Living Evidence - COVID-19 vaccines

Living evidence tables provide high level summaries of key studies and evidence on a particular topic, and links to sources. They are reviewed regularly and updated as new evidence and information is published.

There are four main types of vaccines and over 200 candidate vaccines in development. This table includes information on vaccines that have published phase 3 trial data in the peer reviewed literature and are provisionally approved by the Australian Government Therapeutic Goods Administration (TGA). It focuses on information related to efficacy, safety and rollout.

Daily checks are conducted for new content and any updates that occur during the week are highlighted. All highlights are removed each Monday.

  Comirnaty (Pfizer/BioNTech) BNT162b2Vaxzevria (Oxford/AstraZeneca) AZD1222Spikevax (Moderna) mRNA-1273 Johnson & Johnson Ad26.COV2.S

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

Vaccine type

mRNA (nucleic acid)

Viral vector

mRNA (nucleic acid)

Viral vector

Dosing schedule from phase 3 trial

Two 30µg doses;

Dose interval 21 days

Two doses (5x1010viral particles);

Dose interval 28 days

Two 100µg doses;

Dose interval 28 days

One dose (5x1010 viral particles)

Efficacy - various endpoints

    

SARS-CoV-2 infection

14 to 20 days after Dose 1: 46%*
≥7 days after Dose 2: 92%* (2)

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

At day 71 days: 65.5%*

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%*

Mortality

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

Not yet available

Not yet available

Not yet available

Transmissionⱡ

Not yet available. 

Overall reduction in any PCR+ was 54.1% indicating the potential for a reduction of transmission with a regimen of two SDs.*^ (4)

Not yet available

Not yet available

Effectiveness ('real world' data)

Symptomatic/infection

The CDC reports low rate of new infections vaccinated people (approx. 5800 of 77 million).^

Multiple studies show 73% to 97% effectiveness 7 days after Dose 2 (general population and healthcare workers).

0.35% to 0.46% of fully vaccinated people had breakthrough infections.

VE for infection: 18-49yr: Up to 93.6%. 50-64yr: Up to 95.3%. >65yr: Up to 91.9%.

Asymptomatic

Multiple studies show 90% to 92% effectiveness 7 days after Dose 2.

Hospitalisation

Multiple studies show 71% to 97% effectiveness.^

At the 15–21 day period after the second dose, VE is 98.6% for severe/critical disease. As low as 0.09% of vaccinated people are hospitalised.

VE for hospitalisation: 18-49yr: up to 96.4%. 50-64yr: Up to 95.8%. >65yr: Up to 95%.

Mortality

Multiple studies show 85% to 98.7% effectiveness.^ mRNA vaccines 64.2% effective for partially vaccinated individuals.^

At the 15–21 day period after the second dose, VE is 97.7% for deaths.

Transmission

Effectiveness against transmission has been shown to be up to 88.5%.

Risk of household transmission 49% lower if index cases vaccinated ≥21 days prior to testing positive (compared to no vaccination).^

Effectiveness of two doses against transmission of Delta was 31%.

Symptomatic/infection

Multiple studies show reduced infections, 65% to 74% after dose 1 and from 93% reduction up to no symptomatic infection in healthcare workers after dose 2.

In general population, 96.1% antibody responses after dose 1 and 98.8% after dose 2 .^

Hospitalisation

Multiple studies show effectiveness ranging from 73% to 95%.*^

As low as 0.09% of vaccinated people are hospitalised.

Transmission

Vaccination of health care workers was associated with a substantial reduction of cases in household contacts.^

Risk of household transmission 38% lower if index cases vaccinated ≥21 days prior to testing positive (compared to no vaccination).^

Effectiveness of two doses against household transmission of Delta was 42%

Mortality

Up to 97.9% effective at preventing deaths among 20-39 year olds.

Symptomatic/infection

The CDC reports low rate of new infections vaccinated people (approx.. 5800 of 77 million).^

In general population, efficacy range from 78.3% to 96.9% after 2 doses.^

In healthcare workers, the incidence of infection was 0.7% after 1 dose and 0% after 2 doses, and vaccine effectiveness was 38.2% at 14d after 1 dose and 100% after 2 doses.

