Vaccine experts are doing their best to see us through the pandemic, but they are not sure what to make of the situation in which we find ourselves this late summer.
The experts are torn, (not at the CDC which recommends the shots for the adult population). An article in STAT News, a medical and science journal, describes that independent vaccine experts are split about the benefits of broadlyoffering the recently-released, bivalent, reconfigured doses. And their debate is playing out publicly. Let’s visit the issue of why this vaccine version has them perplexed.
This pandemic has been mind-boggling. We have seen new intracellular technology rise to center stage with the advent of human licensing for mRNA technology with these shots.
We have learned a lot as these product have been rolled out as our best path forward. They were novel, unprecedented and unproven. Drastic times call for drastic measures. We based our original strategy on very preliminary data from the drug company trials. We went full steam ahead based on the promise of the data points from the first month of the trial. There was much at stake.
Public Health has been bruised from some early missteps, such as describing breakthrough cases as exceedingly rare. The picture was not clear at the outset and is actually still emerging. Side effects, including serious ones, still need to be precisely calculated. The safety signals around these vaccines are currently being vetted. It takes time to decipher. Like any drug there is a risk-benefit consideration. Take on the risk when the benefit stands to be great.
Fortunately, we are not in nearly the drastic times of 2020. Does it mean we can be more discerning? More calculated?
With the release of the newly reformulated bivalent boosters this month, we have a new ingredient being proposed to carry us through the fall campaign: hope.
Follow me closely here. The main promotion of the new booster is hope — hope as opposed to data. Hope is leading us when data cannot. There is no human data on these shots. It wasn’t studied. Not enough time, perhaps?
In June 2022, the FDA granted a pass to the companies that make mRNA vaccines. They were allowed to skip future human trials. No more human studies were deemed necessary to pass future versions of these covid shots. It is a gift for the companies in one sense, and let’s us have newer products; but without data to back them, it leaves room for questions and leaves us in the position of having to hope for the best.
“This will hopefully give us the kind of immunity we need right now,” FDA vaccine chief Peter Marks said.
At the CDC advisory committee meeting to review data on these shots last week, new data from 8 mice were presented (from Pfizer). The mice had a meaningful antibody response to the vaccine.
We hope it translates into enough benefit in our already vaccinated, already infected population. We hope it translates to something meaningful in the setting of a thankfully weak variant which has low affinity for receptors in the lungs. We hope the immune system incorporates the immune stimulus in a helpful and meaningful way after 2, 3, or 4 previous shots. But we don’t know because we have no human studies.
Not an Emergency but Not Free and Clear
Cases are low. The case load nationally is down to just over 70,000 cases daily. Locally we had an average of 27 cases per day recorded in Berkshire County. Severe disease is thankfully more rare. There are decent treatment options.
“Most Americans might not get, or even particularly need, another booster right now,” the STAT article states.
“Nor are we sure how long the new vaccine’s protection will last, a foggy question that shifts with each new variant’s lessons. [Officials] are careful not to promise reduced transmission, particularly without solid human data for the new vaccines on the table.”
“Biden officials are tiptoeing around messaging on what the updated shots can do, and what they can’t, stymied in part by the fact that there is not yet solid human data. Officials and outside allies described to STAT a need to temper expectations that this booster will protect against future variants, or to dispel notions that this booster might be the last one a person needs.”
Action is Best?
But it still is a serious task to protect our most vulnerable populations this winter. The shots have always made more sense in the more vulnerable who have more to gain. If there were no risk with medical intervention it would make sense to broadly recommend it. But with investigational and emergency measures that’s not the case. The track record isn’t established.
I work with some basic principles around medicine that form my foundation. Maybe you will find them helpful.
- Your belief matters. If you have affinity for a medicine, it matters. It can go a long way to establishing it as a good medicine for you… and vice versa.
- Hesitancy has been given a bad name, but the precautionary principle is an important pillar on which I’ve built my practice. The pharmacology department at my medical school ingrained in me the risks of incorporating new products right away. Over 4% of new drugs get pulled off the market after approval.
- I say frequently the least amount of medicine you need is the right amount.
- Let your actions be your best medicine. Learn good detox habits like exercise and exercise. Did I mention exercise? And a whole food diet rich in vegetables is as important as good rest and habits reinforcing a balanced soul life.
I don’t think there is a right or a wrong action on this topic. I think it’s notable that sweeping recommendations are hard for the experts right now. Certainly considering individual affinity for the intervention and individual risk profiles makes a lot of sense to me.
In the future society will think differently on many topics compared to what we think now, and individually we will be satisfied if we can say we wrestled with the facts and took an active part of drawing a sensible conclusion. In this particular instance feeling the complexity and perplexity are authentic, for better or for worse. As always, we are here to help you navigate any and all issues. Reach out with any questions.
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