Provisional determination granted to Pfizer in relation to COVID 19 vaccine, COMIRNATY - for use in individuals 12 years of age and older
The Therapeutic Goods Administration (TGA) has granted provisional determination to Pfizer's COVID-19 vaccine, Comirnaty™ as part of an application process to lower the approved age limit of vaccine administration from 16 years and above, to individuals aged 12 years and above.
Provisional determination is the first step in the provisional registration pathway. The provisional pathway for registration provides a formal and transparent mechanism for speeding up the registration of promising new medicines based on preliminary clinical data. Having provisional determination does not mean that provisional registration will be granted.
To read more follow the link below:
nature: COVID vaccines and kids- five questions as trials begin
With a number of COVID-19 vaccine trials now focusing on paediatric populations across various age groups, specific factors need to be considered.
The following article explores issues such as the consent process for paediatric involvment, the robust immune responses of children, and monitoring for signs of exacerbated immune responses and multisystem inflammatory syndrome in children.
Whilst severe COVID-19 disease in children is rare, the immunisation of children against COVID-19 disease will play an important role in achieving herd immunity.
To read more, please read the article below:
nature: COVID vaccines and kids: five questions as trials begin
NEJM: Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants
The following article, published in the NEJM, assessed the vaccine efficacy of Comirnaty™ (BNT162b2) in Qatar where the predominant circulating strains of SARS-CoV-2 were the UK and South African variants.
By extracting information from the national COVID-19 databases, vaccine effectiveness against the B.1.1.7 (UK) strain was estimated at 89.5%, and 75.0% against the B.1.351 (South African) strain. Vaccine effectiveness against severe disease caused by infection with either variant strain was 97.4%.
For more information on these results refer to the link below:
NEJM: Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants
Australia secures Moderna vaccines
The Australian Government has secured the supply of 25 million doses of the Moderna COVID-19 vaccine. This agreement will allow access to the current Moderna vaccine formulation (10 million doses) as well as variant-specific versions of the vaccine (15 million doses) in order to address the need for long term immunity and emerging SARS-CoV-2 variants.
Clinical trial results have demonstrated that the Moderna vaccine has 100% efficacy against severe COVID-19 disease, as well as a longer term efficacy of of 90% at least 6 months after the 2nd dose. Supply of the vaccine to Australia will begin only if approval has been provided by the Therapeutic Goods Administration (TGA).
Discussions with Moderna are also underway regarding the establishment of manufacturing facilities within Australia to ensure continued vaccine supply.
To read more follow the link below:
Australia secures Moderna vaccines
NEJM: Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant
Novavax have published preliminary phase 2a-b clinical trial results for their COVID-19 vaccine candidate (NVX-CoV2373), assessing vaccine efficacy against SARS-CoV-2 variants (B.1.351- South African strain). This vaccine candidate is a nanoparticle based vaccine containing pieces of the SARS-CoV-2 spike protein.
In this study, participants aged between 18 and 84 years, received either a 2 dose course of the candidate vaccine or a 2 dose course of a placebo (normal saline). Approximately 30% of participants were seropositive for SARS-CoV-2 prior to commencing the trial. Among the seronegative participants, approximately 94% were HIV-negative and 6% were HIV-positive.
A vaccine efficacy of 49.4% was seen among participants who were seronegative at baseline, regardless of HIV status. In the HIV-negative cohort, vaccine efficacy was 60.1%. A history of previous SARS-CoV-2 infection did not reduce the risk of subsequent infection with the new variants of SARS-CoV-2.
To read the article and view these results in full please refer to the below link:
NEJM: Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant
New resource: Australia's COVID-19 vaccine rollout
For easily accessible information relating to the COVID-19 vaccine rollout, the Australian Government Department of Health have created a new resource page. This page will be updated daily and describes the number of vaccine doses administered via the various providers, makes comparisons to international COVID-19 vaccine programs, and provides other sources of useful data.
To view this page please refer to the link below:
Australian Government Department of Health: Australia's COVID-19 vaccine rollout
NEJM: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Whilst there is currently limited safety data on the use of COVID-19 vaccines in pregnancy, immunisation in this patient group is not contraindicated. ATAGI advises that COVID-19 immunisation may be recommended after considering factors such exposure risk and underlying medical conditions.
The following study involving 35,691 pregnant participants who received mRNA COVID-19 vaccines did not show any safety signals regarding pregnancy or neonatal outcomes. Preliminary results showed that injection site pain was reported more commonly amongst pregnant women than non-pregnant women, and headache, myalgia, chills and fever were reported less commonly.
To read more, follow the link below:
NEJM: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
VACSIG Webinar Events: Register to attend
The Vaccination Special Interest Group (VACSIG) will be hosting a webinar on Wednesday 5 May featuring a panel of expert speakers including MVEC's Professor Jim Buttery and A/Prof Nigel Crawford. The topic for the webinar is COVID-19 vaccines and rare side effects - now blood clots/bleeding, what’s next?. This event is open to both ASID members and non-members. Further information and details on registration can be found via the link below:
VACSIG Webinar Wednesday 5 May
ATAGI reinforce recommendations on use of COVID-19 vaccines following review of vaccine safety data and benefits
As of April 23, 2021 a total of 6 cases of thrombosis with thrombocytopenia syndrome have been reported in Australia in people who have received dose 1 of COVID-19 AstraZeneca. Severity of cases have varied including 1 fatal outcome. In all reported cases, symptoms of TTS began 4-26 days after immunisation.
The latest statement from ATAGI reinforces the current advice:
- Comirnaty™ is the prefered COVID-19 vaccine brand for administration in those < 50 years of age. COVID-19 AstraZeneca may be administered in this age group if the benefits of immunisation are deemed to outweigh any risks
- Due to the ongoing potential for a COVID-19 outbreak, as well as an increased risk of severe disease and mortality associated with COVID-19 infection, the benefit of immunisation with COVID-19 AstraZeneca for adults > 50 years of age continues to outweigh the risks associated with the vaccine
- TTS can occur at any age, however current evidence shows that the incidence of TTS is less for older adults than younger adults
- ATAGI continues to recommend that people who received the first dose of COVID-19 AstraZeneca without any serious adverse event (eg. anaphylaxis or TTS) can receive the second dose. Current data suggests that the risk of TTS following receipt of a second dose of COVID-19 AstraZeneca is considerably lower. From more than 2 million second doses administered internationally, there has been 1 case of TTS reported following dose 2 of COVID-19 AstraZeneca (reported in the UK)
To read the statement in full refer to the link below:
TGA: Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
The Therapeutic Goods Administration (TGA) have approved wider storage and transportation conditions for Comirnaty™ (the Pfizer COVID-19 vaccine).
Long-term storage of Comirnaty™ still requires ultra-cold temperatures of -90°C to -60°C. Unopened vials can be stored and transported at domestic freezer temperatures (-25°C to -15°C) for up to 2 weeks. Vials stored or transported at domestic freezer temperatures can be returned to ultra-cold longer term storage within the original shelf life of the product. Unopened vials can be stored for up to 5 days at temperatures of 2°C to 8°C. Once thawed, Comirnaty™ cannot be refrozen.
Once diluted, Comirnaty™ can be stored or transported at room temperatures of up to 30°C for up to 6 hours either in vials or syringes.
The product information contains the most up-to-date storage and transport requirements.
The full TGA statement can be accessed via the link below:
TGA: Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved