AstraZeneca, the renowned pharmaceutical company that is leading one of the world’s largest COVID-19 vaccine development effort, has reportedly unveiled details of the COVID-19 vaccine trials recently. The latest instance, where trial blueprints have been released to public, is third in a row of rare divulgements by drug developers who are under pressure to be more unambiguous regarding how the drugs, that are currently the greatest hope to end the pandemic, are being tested.
According to recent polls, Americans are becoming increasingly wary of getting vaccinated for COVID-19. Additionally, scientists outside and inside the government are concerned that the regulators might release an unsafe or unproven vaccine, as a result of being pressured by the U.S. President to launch the vaccine before the election day; November 3rd, 2020.
A biostatistician and a clinical trial design expert for vaccines working at the University of Florida, Natalie Dean, stated that the release of the protocols reflects public pressure to do so.
Experts have been especially worried about the vaccine trials of AstraZeneca, which started in April in the UK, due to the company’s denial to divulge details about severe neurological illnesses observed in two participants, both women who were administered the experimental COVID-19 vaccine. These two cases led the company halting the trials twice, with the second time being earlier in September. While clinical studies have resumed in India, South Africa, Brazil, and Britain, they are still paused in the U.S. Approximately 18,000 people across the globe have been administered the AstraZeneca vaccine.
The company’s 111-page blueprint of the trial, called protocol, states that the firm aims to develop a vaccine with 50% effectiveness. This effectivity is the same as set by the U.S. FDA under its guidance for COVID-19 vaccine development. To determine through statistical confidence that the vaccine is in fact effective, these need to be approximately 150 people who are COVID-19 positive among participants that have been vaccinated or have received placebo shots.