As stakes soar for Covid-19 vaccine, concerns rise about this one big bet

vaccination-300x199As the novel coronavirus infections and deaths keep skyrocketing, Americans more and more have been forced into tough risk analyses, and frankly, too often thinking like gamblers. They are, for example, looking a lot at the much-promoted possibility of a Covid-19 vaccine in desperate poker ways — “betting on the come” and playing “river, river …”

Experts are asking just how savvy this health care approach is, putting in high stakes in the hopes the deck is dealt just so, or believing in a cliff’s edge rescue when the last cards on the table are flopped over to reveal a winner? Is it reality check time? And is there is a Plan B?

Vaccine makers around the world are racing to produce a viable response to Covid-19. U.S. infections have skyrocketed past 4 million and the disease is heading toward killing 150,000 Americans. Politicians and public health officials continue to speak optimistically about “Operation Warp Speed” and other campaigns globally to develop a vaccine that experts say will play a vital role in blunting Covid-19’s sickening and lethal spree through humanity.

In recent weeks, Big Pharma firms have reported promising data as they push through at a record pace a vaccine’s development and clinical trials. Several different vaccines have gotten through the first two phases of trials showing on not much more of a handful of test subjects that the fundamental theories for a given vaccine make sense, don’t seem to imperil people, and produce responses in the body that would be helpful in battling Covid-19 infection.

Several companies now are muscling into the biggest and toughest phase in getting a product to market — testing their inoculation on tens of thousands of subjects in rigorous fashion to show that a vaccine safeguards at least half the subjects who get it from the virus for some time while not causing them undue harm. How does the vaccine work with the old and the young? Men and women? What kind of side-effects may it have?

Even under hurried circumstances, this testing phase will take time — several months at least, if it proceeds without complication.

But so far, so good, right? Experts have said so. To avoid “irrational exuberance,” however, it may be worth pushing back from the gaming table, so to speak, and heeding some of the cautions and even alarms sounding about the high hopes for a coronavirus shot.

To be clear, a vaccine is not a vaccination — getting the protective material in place is just a first step in what can be a big and complex logistical challenge. This includes coming up with hundreds of millions of specially designed glass vials to contain vaccine dosages, as well as ensuring there are hundreds of millions of syringes to inject the shots. Or that alternative options to get the vaccine in the body really do work and are available. Patients may need two doses of the coronavirus vaccine to ensure its maximum effect, doubling the supply chain demands.

Vaccines also typically must be handled differently than other medical supplies — notably they require refrigeration. This complicates their shipping and storage, especially because some of the vaccines in the works may require much cooler temperatures than usual to keep them viable before use.

If a vaccine is developed and ready to go, it may take time for makers to scale up to meet the whopping worldwide demand. So, what will be the priority for inoculating various people or groups across the country? Can the wealthy jump the waiting lines? Should older Americans — who have experienced scary mortality rates with the disease — get the shot first? Should it be given early to residents of nursing homes and other long-term care facilities? Will priority be given to health care workers, first responders, military personnel, and law enforcement? How about the low-paid “essential workers” who have kept the country running? And who will ensure that no inequities occur in vaccinating communities of color, especially African Americans, Latinos, and Native Americans (people, again, who have taken a disproportionate hit from the disease)? Will there be due attention paid to vaccinating the poor, homeless, and incarcerated?

A giant, nationwide vacation campaign would seem to call out for big, sustained federal involvement and leadership. Is the Trump Administration, which has run a shambolic response to the pandemic, thus far, up to the challenge? What could be forecast about this prospect, based on the federal action in just the last few weeks and months, on Covid-19 testing or the handling of personal protective equipment (PPE) and other medical equipment and supplies (think ventilators)?

The president has sidelined existing federal expertise on epidemics and medical matters, for example, mostly sending the Centers for Disease Control and Prevention into exile. How will the White House coordinate and direct the officials and agencies that have run vaccination efforts before, especially if they jostle among themselves over difficult and critical concerns like determining who gets the vaccine first and how?

The administration — noted for unceasing investigations of its cronyism and corrupt practices — has sunk billions of dollars into prospective vaccines, making big investments in companies that have never produced a vaccine before and with no record of having the capacity of producing inoculations at the scale now envisioned. Companies have been candid and blunt that they intend to profit off their vaccines if they work. Big Pharma firms are raking in billions of dollars by asserting even tangential ties to Operation Warp Speed.

How might unchecked corporate avarice or nationalism or xenophobia complicate Americans’ prospects for having an effective and helpful Covid-19 vaccine?

With science denialism peaking, too, especially in the White House itself, will leaders be able to persuade a skeptical public to get coronavirus shots at numbers high enough to trigger the much desired “herd immunity” that will extend a vaccine’s protective effects? Have the extreme and unfounded views that have proliferated during the pandemic magnify the counter factual beliefs of those who oppose vaccines or hesitate to get them? Will the anti-face covering, authority suspicious advocates go on public jags about the Covid-19 shot(s), damaging their usefulness?

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the real benefits they can enjoy by staying healthy and out 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, the system needs public support as never before, especially to ensure that the Covid-19 pandemic does not overwhelm or wreck it beyond repair.

We’ll need to wait, with hope and caution, to see what medical scientists can develop to prevent the coronavirus or to treat it much better. Vaccines have been game changers before, eliminating infections that have plagued civilizations for centuries. Just as with any medical intervention, they come with risks. But these have been far outweighed by their benefits.

The world will benefit in a big way, if vaccines can help slash the coronavirus’ rack and ruin. We can’t see them, unrealistically, as the alpha and omega of stopping the Covid-19 pandemic. We’ve got a lot of work to do in the meantime to fight the disease as we can now — with distancing, hand hygiene, face covering, and common sense.

Shown above in CDC file photo: Care giver and patient receiving inoculation
Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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