The first covid-19 vaccine in the world, from BioNTech & Pfizer, has been released for mass vaccination of the public - in the UK. Outwardly, given the publication of Phase 3 trials in the peer reviewed literature, many may feel that everything they need to know if they are to give their informed consent for vaccination is already known - and is in the public domain.

This simply isn't true.

That is why we've seen fit to create a tracker that can be used to evaluate vaccine transparency for individual vaccines, in specific countries. 

In launching the tracker, Transvac, and placing it in the public domain to allow others to engage with the interactive algorithm (in Excel), we hope to be able draw attention to the continued withholding of data that we consider to be essential for properly informed consent.

We have initially evaluated with Transvac two vaccines: the BioNTech/Pfizer vaccine in the UK, and the Moderna vaccine in the US. The results showed there is a long way to go before transparency can be declared, the former yielding a 'transparency index' of just 35%, marginally better than Moderna's 30%.

We issued a press release this morning (below) to publicise the new vaccine transparency tool. 

 

PRESS RELEASE
For immediate release
17 December 2020

Newly launched vaccination transparency tool yields ‘transparency index’ of 35% or less for Pfizer and Moderna vaccines

 


The Alliance for Natural Heath International, a UK-based, internationally active, non-profit campaign, research and education organisation, has released into the public domain an open source vaccine transparency tool, TransVac, that allows comparison of the relative degree of vaccine transparency relating to citizen-facing information for the new generation of covid vaccines.

Using the new tool, Pfizer/BioNTech’s vaccine, currently being administered to the UK public, was found to have a ‘transparency index’ of just 35%. The Moderna vaccine, destined for imminent release in the US, fared even worse with an index of just 30%.

In April, together with colleagues at the British Society for Ecological Medicine (BSEM), the Alliance for Natural Health (ANH) International published an open letter to Matt Hancock, the UK Minister for Health and Social Care, calling for vaccine transparency prior to roll-out of synthetic biology covid vaccines in what is described as the “biggest vaccination drive in British history”.

Given it is crunch time for an increasing number of Britons, and will be soon for US citizens, and others around the world, the vaccine transparency tool was developed to help citizens understand more about the nature and availability of information required for properly informed consent. The tool uses an algorithm to determine compliance with the ten criteria outlined by the ANH and the BSEM in their vaccine transparency manifesto issued earlier this year.

Transvac generated a transparency index for the Pfizer/BioNTech vaccine in the UK of just 35%, with the index varying between 0% and a maximum of 68% for the 10 different criteria. That was marginally greater than the 30% found, using identical criteria, for the Moderna vaccine in the USA, which is expecting an imminent greenlight from the US Food and Drug Administration (FDA).

The results suggest that information required by citizens on which to be able to give informed consent is severely limited, and more opaque than it is transparent.

ANH executive and scientific director Rob Verkerk PhD said,

“We’ve developed the Transvac tool to help people understand what they should be asking health professionals and authorities if they wish to exercise properly informed consent, which is a legal right in most parts of the world for any medical intervention. Historically, vaccine transparency has been poor, and given the synthetic biology platforms and fast-track development timetables for the new generation of covid vaccines, a high degree of transparency is more important than ever.”  

 

Although both the Pfizer/BioNTech and Moderna vaccines use the same mRNA platform, one of the main differences in transparency between the two vaccines is that the lipid nanoparticle (LNP) ingredients used by Moderna, unlike Pfizer, have yet to be released to the public. This prevents any independent scientific risk assessment. In neither case have the amounts of the LNP adjuvants or their specific physico-chemical properties been released. It has been well established that nanoparticle delivery can greatly alter—and increase—the intrinsic toxicity of nanoparticles compared with the same ingredients in non-nano form. It is therefore unsurprising that “Moderna warned that they cannot be sure their LNP’s will not have adverse effects.”

The ANH is calling on the public, independent scientists, elected representatives and health professionals to engage with the open source Transvac tool. Most of the 10 criteria are subdivided into 4 to 6 sub-components and as more information materialises, the indices will change.

Dr Verkerk said that the ANH has been inundated by members of the public who say they are hesitant to receive covid vaccines because of a lack of information, and added:

“The public is often blamed for vaccine hesitancy. But accountability lies more with the vaccine makers and regulators for information that generates confidence. Transvac provides transparency over the nature of information that the public should have access to if the right to informed consent is to be respected during the forthcoming mass vaccination programs.”  

 

The Transvac Dashboard

Table 1: Data source: ANH-Intl Transvac vaccine transparency tool

Transvac Dashboard
  Source data: 16 December 2020    
  CRITERIA Pfizer/
BioNTech
%

