Last week, news began to spread that AstraZeneca, the pharmaceutical giant that has its U.S. headquarters in suburban Wilmington, was putting a large, Phase 3 clinical trial of its COVID-19 vaccine on pause. The worldwide ...
[caption id="attachment_187984" align="alignleft" width="257"] Jacob Owens Editor[/caption]
Last week, news began to spread that AstraZeneca, the pharmaceutical giant that has its U.S. headquarters in suburban Wilmington, was putting a large, Phase 3 clinical trial of its COVID-19 vaccine on pause.
The worldwide trial, which began in the United States in late August and intends to enroll 30,000 volunteers here, had run into a problem. Phase 2 and 3 trials were already underway in the United Kingdom, Brazil and South Africa, and a single trial patient in the U.K. experienced a suspected serious adverse reaction.
According to reporting from STAT, the healthcare industry publication that broke the news, the patient is expected to recover, but it has set off a review of all of the vaccine trials underway in search of any other potential cases of such a reaction.
For AstraZeneca CEO Pascal Soriot, the choice to pause the trial was simply a part of his company’s culture and safety protocols.
“At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” he said in a statement after the news broke.
[caption id="attachment_195425" align="aligncenter" width="1024"] AstraZeneca's Wilmington Campus | PHOTO COURTESY OF ASTRAZENECA[/caption]
AstraZeneca’s decision didn’t come without consequences though. In the short term, its stock price fell 6% in the wake of the news while nearly all of its competitors saw gains. Longer term, it also may slow the company’s work amid the breakneck race between nine vaccine candidates in Phase 3 trials after having widely been seen as a frontrunner.
On Sept. 8, the CEOs of nine companies working on vaccines – including AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novovax, Pfizer and Sanofi – signed a pledge to “uphold the integrity of the scientific process as they work toward potential global regulatory filings and approvals of the first COVID-19 vaccines.”
That pledge from many of Big Pharma’s biggest names comes as public frustration grows amid the lingering pandemic and disparate messaging intensifies from federal leaders.
The U.S. Centers for Disease Control and Prevention recently notified states to prepare for a vaccine as soon as Nov. 1, and President Donald Trump has been hinting that one may be available
before Election Day on Nov. 3.
It’s an assertion that National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci later said in interviews was too ambitious. The Phase 3 trials aren’t expected to reach their enrollment goals until the end of September, and the studies include a two-shot cycle over two months. That means efficacy data likely won’t begin to be available until late November or December at the earliest, Fauci said. That understanding was shared by Dr. Francis Collins, the director of the National Institutes of Health, during his Sept. 9 testimony before a Senate committee regarding the nation’s progress on a vaccine.
The end result in the cacophony of voices regarding the pandemic, however, is an increasingly wary public. While politicians are touting the possibility of a cure-all vaccine to wash away our 2020 woes, many are debating the vaccine in private.
Would you get it as soon as it’s available? Would you vaccinate your kids right away or wait to see how it goes?
Frankly, these are questions that are arising due to the highly politicized timing of the crisis and a long-running distrust of the pharmaceutical industry overall. The 2019 annual Gallup poll of American opinions on 25 different industries found Big Pharma ranked last with its lowest score ever in the poll. Americans were more than twice as likely (58%) to rate the pharma industry negatively than positively (27%). That hasn’t necessarily improved during the pandemic, as a STAT and Harris Poll done in late August found that 78% of Americans worry the COVID-19 vaccine approval process is being driven more by politics than science.
That distrust is built off of systemic price gouging, where costly prescription drugs sold here are often backed by government research subsidies, cost pennies on the dollar to produce generically overseas and face greater price caps in Europe and other markets. Trust was eroded during the abuses of the opioid crisis, where companies pushed addictive narcotics onto the market despite warning signs of their lethality.
It’s also a byproduct of previous failures, such as the 1976 swine flu vaccination debacle that led to 450 people developing the paralyzing Guillain-Barré syndrome after the government used a live virus rather than a dead one. Coincidentally, that episode occurred in the spring ahead of President Gerald Ford’s re-election campaign and many argued that it smacked of politicization.
All of these things lead to lower rates of vaccination, a necessary preventative measure to slow the spread of dangerous viruses. In the 2018-19 flu season, only 45% of adults got an annual flu vaccination in the U.S., although rates for children and senior citizens were considerably higher. Several members of the European Union reported higher vaccination rates, due in part to objectives set out to reach the elderly and at-risk.
We were heartened to see AstraZeneca make the difficult decision in dialing back its trial to explore a potentially serious side effect as well as the reassurance from leading Big Pharma voices on their dedication to the scientific process. As the political climate ratchets up in coming weeks, we hope to see continued hewing to these standards in this important enterprise.
Regardless of who occupies the White House come January, what’s more important is that our leaders make clear-eyed decisions now that will have a lifetime of ramifications in the public’s view of vaccination in general.