The TGA grants provisional approval for Pfizer’s BA.4/BA.5 bivalent booster for Australians 12 years and older
The TGA has granted provisional approval for Pfizer’s bivalent Covid vaccine to be administered as a booster dose in Australians aged 12 years and older.
This is the first bivalent booster to be made available to adolescents under 18 years of age. It is also the first Covid vaccine to target the Omicron BA.4/BA.5 strain as well as the Wuhan strain. Bivalent boosters targeting the BA.1 strain, by both Moderna and Pfizer, were provisionally approved for adults 18+ in August and October 2022, respectively.
In case you’re wondering, yes, this is the booster that was only tested on 8 mice prior to being granted provisional approval by the FDA late last year. Read the preliminary findings that were provided to the FDA, HERE, and a summary of the results by Igor Chudov, HERE.
There is testing on real people in progress though, and the TGA states that their provisional approval of the Pfizer bivalent was based on data from an ongoing Phase II/III study which showed that the vaccine elicited a satisfactory neutralising antibody response one month after the booster dose.
We could get into the weeds about the effectiveness of bivalent boosters over very short windows of time, but actually, there’s little point, because it’s a myopic argument.
The human trials for this product will not be complete until 23 April 2023. What we have so far is surrogate markers (titers) from 8 mice, and assurances that the data from part-way through an ongoing trial in humans is promising. What we don’t have is: any understanding of dose effect; knowledge of effects of mixing brands across multiple doses over time; and medium-long term efficacy and safety data.
In other words, the “largest global vaccination trial ever” is still unfolding with the (unwitting?) participation of the Australian public.
There are any other number of arguments that can be made to seriously question the TGA’s decision, including:
- The fact that the the TGA is funded almost exclusively by industry,
- And that it conducts its Covid vaccine assessments based on, “the information provided by the vaccine’s sponsor.”
- Even vaccine proponent and inventor Paul Offit thinks endless boosting for healthy young people is ineffective and a bad idea.
- Boosters are likely driving new immune escaping variants,
- And increasing infection rates.
- The younger the (healthy) person, the greater the risks compared to benefits of Covid vaccination,
- Particularly with cardiac issues for young males,
- And there appears to be a dose effect – risk increases with each dose.
- Reanalysis of original mRNA trial data found a 1/800 serious adverse event rate – for perspective, the swine flu vaccine (1976) was withdrawn for a severe adverse event rate of 1/100,000.
- According to the Australian DoH, Covid is of virtually no risk to young people (up to 17 years of age),
- And the number needed to treat to prevent one Covid hospitalisation is stupidly high – this analysis published in the BMJ estimated that 31, 207–42, 836 young adults aged 18–29 years must receive a booster to prevent one Covid hospitalisation over a 6-month period.
Based in reality.
The TGA says that the new bivalent Pfizer vaccine has a similar safety profile to the original COMIRNATY booster, which we can presumably take to mean that it will cause net harm.
On safety – the TGA says that they “closely monitor” reports of suspected side effects in, “the most intensive safety monitoring ever conducted of any vaccines in Australia.” In all my interviews for Jab Injuries Australia, I have not spoken to one person, ever, who has received any follow-up by the TGA after lodging a report. Coverse, an Australian not-for-profit that runs Covid vaccine injury support groups, similarly reports that of all the injured people it has dealt with, not a single one has been followed up by the TGA or any other drug safety agency (Long Covid Inquiry Submission 516).
The decision now falls to the Australian advisory body, ATAGI, as to whether to recommend the Pfizer bivalent booster, or not. They typically do follow through with recommendation of provisionally approved Covid vaccines, but occasionally they stop short of blanket recommendations. Pfizer’s COMIRNATY was provisionally approved for 6 months to 5 years old, but was recommended only for at risk children (not the general population in that age group). The fourth shot has been recommended for 50+ year old Australians, but is not outright recommended for anyone under 50 due to lack of evidence of benefit (although it is available to 30-49 age group, and state premiers and health officials have not held back in recommending it to this cohort of their own accord).
The main issue for people to take away, and parents in particular, is that the safety and efficacy of these new bivalent boosters is not ‘settled science.’ Even when the Pfizer trial finishes at the end of April, we will have no medium or long term safety and efficacy data.
Finally, while we’re discussing mouse data, Alex Berenson reports that after four shots, Covid jabs sharply reduced immune function in mice:
Given that the FDA only required testing on mice to ok the bivalent booster, we can safely assume they will stop the shots based on these results in mice. Right?
Chinese researchers who found that more than four Covid vaccine shots produced near-complete immune collapse in mice: https://t.co/drfoF2ikA612:30 AM ∙ Jan 19, 20231,403Likes375Retweets
From the article, there are 3 scientific problems with the bivalent boosters:
”First, the virus is evolving much faster than the vaccines can be updated. Second, vaccines have hard-wired our immune systems to respond to the original Wuhan strain, so we churn out fewer antibodies that neutralize variants targeted by updated vaccines. Third, antibodies rapidly wane after a few months.”