VE for infection: 18-49yr: Up to 96.5%. 50-64yr: Up to 97.4%. >65yr: Up to 96.2%.

Asymptomatic

Significantly reduced risk in vaccinated adults.*

63% to 84% effectiveness from 14 days onward.

Hospitalisation

Significantly lower 14-day hospital admission rates than unvaccinated individuals.^ mRNA vaccines are 91% to 96% effective at preventing hospitalisation; 77% for partially vaccinated individuals.^

Effectiveness against any severe, critical or fatal COVID-19 disease due to any SARS-CoV-2 infection was 95.7% after the second dose,  and up to 98.2%.

As low as 0.05% of vaccinated people are hospitalised.

VE for hospitalisation: 18-49yr: Up to 97.5%. 50-64yr: Up to 97/3% >65yr: Up to 97.2%.

Mortality

mRNA vaccines 98.7% effective at preventing deaths; 64.2% effective for partially vaccinated individuals.^

Symptomatic/Infection

Between 74% to 86.6% effectiveness against infection >14 days after vaccination*^

VE for infection: 18-49yr: Up to 89.4%. 50-64%: Up to 86.4%. >65yr: Up to 81.7%.

Hospitalisation

Effectiveness from 68% to 71%.

VE against ED visits is 73%.

Adjusted effectiveness against clinical outcomes was 72.9% for hospitalization, 92.5% for ICU admission, and 88.7% for mechanical ventilation.

VE for hospitalisation: 18-49yr: Up to 95.9%. 50-64%: Up to 92.8%. >65yr: Up to 85.5%.

Mortality

Adjusted effectiveness against clinical outcomes was 90.5% for death.

Safety

Initial assessment determined acceptable safety profile.

Reports of anaphylaxis (4.7 cases per 1 million vaccinations).*^

Extremely rare cases of immune thrombocytopenia (<1 case per million) in USA and 33 per 1 million in Europe. Rare reports of cerebral venous sinus thrombosis (CVST)^ and cerebral venous thrombosis. Risk of cerebral blood clots from COVID-19 is 10 times that from vaccination.

An estimated one myocarditis events per 1 million people.

Post-vaccination cardiac adverse events rates following dose two is 162.2 and 94.0/million for boys aged 12-15 and 16-17, respectively.

Standardised incidence ratios for VTE have been reported to be at 1.29 and 0.90 after first- and second-doses.^

No association was found between vaccination, Bell's palsy, herpes-zoster or GBS.

Regulatory advice

TGA and CDC continue to monitor events. TGA safety data consistent with known side effects.

In Australia to 12th December 2021, TGA have received 826 reports of suspected myocarditis and 1771 reports of suspected pericarditis, out of 25.3 million doses administered. ^

Initial assessment determined acceptable safety profile.

Standardised incidence ratios for VTE has been reported to be at 1.15 after first dose.^

An estimated two myocarditis events per 1 million people.

Regulatory advice

TGA and CDC continue to monitor events. TGA safety data consistent with known side effects.

TGA has found no evidence of increased risk by anaphylaxis. To 12th December 2021, the TGA has received 154 reports of suspected Guillan-Barre Syndrome and 89 reports of suspected Immune thrombocytopenia in people who have received the vaccine.^

In Australia, the total number of cases of thrombosis with thrombocytopenia syndrome (TTS) is 170 from 13.6 million doses of vaccine administered to date.

Eight deaths from TTS and one death from immune thrombocytopenia have been reported out of 13.6 million doses of vaccine.

Initial assessment determined acceptable safety profile.

Reports of anaphylaxis (2.5 cases per 1 million vaccinations).*^

Extremely rare cases of immune thrombocytopenia (<1 case per million).^ Rare reports of cerebral venous sinus thrombosis (CVST); no significant link with vaccine.^ Risk of cerebral blood clots from COVID-19 is 10 times that from vaccination.^

Myocarditis/myopericarditis accounted for 0.4% of adverse events reported to the Moderna global safety database to 30th September 2021.

An estimated six myocarditis events per 1 million people.

Regulatory advice

Case reports of adverse events published throughout literature. CDC continue to monitor events. TGA safety data consistent with known side effects.

