At myndighetene verden over kan anbefale disse vaksinene, når det mangler så mye viktig informasjon om dem, er midlt sagt sinnsykt. Publisert 8. august 2021:

“While several trials have at this point published protocols and statistical analysis plans along with the study publications, with some even released while the trials were underway, many key trial documents remain inaccessible (table 1).

For example, a WHO report found that out of 86 clinical trials for 20 COVID-19 vaccines, 12% of clinical trial protocols were made publically available.12 In our analysis, trial protocols and informed consent forms were not available for trials involving special populations such as children (NCT04816643) and pregnant women (NCT04754594).

And despite vaccine roll-out, electronic individual participant data is not available for most trials.12 Some sponsors, such as Moderna, have sent mixed messages on whether they even intend to share data, while others, such as Pfizer and Sinopharm, indicate they will not even begin accepting data requests for many months or years (table 2). In other cases, trialists have indicated very narrow time frames for sharing data, for example, ‘beginning 3 months and ending 1 year after publication’ (ChiCTR2000032459).

Additionally, there is a need for transparency around any deliberations regarding the length of follow-up necessary to adequately assess efficacy and safety prior to licensure. Longer follow-up for investigational products such as COVID-19 vaccines and therapeutic agents are necessary to evaluate duration of protection and ensure public and professional confidence.

The International Coalition of Medicines Regulatory Authorities (ICMRA), a global collaborative coalition of 30 medicine regulators including the FDA, Health Canada and EMA, published a statement in November 2020 stating that follow-up for treatment and placebo arms should continue ‘for as long as possible after any regulatory approval’ and recommended a follow-up period of ‘at least 1 year or more from completion of assigned doses’.

Despite this, placebo controlled follow-up, originally planned for 2 years in many trials, was eliminated after a few months, when manufacturers began offering vaccine to placebo recipients within weeks of receiving emergency use authorisations. (Debates took place regarding the ethics of denying placebo recipients vaccine, and proposals to redesign the trials as cross-over trials were not taken up).

In addition to ensuring the public accessibility of follow-up data from continuing trials, greater transparency is necessary into the ongoing deliberations and thinking of regulators who are currently evaluating applications from sponsors seeking to move from emergency use authorisations to actual approval or licensure.

The lack of adequate transparency about COVID-19 vaccine trials and their regulation cannot be dismissed as unfortunate, stubborn problems emblematic of the present culture in biomedicine.

In a time of increasing public scrutiny, transparency of regulatory decision making leading to the approval of drug treatments and vaccines for COVID-19 is important to ensure patient and stakeholder trust. It is a scientific, moral and ethical imperative that access to complete trial data of these global public health interventions is urgently granted to patients, researchers and other key stakeholders.”