On the 25th of January 2021, the Therapeutic Goods Administration (TGA) granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, for individuals 16 years and older. The Prime Minister Scott Morrison indicated that the vaccine roll out will begin in late February, with the elderly, aged-care workers and health care workers to be amongst the first to receive the jab. The TGA have released the Australian Public Assessment Report and the Australian Product Information for the COVID-19 vaccine following its provisional approval.
The Australian Public Assessment Report states that the “duration of protection is not yet known and is to be assessed in the ongoing trial”. This is one of the many reasons why vaccine development takes 10-12 years on average. Do we need to take the vaccine every year? If someone receives the vaccine, how do we know that the individual is not transmitting the virus a few months later if we don’t know the duration of protection. Will we need to take the vaccine during the flu season? We simply do not have the answers to these very important questions at this stage.
The report continues by outlining that “in addition to the unknown longer term safety and unknown duration of vaccine protection, there are other limitations with the submitted data.” We don’t know how long the vaccine will protect us for, and now we don’t know if the vaccine is safe long term. This is one of the reasons why phase 3 clinical trials are so critical, as they help to determine the long term safety of a vaccine. What will the long term side effects be? Will the vaccine create antibody dependent enhancement (ADE), resulting in an enhanced immune response to the virus? Will the antibodies created by the vaccine attack the spike protein syncytin-1, which can potentially cause infertility in females? Will we develop antibodies to polyethylene glycol (PEG), which may cause an allergic reaction to the vaccine? Will the vaccine create autoimmunity? We cannot answer any of these questions because we have no long term safety data, and the studies have not been conducted.
The Australian Public Assessment Report acknowledges that “the following questions have not yet been addressed:
Although the vaccine efficacies against certain outcomes have been demonstrated in the pivotal study, the real world vaccine effectiveness when this vaccine is rolled out to a larger and more diverse population is not known. The vaccine efficacy in the Aboriginal and Torres Strait Islander population has not been studied.” Aboriginal and Torres Strait Islander people are some of the most vulnerable people in our community. These are the people that we are trying to protect, yet we have no data on how the vaccine may affect this group of people.
We don’t know if the vaccine stops transmission, and we don’t know if it protects asymptomatic people, of which there are many. At this stage, the TGA have advised against giving the vaccine during pregnancy and breast feeding, as well as to children under the age of 16. We also don’t know how the vaccine interacts with other vaccines such as the influenza vaccine, which people will begin to take as we get closer to winter, which coincidentally, will not be that long after the COVID-19 vaccine rollout begins.
The Australian Product Information states that we have no data for “use in frail patients with co-morbidities (for example, COPD, diabetes, chronic neurological disease, cardiovascular disease)” or for “use in patients with autoimmune or inflammatory disorders”. These are two of the more vulnerable demographics, and the very people that we are trying to protect, yet we have no information on how the vaccine will affect these people. Which begs the question… Why have frail patients received the vaccine in other countries if we have no safety data? We have already witnessed the devastating consequences.
The Australian Product Information also states that “neither genotoxicity or carcinogenicity studies were performed. The components of COMIRNATY (lipids and mRNA) are not expected to have genotoxic potential.” Genotoxicity refers to chemical agents that damage the genetic information within a cell causing mutations, which may lead to cancer, whilst carcinogenicity refers to the ability or tendency to produce cancer. Despite the fact that the vaccines are “not expected” to create these issues, one would assume that it would be imperative that we conduct studies in these areas before rolling out a vaccine to the entire population. The consequences could be catastrophic if the vaccine is found to cause these issues.
The Pfizer vaccine is an mRNA vaccine that is new, experimental and rushed to market. It has never been used in humans previously, and it has bypassed critical animal studies. The lack of data is astounding, in particular, the lack of safety and long term data. We don’t know if it stops transmission, if it protects asymptomatic people or how long protection lasts. We have already seen a number of adverse reactions to the Pfizer vaccine in many countries around the world. The potential side effects of this vaccine may be irreversible, which makes it even more important that we rule them out rather than experimenting of the unsuspecting public.