Living Evidence - COVID-19 vaccines

Phase 3 trial publication

The New England Journal of Medicine (1)

The New England Journal of Medicine (2)

The Lancet (3)

The Lancet (4)

The New England Journal of Medicine

The New England Journal of Medicine

The New England Journal of Medicine (1)

The New England Journal of Medicine (2)

Vaccine type

mRNA (nucleic acid)

Viral vector

mRNA (nucleic acid)

Two 5µg doses;

Dose interval 21 days

Efficacy - various endpoints

SARS-CoV-2 infection

55.7%* (3)

54.1%* (4)

89.6%*

Not yet available

Asymptomatic infection

14 to 20 days after Dose 1: 29% (estimated)*

≥7 days after Dose 2: 90% (estimated)* (2)

LD/SD (initial half dose) 58.9% /SD/SD (full dose) recipients 3.8%
Total combined 27.3%*ꝉ (3)

COV002 UK study participants only: LD/SD 49.3%* / SD/SD 2.0%*
Total combined 22.2%* (4)

Not yet available

Severe COVID-19

88.9% after Dose 1* (1)

14 to 20 days after Dose 1: 62%*
≥7 days after Dose 2: 92%* (2)

For hospitalisation:
14 to 20 days after Dose 1: 74%*
≥7 days after Dose 2: 87%* (2)

100%*ⱶ (3)

100% (US Phase 3 trial; 2 Doses administered 4 weeks apart)^

100%*

≥14 days after dose: 76.7%

≥28 days after dose: 85.4%

For hospitalisation:
≥14 days after dose: 93.1%*
≥28 days after dose: 100%*

100%*ⱶ (No hospitalizations or cases of severe infection were reported among the 10 cases in the vaccine group) (1)

100%*ⱶ (No hospitalizations or cases of severe infection were reported among the 14 cases in the vaccine group) (2)

Mortality

14 to 20 days after Dose 1: 72% (estimated)* (2)

Not yet available

Not yet available

≥28 days after dose: 82.8%, with protection sustained through at least 6 months after administration.

Transmissionⱡ

Reduction in PCR positivity in contacts of index cases who received 2 doses versus non-vaccinated: adjusted rates ratio 0.48 for Alpha and 0.76 for Delta

Not yet available

Not yet available

Severe disease

Primary 0.5 to <3m: ~70%

Primary 3 to <6m: ~65%

Primary >6m: ~55%

First booster 0.5 to < 3m: ~85%

First booster 3 to < 6m: ~75%

First booster ≥ 6m: ~35%

Second booster 0.5 to < 3m: ~50%

Second booster 3 to < 6m:  ~30%

Symptomatic disease

Primary 0.5 to <3m: ~60%

Primary 3 to <6m: ~25%

Primary >6m: ~15%

First booster 0.5 to <3m: ~65%

First booster 3 to <6m: ~50%

First booster ≥ 6m: ~5%

Second booster 0.5 to < 3m: ~40%

Second booster 3 to < 6m:  ~10%

Any infection

Primary 0.5 to <3m: ~50%

Primary 3 to <6m: ~20%

Primary >6m: ~15%

Booster 0.5 to <3m: ~55%

Booster 3 to <6m: ~30%

Severe disease

Primary 0.5 to <3m: ~65%

Primary 3 to <6m: ~60%

Primary >6m: ~50%

First booster (either with Comirnaty or Spikevax) 0.5 to <3m: ~85%

First booster (either with Comirnaty or Spikevax) 3 to <6m: ~80%

Symptomatic disease

Primary 0.5 to <3m: ~30%

Primary 3 to <6m: <0%

Primary >6m: <0%

First booster (either with Comirnaty or Spikevax) 0.5 to <3m: ~50%

First booster (either with Comirnaty or Spikevax) 3 to <6m: ~25%

Any infection

Primary 0.5 to <3m: ~50%

Primary 3 to <6m: ~50%

Primary >6m: ~0%

First booster (with Comirnaty) 0.5 to <3m: ~45%

Severe disease

Primary 0.5 to <3m: ~60%

Primary 3 to <6m: ~70%

Primary >6m: ~55%

First booster 0.5 to < 3m: ~85%

First booster 3 to < 6m: ~80%

Second booster 0.5 to < 3m: ~80%

Symptomatic disease

Primary 0.5 to <3m: ~55%

Primary 3 to <6m: ~20%

Primary >6m: ~10%

First booster 0.5 to <3m: ~60%

First booster 3 to <6m: ~25%

Second booster 0.5 to <3m: ~65%

Any infection

Primary 0.5 to <3m: ~40%

Primary 3 to <6m: ~30%

Primary >6m: ~15%

First booster 0.5 to <3m: ~65%

First booster 3 to <6m: ~20%

Second booster 0.5 to < 3m: ~60%

Second booster 3 to < 6m:  ~25%

Severe disease

Primary 0.5 to <3m: ~25%

Primary 3 to <6m: ~35%

Primary >6m: ~50%

Booster 0.5 to <3m : ~75%

Symptomatic disease

Primary 0.5 to <3m: ~70%

Booster 0.5 to <3m: ~50%

Any infection

Primary 0.5 to <3m: ~60%

Primary 3 to <6m: ~40%

Primary >6m: ~40%

Direct evidence on efficacy against the Omicron variant is not yet available.

