AstraZeneca published its COVID-19 vaccine clinical trial protocol Sept. 19, shortly after Moderna and Pfizer both released their protocols, The New York Times reported. The three drugmakers are the furthest along in clinical trials for a COVID-19 vaccine.
A spokesperson for AstraZeneca said the company decided to publish the protocol “given the unprecedented global impact of the Coronavirus pandemic and the need for public information,” according to Endpoints News.
The 111-page protocol states that AstraZeneca’s goal is to develop a vaccine with 50 percent effectiveness, which is what the FDA has set as its threshold for approval.
Eric Topol, MD, a clinical trials expert at Scripps Research in San Diego, told the Times that AstraZeneca’s plan is more rigorous than Moderna or Pfizer’s because it only allows one interim analysis to determine effectiveness. If the vaccine is 50 percent effective at the time of the analysis, AstraZeneca might halt the trial and apply for emergency use authorization.
But all three plans have a problematic feature, according to Dr. Topol: They all count relatively mild cases of COVID-19 when measuring efficacy, which may hamper efforts to determine if the vaccine prevents moderate to severe illness.
Experts have been particularly concerned with AstraZeneca’s trials because of the company’s refusal to release details about two cases of serious neurological illnesses in participants that both times caused it to halt its trial. The trial has been resumed in the U.K., Brazil, India and South Africa, but is still on pause in the U.S.
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