11 November 2021
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Emma Vines
Social Policy
Vaccines are central to Australia’s COVID-19
pandemic response. The Australian, state and territory governments have said that
a high vaccination rate is crucial to avoiding future widespread lockdowns,
with the National
Plan to transition Australia’s National COVID-19 Response providing ‘a graduated
pathway to transition Australia’s COVID-19 response from its current
pre-vaccination settings focused on continued suppression of community
transmission, to post-vaccination settings focused on public health management
of COVID-19 [that] is consistent with other infectious diseases’.
The reopening of international borders has also been
largely based on vaccination rates, with the Therapeutic Goods Administration
(TGA) listing ‘recognised
vaccines’, which are those used internationally, but not currently
registered in Australia. As at 1 November, these vaccines include the
Covishield (AstraZeneca/Serum Institute of India), the Coronavac (Sinovac), the
Covaxin (Bharat Biotech, India) and BBIBP-CorV (Sinopharm, China) vaccines.
Those vaccines whose efficacy is not currently considered to be supported by
sufficient evidence, such as the Sputnik V and Convidecia (Cansino) vaccines,
have not been designated ‘recognised vaccines’ as at 1 November 2021. One
consequence of recognising common vaccines used in countries such as India and
China is the
reopening of borders to international students—a group specifically identified
by the National Cabinet as an important returning cohort once borders
reopen.
Australia has entered into several
separate agreements for COVID-19 vaccines, investing over $8 billion.
This quick guide provides an overview of COVID-19 vaccines
provisionally approved for use in Australia, including the types of vaccines
and the approval process. It also briefly considers the COVAX agreement, a program
designed to ensure equitable vaccine access worldwide.
This guide does not discuss the rollout of the vaccination
program. For information on the number of vaccinations administered in
Australia, see the Department
of Health’s website.
Given that the pandemic continues to unfold, this guide is
up to date as at 11 November 2021. While vaccines often have multiple names and
may have changed over time, this guide uses the names most widely recognised in
Australia at the time of writing.
Disclaimer: This Quick Guide has been prepared to provide information
to support the work of the Australian Parliament. It is for informational
purposes only and is not a substitute for independent professional medical
advice.
(Provisional)
approval process for COVID-19 vaccinations
The TGA is responsible for evaluating and
regulating therapeutic goods, including vaccines. Given the nature of the
pandemic, COVID-19 vaccines have been considered through the provisional
approval pathway process, which allows for temporary registration of
promising new medicines and vaccines where the need for early access is
considered sufficiently important to outweigh the risks.
For a COVID-19 vaccine to be considered for provisional
approval, the vaccine must first be considered for provisional
determination by the TGA. Table 1 provides a summary of the COVID-19
vaccines that have received a provisional determination. Sponsors then have six months to
apply for provisional registration.
Table 1: date of provisional
determinations
|
Effective
date
|
Vaccine
|
Sponsor
|
|
9 October
2020
|
ChAdOx1-S
[recombinant]
|
AstraZeneca
Pty Ltd
|
|
14 October
2020
|
BNT162b2
[mRNA]
|
Pfizer
Australia Pty Ltd
|
|
16 November
2020
|
Ad26.COV2.S
|
Janssen-Cilag
Pty Ltd
|
|
19 January
2021
|
NVX-CoV2373
|
Biocelect Pty
Ltd (on behalf of Novavax Inc.)
|
|
24 June 2021
|
Spikevax
(elasomeran)
|
Moderna Australia
Pty Ltd
|
Source:
Therapeutic Goods Administration, ‘COVID-19 vaccine provisional determinations’, Department of Health, 24 June 2021.
To apply for
provisional approval of its vaccine, the sponsor must submit an application
that includes information on ‘clinical studies, non-clinical/toxicology
studies, chemistry, manufacturing, risk management and other information’.
Table 2 shows the dates of provisional registrations granted to COVID-19
vaccines.
