… [lipid nanoparticles / LPNs]… polyethylene glycol [PEG]… tromethamine… tromethamine hydrochloride…
SPIKEVAX has not been evaluated for carcinogenic, mutagenic potential, or impairment of male fertility in animals.