Melbourne Childrens Campus Weekly COVID 19 Vaccine Updates 17 June 2021
Melbourne Childrens Campus Weekly COVID 19 Vaccine Updates 17 June 2021
Melbourne Childrens Campus Weekly COVID 19 Vaccine Updates 17 June 2021
Vaccine Updates
Number 14, 17 June 2021
2
Introduction New updates
This document summarises the vaccine efficacy and effectiveness, the vaccine specifications, the Key updates include (also highlighted in yellow text in the document):
vaccine development pipeline and the timeline for World Health Organization (WHO) review of the
various COVID-19 vaccines in late phase development. This document is updated weekly. • Novavax press release on Phase 3 trial results – vaccine efficacy in USA and Mexico
(Pages 4 and 7):
• Vaccine efficacy refers to the performance of a vaccine in a controlled clinical trial (study) o Overall: 90.4% (82.9-94.6)
situation o Moderate-severe disease: 100% (87.0-100)
o High risk groups (comorbidities, age ≥65 years, or frequent COVID-19 exposure: 91.0%
• Vaccine effectiveness refers to the performance of a vaccine in a population under real-world (83.6-95.0)
conditions
• Effectiveness of Johnson & Johnson vaccine against any infection in USA (Page 5):
Key messages o 76.7% (30.3-95.3)
• COVID-19 vaccine efficacy results from different trials cannot be directly compared against • Effectiveness against any infection in Scotland (Page 6):
each other. They must be interpreted in the context of study designs (including case o Pfizer/BioNTech
definitions, clinical endpoints, access to testing), target populations, and COVID-19 § Alpha variant: 92% (90-93)
epidemiologic conditions (including circulation of variants of concern) § Delta variant: 79% (75-82)
• All COVID-19 vaccines in late phase development report high vaccine efficacy against severe o AstraZeneca
COVID-19 and favourable safety profiles § Alpha variant: 73% (66-78)
§ Delta variant: 60% (53-66)
• Pfizer/BioNTech and AstraZeneca both show high vaccine effectiveness in the UK and Israel
where the B.1.1.7 (UK) variant is circulating. Both vaccines have shown they are similarly • Increased risk of hospital admission with the Delta variant compared to the Alpha variant in
Scotland: hazard ratio (HR): 1.85 (1.39-2.47)
effective against transmission in UK. Sinovac has shown high vaccine effectiveness in Chile
where the P1 and B.1.1.7 variants are circulating. Sinopharm has shown high vaccine • Effectiveness against hospitalisation with the Delta variant in England (Page 6):
effectiveness in Bahrain. o After single dose:
§ Pfizer/NBioNTech: 94% (46-99)
• The US FDA, UK MHRA, EU EMA and Health Canada have authorised the Pfizer/BioNTech § AstraZeneca: 71% (51-83)
vaccine for emergency use in adolescents aged 12-15 years1–4 o After 2 doses:
§ Pfizer/BioNTech: 96% (86-99)
• Mixed vaccine schedules (i.e. delivering different types of vaccine for the first and second
§ AstraZeneca: 92% (75-97)
dose) are under investigation as these could facilitate better protection against variants of
concern and enable vaccination programs to continue if a particular vaccine is unavailable. • Effectiveness against asymptomatic infection with weekly testing for a month followed by monthly
testing of a randomly selected sample of UK households (Page 8):
• A very rare clotting disorder with low platelets (Thrombosis with Thrombocytopaenia o Pfizer/BioNTech: 80% (73-85)
Syndrome – TTS) has been associated with the AstraZeneca and Johnson & Johnson o AstraZeneca: 79% (65-88)
vaccines.5–7 The majority of cases fully recover with adequate treatment. The risk following
• Effectiveness of Pfizer/BioNTech vaccine in USA (Pages 5 and 8):
the first dose of AstraZeneca vaccine has been estimated by the EMA as 1 in 100,000 and by
o Symptomatic infection: 84% (75-90)
the Australian Technical Advisory Group on Immunisation (ATAGI) as 1 in 54,000.8,9 Risk of
o Asymptomatic screening: 90% (78-96)