Table 2: date of provisional
registrations and amendments to approved age cohorts
|
Effective
date
|
Sponsor
and vaccine
|
Age modifications
|
|
25 January
2021
|
Pfizer Australia Pty Ltd (BNT162b2)
|
22 July
2021: provisionally approved for individuals aged
12–15 years
27
October 2021: provisionally approved for a third dose for individuals
aged 18 years and over and for severely immunocompromised individuals aged 12
years and over
|
|
15 February 2021
|
AstraZeneca Pty
Ltd (ChAdOx1-S)
|
8
April 2021: Pfizer recommended as preferred vaccine for those aged under
50 years
17
June 2021: Pfizer recommended as preferred vaccine for those aged 16–60
years
|
|
25 June 2021
|
Janssen-Cilag
Pty Ltd(Ad26.COV2.S)
|
Approved for
those 18 years and over
|
|
9 August 2021
|
Moderna Australia
Pty Ltd (Spikevax (elasomeran))
|
3
September 2021: provisionally approved for individuals aged
12–17 years
10
November 2021: granted provisional determination to apply to vary the provisional
approval in relation to administering the vaccine to children aged 6 to 11
years.
|
Source:
Therapeutic Goods Administration, ‘COVID-19 vaccine: Provisional registrations’, Department of Health, 27 October 2021.
The decision
to approve or reject an application is ‘always made by the TGA on the basis
that the benefits outweigh the risks’ and the decision is based on factors such
as:
- the safety, quality and effectiveness of the vaccine has been
satisfactorily established for its intended use
-
the sponsor's plan to submit comprehensive clinical data,
stability data and other information before the provisional registration ends.
Once approved, a vaccine is included in the Australian
Register of Therapeutic Goods (ARTG) and, under provisional registration,
may be lawfully supplied in Australia by the sponsor for a period of two years,
with the possibility of up to two extensions to a maximum of six years overall.
Vaccine agreements
Agreements are in place for the
vaccines approved for use in Australia, shown in Table 3. Of the five, one was
cancelled, with the University of Queensland vaccine not proceeding past Phase
1 trials and consequently not receiving provisional approval.
Secretary of the Department of Health, Brendan Murphy, has explained
the Government’s initial decisions in relation to these agreements as follows:
… at the time
when we made the strategic investment in Pfizer none of the vaccines had proven
phase 3 clinical trial data and no mRNA vaccine had ever been used in humans.
So our scientific and technical advisory group [Science and Industry Technical
Advisory Group (SITAG)] had a strong preference for protein subunit
vaccines, which is why we did University of Queensland and Novavax—50,000-plus
of each—and then a strategic purchase with local production of an adenovirus
vaccine, AstraZeneca, which was the next most proven technology, and a
strategic investment in the as yet unproven Pfizer on the 10 million they
offered us, with an option to increase should it be successful and should we
have issues with other vaccines. All of those options have been exercised.
In relation to the decision to initially invest in Pfizer,
rather than Moderna, Mr Murphy previously
said that SITAG ‘wanted to make a recommendation of an investment of one of
the MRNA [sic] vaccines and, for a variety of reasons, we recommended Pfizer.
They're both very similar vaccines with very similar efficacy; there is not
much difference between them in the published data’. The Government has since announced
an agreement to provide the Moderna COVID-19 vaccine.
Table 3: vaccine agreements
Source:
Department of Health, ‘Australia’s vaccine agreements’, Australian Government, 2 September 2021.
* Cancelled
** Extra doses secured for
booster vaccines to be provided in 2022–23
*** Extra doses secured from
Poland
**** Extra doses secured
through a dose sharing partnership with the United Kingdom
Types of vaccines approved for use
in Australia
Currently, the COVID-19 vaccine
types in use in Australia are messenger RNA (mRNA) vaccines (Pfizer/BioNTech
Comirnaty and Spikevax
(Moderna)) and a viral vector vaccine (AstraZeneca
(now known as Vaxzevria)).
Australia also has an agreement for the Novavax
vaccine, which is a protein subunit vaccine currently
undergoing evaluation by the TGA. Although not currently in use in
Australia, an explanation of this type of vaccine is included below.
The cancelled UQ-CSL v451 COVID-19 vaccine, developed by the
University of Queensland and Australian biotechnology company CSL Limited, was
also a protein subunit vaccine. This vaccine did not proceed past Phase 1
trials as it generated antibodies that
led to ‘false-positive’ HIV test results.