To 12th December 2021, approximately 1.3 million doses have been given. The TGA have received 65 reports of suspected myocarditis and 100 reports of suspected pericarditis.

Initial assessment determined acceptable safety profile.

Six possible cases of CVST. EMA investigation reports that unusual blood clots are a “very rare side effect” of the vaccine and confirms positive overall benefit-risk. CDC concludes that benefits of resuming vaccination outweighs risks.^ WHO concludes the causal relationship of TTS is considered plausible, but the risk is very low (<1 in 100 000 people vaccinated).^

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.

Regulatory advice

Case reports of adverse events published throughout literature. CDC continue to monitor events. TGA safety data consistent with known side effects.

Specific populations

Children

Aged 12-15: 100% efficacy and robust antibody responses

Aged 5-11: two 10-μg doses administered 21 days apart was found to be safe, immunogenic, and efficacious.

TGA approved for use in individuals 12 years and older.

TGA has provisionally approved use in individuals 5 years and over.

Immunocompromised people

Multiple studies of effectiveness with few serious adverse events.^*

Compared to healthy controls, multiple studies show weaker antibody and humoral response and higher rate of infection after single and double doses.*

Breakthrough infections are 3 times higher in vaccinated immunocompromised people compared to vaccinated non-immunocompromised people, with 13% of infected immunocompromised people being hospitalised.

Antibody response to the vaccine is variable among different immunocompromised patients.

Pregnant and lactating women

Multiple studies suggest similar immune response in vaccinated pregnant and lactating women compared to vaccinated non-pregnant women, with effectiveness up to 97%.

No obvious safety signals in pregnancy or neonatal outcomes, especially in women vaccinated during third trimester* No significant differences in side effects when receiving vaccine during any trimester.

No detectable levels of vaccine mRNA in breastmilk.* However, breast milk contained specific anti–SARS-CoV-2 IgG(S1) antibodies.

Infants who consumed post-vaccination human milk had no reported adverse effects.

Older adults

Vaccination elicited relatively lower antibody levels in older adults vs younger adults.

Aged >70: 61% effective against symptomatic infection after 28-34 days; 43% effective for reducing hospital admission and 51% at preventing deaths after dose 1. Delayed and reduced antibody response compared to healthy HCWs.

80-91% reduction in infection, hospitalisations and mortality among nursing home residents for up to five months.

With full vaccination, pre-Delta period adjusted VE was 74.2%. Delta period adjusted VE is 52.4%.

Aged >80: 71.4% effective at reducing hospitalisation.

Children

Aged 6-17: trial underway^

Immunocompromised people

Weaker antibody response compared to non-immunocompromised individuals, especially after single dose.*

Pregnant and lactating women

No evidence of an association between reduced fertility and vaccination. Rate of miscarriage was no higher than in controls.

Older adults

Effectiveness of the two-dose schedule was 77% against Covid-19 (Gamma variant), 87% against hospitalization, and 93% against death.

83.5% efficacy for those aged over 65 years.

Aged >70: 60%-73% effective against symptomatic infection after 28 days; 37% effective for reducing hospital admission after dose 1.

Aged >80: About 80% effective at preventing hospitalisation after dose 1. 91.2% efficacy against death.^

Rate of 10.8 hospitalisation or death events per 1000 person-years.

Aged care residents

Multiple studies showed single dose led to protection against asymptomatic infection for up to 7 weeks.^

Children

Aged 6months to 12 years: trial underway^

Provisional determination granted for proposed use in children (6-11yrs)

Adolescents

No serious adverse events and no cases of infection with an onset of 14 days after the second injection.

Provisional TGA approval for use in 12-17 years age group.

Immunocompromised people

Weaker antibody response compared to healthy controls^

Multiple studies show increased antibody titers in solid transplant patients after 3rd dose of either Pfizer/Moderna/Janssen.*

Pregnant and lactating women

Similar immune response in vaccinated pregnant and lactating women compared to vaccinated non-pregnant women.

