Just a day after AstraZeneca announced long-awaited interim results from its U.S. phase 3 trial earlier this week, the company again became mired in controversy about what’s going on with its vaccine.
The trial’s Data and Safety Monitoring Board (DSMB) — a group of independent experts who monitor the safety and efficacy of a drug or intervention during a trial — sent a memo to the company and government health officials, including the National Institutes of Health (NIH), contesting the company’s portrayal of its vaccine’s efficacy.
The March 22 press release reported “79% vaccine efficacy at preventing symptomatic COVID-19,” but the DSMB pointed out that this figure was based on outdated data. When the most recent data from the trial is factored in, the efficacy falls somewhere between 69% and 75%. The latter percentage is still good efficacy, and a variety of public health experts, including Anthony Fauci, have said the AstraZeneca vaccine is likely very good. But the company’s repeated communication snafus run the risk of eroding trust in not only the company and its vaccine but potentially other COVID-19 vaccines as well, some experts fear.
The AstraZeneca vaccine, developed with Oxford University, is already approved in the U.K. and several dozen other countries. Its most significant benefit is its low cost, making it more accessible to low- and middle-income countries. But from early in its development, the vaccine has faced scrutiny for missteps or uncertainties in its protocol and results. If the FDA ultimately authorizes the vaccine — as many public health experts expect it will — journalists will need to explain much of this background to a potentially confused and wary public.
Briefly, here is a timeline of the highlights, with links to help journalists gain the background they need for writing explainers and providing context in articles:
Timeline
- Spring 2020: AstraZeneca/Oxford was ahead of most other companies in vaccine development.
- May 2020: Operation Warp Speed puts in the largest single order of vaccines from AstraZeneca/Oxford.
- September 2020: AstraZeneca/Oxford trials are put on hold to investigate potential neurological side effects. The condition that the participant experienced was ultimately determined to be unrelated to the vaccine, but the company faced hard questions about its transparency.
- October 2020: The trial resumes.
- November 2020: Baffling interim results showed a higher efficacy with half doses, leading to the discovery that a major error in dosing had occurred during the trial, bringing more questions about the vaccine and its trials.
- December 2020: The U.K. approves the AstraZeneca/Oxford vaccine.
- January 2021: The European Union approves the vaccine.
- March 2021: The European Medicines Agency begins investigating whether blood clots were linked to the vaccine, leading more than a dozen countries to halt its administration. The vaccine is ultimately determined to be safe — though a link could not be entirely ruled out — administration resumes in several countries.
- March 22, 2021: The company announces its U.S. phase 3 interim trial results.
- March 23, 2021: The DSMB sends its memo, leading the NIH to issue its own statement.
- The company has also come under fire for falling short on delivering as many doses as countries were expecting several times in recent months.
Check out these excellent articles for an overview of the company’s troubles:
