FDA’s vaccine head calls for accelerated approvals for gene therapy products

Written by Meryl Nass on March 23, 2023. Posted in Current News

Here is the information from New Zealand on what the NZ regulators knew as early as February 2021, before they authorized the jabs

But first, I hope you will be as angry as I am at the USA’s top vaccine and gene therapy regulator promising to rush headlong into licensing more experimental gene therapy products.

A top Food and Drug Administration official [Peter Marks, an MD, PhD cancer doctor and pharma shill] said Monday that the agency needs to start using accelerated approval, a much-debated path commonly used for advancing cancer drugs, to advance gene therapies for rare disease. [COVID is getting rare, isn’t it?]

“We always are going to keep safety, front and foremost,” Peter Marks, head of the Center for Biologics Evaluation and Research, told attendees at the annual meeting of the Muscular Dystrophy Association. “But I think the issue here is we can’t be so careful about our approvals under accelerated approval that we prevent potentially lifesaving therapies from getting to market in a timely manner.”

he below is excerpted directly from a web post yesterday by a New Zealand attorney, Thomas Cranmer. He did not link directly to the documents he discusses. However, the website is a reliable one and I have no reason to doubt what he reports. Here goes:

“… On 10 February 2021, Chris Hipkins, Minister for COVID-19 Response, received a briefing paper from Dr Bloomfield and another Ministry of Health official titled, Maximising uptake of COVID-19 vaccines in Tier 1. The paper stated:

While we do not yet know the extent to which the vaccines prevent COVID-19 transmission, vaccination is expected to reduce transmission through reducing the severity of disease and therefore the risk of onward transmission. Therefore, COVID-19 vaccination will support other public health measures to reduce the risk of these workforces contracting and spreading the virus. The use of Personal Protective Equipment (PPE), social distancing, and mandatory COVID-19 testing for border staff will still be needed to ensure that people continue to be safe.

… vaccination, unlike testing, is a medical treatment, which everyone has a general right to refuse under Section 11 of the Bill of Rights Act 1990.

Although vaccination has a beneficial effect on personal health, that does not provide a public health justification for infringing on a right to refuse medical treatment. It is the existence of a threat to wider public health, and a measure that will enhance or preserve it, that is the essential component to justify limiting the right to refuse medical treatments under the Bill of Rights Act.

We do not yet have conclusive evidence on the effectiveness of the Pfizer vaccine at preventing or reducing transmission to be confident of the public health value of this vaccination, beyond the individual level. So, unlike testing, which had a clear public health benefit, vaccination at this point in time is expected to reduce risk through a reduction in the likelihood of severity of disease and onward transmission. This may change as more evidence becomes available. However, at this time, mandatory vaccination is unlikely to be a justifiable limitation of the right to refuse medical treatment under Section 11 of the Bill of Rights Act.

“Medsafe also confirmed in the same letter that, “A benefit/risk analysis was undertaken by Medsafe prior to the Pfizer COVID-19 vaccine (Comirnaty) being granted provisional consent for use in New Zealand.

The assessment has been released in a previous response under the Act and can be found here. Please refer to Document 10 on page 94.” That assessment is as described above [I have omitted much of the material but you can review it at the web page linked above—Nass]- in other words, an assessment that the benefit-risk balance was “not clear”.

The approval of the Pfizer vaccine in New Zealand was undoubtedly a challenging proposition. Medsafe undertook a thorough and rigorous evaluation in consultation with other expert bodies in New Zealand and from overseas.

However there does appear to be serious questions about how the government then represented Medsafe’s clinical evaluation to the public during the vaccine rollout and how this impacted on informed consent and on the legality of the mandates.

In particular, it is clear from the documentation that Medsafe and relevant government Ministers knew from very early in the vaccine rollout that it was questionable whether the vaccine would prevent or limit transmission, and furthermore they were advised that having “credible evidence” of transmission reduction was absolutely crucial in the legal justification of any mandate that required vaccination.”

See more here substack.com

Please Donate Below To Support Our Ongoing Work To Expose The Lies About Covid 19

PRINCIPIA SCIENTIFIC INTERNATIONAL, legally registered in the UK as a company incorporated for charitable purposes. Head Office: 27 Old Gloucester Street, London WC1N 3AX. 

Trackback from your site.