No obvious safety signals in pregnancy or neonatal outcomes, especially in women vaccinated during third trimester*

Maternal antibody production 5 days after dose 1, transplacental transfer of immunity to neonate 16 days after dose 1.*

Older adults

Aged ≥65: 86.4%-100% effective against infection after 2 doses.^

With full vaccination, pre-Delta period adjusted VE was 74.7%. Delta period adjusted VE is 50.6%.

Aged care residents

There is no difference in post-boost antibody levels in older adults vs younger adults.

Lower incidence of infections, symptomatic illness, hospitalisations, and death following vaccination* Report of few breakthrough infections after dose 1 in full vaccinated individuals, most with asymptomatic illness.*

Immunocompromised people

Breakthrough infection ranges from 0.8%-1.4% among solid transplant recipients.

People with rheumatic and muscular disease had a lower rate of seroconversion. One in five people did not mount a detectable antibody response.

Older adults

Aged>=65: 76.5% effective against moderate to severe COVID-19 disease.

Single dose protection*

52.4%

Reduction in positive cases range from 30%, to 84%

VE for the 14–20 day period after the first dose is 54.3% for infection and 77.3% for severe/critical disease.

77.6% VE for infection.

VE against hospitalisation for partial vaccination (dose 1) is 33%.

VE against ICU admission for partial vaccination (dose 1) is 56%.

VE against ED visits for partial vaccination (dose 1) is 58%.

Children: VE against symptomatic disease increased to 80% within two weeks of the first dose and then declines to 40% within 8 weeks.^

73%*^

Reduction in positive cases range from 49% to 86.2%.

93.4% of previously naïve individuals seroconverted after a single dose.

VE against symptomatic COVID-19 (Gamma and Delta variants) after 21 days of one dose was 42.4%.

VE against hospitalization was 96%.

Virus specific antibodies were maintained at ≥16 weeks after receiving a single dose.

95.2%*

Single dose may be insufficient to neutralise B.1.351 variant in previously uninfected individuals.^

Reduction in positive cases ranging from 38.2% to 85.7%.

88.9% VE for infection.

VE against hospitalization was 68% up to 85%.

VE against ED visits is 73%.

One-dose VE against Delta infection is 77%.

See efficacy above (dosing schedule is single dose)

Dosing schedule

Gaps between doses should not exceed 42 days*^

Higher two-dose efficacy was observed with >6 week intervals, including in ≥80 year-olds. Increase in neutralizing antibody activity was observed with  9 to 12 weeks interval.

Antibody levels 14–35 days after dose two are higher with an extended vaccine interval (65–84 days) compared with those vaccinated with a standard (19–29 days) interval.

A third dose provided additional protection against detected infection and severe disease, particularly in immunocompromised people. In this population, a longer time interval between the second and the third dose gave a better response to the third dose.

Across all age groups, rates of confirmed infection and severe illness are substantially lower among those who received a booster dose.

VE >7 days after the third dose was estimated to be 93% for admission to hospital, 92% for severe disease, and 81% for COVID-19-related death.

A third dose in adults aged 60 years and older was associated with significantly increased IgG titers after 10 to 19 days, with no major adverse events.

Vaxzevria, Comirnaty, Spikevax, Novavax, Ad26.COV2.5, and CureVac as a third dose all boosted immunity after a full dose of Comirnaty.

Participants who received a booster at least 5 months after a second dose had 90% lower mortality due to COVID-19 than participants who did not receive a booster.

Heterologous vaccination

Comirnaty and Vaxzevria at 28-day intervals: 41% mild systemic reactogenicity as opposed to 21% with two Comirnaty doses.

Multiple studies show Comirnaty given as a second dose in individuals already given Vaxzevria  is safe, induced a robust immune response, and an acceptable reactogenicity profile, including at a 10–12-week interval. The antibody response is comparable to homologous vaccination.

Robust inhibition of variants including the delta variant following heterologous boosting.

53.4% at <6-week interval between doses and 65.4% at ≥6-week interval (3)

81.3% at 12+ weeks (4)

With an 8 to 12 week interval between doses, antibody responses are 1.4 times higher.

Extending the interval between the first and second dose to 45 weeks resulted in higher antibody titres.

