By Victoria Kelly-Clark
U.S. COVID-19 vaccine manufacturer Pfizer has faced a grilling in a Senate Estimates hearing in Australia as executives doubled down on the safety of their shot and failed to explain how it causes myocarditis and pericarditis.
On Aug. 3, Pfizer executives appeared before the Education and Employment Legislation Committee, which is investigating the COVID-19 vaccine rollout as part of the Australian Parliamentary inquiry.
Pfizer Australia’s country medical director, Dr. Krishan Thiru, and head of regulatory sciences, Dr. Brian Hewitt, were questioned on whether the mRNA vaccine was unequivocally safe.
They responded by saying therapeutics testing around vaccines was very thorough.
“Based on our clinical trials and pharmacovigilance data as well as real-world evidence following the distribution now and billions of doses of vaccine, we retain strong confidence in the safety profile of the vaccine,” Dr. Thiru said.
However, the Australian Pfizer heads struggled to answer questions (put to them by Senator Gerard Rennick) about what exact biochemical response could lead to vaccine recipients suffering heart damage, including myocarditis and pericarditis.
Instead, Dr. Thiru said that the number of cases of myocarditis remained small globally. He also said that all therapeutic products and vaccines have benefits and side effects.
“Looking at the totality of the evidence for Pfizer’s COVID-19 vaccine, regulatory authorities, health authorities, experts globally, including in Australia within the Department of Health and the TGA, have maintained that the benefit-risk ratio,” Dr. Thiru said.
Vaccine Aimed at Prevention, Not Transmission: Executives
Pfizer officials also could not provide any evidence as to why the company made a public statement on Twitter that implied vaccination could stop transmission of the COVID-19 virus.
Instead, Dr. Thiru told the Senate hearing that the company was only ever asked to provide proof that the vaccine was designed to protect individuals.
“I’m not familiar with the context or the details of those comments. Let me just say that the primary purpose of vaccination, the approved product label, and the regulatory approvals in Australia and around the world were to prevent infection, prevent severe disease and prevent hospitalisation,” said Dr. Thiru.
“That is what our clinical trial program sought to demonstrate. That is what was demonstrated. That was the evidence that was evaluated by regulatory agencies and by health authorities. That was the strong, robust clinical evidence that led to the approvals that were received in Australia and in many other countries.”
They also did not respond when asked why the company had not clarified the issue around the vaccine’s efficacy.
“By September 2022, Australia had recorded 10 million cases of COVID despite having an adult population vaccinated to the tune of 95 percent. Given those real-world figures in Australia, do you still stand by the statement you’ve just said to Senator Canavan that the vaccine was effective in preventing infection?” Senator Rennick asked
“We strongly believe, and we reiterate, that the vaccine is safe and effective for its intended use. What changed was that the virus evolved,” Dr. Thiru said.
“If we look at the clinical data from before the virus mutated into Delta, Omicron, and subsequent variants, the vaccine maintained high levels of efficacy.
“Despite the fact that the virus had evolved, had mutated significantly, vaccination remained significantly effective against severe disease and hospitalisation for prolonged periods.”
Australia Stops Reporting on Myocarditis and Pericarditis Cases
The comments by the Pfizer executive come just three weeks after Australian health authorities announced that reports on myocarditis and pericarditis cases following mRNA-based COVID-19 vaccines by Pfizer and Moderna would no longer be provided.
Australia’s national drug authority says this is because the rates have stabilised.
However, the TGA will “continue to monitor and review these adverse effects and will communicate any updated safety advice if needed,” they said in a statement.
Both myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) are considered side effects of mRNA vaccines manufactured by Pfizer and Moderna, according to the U.S. Food and Drug Administration.
The Centers for Disease Control and Prevention’s independent committee of vaccine experts has also found a link between heart inflammation and the mRNA vaccines after over 1,200 cases were reported in people post-jab.
In Australia, the total number of pericarditis cases resulting from a COVID-19 vaccine is 3,825, with six cases resulting in death, based on data from the Database of Adverse Event Notifications (DAEN) as of Aug. 8.
There have also been 1,334 cases of myocarditis to date, with 17 resulting in death.
Additionally, there have been 139,069 adverse events reported from COVID-19 vaccines, with 997 of those resulting in death in the past three years.