Death

~35%-90% (any mRNA vaccine as a second booster)

Severe disease

~30%-90% (any mRNA vaccine as a second booster)

Symptomatic disease

~30%-90% (any mRNA vaccine as a second booster)

Any infection

~0%-80%

Not yet available

Death

~35%-90% (any mRNA vaccine as a second booster)

Severe disease

~30%-90% (any mRNA vaccine as a second booster)

Symptomatic disease

~30%-90% (any mRNA vaccine as a second booster)

Any infection

~0%-80%

Not yet available.

Safety

Commonly reported adverse events after the dose two include local reaction, fatigue, headache, and muscle or joint pain. They are generally mild and short-lived.

Myocarditis is more commonly reported after the second dose in 12-17 year-old boys (14 cases per 100,000 Comirnaty doses) and men under 30 (9 cases per 100,000 Comirnaty doses).

Pericarditis is reported in about 2 in every 100,000 people who receive an mRNA vaccine.

The rate of reporting of myocarditis and pericarditis is less than 1 in every 100,000 people after a booster (either a third or fourth) dose.

The most common adverse events reported to the TGA following a booster dose are headache, swollen lymph nodes, chest pain, fatigue and muscle pain.

Commonly reported adverse events after the dose two include fatigue, local reaction, headache, and muscle or joint pain. They are generally mild and short-lived.

Thrombocytopenia syndrome (TTS) reported in about 2 in every 100,000 people

Immune thrombocytopenia (ITP) and Guillain-Barre Syndrome (GBS) reported in about one in every 100,000 people

TGA has found no evidence of increased risk by anaphylaxis.

Commonly reported adverse events after the dose two include fatigue, local reaction, headache, and muscle or joint pain. They are generally mild and short-lived.

Myocarditis is more commonly reported after the second dose in 12-17 year-old boys (24 cases per 100,000 Spikevax doses) and men under 30 (23 cases per 100,000 Spikevax doses).

Pericarditis is reported in about 2 in every 100,000 people who receive an mRNA vaccine.

The rate of reporting of myocarditis and pericarditis is less than 1 in every 100,000 people after a booster (either a third or fourth) dose.

The most common adverse events reported to the TGA following a booster dose are headache, swollen lymph nodes, chest pain, fatigue and muscle pain.

Initial assessment determined acceptable safety profile.

WHO estimates that approximately 2 cases per million doses administered globally experience TTS. No TTS cases have been recorded after a second or subsequent dose.

The overall estimated observed to expected rate ratio for presumptive Guillain-Barre Syndrome was 4.18, corresponding to an absolute rate increase of 6.36 per 100 000 person-years.

Commonly reported adverse events after the dose two include local reaction, fatigue, headache, and muscle or joint pain. They are generally mild and short-lived.

Pericarditis is reported in about 13 in every 100,000 doses, most commonly in males aged 18-49 years old. .

Storage

-80°C and -60°C

-20±5°C for up to 2 weeks within the shelf life when stored at -90 to -60°C 2°C to 8°C for unopened thawed vials up to 31 days.^

2°C to 8°C

-25°C and -15°C

2°C to 8°C: Unopened for up to 4.5 months.

2°C to 8°C: Opened up to 6 hours.

Freezer at -25°C to -15°C: Up to 24 months to the expiry date.

Study participants

43,548 enrolled, 43,448 received injections (randomly assigned 1:1 ratio) (1)

596,618 vaccine recipients matched 1:1 ratio to controls. (2)

23 848 enrolled, 11 636 included in interim primary efficacy analysis (randomly assigned 1:1 ratio) (3)

17178 participants included in the efficacy analysis after a further month of data collection from original Lancet article* (4)

30,420 enrolled (randomly assigned 1:1 ratio)

15,187 enrolled, 15,139 underwent randomisation (randomly assigned 1:1 ratio)

14,039 participants met the criteria for the per-protocol efficacy population

Study population

49% female, 35% obese, 21% at least one coexisting condition. Majority White (83%). Median age 52 years; 42% older than 55y (1)

Participants from Clalit Health Services data, which insures 4.7 million patients (53% of the population). (2)

Majority aged 18–55 years (86.7% in UK; 89.9% in Brazil cohort). 60.5% female. Majority White (91.4% in UK; 66.6% in Brazil)

47.3% female, mean age 51.4 years; 24.8% were 65 years of age or older. Majority White (79.2%)

45.0% female, median age 52 years; 33.5% were 60 years of age or older. Majority White (58.7%). Latin America 40.9%; South Africa 15.0%; US 44.1%