The Therapeutic Goods Administration released documents requested under the Freedom of Information process on the 15th of July, 2021.
The 9 documents they provided pertain to the Provisional Approval of the Pfizer Biontech COVID-19 vaccine known as 'Comirnaty'
FOI 2389
The below excerpts were extracted directly from the FOI documents.
All text in italics comes directly from the documents and HAS NOT been modified.
"A very low number of severe case were reported in this study .There was only 1 case in the vaccine group and 4 cases in the placebo group, 7 days post dose 2.
None of the severe cases were baseline positive for SARS-CoV-2. This outcome did not meet the pre-specified success criterion for this endpoint, and no reliable conclusion towards protection against severe Covid-19 disease can be drawn based at the current data."
Safety concerns to be addressed in ongoing and planned pharmacovigilance activities:
Anaphylaxis
Vaccine-associated enhanced disease (VAED) including vaccine-associated enhanced respiratory disease (VAERD)"
Use in patients with co-morbidities, including frail patients with co-morbidities (e.g., chronic obstructive pulmonary disease, diabetes, chronic neurological disease, cardiovascular disorders)
Use in immunocompromised patients, and patients with autoimmune or inflammatory disorders
Use in pregnancy and while breast feeding
Interaction with other vaccines
Long term safety data.or other groups who may respond poorly to vaccines
ACV advice provided to the TGA Delegate
The ACV advised the following in response to the TGA Delegate’s specific requests for advice:
1. Based on the evidence at this point in time, can the ACV advise whether the
benefits-risks balance is positive for the use of Comirnaty COVID-19 vaccine in
individuals 16 years and older in the Australian context to support the
provisional registration?
The ACV advised that the efficacy and safety data were sufficient to support provisional registration of Comirnaty COVID-19 vaccine in individuals 16 years and older in the Australian context.
There is limited or no information regarding patients with autoimmune or inflammatory
disorders, immunocompromised individuals, pregnant women and individuals with a history of anaphylaxis. Clinical guidance will be required to assist individuals with decision making.
3. As the safety follow up is currently limited to a median 2 months post-Dose 2,
can ACV comment on the likelihood of vaccine-related adverse events occurring
after more than 2 months post vaccination, particularly with the new mRNA
vaccine?
The ACV advised that it is unlikely for vaccine-related adverse events to occur more than 2 months after vaccination based on available data. However, there is limited information on the use of mRNA vaccine in humans, which underpins the need for post market vaccine safety surveillance.
Pregnancy, Fertility, Breastfeeding, and an extra Rib?
The ACV noted that pregnant women are not included in any study.
The ACV also noted non-clinical studies do not suggest direct or indirect harmful effects with regard to fertility, embryo-fetal development or post-natal development.
The reports of supernumerary lumbar ribs are of uncertain clinical relevance to humans and may reflect different reporting in historical controls.
Following additional information from the sponsor, the TGA evaluators now agreed with the sponsor’s proposal of Use in Pregnancy Category B1. It was felt there are no significant concerns for the use of this vaccine in breastfeeding women.
COVID-19 Reinfection
Patients who had had COVID-19 previously experienced same or fewer AEs (noting
small numbers).
Power of Clinical Trials
Clinical trials were powered to detect adverse events up to a rate of approximately 1 in 5,000 persons.
The results from the Phase 3 study demonstrated a high protective efficacy in subjects ≥65 years of age (95%, 95% CI: 66.8; 99.9). However, due to small numbers , vaccine efficacy in age group ≥75
years subjects remain uncertain.
A very low number of severe case were reported in this study .There was only 1 case in the vaccine group and 4 cases in the placebo group, 7 days post dose 2.
None of the severe cases were baseline positive for SARS-CoV-2. This outcome did not meet the pre-specified success criterion for this endpoint, and no reliable conclusion towards protection against severe Covid-19 disease can be drawn based at the current data.
Based on information contained within the TGA-provided FOI 2389 documents, the Pfizer Biontech clinical trials and studies DID NOT provide evidence of:
Reduced disease incidence
Reduced disease severity
Reduced disease mortality rates
Reduced disease transmission
Reduced asymptomatic disease incidence and transmission
Reduced disease incidence and mortality in the highest risk group (elderly people aged 75+)
Immunological correlates of protection
Long-term protective immunity
In light of this information...