Vaccine developers unite to stand with science

The statement of the CEOs of AstraZeneca, BioNTech SE, GlaxoSmithKline plc, Johnson & Johnson, Merck/MSD, Moderna, Inc., Novavax, Inc., Pfizer Inc., and Sanofi (NASDAQ: SNY) came as a reaction to US President Donald Trumpp‘s announcement that a first COVID-19 vaccine would be available before US elections in November. In aunited commitment, the company leaders said that they are committed to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

The pledge was a committment to the US regulatory authority FDA, which seems to be under politcal pressure to speed up its review process. Another example for political intervention into the agency’s scientific evaluation was the emergency use authorisation of undefined, pooled polyclonal convalsecent serum isolated from COVID-19 patients who survived the infection with the novel coronavirus SARS-CoV-2.

Pivotal Phase III studies are designed to assess the safety of broad vaccination campaigns and to compare titres of virus-neutralising antibody titres induced by the COVID-19 vaccine candidates. Whether a vaccine is protective against SARS-CoV-2 and for how long will be seen, when millions of humans have been vaccinated. Up to now nobody knows if there will be a vaccine, as there are viruses such as HIV, RSV or HCV for which no vaccine but therapeutics are available. Currently we have about 20 jabs against 100 known human-pathogenic viruses.

whether the shots can reduce rates of symptomatic Covid-19 disease compared with people without vaccination

The CEOs stressed that they remain committed to the FDA’s clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorisation or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

The CEOs assured that they will

Always make the safety and well-being of vaccinated individuals our top priority.

Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.

Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.

Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.