- Nine companies involved in coronavirus vaccine research inked a pledge to uphold the scientific principles that would ensure the safe development of COVID-19 vaccines.
- A report a few days ago said the pledge was in development, in response to recent coronavirus vaccine-related developments.
- Russia and China have started providing vaccine candidates under emergency programs before completing the final stages of testing. At the same time, rumors of the Trump administration issuing an emergency approval of its own before the presidential election began to spring up.
A vaccine might end the coronavirus the pandemic, but it will take a while longer for that to happen. First of all, the world needs at least one safe, effective vaccine to complete the last phase of testing successfully. We then need to wait for governments to devise and execute vaccination campaigns, and we’ll need to continue observing safety measures meant to reduce the spread of the illness. We’ll have to wear face masks, social distance, and wash our hands often. That’s because it’ll be a while until a large percentage of the world’s population is immunized. Even then, the virus won’t be eradicated. For that to happen, we’ll need incredibly effective vaccines, and we’ll need everyone to take them.
But as we approach the end of the year, people are increasingly concerned about vaccine safety. More Americans than ever have started to question the effectiveness and safety of experimental drugs. It’s come to the point where two-thirds of Americans said in a recent poll that they aren’t inclined to take a COVID-19 vaccine as soon as it becomes available, while a quarter of respondents said they’d never get one. This prompted some of the biggest names in the pharmaceutical industry to sign a coronavirus vaccine research pledge meant to ensure the general public that coronavirus vaccines will only be approved for public consumption once their safety is guaranteed.
In a matter of weeks, we saw Russia announce that it will start using its first COVID-19 vaccine candidate before the Phase 3 trial is complete. The country released the first research data to prove the drug works as designed and has no side effects weeks after announcing that it has made up its mind. Separately, reports from China showed the country approved three of its late-stage vaccine candidates for emergency use on some categories o people. Unlike Russia, Chinese companies had already published studies detailing the results of the first phases of those trials.
Add to that recent reports that said the Trump administration might want to issue an emergency approval for one of the Phase 3 drugs before the November 3rd presidential election, and you have the complete picture that explains why more people are circumspect about the current COVID-19 vaccine efforts.
Nine companies announced they’ve signed the pledge to “stand with science”. Pfizer and its COVID-19 vaccine partner BioNTech, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Moderna, Novavax, and Sanofi have all inked the following “historic” pledge, as they describe it:
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 safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization 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.
Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
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 3 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.
We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.
Words on a piece of virtual paper might not mean much to people who are hesitant about vaccines, but it’s still a notable effort from these fierce rivals. Acknowledging the importance of science is incredibly important in a year where conspiracy theories and unproven therapies hindered COVID-19 containment and treatment efforts. It might reassure some people that COVID-19 vaccine projects that are currently underway will put science first, not political or financial gain.
Pfizer/BioNTech, AstraZeneca/Oxford, and Moderna will likely report the conclusions of their Phase 3 trials in the months to come. The other signatories of this pledge will also have more vaccine data in the near future. And we might soon know what to expect from COVID-19 vaccination campaigns, assuming the drugs are effective and safe.