In recipients aged ≥80 years, two-dose VE after 14 days was 96% following a 45–64 day interval and 82% following a 65–84 day intervals.

A third dose induces antibodies to a level that correlates with high efficacy.

Vaxzevria, Comirnaty, Spikevax, Novavax, Ad26.COV2.5, CureVac, and Valneva as a third dose all boosted immunity after a full dose of Vaxzevria.

Heterologous vaccination

Multiple studies show there is a higher immunogenicity of an Vaxzevria/Comirnaty heterologous schedule compared with an Vaxzevria-only schedule. A 10–12-week interval is well tolerated and improves immunogenicity.

Reduction in the risk of infection 14 days after the second dose of Vaxzevria plus an mRNA vaccine, with effectiveness at 88%.

Robust inhibition of variants including the delta variant following heterologous boosting.

A booster shot given 6 months after the 2-dose vaccination shows increased neutralization titers.

VE of a third dose was 46.0% SARS-CoV-2 infection and 44.7% for COVID-19 hospitalization.

Booster shot for adults has been approved by the TGA.

Heterologous vaccination

Spikevax can efficiently stimulate specific B-cell memory that has been generated by a prime dose of Vaxzevria vaccine 9 to 12 weeks earlier and may provide better protection against the B.1.351 variant than a Vaxzevria boost.

Having a dose of the Spikevax after an initial Vaxzevria or Comirnaty dose induced a higher binding and neutralising antibody response than seen after two doses of either Vaxzevria or Comirnaty.

A booster vaccination resulted in an increase in SARS-CoV-2-specific binding antibodies, neutralizing antibodies and T-cell responses when compared to single vaccination (full vaccination schedule).

Heterologous vaccination

In comparison with the homologous boost, a heterologous regimen with mRNA-based vaccines showed a significantly larger increase. Spikevax boosting was the most immunogenic, associated with higher reactogenicity.

Jurisdictional policy on dosing schedule

UK delaying second dose until 12 weeks after first dose*^ Priority groups can have second dose 8 weeks after second dose.

Canada’s NACI recommends that a mRNA vaccine (Comirnaty, Spikevax) is preferred as the second dose for individuals who received a first dose of the Vaxzevria vaccine.

Heterologous Vaxzevria-Comirnaty immunisation with 10–12-week interval, recommended in Germany.

UK has recommended that people with severely weakened immune systems should have a third dose.

Australia’s ATAGI recommend an interval between 4 and 8 weeks in outbreak situations.

Planned roll-out in the UK is administration of two doses, 8-12 weeks apart*^ (4)

Canada’s NACI recommends that an mRNA COVID-19 vaccine is now preferred as the second dose for individuals who received a first dose of the Vaxzevria vaccine.^

Canada’s NACI recommends that a mRNA vaccine (Comirnaty, Moderna) is preferred to start a vaccine series and as the second dose for individuals who received a first dose of the Vaxzevria vaccine.^

UK has recommended that people with severely weakened immune systems should have a third dose.

Not applicable

Prior COVID-19 infection

Most studies report prior infection enhances neutralising antibody response, including following a single dose and at 2-3 weeks after second dose. One study found no difference between previously infected and not infected individuals who were vaccinated.

Multiple studies indicate a greater humoral response than uninfected individuals after a second dose.

Humoral immune response after vaccine doses in individuals infected >6 months prior was shown to be at least similar to those recently infected.

Incidence rates of infection among vaccinated persons with prior infection was estimated at 1.66 per 10,000 person-weeks.

Vaccinated infection-naïve people had a 5.96-fold increased risk for breakthrough infection, a 7.13-fold increased risk for symptomatic disease and were at a greater risk for hospitalizations compared to those that were previously infected.

Elderly populations can mount a strong antibody response upon receiving a single dose 15 months after recovery from COVID-19.

There is limited data on efficacy and effectiveness of vaccination to prevent infection specific to those with prior infection, and no information on the effectiveness of the vaccine to prevent re-infection.

Incidence rates of infection among vaccinated persons, with and without prior infection, were estimated at 1.55 and 1.83 per 10,000 person-weeks.

