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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 daily 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. It focuses on information related to efficacy, safety and rollout.

 Pfizer/BioNTech BNT162b2Oxford/Astra-Zeneca AZD1222Moderna mRNA-1273 Sputnik V Gam-COVID-Vac

Study

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 Lancet

Type

mRNA (nucleic acid)

Viral vector

mRNA (nucleic acid)

Viral vector

Storage

-80°C and -60°C
Delays in Europe due to transport requirements*^

2°C to 8°C

-25°C and -15°C

-18°C (liquid, used in trial) and 2–8°C (freeze dried, approved by Ministry of Health of the Russian Federation)

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 on variables associated with the probability of both vaccination and infection or severity of COVID-19. (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)

21,977 enrolled, 19,866 included in primary outcome analysis (randomly assigned 3:1 ratio)

Study population

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

Participants from Clalit Health Services data, the largest of four integrated health care organizations in Israel, 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 Caucasian (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 Caucasian (79.2%)

38.8% female, mean age 45.3 years; 10.8% were 60 years of age or older. Majority Caucasian (98.5%)

Efficacy

    

SARS-CoV-2 infection

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

Preprint real-world data from Israel:

For age 60+, 66-83%

For age <60, 76-85%^

In healthcare workers (antibody negative) in England:
21 days after Dose 1: 72%
7 days after Dose 2: 86%

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)

≥12 days after Dose 1: a four-fold decrease in risk among vaccinated UK Health care workers compared to unvaccinated health care workers^

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

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

100%*ⱶ (3)

100%*

100%*

Mortality

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

Single dose 85% effective at preventing mortality in age ≥70 in UK.^

Not yet available

Not yet available

Not yet available

Transmissionⱡ

Prevention of symptomatic and asymptomatic infections in UK health care workers suggests reduced transmission.^

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

Overall cases of any PCR+ were reduced by 67% after a single SD vaccine suggesting the potential for a substantial reduction in transmission.*^ (4)

Not yet available

Not yet available

Safety

Acceptable safety profile

Following early Norwegian investigation on risks for elderly frail after 30 deaths*^, TGA conclude no specific risk for elderly.*^ Reports of anaphylaxis (4.7 cases per 1 million vaccinations).*^

Extremely rare cases of immune thrombocytopenia (<1 case per million), but ‘impossible’ to determine attribution at this time.^

Acceptable safety profile

Some European countries advise against for older people due to lack of data.*^

0.9% in vaccine group reported serious adverse effects. No hospital admissions for COVID-19 after the initial 21-day exclusion period.*(4)

Acceptable safety profile

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

Extremely rare cases of immune thrombocytopenia (<1 case per million), but ‘impossible’ to determine attribution at this time.^

Acceptable safety profile

Single dose protection*

52.4%

A single dose was shown to be immunogenic in 92% of study cohort 21 days post vaccination*^, and for age 60+, a 43% reduction in positive cases between days 14 to 21 of Dose 1.^

The adjusted rate reduction in vaccinated (vs unvaccinated) was: 1–14 days after Dose 1, 30% (47% in symptomatic COVID-19) and  15–28 days after Dose 1, 75% (85% in symptomatic COVID-19)*

Multiple studies show immune response is higher in previously infected individuals.*

73%*^

76% from 22 to 90 days after first dose^ and modelled analysis indicated that protection did not wane during initial 3-month period after first dose*^ (4)

95.2%*

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

Multiple studies show immune response is higher in previously infected hindividuals than in infection naïve individuals.*^

73·6% from 15 to 21 days after first dose*

Extended dosing schedule

Gaps between doses should not exceed 42 days*^

A pre peer-reviewed study showed vaccine was effective from day 11 after single dose; then no detectable increase in efficacy following the second vaccination.^

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

After the second dose, efficacy was higher with a longer prime-boost interval: VE 81.3% at 12+ weeks, compared with VE 55.1% at <6 weeks.*^ (4)

Not yet available

Not yet available

Jurisdictional policy on timing of second doses

UK delaying second dose until 12 weeks after first dose*^

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

Not yet available

Not yet available

Prior COVID-19 infection

Following a single dose, prior infection to SARS-CoV-2 led to a boost response upon vaccination (IgG titres ~one order of magnitude higher than in those without prior infection).

Prior exposure to SARS-CoV-2 demonstrated muted responses to the second dose of the vaccine.*^

Not yet available

Not yet available

Not yet available

Longevity of protection

Not yet available

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

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

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

Impact of new variants on vaccines

Multiple studies show effective at neutralizing B.1.1.7.*^

Reduction in neutralization by approximately two thirds for B.1.351.*^

Reports of vaccine booster to target B.1.351 variant.^

Significant reduction in neutralization by P.2 and P.1 (Brazil and Japan) variants in fully vaccinated individuals.

Preprint data reports as little as 10.4% protection against mild to moderate disease for the B.1.351 variant,*^ while WHO suggests vaccine ability to protect against severe COVID-19.^

Reports of 74.6% efficacy for B.1.1.7.*^

Multiple studies show effective at neutralizing  B.1.1.7 variant.*^

Effective however sixfold reduction in level of neutralising titres to the B.1.351 variant.*^ Preprint data reports a 3.5-fold reduction in neutralizing antibody titers; however most individuals neutralize the SARS-CoV-2 B.1.351 variant suggesting that protective immunity is retained.*

Significant reduction in neutralization by P.2 and P.1 (Brazil and Japan) variants in fully vaccinated individuals.

Not yet available

Authorisation granted in Australia

Yes

Yes

No

No

Number of countries authorisation granted

39 plus EU and WHO^

32 plus EU and WHO^



Rollout halted in South Africa (7 February 2021)^ who are currently evaluating a stepwise rollout, assessing impact on hospitalisation rates in the first 100,000 people.^

13 plus EU^37^

Phase 3 trials reported in the grey literature  / press releases

The following vaccines have had initial results from phase 3 trials reported in the grey literature and press releases. The information will be added to the living table once results are published in the peer reviewed literature.

Novavax NVX-CoV2373
  • Over 15,000 participants in UK phase 3 results
  • Primary endpoint is COVID-19 symptomatic disease
  • The first interim analysis is based on 62 cases and resulted in a point estimate of vaccine efficacy of 89.3%
  • Efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain
  • A pre-peer review South African Phase 2a/b study reported 60.1% overall efficacy; and 51.0% against the South African variant in HIV negative individuals.
Janssen Vaccines (Johnson & Johnson) JNJ-78436735
  • Single dose vaccine
  • 43,783 participants accruing 468 symptomatic cases of COVID-19
  • Primary endpoint is moderate to severe COVID-19
  • 66.1% effective overall against moderate to severe COVID-19 occurring 28 days after vaccination in participants without prior evidence of infection
  • Overall efficacy rate of 72% in the US, 64% in South Africa, and 61% in Latin America
  • 85.4% effective overall against severe or critical disease and demonstrated protection against COVID-19 related hospitalization and death as of day 28
  • Protection across geographies, ages, and multiple virus variants, including the SARS-CoV-2 variant from the B.1.351 Lineage
  • Acceptable safety profile, with no serious adverse effects in participants and similar side effects to other vaccines

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.

* 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

Oxford/Astra-Zeneca has two papers published, (1) and (2).

Background

Evidence check - Emerging evidence about COVID-19 vaccines (PDF)

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 4 Mar 2021

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