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QUESTION ON NOTICE

Question:

21 November 2022

1. Can the Health Department provide studies proving the IgA levels increased in the mucosal system as a result of receiving the Covid vaccine? A Pfizer executive said in a hearing before the European Parliament that no testing was done on the vaccine stopping transmission before going to market. Why did ATAGI and or other health authorities claim the vaccine was going to stop transmission when there were no studies done (as per non-clinical report at least) showing an IgA response? The animal trials in the TGA Non-clinical evaluation reports did not show any testing to measure antibody levels in the mucosal system at all. 2. With over 10 million Covid cases in Australia in 2022, will the TGA and Health Department acknowledge the vaccines were not effective in stopping transmission and infection? 3. In August 2021 when approving the Moderna vaccine, while standing next to the prime minister at Parliament House, John Skerritt made a patently false – and what’s more, a ludicrously false – claim about its effectiveness. It was a claim that has not been withdrawn or ‘clarified’ by the TGA since. It throws into serious question the competence of the TGA and our ability to trust it to provide effective regulation of the vaccines and Covid medications more broadly. These are his exact words, taken from the transcript of the press conference at the PM’s website. “Moderna is even after six months, it’s proving to be 93 per cent efficacious against any infection, 98 per cent against severe disease and 100 per cent against death”. Given the rate of infection, and reported death from the Moderna vaccine with John Skerritt apologise for misleading the Australian public about the effectiveness of the Moderna vaccine?

Answer:

Question Number: 152
PDR Number: SQ22-000521
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 1 IgA levels were not determined in animal studies due to the lack of validated assays. However, extensive studies later demonstrated a strong human IgA response following covid vaccination (available at: https://pubmed.ncbi.nlm.nih.gov/34133415/, https://pubmed.ncbi.nlm.nih.gov/33288661/, https://pubmed.ncbi.nlm.nih.gov/34136730/, https://pubmed.ncbi.nlm.nih.gov/34960244/). The development of Australian Technical Advisory Group on Immunisation’s (ATAGI) advice is based on a thorough review of all the current and emerging evidence on COVID-19 vaccines, including data on effectiveness, waning of immunity, international program settings, national vaccination coverage and operational flexibility where appropriate. The primary goal of the Australian COVID-19 vaccine program is to minimise the risk of severe disease, including hospitalisation and death, from COVID-19. The secondary aims of the COVID-19 vaccination program are preventing infection and preventing transmission of the virus, where possible.

Since the roll out of the vaccines commenced internationally two years ago a number of articles in major medical journals demonstrating the efficacy of COVID-19 vaccines have been published. Examples of reports from the US Centres for Disease Control and Prevention (CDC) include:
• In March 2022, the CDC published Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022 (Tenforde et al, 2022) (available at: www.archive.ph/lMg77#selection-647.0-647.150).
• In July 2022, the CDC published Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated — VISION Network, 10 States, December 2021–June 2022 (Link-Gelles et al, 2022) (available at: www.cdc.gov/mmwr/volumes/71/wr/mm7129e1.htm?s_cid=mm7129e1_w).
• In August 2022, the CDC published Laboratory-Confirmed COVID-19–Associated Hospitalizations Among Adults During SARS-CoV-2 Omicron BA.2 Variant Predominance — COVID-19–Associated Hospitalization Surveillance Network, 14 States, June 20, 2021– May 31, 2022 (Havers et al, 2022) (available at: www.cdc.gov/mmwr/volumes/71/wr/mm7134a3.htm?s_cid=mm7134a3_w).
• In August 2022, the CDC updated information on the Benefits of Getting a COVID-19 vaccine (available at: www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccinebenefits.html. Question 2 Efficacy and transmission effects of the Pfizer COVID-19 vaccine have been addressed in the response to Question 2a in SQ22-000421. The primary goal of the Australian COVID-19 vaccine program is to minimise the risk of severe disease, including hospitalisation and death, from COVID-19. On 25 March 2022 ATAGI noted that while protection against severe disease is relatively well maintained after a first booster dose of COVID-19 vaccine, protection against transmission of the Omicron variant may be limited – available at: www.health.gov.au/news/atagi-statement-on-recommendations-on-a-winter-booster-doseof-covid-19-vaccine.

Question 3 The Department of Health and Aged Care (the department) stands by the comments made by Adjunct Professor Skerritt. They were not patently false or misleading, but were absolutely consistent with the data that was available at that time. The statement will not be withdrawn. These data, which was evaluated by the Therapeutic Goods Administration (TGA), is now published online available at: www.nejm.org/doi/full/10.1056/NEJMoa2035389 which is one of the world’s top three medical journals. A total 30,420 volunteers were enrolled in this pivotal phase III clinical trial conducted to support the safety and efficacy of the Moderna COVID-19 vaccine. Of these, 14,550 participants received the vaccine and 14,598 received a placebo. The data strongly supported the efficacy of the Moderna COVID-19 vaccine:
• 94.1% efficacy at preventing symptomatic SARS-CoV-2 infection as compared with placebo (11 in vaccinated group, 185 in placebo group), and
• 100% efficacy at preventing severe COVID-19 (0 in vaccinated group, 30 in the placebo group) The data from the six-month follow-up (15,209 participants in the vaccinated group, 15,206 in the placebo group) is also available online at: www.ncbi.nlm.nih.gov/pmc/articles/PMC8482810

These data continued to support the initial findings and Adjunct Professor Skerritt’s comments:
• 93.2% efficacy at preventing symptomatic SARS-CoV-2 infection as compared with placebo (55/15,209 in the vaccinated group, 744/15,206 in the placebo group)
• 98% efficacy at preventing severe COVID-19 (2 in vaccinated group, 106 in the placebo group), and
• 100% efficacy against death (0 in the vaccinated group, three in the placebo group). Variants of concerns have changed multiple times since these studies were conducted and provisional approval granted. In the same press conference in August 2021, Adjunct Professor Skerritt acknowledged that further work on the efficacy of the vaccines against variants was being undertaken by Moderna.