At first blush, AstraZeneca’s decision to pause late-stage trials of its COVID-19 vaccine candidate when a person developed a serious side effect might not sound like good news. After all, more than 29 million people worldwide have contracted the novel coronavirus, and the global death toll is approaching 1 million. The U.S. has recorded more than 6 million cases and nearly 200,000 deaths. A vaccine is needed.
But the pause should reassure a skeptical public safety isn’t being compromised even with a global push – in the U.S. the Trump administration has dubbed it Operation Warp Speed – to develop a vaccine in record time. (AstraZeneca and the University of Oxford resumed the trial Saturday after the Medicines Health Regulatory Authority deemed it safe.)
Vaccines typically take years. This pandemic hit with intensity in February, and there is a real possibility that drug companies might have results to present to regulators as early as the end of next month and vaccinations available soon after. Years are being compressed into months as we deal with the first pandemic of this scale since the Spanish flu of 1918.
President Trump would like to take credit if that happens and has a political motive to do so. His record of exaggeration and deception do nothing to bolster his credibility. But in an election year everything is about the election, and his opponents are guilty of using the issue to their benefit as well.
When vice presidential candidate Kamala Harris calls into question whether it would be safe to take a vaccine developed under Operation Warp Speed, she does a major disservice and potentially puts people at risk. Public trust will be crucial, and politicians don’t need to create more vaccine skeptics.
Meanwhile, the chief executives of the nine frontrunners in the push for a vaccine – there are different approaches – have pledged to avoid shortcuts on science even as they rush to get a vaccine to market. “In the interest of public health, we pledge to always make the safety and well-being of vaccinated individuals our top priority,” they wrote in an unusual pledge.
Dr. Anthony Fauci publicly said last week that in no way would he be “muzzled” about expressing concerns if he thought a vaccine was being rushed at the expense of safety.
Trump’s choice to head Operation Warp Speed is Moncef Mohamed Slaoui, a Moroccan-born Belgian-American researcher and former head of GlaxoSmithKline’s vaccines department. A Ph.D. in molecular biology and immunology, he has co-authored more than 100 research papers and oversaw development of a number of vaccines at GSK, including those to prevent cervical cancer, gastroenteritis in children and Ebola. He spent 27 years researching a malaria vaccine, Mosquirix, approved by the Medicines Agency in 2015.
He is far from an unqualified political appointee.
AstraZeneca had thousands of people in clinical trials, and one volunteer in the U.K. was diagnosed with transverse myelitis, inflammation of the spinal cord, the New York Times reported. Slaoui said in response Data Safety Monitoring Boards in the U.S. and U.K. “are conducting an in-depth review of the company’s vaccine candidate … standard procedure when an adverse event occurs.”
Oxford University said the pause was a “routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
Federal regulators have told states to be prepared to start giving the vaccine by November, and New Mexico is preparing to do so with a first priority on health care workers and residents in long-term care facilities.
Dr. David Scrase, the state’s secretary for the Department of Human Services and state government’s lead medical adviser on the virus, says the vaccine could be available to the general public as early as January. New Mexico, he says, has a broad network of potential distribution sites – public health offices, hospitals, pharmacies and other locations – to handle the expected demand.
Whether a vaccine is available on that timetable is anyone’s guess. But the odds are looking better with each passing day.
And the fact this is being done at an unprecedented pace doesn’t mean it is being done recklessly with safety shortcuts. The roles of Fauci and Slaoui, the pledge by pharmaceutical CEOs, the oversight of the Data Safety Monitoring Boards and the late-stage trial pause – seemingly without hesitation – by AstraZeneca should provide reassurance. No matter what politicians of either party say.
This editorial first appeared in the Albuquerque Journal. It was written by members of the editorial board and is unsigned as it represents the opinion of the newspaper rather than the writers.