In mid-September 2021 the
Australian Technical Advisory Group on Immunisation (ATAGI) recommended
focusing on maximising COVID-19 vaccine supply for first and second doses for
the community. On 7 October, ATAGI provided updated
advice, recommending a third primary dose for people who are severely
immunocompromised. In conjunction with the TGA’s
provisional approval on 27 October to use the Pfizer vaccine for booster
doses, ATAGI
recommended booster doses of the COVID-19 vaccine for the general
population, noting, however, that the first priority should continue to be very
high vaccination rates of two doses for all eligible people in Australia. As
part of this recent recommendation, ATAGI indicated that people with risk
factors for severe COVID-19 and/or those at occupational risk of COVID-19 should
be prioritised for the initial booster doses. On 28 October, the Prime Minister
announced COVID-19
vaccine boosters would be available for eligible people from 8 November
2021.
mRNA vaccines
mRNA
vaccines contain pieces of genetic material that enable a person’s cells to
start making a viral antigen. In the case of some COVID-19 vaccines, this is to
make a spike protein (S
protein). S proteins are found on the surface of the SARS-CoV-2 virus
(the virus that causes COVID-19) and assist the virus to enter a human cell. Following a
vaccination, the body starts making copies of the S protein, which the
immune system recognises as foreign and against which it produces long-lasting
immune cells and antibodies. The intended result is that when a person is later
exposed to the SARS-CoV-2 virus, the immune system is better prepared to fight
it.
One of the initial challenges with using mRNA vaccines was
the storage requirements, with the Pfizer vaccine requiring storage at -70 °C.
However, the advice regarding short-term storage has changed over time with advice
in May 2021 approving Pfizer’s application to allow unopened, thawed vials
to be kept in a fridge (2–8 °C) for up to one month instead of five days.
Based on current advice, both Pfizer and Moderna require two
doses of the vaccine to be fully effective. Pfizer requires a minimum
of 21 days between the first two doses, while Moderna requires the two
doses to be 28
days apart. A third Pfizer dose has been provisionally approved for use at six
months after the second dose to extend the vaccine’s effectiveness.
Based on advice current at 13 September 2021, both Pfizer
and Moderna
have been approved by the TGA for use in those aged 12 years and over.
Viral vector vaccines
The AstraZeneca vaccine is a viral
vector vaccine. This type
of vaccine uses a different modified virus (the vector) to deliver genetic
instructions to the body’s cells to start making the SARS-CoV-2 S protein. This
then triggers an immune response producing antibodies and immune cells.
While AstraZeneca is the only viral vector vaccine currently
used in Australia’s vaccination program, a second viral vector vaccine is also
provisionally approved for use: the Janssen or Johnson &
Johnson, vaccine. This vaccine has been used overseas and requires only a
single dose. On 13
April 2021, the Minister for Health, Greg Hunt, stated that the Government
had not been advised to purchase additional viral vector vaccines.
AstraZeneca requires two doses. Initially it was advised
that the doses should be 12 weeks apart, but, given the escalating Delta
variant outbreak, some jurisdictions brought this forward to between four and 12
weeks, based on updated
advice.
Advice regarding AstraZeneca and its use in various age
groups has changed over time. Although it is approved
for those aged 18 and over, Pfizer
and Moderna are currently preferred for those under the age of 60. However,
in July 2021 ATAGI
recommended that individuals younger than 60 in outbreak areas who do not
have access to Pfizer, ‘re-assess the benefits to them and their contacts from
being vaccinated with COVID-19 Vaccine AstraZeneca, versus the rare risk of a
serious side effect’.
Protein subunit vaccines
Protein
subunit vaccines introduce purified pieces of the COVID-19 S protein. The Novavax
vaccine uses laboratory-made spike proteins, assembled into nanoparticles
which resemble the structure of SARS-CoV-2 virus. They do not contain any live
components of the virus. Adjuvants (molecules which boost a person’s immune
system) increase the immune response, encouraging protective immunity.
While Novavax is not currently approved for use in Australia
as at 27 October 2021, it is undergoing
evaluation by the TGA. It is expected that should Novavax be provisionally
approved for use, it will require two doses.
