Stronger evidence should have underpinned the booster rollout than for the original Pfizer doses, given a clear shift in the risk-benefit ratio, yet the opposite holds, says economics professor John Gibson.
A new study by University of Waikato economist John Gibson shows a close relationship between the Pfizer vaccine booster rollout and rising excess mortality, a correlation that was not seen with the rollout of the first two doses.
Gibson’s paper suggests 400 excess deaths from the booster rollout in New Zealand, or 16 excess deaths for every 100,000 doses given. The age groups most likely to be boosted had seven-to-10 percentage point rises in excess mortality rates. The age group too young for boosters saw no such rise in excess mortality.
Increased risk appears to be associated with dose, i.e. the more Covid-19 vaccinations received the higher the risk of adverse events and mortality.
“Here, dose-dependent adverse events may explain why booster rollout is associated with rising excess deaths while rollout of original protocol doses is not. Secondary analysis of serious adverse events reported in the mRNA vaccine RCTs shows higher risks with Moderna than with Pfizer, perhaps from dosage differences (100mg for Moderna versus 30mg for Pfizer). The use of the Pfizer booster raises the accumulated dosage, which may then make these vaccine adverse events more likely,” the paper states.
Gibson used data on weekly deaths in New Zealand from 2011 through to the end of March 2022, to calculate excess mortality during the rollout of the Pfizer injection.
The paper also notes that all-cause deaths used to calculate excess mortality are not reported in real-time. The lag means that few people would be aware in real-time of the risk of increased mortality from the booster.
In the paper’s abstract, Gibson says, “The ratio of vaccine risk to benefits likely has swung more towards risk than during the original randomised trials, due to dose-dependent adverse events and to fixation of immune response on a variant no longer circulating, yet the evidence underpinning mass use of boosters is weaker than was the evidence for the original vaccine rollout.”
Gibson argues that the statistical value of these lives (16 excess deaths per 100,000 booster doses given) is over $1.6 billion, and that even just 1% of this would have been sufficient to fund robust evidence on the impacts of rolling out the boosters.
The paper also notes that concerns were raised at the US Food and Drug Administration at the outset about the boosters. The advisory panel of outside experts voted 16 to two against widespread use of boosters in September 2021, due to lack of safety data and doubts about the benefits of mass boosting over targeted approaches.
However, this vote was ignored by the regulator, and the FDA approved the boosters for the general population. Because of this, two top officials in the FDA’s Office of Vaccines Research and Review resigned and criticised the decision making. Gibson notes that even the World Health Organisation has criticised this approach.
Despite this, many countries moved forward with booster rollouts since the second half of 2021, up until the present day. Globally, 2.1 billion booster doses have been given, compared with 10 billion original protocol doses.
Gibson notes that aggregated data from OECD countries shows higher excess mortality associated with the booster, and that calls have been growing to end coercive practices and even discontinue booster vaccinations.
“Several European countries have already restricted some mRNA vaccines to only those aged over 30 years due to these safety concerns,” Gibson notes in the paper.
Last month, Japaense cardiovascular surgeon, Kenji Yamamoto, in an open letter published in Virology Journal, called for an end to booster programmes on safety grounds. Yamamoto said covid injections were a “major risk factor for infections in critically ill patients”. He had observed both complications and deaths in vaccinated patients in his own practice at Okamura Memorial Hospital.
Gibson says there appears to have been a been a gradual inversion of evidence-based medicine into ‘medicine-based evidence’, exemplified by a remark made by Dr Eric Rubin, editor-in-chief of New England Journal of Medicine, during an FDA advisory panel meeting to give emergency use authorisation of the Pfizer vaccine for five-to-11 year olds in the US.
“We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes. That’s how we found out about rare complications of other vaccines…”