Following primary vaccination, individuals with pre-existing immunity showed higher induction of all antibodies but IgG3. However, COVID-19 recovered subjects did not mount a recall antibody response upon the second vaccine dose.

Not yet available

Longevity of protection and waning immunity

Decline in humoral response six months after receipt of the second dose of the Comirnaty vaccine. However, protection against hospitalization and death persisted at a robust level for six months after the second dose.

87% of immunocompromised adults had adequate antibody titres 1.5 months after the second dose, but only 41% maintained adequate antibody titres three months after vaccination.

Effectiveness against infections declined from 88% during the first month after full vaccination to 47% after 5 months.

VE against Delta was 93% in the first month but declined to 53% after 4 months.

VE against hospital admissions for infections with Delta was 93% for up to 6 months.

VE to reduce infection drops to 70.1% after 7 months; VE to reduce hospitalisation and death stays above 87% through 7 months.^

VE against any PCR-confirmed infection declined from 87% at 0-2 months after the second dose to 53% at 7-8 months.

Breakthrough infections in fully vaccinated individuals have lower viral loads, however this effect ultimately vanishes after 6 months but is restored after a booster dose.

To date, there is no evidence on the effect of waning vaccine immunity and its relationship to onward transmission.

Provision approval as a booster dose for individuals 18 years and older.

Generally, adenoviruses are highly immunogenic, driving long-lasting immune responses*^

Virus specific antibodies were maintained at ≥16 weeks after receiving a single dose.

Effectiveness against symptomatic disease after second dose is 47% by 20+ weeks against the Delta variant. Protection against hospitalisation is 77% effectiveness by 20+ weeks. Effectiveness against deaths was 79% by 20+ weeks for all ages.

VE against any PCR-confirmed infection declined from 83% at 0-2 months after the second dose to 55% at 7-8 months.

Likely to offer protection for a “couple of years”, as antibody decay is very slow.*^

In one study antibodies persisted through 6 months after the second dose. While another found at 6 months, a sharper decline in antibody levels is observed in naïve vaccinees compared to previously infected people.

Effectiveness against symptomatic disease after second dose is 90-96% at 10-14 weeks.

VE to reduce infection drops to 81.9% after 7 months; VE to reduce hospitalisation and death stays above 90% through 7 months.

VE against any PCR-confirmed infection declined from 90% at 0-2 months after the second dose to 65% at 7-8 months.

To date, there is no evidence on the effect of waning vaccine immunity and its relationship to onward transmission.

Booster shot for adults under evaluation by TGA.

Generally, adenoviruses are highly immunogenic, driving long-lasting immune responses*^

Elicits durable humoral and cellular immune responses with minimal decreases for at least 8 months after immunization.

VE to reduce infection drops to 64.3% after 5 months; VE to reduce hospitalisation and death stays above 80% through 5 months.

Impact of new variants on vaccines

Alpha: Estimated effectiveness up to 94.5%.^

Beta: Estimated 5 to <10-fold reduction in neutralisation. Estimated effectiveness from 72% up to 100%.^

Gamma: Estimated 5 to <5-fold reduction in neutralisation. Estimated effectiveness up to 84%.^

Delta: Estimated 5 to <10-fold reduction in neutralisation.^ Estimated effectiveness ranges from 50% to 92%.^
Vaccine effectiveness in adolescents is 91.5% against infection.
VE against death 90%

Omicron:  A 20- to 40-fold reduction in neutralising activity by two doses of Comirnaty compared with other strains^

booster dose of Comirnaty resulted in an increase in neutralising activity irrespective of primary vaccination type (approximately 71% for
those who received Vaxzevria as the primary course and approximately 76% for those who received Comirnaty)^

Two doses of Comirnaty offers 70% protection against hospitalisation.^

Alpha: Estimated 5 to <10-fold reduction in neutralisation.^ Estimated effectiveness up to 74.6%

Beta: Estimated 5 to <10-fold reduction in neutralisation.^ As little as 10.4% protection against mild to moderate disease, up to 48% effective against symptomatic disease.^

Gamma: Estimated 2 to <5-fold reduction in neutralisation.^ VE of 64%. Starting 14 days after the second dose, effectiveness is 77.9% against infection, 87.6% against hospitalization, and 93.6% against death.