TTS is much lower following the second dose of AstraZeneca vaccine: estimate in the UK is 1
in 769,000 second doses.10 • Effectiveness of Pfizer/BioNTech vaccine against asymptomatic infection in Israel:
o 65% (45-79%)
• The risk of TTS following the first dose of Johnson & Johnson vaccine has been estimated as
• Modelling suggests the Moderna vaccine reduces the potential for transmission by at least 61%
1 in 319,000 in the USA11
(Page 8)
• Appropriate communication on the benefit-risk profile of COVID-19 vaccines (Page 12) • Data from US CDC provides ecological evidence of the contribution of vaccination coverage to
remains crucial to maintain confidence in immunisation programmes and to avoid vaccine reducing COVID-19 outcomes. By 1 May 2021, 82% and 42% of adults aged ≥65 and 18–49 years,
hesitancy respectively, had received at least one dose of vaccine. From before the vaccination program (29
Nov-12 Dec 2020) to late April 2021, the rate ratios among adults aged ≥65 compared to 18–49
years were:
o Infection: 40%
o Emergency visits: 59%
o Hospitalisation: 65%
o Death: 66%
Available
- - - -
Through COVAX
Approval by a
Stringent WHO EUL, EMA, Under review by WHO EUL, EMA, FDA, WHO EUL, Under review by WHO EUL, EMA, FDA,
WHO EUL WHO EUL
Regulatory TGA, MHRA WHO SAGE MHRA EMA, FDA WHO SAGE TGA, MHRA
Authority (SRA)
VACCINE B.1.1.7 (ALPHA) VARIANT B.1.351 (BETA) VARIANT P.1 (GAMMA) VARIANT B.1.617.2 (DELTA) VARIANT
ANY INFECTION SEVERE ANY INFECTION SEVERE ANY INFECTION SEVERE ANY INFECTION SEVERE
70·4% (43·6-84·5)
(vs. 81·5% (67·9-89·4) against wild Effectiveness:
variant in UK)42 Hospitalisation
≥21 days after one dose: in England:
Effectiveness: 10.4% 32.9% (19.3-44.3); 1 dose: 71%
AstraZeneca ≥21 days after one dose: 51.4% - Study underway15 - - ≥14 days after second
(−76.8 to 54.8)45 (51-83);
(47.3-55.2); dose: 59.8% (28.9-77.3)43 2 doses: 92%
≥14 days after two doses: 66.1% Scotland: 60% (53-66)44 (75-97)46
(54.0-75.0)43
Scotland: 73% (66-78)44
Moderate to Moderate to
severe/critical: severe/critical:
Johnson &
- - - 64.0% (41.2-78.7) - 68.1% (48.8-80.7)
Johnson
Severe/critical: Severe/critical:
81.7% (46.2-95.4)15 87.6% (7.8-99.7)15
86.3% (71.3-93.5)
South Africa: 51.0%
Novavax (vs. 96.4% (73.8-99.5) against wild - - - -
(−0.6 to 76.2)47
variant in UK)19
Case-control study in Israel:
Vaccinees infected between 2 weeks
after the first dose and 1 week after
the second dose, were Israel case-control
disproportionally infected with B.1.1.7 study:
Vaccinees infected at Effectiveness: Hospitalisation
(OR: 26:10) 48 ≥21 days after one dose:
least 1 week after the in England:
Effectiveness in Qatar: 89.5% Effectiveness in Qatar: second dose were Effectiveness in 33.2% (8.3-51.4); 1 dose: 94%
Pfizer/BioNTech (85.9-92.3)49 100% disproportionally Qatar: - - ≥14 days after second (46-99);
(81.7-100)49 infected with B.1.351 100% (73.7-100)49 dose: 87.9% (78.2-93.2)43
Effectiveness: 2 doses: 96%
≥21 days after one dose: 49.2% (odds ratio: 8:1)48 Scotland: 79% (75-82)44 (86-99)46
(42.6 to 55.0) Effectiveness in Qatar:
≥14 days after second dose: 93.4% 75.0% (70.5-78.9)49
(90.4-95.5)43
Scotland: 92% (90-93)44
Brazil: vaccine effectiveness 1 or 2
doses: 35.1% (−6.6-60.5)50
Chile: 67% (65-69)*23
Sinovac Chile: 67% (65-69)*23 - - - Brazil: ≥70 years: 41.6% (26.9-53.3); -
70-74 years: 61.8% (34.8-77.7);
75-79 years: 48.9% (23.3-66.0);
≥80 years: 28.0% (0.6-47.9)51
* While it is known P.1. and B.1.1.7 were circulating at the time of the study, the extent is unknown based on available surveillance
Pfizer/BioNTech or
Johnson & Johnson - USA: Trial underway with 12-20 week dose interval80 -
followed by Moderna
AstraZeneca, Canada: Trial underway mixing and matching all three vaccines with
Moderna and - -
study arms assssing 4 week and 16 week dose intervals81
Pfizer/BioNTech
For all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration.
