{"id":173637,"date":"2020-11-30T12:00:50","date_gmt":"2020-11-30T12:00:50","guid":{"rendered":"https:\/\/www.transcend.org\/tms\/?p=173637"},"modified":"2020-11-25T08:08:55","modified_gmt":"2020-11-25T08:08:55","slug":"what-the-leading-covid-vaccine-contenders-still-need-to-tell-the-public","status":"publish","type":"post","link":"https:\/\/www.transcend.org\/tms\/2020\/11\/what-the-leading-covid-vaccine-contenders-still-need-to-tell-the-public\/","title":{"rendered":"What the Leading COVID Vaccine Contenders Still Need to Tell the Public"},"content":{"rendered":"

23 Nov 2020 – Given how much we don\u2019t yet know, it\u2019s unclear why those of us asking for more information about the leading COVID vaccines are being marginalised. We\u2019re simply exercising our right to informed consent.<\/em><\/p><\/blockquote>\n

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The race is on<\/strong><\/h3>\n
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When everyone\u2019s trying to pick potential winners of the global race to produce COVID<\/a> vaccines, spare a thought for those of us who are the guinea pigs<\/a>. We, the public, as well as concerned doctors and other health professionals, need to be crystal clear about what information we need to give consent \u2014 assuming vaccine rollout is not made mandatory in your country or state.<\/p>\n

This is a bigger ask than it might be if we had functioning democracies. But in most countries that have enjoyed democratic governance in recent years, emergency measures granted by the World Health Organization\u2019s characterisation of COVID-19 as a \u201cpandemic<\/a>\u201d on Mar. 11, 2020, has seen democracy widely substituted by coercion<\/a> and authoritarian rule.<\/p>\n

Not only that, those who ask questions<\/a> about vaccines have been marginalised as conspiracy theorists. A large international survey with over 13,000 people in 19 countries published<\/a> in Nature Medicine found that 71% of those surveyed would agree to vaccination if it \u201cwas proven safe and effective\u201d (but who adjudicates)?<\/p>\n

The highest acceptance rate (88%) was found in China and the lowest in Russia (55%). The same study found that acceptance was strongly correlated to trust in governments \u2014 another reminder that governments who have not managed to win the trust of their people<\/a> must shoulder some responsibility for lack of vaccine confidence.<\/p>\n

Not enough data<\/strong><\/h3>\n

For many people, the problem isn\u2019t just a lack of trust, it\u2019s a lack of data. Scientists like Dr. Tom Jefferson<\/a> from Cochrane and Oxford University\u2019s Centre for Evidence Based Medicine<\/a> as well as Dr Peter Doshi, the BMJ associate editor, have long argued<\/a> for full transparency of trial data to allow clinical trials by vaccine (and drug) makers to be independently analysed.<\/p>\n

Demand for transparency<\/a> is also being called for by M\u00e9decins Sans Fronti\u00e8res\/Doctors Without Borders (MSF) which recently warned \u201c\u2026 the little information that has been revealed around AstraZeneca\u2019s not-for-profit promises should be a warning sign that pharma<\/a> cannot be trusted to act in the interest of public health.\u201d<\/p>\n

While some vaccine makers have agreed to not profit from the pandemic, AstraZeneca has made clear<\/a> that it\u2019s limiting its non-profit pledge to Jul. 1, 2021 which it has determined will be the end of the pandemic period.<\/p>\n

Clearly they have access to a crystal ball that we don\u2019t!<\/p>\n

Pfizer and Moderna announcements<\/strong><\/h3>\n

Pfizer\u2019s<\/a> press announcement on Nov. 9, said its BNT162b2 vaccine was \u201c90% effective<\/a>\u201d. That was followed by Moderna\u2019s<\/a> claim of \u201c94.5% efficacy<\/a>.\u201d Moderna was then pipped at the post by the previous week\u2019s silver medallist, Pfizer, when it came back with its 95% effective claim just yesterday with the completion of its Phase 3 clinical trial. Of course this one half of one percent difference is meaningless in terms of statistical significance.<\/p>\n

All these buoyant claims have been made with passing reference to a lack of serious adverse events<\/a>, which you should know are ones that endanger life. The fact that nine of the leading vaccine developers have signed up to a pledge<\/a> to put consumer and COVID-19 patient safety first (therefore before profits) is no doubt intended to help build confidence<\/a> among a hesitant public.<\/p>\n

If that wasn\u2019t enough \u2014 the airwaves are full of news of the Oxford\/AstraZeneca<\/a> vaccine, courtesy of a newly published article<\/a> in The Lancet journal. The headline was the immunity was as good in older people as younger ones, but we don\u2019t have sufficient detail around the kinetics of the adaptive immune response to really judge this claim objectively. Little emphasis was given to adverse reactions being worse for the genetically modified chimpanzee vaccine targeting SARS-CoV-2 as compared with the control meningitis vaccine.<\/p>\n

But as with any marketing proposition, there\u2019s more than just one USP<\/a>, the claimed efficacy in a Phase 3 trial. Other players like Johnson & Johnson and Novavax are claiming that the standard refrigeration temperatures required for their vaccines will likely be more suited to global logistics and distribution<\/a>.<\/p>\n

Vaccine transparency manifesto<\/strong><\/h3>\n

In May 2020, together with our colleagues at the British Society for Ecological Medicine<\/a>, we launched a manifesto<\/a> for the 10 information criteria we thought should be pre-conditions to providing informed consent for COVID vaccination. These include manufacturers putting raw trial data into the public domain to allow independent analysis, disclosing the full list of ingredients in vaccines and what the state of naturally-acquired immunity is in representative populations prior to vaccination.<\/p>\n

The table below shows how the BioNTech\/Pfizer and Moderna vaccines stack up so far according to our transparency criteria. There is clearly a long way to go before meaningful transparency can be declared.<\/p>\n

Table. Current status of transparency on BioNTech\/Pfizer and Moderna mrna vaccines.\u00a0Nov. 19, 2020<\/strong><\/p>\n

\"\"<\/a>It\u2019s impossible to give properly informed consent without this information.<\/strong><\/p>\n

Engaging with the data<\/strong><\/h3>\n

But having the necessary data and information is just the starting point. Then you have to engage with it. An important priority for many will be to weigh up the known risk\/benefit profile of the vaccine against need. This requires understanding the danger posed by the virus, the virulence of which is likely weakening, as well as knowing the extent of naturally-acquired immunity. It should also take into account other potential interactions, such as the observed correlation<\/a> between flu vaccination and COVID-related deaths.<\/p>\n

A recent study<\/a> has suggested that herd immunity thresholds that interrupt the progress of transmission might be as low as 10 to 20% from naturally acquired immunity, as compared with over 60% if immunity is to be gained by randomised vaccination. The reality is that it will take many more months to compare the complex pattern of sustained immunity<\/a> from memory B and T cells, and it may well be that exposure to the real virus elicits a more robust and persistent response than exposure to, for example, endogenously produced spike protein following injection of synthetic messenger RNA sequences.<\/p>\n

Don\u2019t blame us for asking<\/strong><\/h3>\n

Seen in the context of just how much information we don\u2019t know or have at this stage, it\u2019s not clear to us why those of us who are asking for more information about the current crop of COVID vaccines under development are so marginalised and ridiculed. We\u2019re simply exercising our right to informed consent<\/a>.<\/p>\n