Delta: Estimated 2 to <5-fold reduction in neutralisation.^ Estimated effectiveness from 64% to 91%. Effectiveness after one dose was notably lower compared with the alpha variant.
Estimated effectiveness against death 91%.

VE against SARS-CoV-2 infection of 63·1%. VE of vaccination against moderate-to-severe disease of 81·5%.

Omicron: Preliminary studies suggest reduced effectiveness against symptomatic disease at 15 weeks after the second dose*^, however, a booster dose of Comirnaty resulted in an increase in neutralising activity irrespective of primary vaccination type (~71% for those who received Vaxzevria)*^

Alpha: Estimated <2-fold reduction in neutralisation.^ Estimated effectiveness up to100%.

Beta: Estimated 5 to <10-fold reduction in neutralisation.^ Estimated effectiveness up to 96.4%.

Gamma: Estimated 2 to <5-fold reduction in neutralisation.^ Estimated effectiveness up to 77%.^

Delta: Estimated 2 to <5-fold reduction in neutralisation.^ Estimated effectiveness from 56.6% to 86.7%.^

Omicron: Preliminary studies suggest low-absent neutralisation; however, a booster mRNA may reduce risk of symptomatic breakthrough infections and prevent hospitalisation*^

Alpha: Estimated 2 to <5-fold reduction in neutralisation.^

Beta: Estimated ≥10-fold reduction in neutralisation.^ Estimated effectiveness up to 85%.

Gamma: Estimated 2 to <5-fold reduction in neutralisation.^

Delta: Estimated <2-fold reduction in neutralisation.^

Overall VE against hospitalisation for fully vaccinated = 91%.

Omicron: Neutralisation capacity against Omicron was maintained best against sera from individuals infected and vaccinated or vaccinated and infected*^

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)

44,325 enrolled, 43,783 received vaccine or placebo (randomly assigned 1:1 ratio)

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%

Number of jurisdictions authorisation granted

70 plus EU and WHO^

110 plus EU and WHO^

43 plus EU and WHO^ 41 plus EU and WHO^

Phase 3 trials reported in the grey literature  / press releases

Vaccines which have had initial results from phase 3 trials reported in the grey literature and press releases will be reported here. The information will be added to the living table once results are published in the peer reviewed literature. Recent phase 1 and 2 trial results have been included below, however this is not a complete list of early trial data.

The TGA recognise the following vaccines for the purpose of travel to Australia:

  • Coronavac (Sinovac)
  • Covidshield (AstraZeneca - Serum Institute of India)
  • BBIBP-CorV for people aged 18 - 60 years of age (Sinopharm China)
  • Covaxin (Bharat Biotech).

Notes

Table includes COVID-19 vaccines published as a peer-reviewed phase 3 trial (preliminary or final results). Data is included on these vaccines from additional publications. Studies that capture outcomes in real world settings are tabulated under effectiveness.

* Preliminary data, not fully established, in some cases small numbers or short follow up, or based on previous data; interpret with caution.

^ Commentary, grey literature, pre peer review or news.

ꝉ Asymptomatic/unreported symptoms. Efficacy estimated by study by pooling all cases and applying to entire cohort of sub studies; interpret with caution.

ⱡ Onward transmission in a vaccinated individual.

ⱶThis figure was not reported in the paper but was included on the same basis of the Moderna results for severe COVID-19.

LD/SD = low dose/standard dose and SD/SD = standard dose

Pfizer has two phase 3 trials published (1) and (2), as does Oxford/Astra-Zeneca (3) and (4) and Sinovac (5) and (6).

Modelling studies estimating real world effectiveness are not included in the table.

Where multiple studies are available on an outcome, not all studies are hyperlinked. Those that are more recent, published in peer reviewed journals and are higher on the evidence hierarchy are generally linked.

Background

Living evidence tables include some links to low quality sources and an assessment of the original source has not been undertaken. Sources are monitored daily but due to rapidly emerging information, tables may not always reflect the most current evidence. The tables are not peer reviewed, and inclusion does not imply official recommendation nor endorsement of NSW Health.

Last updated on 19 Jan 2022

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