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. 2021 Jan 7;84(5):1254–1268. doi: 10.1016/j.jaad.2020.12.058

Table II.

Vaccine candidates for COVID-19 and available data on vaccination schedule, efficacy, and safety

Vaccine candidate Vaccination schedule Approximate number of individuals in phase 3 Efficacy Safety Status
Pfizer/BioNTech
BNT162b2 (mRNA)39,40
IM injection on days 0 and 21 44,000 95% efficacy in preventing COVID-19 (162 cases in placebo group, 8 in BNT162b2 group)
Severe COVID-19: 9 cases in placebo group, 1 in BNT162b2 group
  • Most common solicited adverse reactions: injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%)

  • Severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after dose 2 than after dose 1, and were generally less frequent in participants ≥55 years.

  • The incidence of serious adverse events was similar in the vaccine and placebo groups (0.6% and 0.5%, respectively).

  • Four cases of Bell palsy in the vaccine group compared with no cases in the placebo group, consistent with the expected rate

FDA EUA granted December 11, 2020
Safety monitoring will continue for 2 years after administration of the second dose of the vaccine.
Moderna mRNA-1273 (mRNA)41 IM injection on days 0 and 28 30,400 94.5% efficacy in preventing COVID-19 (90 cases in placebo group, 5 in mRNA-1273 group)
Severe COVID-19: 11 cases in placebo group, 0 in mRNA-1273 group
  • Most common solicited adverse reactions: injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%).

  • Severe adverse reactions occurred in 0.2% to 9.7% of participants, were more frequent after dose 2 than after dose 1, and were generally less frequent in participants ≥65 years.

  • Unsolicited adverse events possibly related to vaccine:

  • Local lymphadenopathy: 1.1% in the vaccine group and 0.63% in the placebo group

  • Hypersensitivity: 1.5% in the vaccine group vs 1.1% placebo group

  • Frequency of serious adverse events was similar in vaccine and placebo groups (1.0% for both).

  • Four cases of Bell palsy in the vaccine group compared with 1 case in the placebo group

FDA EUA pending
Safety evaluation until day 759 after administration of second dose
AstraZeneca/Oxford
AZD1222 (replication-deficient chimpanzee adenoviral vector
ChAdOx1, containing the SARS-CoV-2 structural surface glycoprotein antigen)42
2-dose regimen, interval to be determined 40,000
Interim data reported on 11,600
62.1% (2 standard doses); 90% (low dose followed by standard dose); overall, 70.4%
Severe COVID-19: 10 cases in placebo group, 0 in AZD1222 group
  • Serious adverse events: 79 in treatment and 89 in control group

  • Adverse events: vaccine (n = 12,021) vs control (n = 11,724)

  • Anaphylactic reaction: 1 (vaccine) vs 0 (control)

Recruiting
Johnson & Johnson
JNJ-78436735 (nonreplicating viral vector)
1 dose IM injection; 5 × 1010 viral particles (Ad26.COV2.S) Up to 60,000 planned (30,000 per group) TBD TBD Recruiting
Novavax
NVX-CoV2373 (nanoparticle vaccine)
2 doses of 5 μg SARS-CoV-2 rS + 50 μg Matrix-M1 adjuvant (coformulated), 1 dose each on days 0 and 21 Up to 30,000 TBD TBD Recruiting
Inovio Pharmaceuticals
INO-4800(DNA vaccine plasmid)
Participants will receive either 1 or 2 1.0-mg ID injections of INO-4800 based on results from phase 2 segment, followed by EP using the CELLECTRA 2000 device on day 0 and day 28 6578 participants TBD TBD Recruiting
Medicago; GlaxoSmithKline; Dynavax
VIR-7831 (plant-based adjuvant vaccine)
VIR-7831 given by intravenous infusion 1360 participants TBD TBD Recruiting

EP, Electroporation; EUA, Emergency Use Authorization; FDA, US Food and Drug Administration; ID, intradermal; IM, intramuscular; mRNA, messenger RNA; rS, recombinant spike; TBD, to be determined.