Far from cause for celebration, this 4th of July marks the 6th wave of Covid-19, with BA.4 and BA.5 variants leading the parade. As one variant of concern follows another, the world remains in a state of disarray as disarrayed researchers and governments chase the virus in a seemingly unending game of whack-a-mole. Each new variant of concern is either more easily transmissible (as with BA.4 and BA.5), better at evading acquired immune protection from previous acute infection or vaccination, and/or more virulent.
The June 28th meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, VRBPAC meeting was emblematic of the system’s disarray. The panel’s mission was to decide whether to approve a new booster (hopefully, available by this fall) to provide protection against the latest variants of concern. The group recommended the booster by a 19 to 2 vote margin based on data demonstrating no reduction in, much less protection from, BA.4/BA.5 transmissibility.
Acting Chair, Dr. Arnold Monto argued that this action was necessary because Covid-19 is “a virus that doesn’t follow the rules.” Dr. Monto seems to be ignoring the fact that the virus is following the rules – its own. Such thinking marries the hubris of continuing our, at best, anemic past response to the pandemic (which has been reactive instead of proactive) with denial of the fact that other strategies must be developed if we hope to get ahead of the pandemic.
Over the last 30-months, our incomplete understanding of how the SARS-CoV-2 virus works as well as the many weaknesses of our healthcare pandemic response have become manifest. While one cannot change the past, it is possible to acknowledge what has not worked, refocus, and take actions to correct multiple disconnects if we are to reverse direction toward a healthier tomorrow.
Here are 5 issues we must address if we are to get off of this dangerous and descending route:
1. Our Understanding Of Covid-19 Is Still Rudimentary
Beyond the deaths of so many innocents, the continuing paucity of basic scientific information about the disease (as evinced by Dr. Monto’s statement on our understanding virus behavior) is still alarming. Today, too few researchers and critically less clinicians can stand up and give any serious discourse on what happens when viral infection begins and precisely how SARS-CoV2 damage is caused in the body. It should be evident by now that Covid-19 is not a respiratory disease, and we would be far better off acknowledging this as soon as possible. Of course, injury does occur in the airways and lungs but also widely throughout the blood vessels, with one of the virus’ primary damaging effects now known to be activation of the complement system, driven specifically by early hyper-activation of the lectin pathway, an important part of innate immunity.
It ultimately comes down to this – it isn’t just about sparing us from ineffective therapeutics predicated on scientifically inaccurate ideas, it’s about dangerous therapies that slow down and can even preclude the adoption of effective medical protocols. Just to reinforce this principle, here are a few additional questions that would be wonderful to answer: What other damage does Covid do to our bodies and how can we fix it? Once we “get over” Covid-19, what’s the prognosis?
2. Covid-19 vaccinations are becoming problematic in so many ways that we need to rethink their use.
SARS-CoV-2 is not the flu, yet Covid-19 vaccine success it is being measured using influenza vaccine statistical modeling. This is little more than confirmation bias which reinforces preconceived notions that Covid-19 is just another flu and, as expected, is yielding disappointing results. Immune protection, whether from acute infection or vaccination, wanes. With this waning of protection, we become increasingly vulnerable to infection, re-infection, severe infections requiring hospitalization, and death. However well-intentioned, the VRBPAC members, in an attempt to do something, have approved modifying a vaccine that was designed to protect against a viral strain that is barely circulating. The vote to extend approval for the new vaccines is like advocating for administration of the 2019 influenza vaccine for the 2022 flu season.
3. Covid-19 stays with us longer that we think and what does it do?
I recently spoke with Dr. Ami Bhatt, a celebrated hematologist at Stanford University, who lead a team focused on Covid-19 viral fragments that persist in the gut that was recently reported in Nature. She and her team have been studying Covid-19 patients for more than a year. She became interested because, despite reports at the time that much of the virus focused on respiratory concerns, many patients also reported vomiting and diarrhea. She published results last month showing that viral fragments persist in the gut for months after infection.
A few people, she found, shed viral RNA in their stool as long as seven months after a mild or moderate infection. Though the data in her study focused on infections during the first wave of the virus, the Omicron variant(s) raise critical questions, she believes. Dr. Bhatt plans to collect comprehensive longitudinal symptom data on patients to see if new variants are better at infecting the gut. She intends to study whether the GI symptoms with Covid-19 play any role in developing Long Covid. At the root of her work is understanding what role, if any, a person’s microbiome might play in terms of Covid infection and outcome.
4. Our healthcare system is fragile and persistent Covid-19 stress will accelerate exposure of critical weakness
A rush to formulate and distribute vaccines at the start of the pandemic was an understandable effort to save our healthcare system from being overwhelmed. Operation Warp Speed was initiated in the belief that this pandemic would be both short-lived and containable if we could stop transmission. While well intentioned, the basic premise was flawed because it was based on seasonal influenza models. SARS-CoV-2 is neither influenza nor is it seasonal.
Covid-19 did not create nationwide healthcare staffing shortages or overstretched hospital systems, but it did accelerate the problems. We now have health care providers at the point of burnout and hospital systems taxed to their breaking points. Without considerable reform and support, this status is unsustainable.
5. A declining global economy, a declining will to fight Covid-19 and all of this as we enter into another pandemic surge
We are now in the second half of 2022 and here in the US, President Biden has yet to obtain any new large-scale funding commitments from Congress to continue our Covid-19 fight. Even basic research into Covid-19 and investment in critically needed medicines have become sparce. Here and abroad elected officials don’t want to discuss the pandemic anymore, let alone spend any money on it. The public and even the media are exhausted from even thinking about it.
Yet, if you look at the rates of infection and re-infection, it is far more reasonable to say that we are only half-way through the pandemic. And all of this as global conflicts, inflation pressures, supply chain upheavals, societal polarization and general psychological distress have taken their toll. This should give us pause.
We must change this parade route
As we should understand by now, Covid-19 is a problem that cannot be dealt with piece by piece or on a stop and start basis. It is not a problem that can be dealt with by a single country. This pandemic is and always will be a global problem that requires global efforts to solve. If together we remember these points then in the future we can look forward to healthier and happier 4th of July celebrations.