USA: Myocarditis or
myopericarditis in 7 males
aged 14-19 years within 4 days
Adverse of the second dose – all cases
Thrombosis with
events of Myocarditis;89 resolved91
thrombocytopaenia syndrome
special Israel: Myoarditis estimated to TTS (see page 11 for
(TTS) (see page 11 for Immune thrombocytopaenia - -
interest occur in 1 in 3,000 to 1 in 6,000 estimated risk)
estimated risk); (ITP)**90
(AESIs) men aged 16-24 following the
Guillain-Barre syndrome88
second dose – mostly mild and
resolved92
ITP**90
*Details for AstraZeneca, Moderna, Pfizer/BioNTech and Johnson & Johnson from product information sheets in SRA countries, based on data from clinical trials; Sinopharm and
Sinovac details from published clinical trials
**The ITP cases are mostly without the thrombotic events characteristic of TTS
108 SAEs in 12,282 (0.9%) vaccine recipients and 127 in 11,962 (1.1%) placebo recipients
12 thromboembolic events (4 vaccine; 8 placebo)
7 deaths, all considered unrelated to vaccination (2 vaccine, 5 placebo)12
US Phase III study: No serious safety concerns involving 32,449 participants13 (not peer-reviewed)
EMA investigation: possible link between the AstraZeneca vaccine and Thrombosis with Thrombocytopaenia Syndrome (TTS)
Blood clots affected the brain (central venous sinus thrombosis, CVST) and abdomen (splanchnic vein thrombosis)
AstraZeneca There have been reports of 169 cases of CVST and 53 cases of splanchnic vein thrombosis in ~34 million vaccinated people in Europe
The EMA confirmed the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects6
Australia: 20 cases of TTS reported in 1,500,000 people vaccinated93
Several countries have recommended that only older adults should receive the vaccine (including only those aged over 60 years in Germany; over 55 years in
France and Canada; over 50 years in Australia; and over 30 years in the UK94–96
EMA has started a review of reports of capillary leak syndrome following 5 cases of this very rare disorder post vaccination97
45 SAEs in 16,427 (0.3%) vaccine recipients and 23 in 5,435 (0.4%) placebo recipients
Gamaleya All SAEs were considered unrelated to vaccination
4 deaths, all considered unrelated to vaccination (3 vaccine, 1 placebo)14
83 SAEs in 21,895 (0.4%) vaccine recipients and 96 SAEs in 21,888 placebo recipients (0.4%)
19 deaths all considered unrelated to vaccination (3 vaccine, 16 placebo)15
EMA investigation of 8 reports of TTS: possible link between the Johnson & Johnson vaccine and TTS. Most cases occurred in women <60 years of age but
Johnson & Johnson specific risk factors have not been confirmed7
The CDC and FDA have now recommenced the vaccination program in the USA following a thorough safety review98
15 cases of TTS have been reported in 7.98 million people vaccinated in USA5
153 SAEs in 15,166 (1.0%) placebo recipients and 147 in 15,185 (1.0%) vaccine recipients
5 deaths considered unrelated to vaccine (2 vaccine, 3 placebo)16
Moderna
Anaphylaxis reported in the US at a rate of 2.5 per million doses99
No obvious safety signals among pregnant women who received mRNA COVID-19 vaccines in USA100
Novavax SAEs at low levels and similar between vaccine and placebo groups101
SAEs and deaths were low and comparable between vaccine and placebo groups (total 37,586 participants)21
Pfizer/BioNTech Anaphylaxis reported in the US at a rate of 4.7 per million doses99
No obvious safety signals among pregnant women who received mRNA COVID-19 vaccines in USA100
JOHNSON &
ASTRAZENECA MODERNA PFIZER/BIONTECH SINOPHARM SINOVAC
JOHNSON
Yes if high priority Yes if high priority Yes if high priority Yes if high priority Yes if high priority Yes if high priority
Pregnancy group & approved by group & approved by group & approved by group & approved by group & approved by group & approved by
health provider health provider health provider health provider health provider health provider
Immunocompromised
Including HIV
People Previously Yes, although that Yes, although that Yes, although that Yes, although that Yes, although that Yes, although that
Infected by SARS- person may choose to person may choose to person may choose to person may choose to person may choose to person may choose to
CoV-2 delay vaccination by 6 delay vaccination by 6 delay vaccination by 6 delay vaccination by 6 delay vaccination by 6 delay vaccination by 6
(PCR Confirmed) months months months months months months
History of Yes (unless the allergy Yes (unless the allergy Yes (unless the allergy Yes (unless the allergy Yes (unless the allergy Yes (unless the allergy
Anaphylaxis (Severe is to the vaccine or its is to the vaccine or its is to the vaccine or its is to the vaccine or its is to the vaccine or its is to the vaccine or its
Allergy) components) components) components) components) components) components)
DNA 17 8 2 0 0
Vector
18 6 0 0 0
(replicating)
Live-attenuated 2 1 0 0 0
Virus-like particle 20 4 1 0 0
Other/unknown 33 5 0 0 0
*Not all vaccines in use have SRA (as recognised by WHO) approval (see Vaccine specifications table
and WHO SAGE Emergency Use Listing and prequalification timeline for approval status of vaccines).
BNT162b2/COMIRNATY
Pfizer/BioNTech mRNA Final decision made Authorised 31/12/20
Tozinameran (INN)
Serum Institute of India Covishield (ChAdOx1_nCoV19) Adenoviral vector Final decision made Authorised 15/02/21
Johnson & Johnson Ad26.COV2.S Adenoviral vector Final decision made Authorised 12/03/21
CanSinoBIO Ad5-nCoV Adenoviral vector Rolling data assessment starting June 2021 -
Quality checks: Professor Julie Bines, Associate Professor Nigel Crawford and Associate Professor Margie Danchin