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]]>Pfizer Australia and BioNTech SE have announced that the Therapeutic Goods Administration (TGA) has approved the companies’ to release a new COVID-19 vaccine in individuals 5 years and older.1
The Omicron XBB sublineages account for the majority of COVID-19 cases globally.2 The 1.5-adapted monovalent COVID-19 vaccine is targeted towards XBB-related COVID-19. Although Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines provide some protection against a range of outcomes from XBB-related COVID-1,3,4 evidence suggests that the vaccine is better matched to currently circulating strains with help to improve protection against symptomatic and severe COVID-19.5
“We welcome the TGA’s decision and commend them for their careful assessment of the latest version of Comirnaty. This decision reaffirms our commitment to bring a high-qualityvaccine against this virus to Australians,” said Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director.
“In 2022, COVID-19 was one of Australia’s leading causes of death, behind heart diseaseand dementia.6 With today’s decision, an updated vaccine will shortly become available that helps address multiple Omicron XBB-related sublineages, which currently account for the vast majority of COVID-19 cases globally.”
“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are that are better matched to relevant circulating virus variants or sublineages to people worldwide,” said Prof. Ugur
Sahin, M.D., CEO and Co-founder of BioNTech. “The new variant-adapted monovalent vaccine aims to further improve protection against severe illness and hospitalisation caused by Omicron XBB descendent sublineages that are antigenically distant from prior Omicron strains.”
The TGA’s decision was based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines.
COVID-19 vaccines are free of charge for Australians and are available in pharmacies and general practices across Australia.
References:
- Australian Government Department of Health and Aged Care. ARTG Public Summary documents
COMIRNATY Omicron XBB.1.5 (raxtozinameran). Available at:tga.gov.au/resources/artg?keywords=XBB+1.5. Accessed October 2023.
- World Health Organization. COVID-19 Weekly Epidemiological Update: Edition 158 published 1 September 2023. Available at: who.int/publications/m/item/weekly-epidemiological-update-on-covid-19—1-september-2023
- Link-Gelles R, Ciesla AA, Roper LE, et al. Early estimates of bivalent mRNA booster dose vaccine
effectiveness in preventing symptomatic SARS-CoV-2 infection attributable to Omicron BA.5– and
XBB/XBB.1.5–related sublineages among immunocompetent adults — Increasing community access to testing program, United States, December 2022–January 2023. MMWR Morb Mortal Wkly
Rep 2023;72:119–124. doi: dx.doi.org/10.15585/mmwr.mm7205e1
- Link-Gelles R, Weber ZA, Reese SE, et al. Estimates of bivalent mRNA vaccine durability in preventing COVID-19–associated hospitalization and critical illness among adults with and without immunocompromising conditions — VISION Network, September 2022–April 2023. MMWR Morb Mortal Wkly Rep 2023;72:579–588. DOI: dx.doi.org/10.15585/mmwr.mm7221a3
- Khoury DS, Docken SS, Subbarao K, Kent SJ, Davenport MP, Cromer D. Predicting the efficacy of variant-modified COVID-19 vaccine boosters. Nature Medicine. 2023 Mar;29(3):574-8. Available at: pubmed.ncbi.nlm.nih.gov/36864253/
- Australian Bureau of Statistics. (2022). Causes of Death, Australia. ABS. abs.gov.au/statistics/health/causes-death/causes-death-australia/latest-release.
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]]>“The first set of results from our Phase 3 Covid-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19,” adds Dr Bourla.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.”
This result is based on the first interim efficacy analysis conducted on 8 November 2020, by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study
Reportedly, the available case count for analysis reached 94 and the DMC performed its analysis on all cases.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate of about 90% at seven days after the second dose, meaning that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule.
So far, the DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.
The Phase 3 clinical trial of BNT162b2 began on 27 July and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of 8 November 2020.
While these results relate to participants without prior evidence of Covid-19 infection, the trial is continuing and will also evaluate the potential for the vaccine candidate to provide protection against Covid-19 in those who had had prior exposure to the virus, as well as vaccine protection against severe Covid-19 disease.
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent Covid-19,” says BioNTech co-founder and CEO, Professor Ugur Sahin.
“When we embarked on this journey 10 months ago, this is what we aspired to achieve.
“Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
A caution check
Although the news of the promising Covid-19 vaccine has generated global excitement today, and while Retail Pharmacy magazine reported that in March 2020 that Pfizer had called on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat Covid-19, as reported by news.com.au earlier today, Dr Norman Swan, host of the ABC’s Radio National Health Report and Coronacast provided a caution check this morning, speaking with ABC News Breakfast.
“I hate to rain on the parade but there are a couple of things we need to be careful of … this is a press release and it is a commercial announcement as much as it is a scientific announcement,” Dr Swan is quoted as saying.
“The other vaccine manufacturers that are at the front have shared the same trial protocol – in other words, they’re doing their randomised trials in the same kind of way, which means they that when they get the results, it will be much easier to compare what they’ve found with each other and find out which is the best vaccine. Pfizer has not been part of that.
“As you can see from the Pfizer results, it doesn’t take very many patients to know that it works. It takes a lot of people to know it’s safe.
“You go too early for an approval and you’re not following people for the wash-out period, for two months or so, to know it’s safe after they’ve had their last dose. Remember, it is a two-dose vaccine,” cautions Dr Swan.
Continuing to accumulate safety data
According to the statement released by Pfizer, Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months safety data following the second dose of the vaccine candidate will be available later this month.
The statement adds that in addition to this, participants in the vaccine trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Retail Pharmacy magazine previously reported that Pfizer Australia and BioNTech SE have an agreement with Australia to supply 10 million doses of their vaccine candidate against Covid-19 in 2021.
Deliveries are planned in 2021 subject to clinical success and local regulatory approval.
More as the story unfolds.
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]]>Pfizer Australia and BioNTech SE have an agreement with Australia to supply 10 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2 in 2021.
Financial details of the Pfizer Australia and BioNTech SE agreement have not been disclosed, but the terms are based on the timing of delivery and the volume of doses.
Deliveries are planned in 2021 subject to clinical success and local regulatory approval.
In addition to engagements with governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organisation (WHO).
The objective is to provide governments, including those in the emerging markets, with early access to a large portfolio of Covid-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers across the world.
In addition, Novavax, a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, has announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the company’s Covid-19 vaccine candidate, NVX-CoV2373, for the Australian community.
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