CoronaVac: A review of efficacy, safety, and immunogenicity of the inactivated vaccine against SARS-CoV-2

Figures & data

Table 1. Efficacy of CoronaVac in clinical trials.

Efficacy	Age	Symptomatic COVID-19	Hospitalization	Requiring assistance	Moderate/severe disease
In Turkey^Citation11	18–59 years	83.5(65.4–92.1)	100.0(20.4–100.0)	NR	NR
In Brazil^Citation12	≥18 years	50.7(35.9–62.0)	NR	83.7(58.0–93.7)	100.0(56.4–100.0)
In Indonesia^Citation13,Citation14	18–59 years	65.0(20.0–85.0)	NR	NR	NR
Overall	—	67.7(35.9–83.7)	—	—	—

Data are efficacies (%) with 95% confidence intervals for the prevention of symptomatic COVID-19 14 days or more after dose 2 before the emergence of variants of concern. NR=not reported.

Table 2. Effectiveness of CoronaVac in the real world studies.

Effectiveness	Doses	COVID-19	Symptomatic COVID-19	Hospitalization	ICU admission	COVID-19-related death
Against non-variants of concern in adults^Citation15,Citation31	≥14 days after dose 1
	≥16 years	17.1(15.5–18.7)	NR	42.9(38.9–46.1)	44.6(38.9–49.9)	42.0(25.6–54.8)
	≥14 days after dose 2
	≥16 years	65.9(65.2–66.6)	NR	87.5(86.7–88.2)	90.3(89.1–91.4)	86.3(84.5–87.9)
	16–59 years	63.5(62.4–64.6)	NR	91.9(90.2–92.2)	94.6(92.2–96.3)	85.8(69.6–93.4)
	≥60 years	66.6(65.4–67.8)	NR	85.3(84.3–86.3)	89.2(87.6–90.6)	86.5(84.6–88.1)
	At 14 days after dose 3
	Unreported age range	70.9(65.0–75.8)	73.6(67.5–78.5)	80.8(72.6–86.5)	85.1(70.4–92.5)	NR
Against alpha variants in healthcare workers^Citation18	Mean 104 days after dose 2 Unreported age range	39(20–64)	NR	NR	NR	NR
Against gamma in adults in a longitudinal study^Citation21	≥14 days after dose 1
	<60 years	31.9(29.5–34.2)	NR	54.3(47.1–60.6)	53.3(37.7–65.0)	56.1(34.3–70.7)
	60–69 years	22.0(18.5–25.3)	NR	37.5(31.5–43.0)	38.4(28.6–46.9)	40.4(31.1–48.5)
	70–79 years	36.8(34.1–39.4)	NR	41.9(37.3–46.1)	41.1(33.7–47.7)	44.4(38.1–50.0)
	80–89 years	22.9(16.9–28.4)	NR	28.9(20.3–36.6)	33.6(19.4–45.4)	30.7(20.1–39.9)
	≥90 years	17.1(2.9–29.2)	NR	17.2(−3.8–33.9)	11.4(−34.7–41.7)	19.1(−6.5–38.5)
	≥14 days after dose 2
	<60 years	50.0(48.4–51.4)	NR	82.8(80.0–85.1)	84.1(78.6.0–88.2)	84.8(77.1–89.9)
	60–69 years	59.1(57.4–60.8)	NR	79.6(77.6–81.4)	80.0(76.7–82.7)	82.9(80.1–85.3)
	70–79 years	59.5(58.0–60.9)	NR	72.7(70.8–74.4)	73.8(70.9–76.4)	77.5(75.3–79.5)
	80–89 years	48.8(45.5–52.0)	NR	58.2(53.9–62.1)	58.5(51.2–64.7)	63.5(58.7–67.7)
	≥90 years	36.5(27.5–44.4)	NR	42.4(30.2–52.4)	36.0(8.5–55.3)	48.6(35.0–59.3)
Against gamma variants in older adults in a case-control study^Citation20	≥14 days after dose 1
	≥70 years	NR	12.5(3.7–20.6)	16.9 (5.7–26.8)	NR	16.9(5.7–26.8)
	≥14 days after dose 2
	≥70 years	NR	46.8(38.7–53.8)	55.5 (46.5–62.9)	NR	61.2(48.9–70.5)
	70–74 years	NR	59.0(43.7–70.2)	77.6(62.5–86.7)	NR	83.9(59.2–93.7)
	75–79 years	NR	56.2(43.0–66.3)	66.6(51.8–76.9)	NR	78.0(58.8–88.3)
	≥80 years	NR	32.7(17.0–45.5)	38.9(21.4–52.5)	NR	44.0(20.3–60.6)
Against gamma variants in healthcare workers^Citation23	≥14 days after dose 1
	≥18 years	NR	49.6(11.3–71.4)	NR	NR	NR
	≥14 days after dose 2
	≥18 years	NR	36.8 (−54.9–74.2)	NR	NR	NR
Against delta variants in adults^Citation25	1–2 months after dose 2
	≥18 years	74.5(70.6–78.0)*	NR	NR	56.0(51.2–60.2)	79.2(76.8–81.4)
	18–39 years	73.9(68.4–78.5)*	NR	NR	81.9(75.1–86.8)	88.3(81.1–92.7)
	40–59 years	70.5(64.1–75.7)	NR	NR	71.2(66.1–75.5)	85.5(82.1–88.3)
	≥60 years	78.6(74.4–82.2)	NR	NR	46.1(37.1–53.8)	76.3(72.7–79.4)
	3–5 months after dose 2
	≥18 years	30.4(18.8–40.3)*	NR	NR	28.7(12.2–42.1)	76.2(68.8–81.9)
	18–39 years	67.3(60.1–73.3)*	NR	NR	43.5(−5.1–69.6)	59.5(−11.5–85.3)
	40–59 years	32.4(16.7–45.2)	NR	NR	38.3(10.9–57.2)	82.6(63.6–91.7)
	≥60 years	38.6(68.4–14.1)	NR	NR	30.3(7.7–47.4)	75.4(66.7–81.9)
Against omicron variants^Citation28	≥14 days after dose 1
	20–59 years	NR	NR	2.1(−53.3–37.5)^a	60.9(40.6–74.3)^b	65.4(38.6, 79.4)
	60–69 years	NR	NR	NR^a	55.1(30.9, 70.9)^b	70.2(51.3, 81.7)
	70–79 years	NR	NR	NR^a	33.9(8.1, 52.5)^b	48.9(28.1, 63.7)
	≥80 years	NR	NR	NR^a	35.0(8.8, 53.7)^b	40.5(14.9, 58.4)
	≥14 days after dose 2
	20–59 years	NR	NR	17.9(−18.0, 42.9)^a	91.7(87.8, 94.4)^b	94.0(89.6, 96.5)
	60–69 years	NR	NR	NR^a	82.6(74.2, 88.2)^b	87.6(80.9, 91.9)
	70–79 years	NR	NR	NR^a	80.8(72.8, 86.5)^b	84.4(77.5, 89.2)
	≥80 years	NR	NR	NR^a	60.2(43.9, 71.8)^b	66.8(51.9, 77.0)
	≥14 days after dose 3
	20–59 years	NR	NR	42.3(11.4, 62.4)^a	98.5(95.2, 99.5)^b	NR
	60–69 years	NR	NR	NR^a	98.5(95.3, 99.6)^b	98.7(94.4, 99.7)
	70–79 years	NR	NR	NR^a	96.7(92.3, 98.6)^b	97.2(92.3, 99.0)
	≥80 years	NR	NR	NR^a	98.6(94.3, 99.7)^b	99.2 (94.3, 99.9)

Data are effectiveness (%) with 95% confidence intervals. Superscript letters a and b indicate the effectiveness against mild/moderate disease, severe/fatal disease, respectively. * indicates effectiveness in persons with a lower age limit of 15. Variants of concern that were not reported are not listed. NR=not reported.

Table 3. Safety of CoronaVac in clinical trials and real world surveys.