Efficacy of vaccines approved for
use in Australia
The TGA has reviewed the efficacy of vaccines approved for
use in Australia and those used overseas and recognised by Australia.
The efficacy of each vaccine approved for use in Australia
against specific outcomes as assessed by the TGA is shown in Table 4.
Table 4: Efficacy of vaccines in preventing infection and
hospitalisation
|
Vaccine
|
Outcome prevented
|
Average vaccine efficacy
|
|
AstraZeneca (Vaxzevria)
|
Symptomatic infection
|
65%
|
|
Severe infection / hospitalisation
|
85%
|
|
Pfizer (Comirnaty)
|
Symptomatic infection
|
81%
|
|
Severe infection / hospitalisation
|
88%
|
|
Moderna (Spikevax)
|
Symptomatic infection
|
86%
|
|
Severe infection / hospitalisation
|
81%
|
|
Janssen (COVID-19 Vaccine Janssen)
|
Symptomatic infection
|
66%
|
|
Severe infection / hospitalisation
|
85%
|
Source: Therapeutic Goods
Administration, ‘COVID-19 vaccines not registered in Australia but in
current international use—TGA advice on “recognition”’, Department of Health, 1 October 2021.
Adverse events
The TGA continues to monitor approved vaccines and publishes
weekly
safety reports that contain information about reported adverse events.
Anyone can report an adverse event by
phone, email or online. Reported adverse events are then searchable through the
Database
of Adverse Event Notifications (DAEN). There are separate databases for
medicines and medical devices. The DAEN is searchable by medicine and includes
information on the organ class affected (for example, nervous system disorder);
the reaction (for example, headache or lethargy); the number of cases reported;
the number of cases with a single suspected medicine involved; and the number
of cases where a death was reported.
The
TGA makes clear that these reports do not necessarily mean the specific
medication or vaccine necessarily caused the adverse event. The most publicised
adverse events have been those related to the AstraZeneca vaccine, which
has been connected to a rare and serious condition known as thrombosis with
thrombocytopenia syndrome (TTS) (blood clots with low platelet levels). The
majority of TTS cases have occurred following the first dose of the vaccine and
the onset
of symptoms is generally between four and 30 days after vaccination and
more common among those aged under 60 years.
As at 5 November 2021, the risk
of TTS is estimated in Australia following
this vaccine is around:
- 2.5 per 100,000 people aged less than 60 years
- 1.8 per 100,000 people aged 60 years and over.
TTS
has also been reported following vaccination with the Johnson & Johnson
COVID-19 vaccine.
COVAX
In September
2020, Australia
joined the COVAX Facility,
which aims to ‘accelerate
the development and manufacture of COVID-19 vaccines, and to guarantee fair
and equitable access for every country in the world’. It is jointly led by
Gavi, the Coalition for Epidemic Preparedness Innovations, UNICEF and the World
Health Organization. COVAX involves over 90 ‘upper-income countries’, including
Australia, and 92 ‘lower-income countries’ and originally aimed to mobilise two
billion doses by the end of 2021. However, revised
estimates are that 1.4 billion doses will have been made available by the
end of 2021, with a total of 2.6 billion doses forecast to have been made
available by the end of March 2022.
Australia has made three financial commitments to the COVAX
Facility, including two investments to the Advanced
Market Commitment (AMC) of the COVAX Facility. These include an investment
in August 2020 of $80
million and a further $50
million to the AMC in June 2021. This
money is intended ‘to improve access for Pacific and Southeast Asian
countries to safe, effective and affordable COVID-19 vaccines’.
Australia also has an agreement to
secure ‘up to 50 per cent [Australian] population coverage through COVAX’.
In June 2021, Minister
Hunt announced that 500,000 Pfizer doses had been secured through COVAX as
part of the Australian Government’s $123.2
million purchase made through the program in September 2020.
However, the distribution of doses to upper-income countries
including Australia has
been questioned by groups such as the Australian Council for International
Development and a
report co-authored by an Expert Advisory Group formed by members of humanitarian
organisations has called on the Australian Government to make further
financial commitments to COVAX.
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