Vaccines Don’t Save Lives…Vaccination Does

Moving our nation and the world in the direction of the era A.P. (After Pandemic) has been one decidedly fraught with uncertainty, frustration, loss, and grievance. But it is the right direction in which we all choose to move. Ending the “pandemic” moniker will only happen through immunization, and most of that is being conducted by the administration of COVID-19 vaccines.

The former Surgeon General of the United States, C. Everett Koop, once noted “Drugs only work in people who take them.” That’s true, and it’s also true with vaccines. Having supply sitting on shelves (and not administered to communities) isn’t solving the pandemic. In working with some federal and regional organizations to solve the challenges of vaccine hesitancy, it’s clear that there is an intense interest by most of the population to be immunized; And also that a small proportion continues to exist for whom data and evidence cannot subvert emotion and opinion.

But this brings to mind two issues as I forecast out for the year regarding the pandemic and what’s next:

1. We’ll probably never reach ‘herd immunity’
2. The pandemic’s end will be as divisive as some of its worst days

We’ll probably never reach ‘herd immunity’

In epidemiological circles, we’ve discussed concepts such as R0 and herd immunity for decades. Unfortunately, the past year has made the laypublic their own favorite armchair epidemiologists. They often live in a “data-free” zone, where they can cherry-pick the material they choose to surround themselves with on social media, and thus can endlessly succumb to ‘confirmation bias’ – which is the idea of only subscribing to those ideas which ipso facto agree with your opinions.

For this particular virus’ virulence, it’s estimated that ~60%-80% of the population would need to be immunized to build what we call ‘herd immunity.’ This is simply the idea that if this proportion of the population are immune to being infected or transmitting the virus, then it becomes very much harder for the virus to propagate through vectors in the community to reach naïve patients to make them ill.

This is a level of vaccination that is unlikely to be achieved through our Federal and state rollouts even in all potential adults. In addition to this, we still don’t have an authorized vaccine for children, which represent a large number of people in the nation.

There are several trials ongoing for the COVID-19 vaccines in kids, one in ages 12-15, and another in age groups 6 months to 12 years. The data from the first of these trials should be available by this summer, after which a determination can be made if we should authorize the vaccine for that particular age range.

While this would allow some kids to be immunized this fall for the next school year, it wouldn’t include all age groups. It continues to be true that kids aren’t at risk for COVID-19 to the same degree as older adults, but there are certainly parents who would elect to vaccinate their children if they had the opportunity. This also means that kids could continue to be a reservoir as long as they are not immunized, and thus preventing achievement of a threshold of herd immunity.

The pandemic’s end will be as divisive as some of its worst days

The Biden Administration has repeatedly touted the idea of a summertime line in the sand for vaccination, including suggesting that small group gatherings could occur for Independence Day. For those who are immunized, this will continue to be difficult messaging. Those who are a couple weeks beyond their final vaccination dose (whether with the 1- or 2-dose vaccine) are considered immune, and can re-engage in normal behaviors to the extent they are publicly or privately allowed.

We have seen severe cases of COVID-19 drop in many regions of the US, and also deaths associated with COVID-19 cases. Once these metrics continue to plummet, and at the same time we have our ever-accruing vaccine administration metrics telling what percentage of the country (or state, etc.) are immunized, there will begin to be contrasts drawn between the rationale of the pandemic’s extent, and other infectious diseases. For example, we incur between about 5,000 and 80,000 deaths in the United States each year from influenza. In fact, 4 out of the last 5 pandemics (80%) have been due to flu.

At some point in time, the rate of hospitalizations and deaths from COVID-19 will pass some ‘breakeven’ point with other community illnesses (flu, colds, pneumonia, etc.), and there will be intense pushback from members of the public to justify the continued recommendation or enforcement of our preventive measures (masks, distancing, etc.) when we haven’t clinically applied these measures for other competing pathogens.

The different risk calibration and tolerance of individuals in the general public will be a cause for a very divisive end to the pandemic.

The state of vaccine safety

As you’ve no doubt seen in the news, there have been breakthrough stories of incredible optimism about the effectiveness and distribution of the vaccines – and also the counterpoints of manufacturing and supply problems as well as adverse safety signals, which may or may not be statistical phantoms (i.e., with AstraZeneca/Oxford’s ChAdOx1 vaccine candidate). At the moment, it appears that issues with AZ’s vaccine candidate (that it causes blood clots) is a statistical fluke that appears to be a very very rare occurrence, and happening at a rate no different from the ‘background rate’ (the rate we would otherwise see in a normal untreated population).

These analyses are being conducted right now by trained pharmacovigilance experts. It’s easy to introduce doubt or fear into the public. It has been an oft-used strategy by nefarious nation-states since the dawn of civilization. But undoing fear requires much more work.

What is true is that the checks-and-balances we have (FDA, CDC, ACIP, VRBP, etc.) exist to protect public health by requiring compliance to regulatory standards. Issues that have been seen and resolved with these vaccines are all underpinned by our industry’s best practices, and the authorized vaccines available now (Pfizer/BioNTech, Moderna, Janssen) remain spectacularly effective and very safe.

Of recent note in the news, the FDA and CDC have recommended a pause in the national administration of Janssen’s COVID-19 vaccine. This was due to the presence of 6 cases of blood clots that presented in patients. For full context, there were also 6,800,000 doses administered so that the rate of blood clots seen is about 1 case in 1.14 million doses. This is extraordinarily low. However, it is a particular type of blood clot known as a cerebral venous sinus thrombosis, and that is why it is being investigated to see if there is any plausible link to the vaccine or any of its constituent ingredients. All of the authorized COVID-19 vaccines (Janssen, Pfizer/BioNTech, Moderna) have very few ingredients, and so the investigation into potentially-related factors should be relatively straightforward.

Additionally, Pfizer/BioNTech and Moderna have been delivering more than 23 million doses – weekly – of their two-dose mRNA vaccines to the US, comprising a significant majority of the US’ vaccine distribution and administration. No significant safety concerns have emerged from either of these vaccines.

We have been directly involved as an organization in the development of many vaccine candidates, which are not only helping in the current global crisis, but they also include technologies that are being adapted for future emerging diseases;

Your work is truly at the frontlines of directly impacting public health.

Footnote on immunization

We believe that vaccination continues to be the only way to truly get to the end of the pandemic, and epidemiologically-speaking, achieving immunity in the community via vaccination rather than natural infection leads to significantly fewer poor health outcomes, severe illnesses, and deaths. There is also strong vaccinological evidence that immunity developed by vaccines is stronger than that generated by recovery from a natural infection, and likely to last longer, too.

Black Diamond CEO, Mike Sklar, has recently communicated across the organization his advocacy for protecting friends and family by being vaccinated.

Remember – Vaccines don’t save lives, vaccination does.