Adverse events/reactions	Vaccine recipients (%)											Placebo recipients (%)
	Healthy adults in phase 3 in Turkey^a ^Citation11	Healthy adults in phase 3 in Brazil^b ^Citation12	Healthy adults in phase 3 in Indonesia^c ^Citation13	Healthy adults in phase 4 in Brazil^d ^Citation33	ARD in phase 4 in Brazil^e ^Citation33	Patients with AIIRD^f ^Citation34	Patients with cancer^g ^Citation35	Healthcare workers in China^h ^Citation36	Healthcare workers in Turkey^i ^Citation38	Medical clerkship students^j ^Citation37	Healthy adults in following the third dose^k ^Citation40	Healthy adults in phase 3 in Turkey^a ^Citation11	Healthy adults in phase 3 in Brazil^b ^Citation12	Healthy adults in phase 3 in Indonesia^c ^Citation13	Healthy adults in following the third dose^k ^Citation40
Total adverse events or reactions	18.9	77.1	57.8	40.1	50.5	54.5	18.9	15.6	62.5	38.0	15.0	16.9	66.4	43.0	8.0
Local adverse events or reactions	2.7	61.5	NR	19.8	23.4	36.4	8.4	9.6	45.0	22.9	NR	1.5	34.6	NR	NR
Pain	2.4	60.3	33.5	17.0	19.8	36.3	4.2	<9.6	41.5	17.4	12.0	1.1	32.5	23.7	0.0
Erythema	0.2	0.0	0.0	2.7	2.8	0.0	0.0	0.0	0.0	0.0	0.0	0.1	0.0	0.0	0.0
Paraesthesia	0.1	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.1	0.0	0.0	0.0
Swelling	0.1	5.8	2.2	6.6	4.7	0.0	2.1	<9.6	2.6	2.1	2.0	0.1	2.1	0.7	0.0
Induration	0.1	3.8	8.4	2.2	6.2	0.0	0.0	<9.6	0.0	0.0	0.0	0.1	1.1	4.4	0.0
Pruritus	0.0	4.2	0.0	2.2	3.1	0.0	2.1	<9.6	0.0	1.4	2.0	0.1	2.9	0.0	0.0
Redness	0.0	3.9	6.2	0.0	0.0	0.0	0.0	<9.6	1.4	2.1	0.0	0.0	1.4	3.7	0.0
Bruising	0.0	0.0	0.0	3.3	3.1	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Systemic adverse events or reactions	17.7	48.4	NR	33.5	43.3	31.8	10.5	NR	71.0	25.0	NR	16.0	47.6	NR	NR
Fatigue	8.2	0.0	17.3	7.7	10.9	13.6	4.2	8.3	23.6	5.6	2.0	7.0	0.0	8.9	0.0
Headache	5.9	34.3	0.0	11.0	20.2	13.6	2.1	<6.0	18.7	1.1	2.0	5.9	34.8	0.0	4.0
Myalgia	4.0	11.7	25.6	5.5	8.9	18.1	2.1	8.1	11.2	0.0	0.0	3.0	10.5	12.6	0.0
Chill	2.5	5.0	0.0	0.0	0.0	9.0	0.0	0.0	2.6	0.7	0.0	1.8	5.1	0.0	0.0
Fever	1.8	0.2	2.4	2.7	2.8	4.5	2.1	2.9	3.0	1.1	2.0	1.5	0.1	0.0	4.0
Diarrhoea	1.6	7.9	0.0	4.9	6.2	0.0	0.0	<1.6	0.0	0.0	2.0	1.7	8.1	0.0	0.0
Cough	0.8	5.5	0.0	4.4	6.9	0.0	0.0	<1.2	0.0	0.0	0.0	0.7	5.2	0.0	0.0
Arthralgia	0.7	5.7	0.0	6.0	13.5	0.0	0.0	0.0	5.9	0.0	0.0	0.5	5.2	0.0	0.0
Nausea	0.7	7.9	0.0	2.2	6.1	9.0	0.0	<1.4	5.3	0.0	0.0	0.2	8.4	0.0	0.0
Vomiting	0.3	1.0	0.0	0.5	1.5	0.0	0.0	<1.6	0.0	0.0	0.0	0.2	1.0	0.0	0.0
Rash	0.1	0.8	0.0	1.6	1.0	0.0	0.0	<1.0	1.5	0.0	0.0	0.2	0.7	0.0	0.0
Allergic reaction	0.1	0.0	0.0	0.0	0.0	0.0	0.0	<1.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Appetite impaired	0.0	3.5	0.0	3.8	4.1	0.0	0.0	<1.4	0.0	0.0	0.0	0.0	3.9	0.0	0.0
Hypersensitivity	0.0	0.9	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.9	0.0	0.0
Malaise	0.0	0.0	0.0	4.4	9.5	0.0	0.0	0.0	0.0	13.9	0.0	0.0	0.0	0.0	0.0
Somnolence	0.0	0.0	0.0	10.4	13.6	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Abdominal pain	0.0	0.0	0.0	3.8	4.8	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Vertigo	0.0	0.0	0.0	4.9	7.0	0.0	0.0	<6.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Tremor	0.0	0.0	0.0	0.5	2.4	0.0	0.0	0.0	0.0	0.7	0.0	0.0	0.0	0.0	0.0
Sweating	0.0	0.0	0.0	1.1	5.6	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Muscle weakness	0.0	0.0	0.0	3.8	7.5	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Back pain	0.0	0.0	0.0	4.9	9.8	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Sneezing	0.0	0.0	0.0	4.9	8.3	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Coryza	0.0	0.0	0.0	7.1	8.3	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Stuffy nose	0.0	0.0	0.0	4.4	5.7	0.0	0.0	<0.9	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Sore throat	0.0	0.0	0.0	3.8	7.4	0.0	0.0	<1.2	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Shortness of breath	0.0	0.0	0.0	3.3	3.2	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Conjunctivitis	0.0	0.0	0.0	0.0	1.3	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Leg pain	0.0	0.0	0.0	0.0	0.0	9.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Dyspnea	0.0	0.0	0.0	0.0	0.0	4.5	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Lymphadenopathy	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.7	0.9	0.0	0.0	0.0	0.0	0.0	0.0
Oropharyngeal pain	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	2.0	0.0	0.0	0.0	0.0
Oral diseases	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	11.3	0.0	0.0	0.0	0.0	0.0	0.0
Acne	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.1	0.0	0.0	0.0	0.0	0.0	0.0
Urticaria	0.0	0.0	0.0	0.0	0.0	0.0	0.0	<1.0	0.8	0.0	0.0	0.0	0.0	0.0	0.0
Dysphagia	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0	1.4	0.0	0.0	0.0	0.0	0.0
Serious adverse events	0.1	0.5	<0.6	0.0	0.0	0.0	0.0	0.0	0.5	0.0	5.0	0.1	0.5	<0.6	4.0