Moderna
%
    UK US
1 Full disclosure of all raw data from safety studies of commercial Covid-19 vaccines
  No raw data in the public domain 0 0
  1-25% raw data in public domain 0 0
  ≥25%%<50% of raw data in public domain 0 0
  ≥ 50% < 99% raw data in public domain 0 0
  ≥ 99% of raw data in the public domain 0 0
  SUB-TOTAL 0 0
2 Transparency in relation to safety and efficacy studies
  No peer review publication of any safety or efficacy data 0 0
  Peer review publication of safety and efficacy data (partial or summary data) from Phase 1/2 trials 17 17
  Peer review publication of safety and efficacy data (complete data) from Phase 1/2 trials 17 17
  Press release of partial topline data from Phase 3 trials 17 17
  Press release of comprehensive topline data from Phase 3 trials 0 0
  Peer review publication of safety and efficacy data (partial or summary data) from Phase 3 trials 17 0
  Peer review publication of safety and efficacy data (complete data) from Phase 3 trials 0 0
  SUB-TOTAL 68 51
3 Transparency over the type of platform used for commercial vaccines
  Platform unknown 0 0
  Platform type declared by WHO or national regulator 33 33
  Platform declared in citizen facing promotion of mass vaccination programme 33 0
  Synthetic biology terminology  (or related nomenclature e.g. synthetic, gene edited) declared in citizen facing promotion of mass vaccination programme  0 0
  No declaration in citizen facing promotion of absence of previous use of novel vaccine technology in mass vaccination programmes   -25 0
  SUB-TOTAL 41 33
4 Conduct and transparency of studies to elucidate any risks associated with adjuvants as distinct from antigens
  No published (including peer reviewed) safety studies on adjuvants used in same format as vaccine 0 0
  Third party peer review safety studies for adjuvants that are bioequivalent  0 0
  Raw data for third party peer review safety studies (for adjuvants that are bioequivalent) available in public domain  0 0
  Product specific safety studies published in peer review 0 0
  Raw data for product specific safety studies available in public domain  0 0
  SUB-TOTAL 0 0
5 Transparency in relation to vaccine composition 
  No declaration by manufacturer or regulator approving emergency use of all ingredients present in vaccine 0 0
  Declaration by manufacturer or regulator approving emergency use of all ingredients present in vaccine 25 0
  Declaration by manufacturer or regulator approving emergency use of amounts of all ingredients present in vaccine 0 0
  Declaration by manufacturer or regulator approving emergency use of quality assurance tests for any contaminants in vaccine 0 0
  Declaration by manufacturer or regulator approving emergency use of physico-chemical characteristics (including of any nanoparticles) of all ingredients present in vaccine 0 0
  SUB-TOTAL 25 0
6 Full disclosure of cases and potential cases of vaccine injury (= adverse events, whether short- or long-term, whether from active constituents, adjuvants or contaminants, intentionally or unintentionally added to the vaccine)
  No data on nature or severity of data from Phase 3 trial or commercial use in public domain 0 0
  Summary data from Phase 3 trial safety endpoints available in public domain  25 25
  National authority has published, or declared its intention to publish in the public domain, postmarketing surveillance data relating to safety/adverse events  0 0
  National register established for recording vacccine adverse reactions  25 25
  Primary care physicians have been formerly notified by appropriate health authorities to add patients presenting with adverse reactions to national register 0 0
  SUB-TOTAL 50 50
7 The Government must clarify eligibility and criteria for no-fault vaccine injury payments for Covid-19 vaccines
  The national government has provided no public clarification of eligibility and criteria for no-fault vaccine injury compensation 0 0
  The national government has placed in the public domain some, but inadequate, information about  eligibility and criteria for no-fault vaccine injury compensation 50 50
  The national government has placed in the public domain comprehensive information about eligibility and criteria for no-fault vaccine injury compensation 0 0
  SUB-TOTAL 50 50
8 The Government must clarify indemnity offered to vaccine manufacturers
  No information provided to the public about government indemnity of vaccine industry against liability in the event of 'no-fault' vaccine-injury 0 0
  Some, but grossly inadequate information, provided to the public about government indemnity of vaccine industry against liability in the event of 'no-fault' vaccine-injury 33 33
  Some, but nevertheless inadequate information, provided to the public about government indemnity of vaccine industry against liability in the event of 'no-fault' vaccine-injury 33 33
  Comprehensive information, provided to the public about government indemnity of vaccine industry against liability in the event of 'no-fault' vaccine-injury 0 0
  SUB-TOTAL 66 66
9 The public must be informed of the extent of naturally-acquired immunity prior to public release of Covid-19 vaccines 
  No publicly accessible data on main national covid-19 portal on proportion of national population with naturally-acquired immunity (antibodies and/or T-cells)  0 0
  Some, but inadequate, publicly accessible data on main national covid-19 portal on proportion of national population with naturally-acquired immunity (antibodies and/or T-cells)  0 0
  Comprehensive publicly accessible data on main national covid-19 portal on proportion of national population with naturally-acquired immunity (antibodies and/or T-cells)  0 0
  Regional publicly accessible data on main national covid-19 portal on proportion of regional population with naturally-acquired immunity: antibodies only  0 0
  Regional publicly accessible data on main national covid-19 portal on proportion of regional population with naturally-acquired immunity: antibodies and T-cell responses  0 0
  Members of the public given the option to have immunity status tested prior to vaccination 0 0
  SUB-TOTAL 0 0
10 Any decision to mandate Covid-19 vaccines or limit freedoms of the unvaccinated must be democratic 
  Government or national authority has formally deliberated mandating covid vaccines or limiting freedoms of the unvaccinated but has not engaged with the democratic process (elected representatives)   0 0
  Government or national authority has formally deliberated mandating covid vaccines or limiting freedoms of the unvaccinated but has not engaged with any aspect of the democratic process (e.g. elected representatives and public consultation)   25 25
  Government or national authority has formally deliberated mandating covid vaccines or limiting freedoms of the unvaccinated with input from elected representatives   25 25
  Government or national authority has deliberated mandating covid vaccines or limiting freedoms of the unvaccinated and has included input from a public consultation 0 0
  Government or national authority has deliberated mandating covid vaccines or limiting freedoms of the unvaccinated final decision will be made on the basis of a democratic vote by elected representatives 0 0
  SUB-TOTAL 50 50
  TOTAL TRANSPARENCY INDEX 35 30