BMJ Transparency of Covid19 vaccine research: Aug.8, 2021

Transparency of COVID-19 vaccine trials: decisions without data

Sarah Tanveer, Anisa Rowhani-Farid1, Kyungwan Hong1, Tom Jefferson, Peter Doshi1

Correspondence to Dr Peter Doshi, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA; pdoshi@rx.umaryland.edu

Excerpts:

The overall picture is one of varied transparency. 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).13....

.....The greatest availability of data at present comes from the EMA, Health Canada, and Japanese Pharmaceuticals and Medical Devices Agency which have released thousands of pages from company submissions for COVID-19 vaccines, far exceeding what is available elsewhere. The Food and Drug Administration (FDA) does not routinely make any industry documents it receives publicly available. It should be noted, however, that the EMA and Health Canada’s commitment to transparency does not necessarily equate with the public availability of critical study documents. Judging from the availability of documents, regulators themselves appear to be receiving less complete and granular data than normal due to the compressed timeline from study start to regulatory decision making.....

.....Sinovac and Sinopharm, developed by Chinese pharmaceutical companies, account for the majority of vaccines being in Asia, South America, the Carribean and Africa.17 They are authorised by the WHO and included in the WHO COVID-19 Vaccines Global Access initiative. However, transparency of trial data and documents is extremely limited, similar to other COVID-19 vaccines.....

....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’.22 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.....