Superscript letters indicate: ^aadverse events after one and two doses, ^bsolicited adverse reactions after one and two doses, ^csolicited adverse events after one dose, ^dadverse events after one dose, ^eadverse events after one dose, ^fadverse events after vaccination, ^gadverse reactions after one dose, ^hadverse reactions after one dose, ⁱadverse reactions after one or two doses, ^jadverse events after one dose, and ^kadverse reactions after three doses. ARD=autoimmune rheumatic diseases. AIIRD=autoimmune and inflammatory rheumatic diseases. NR=not reported.

Figure 1. Immunogenicity of CoronaVac in different populations. We summarize immunogenicity of two-dose CoronaVac in healthy population aged 18–59 years (a) and three-dose CoronaVac in healthy population aged ≥18 years (b); immunogenicity of two-dose CoronaVac in breakthrough cases (c), in participants exposed to air pollution (d), against SARS-CoV-2 variants (e), in pregnant woman (f), in kidney transplant recipients (g) and in healthcare workers with previous COVID-19 infection (h). Numbers above the bars in panels a-h are geometric mean titers of neutralizing antibodies against SARS-CoV-2 (a-c, e), median of neutralizing antibody titers (Au/ml) (d), anti-RBD antibody levels (Au/ml) (f), median of anti-SARS-CoV-2 IgG levels (Iu/ml) (g), geometric mean titers IgG antibody of viral spike protein (h). The error bars in panels a-c, h indicate 95% confidence intervals, while those in panel g indicate interquartile ranges. All dotted line denotes the cutoff level for positivity.

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