With speeding vaccine clinical trials, a pause that may prove reassuring

cdcinoculate-300x240The “warp speed” race to develop a Covid-19 vaccine has gotten hit with a yellow flag.

It could be a good thing that the product’s makers — Oxford University and AstraZeneca — followed medical-scientific protocols and paused their Phase III clinical trial due to a participant’s unexplained illness.

Officially, the company offered spare information about the occurrence, especially because it affects the private medical information of a single individual.

But Stat, a science and medical news site, reported (based among other things, on an investors’ call by the drug maker) that a female study subject in Britain “experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis.” This led safety advocates overseeing the Oxford-AstraZeneca testing of an adenovirus-based vaccine to pause the firm’s trial.

The research has resumed in the United Kingdom, after independent experts found the illness unrelated to the vaccine trial.

Stat reported that it is not unusual for pauses for safety assessments in clinical trials, and Oxford-AstraZeneca disclosed it had earlier had a similar halt after a trial subject developed multiple sclerosis, with that illness also deemed unrelated to that patient’s participation in the vaccine testing.

With President Trump and his administration talking big and twisting arms for favorable vaccine developments before election day, fears have spiked that political meddling might short-circuit the rigorous medical-scientific processes that would help prove to the public that a coronavirus vaccine, developed at a record pace, will be safe, effective, affordable, and widely available.

(I’ve written about the possibilities for a coronavirus vaccine in my latest newsletter and it provides process details that may be useful for those concerned about how vaccines get developed).

But Big Pharma — in a peculiar development akin to seeing used car dealers don a white hats and swear on a stack of good books — has issued a public pledge (from nine big drug making firms) that they will not be pressured to forgo strict, long accepted clinical trial measures, so as to hurry a Covid-19 vaccine to market.

Dr. Anthony Fauci, one of the nation’s leading infectious diseases experts, and Dr. Francis Collins, the head of the National Institutes of Health, have sought to douse overheated claims and expectations of an early delivery of a coronavirus vaccine.

Some drug makers also have said they will expand, rather than limit, the number of participants in clinical trials to increase assurance about the safety and effectiveness of a potential vaccine.

Practical considerations also may be working against a feared “October surprise,” in which the federal Food and Drug Administration, potentially under White House pressure, would grant an emergency authorization and allow a coronavirus vaccine on the market just before the November election.

The firms that have advanced into the third and decisive phase of trials with possible vaccines say they have not fully enrolled their studies with the tens of thousands of participants needed — a varied group of test subjects numbering at least 30,000 or so at dozens of sites across the U.S. Each trial participant must be carefully screened, with frontline researchers following tough rules to avoid biasing study outcomes, especially by being “blinded” as to whether subjects receive a placebo or the possible vaccine.

Study participants each get not one but two shots, and these must be separated by three or four weeks to give the body time to react and potentially develop its own virus-fighting capacities.

It is theoretically possible, with several clinical trials having launched at the end of July, that researchers soon will see results from a part of the overall trial group. But experts have said that it would be rare for such data to be so overpowering to be persuasive that a vaccine (or a drug or medical device or procedure — all the items subject to clinical trials) would be known to be a boon or bust.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the high value they can experience by staying as healthy as they can — and outside of the U.S. health care system. That system had its big problems before the pandemic, including with infections acquired in care giving institutions (hospitals and nursing homes), misdiagnoses, and medical errors — the third leading cause of death in the nation, by some expert estimates.

That said, we need to protect and improve the health system more than ever, notably with big support for public health and medicine based in science and evidence. We need to let experts with bona fide credentials, proven experience, and demonstrated results do their best work — without heavy mouth breathing and loud mouths hanging all over or attacking them. Our reputable and credible medical scientists need time, space, and resources, so haste does not make waste, and the country sees even more unacceptable, unnecessary, and tragic infections and deaths.

Rigorous study and a long history with vaccines has proven how they can be life savers and game changers, allowing human civilizations to make significant advances by minimizing and even all but eliminating diseases that have plagued people since the dawn of time. As with any medical intervention, vaccines have their risks and they are not absent of harms. But their benefits clearly have outweighed these.

While the world waits to see if modern science can develop a new vaccine at break-neck speed, we all can ensure that we and our loved ones, especially our young people, enjoy the advantages of the array of disease-combatting inoculations already available. We can do all we can to avert an awful double-whammy of doctors and hospitals battling both the seasonal flu and Covid-19 by getting that flu shot.

We know the rest of the valuable protective drill: We can maintain distance, bolster our hygiene (especially by washing our hands, often and well), cover our faces, and, for now, stay closer to home and away from crowded and closed or confined spaces. Maybe we pause our plans to hit the bar or dine inside that trendy restaurant. The coronavirus pandemic has been a terrible time and we have much work to do to battle the disease, so we all get to a healthy, better place.

 

 

 

 

 

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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