Wednesday, October 20, 2021

Who shouldn't get vaccinated? The informed part of informed consent.

 Ten months after the vaccines became available, we now have meaningful data that can guide people deciding if they should or shouldn't get themselves or their children vaccinated against covid.

The best available data about the actual risks of the mRNA vaccines--specifically the Pfizer/BioNTech shots--come from a joint Israeli-Harvard Medical School study evaluating the medical records of more than 1.6 million people, half of whom received two Pfizer jabs while half remained unvaccinated. I reported on this study here, and you can find the peer-reviewed paper itself, published in the New England Journal of Medicine, here.


Of course. But what are the actual risks and benefits?

Credit: Nick Youngson

The study found that just five side-effects occurred more frequently in the vaccinated groups in the six weeks following vaccination relative to a comparable time period for the unvaccinated group. These included swollen lymph nodes (78.4 additional cases per 100,000 people), shingles (15.8 extra cases per 100,000), appendicitis (5 additional cases per 100,000), Bell's palsy (3.5 additional cases per 100,000) and myocarditis (2.7 additional cases per 100,000, almost all in young men).

If we add all those side-effects together we find an incidence of 105.4 per 100,000 fully vaccinated people.

It's worth noting that those symptoms vary in seriousness. The most frequent--swollen lymph nodes--is a predictable, rarely serious, reaction to vaccination, while the remaining four potentially more serious conditions represent a total of just 27 additional cases per 100,000 vaccinated people.

To keep things simple and clear, you can safely estimate that if you get two rounds of the Pfizer vaccine, your risk of suffering any reaction worse than a sore arm is around 1 in 1000, and your risk of a serious side-effect such as shingles or appendicitis is around 1 out of 3700.

We can compare these risks to the risks from covid itself in a variety of ways. Here are several that readers may find helpful:

Risks from covid in the Israeli-Harvard study: Among the 800,000 participants who remained unvaccinated, a significant number contracted covid. As is typical of covid, not all of those developed serious symptoms. However, far more did experience significant symptoms and sequelae from covid than were seen in their vaccinated peers. These included cardiac arrythmia (166 extra cases per 100,000), acute kidney injury (125.4 extra cases per 100,000), pulmonary embolism--a blood clot in the lung--(61.7 extra cases per 100,000), deep-vein thrombosis (43 extra cases per 100,000), myocardial infarction--a heart attack--(25 extra cases per 100,000), myocarditis (11 extra cases per 100,000), pericarditis (10.9 extra cases per 100,000) and intracranial bleeding (7.6 extra cases per 100,000).

So, in the same 6 week period, the unvaccinated group suffered serious, very serious or potentially fatal symptoms such as acute kidney injury, pulmonary blood clots or heart attacks at a combined rate of 443 per 100,000. That's more than four times the rate of all the vaccine side-effects combined, and 16 times the rate of the potentially serious vaccine side-effects.

Risk of contracting covid in the US as a whole. As of 10/18/21, there have been 45,798,599 recorded covid cases in the US. That's a case rate of 13,733 per 100,000 people, accumulated over 22 months. It's not possible to predict the exact course of the pandemic going forward, but for the average American the risk of contracting covid, say in the next 12 months, is probably 50 or 60 times higher than the risk of any side-effect from the vaccine, and several hundred times higher than the risk of any of the more serious side-effects.

As critics of covid vaccination point out, many covid cases are relatively mild. However, in the US over the course of the pandemic so far, about one out of every 20 people who contracted covid got sick enough to require hospitalization.

Risk of covid hospitalization in the US as a whole. As of 10/18/21, the cumulative covid hospitalization rate in the US reached 694 per 100,000. That implies that the average US resident is 6.6 times more likely to have been hospitalized because of covid than they would have been at risk for any negative reaction to the vaccine, and 26 times more likely to have been hospitalized from covid than to have risked a serious reaction to the vaccine.

Again, the first 22 months of the pandemic don't tell us what the next 22 months will bring, but the risk continuesespecially among the unvaccinated.

Again, vaccination critics point out that "covid has a 99 percent survival rate." That's not quite true. In the US so far, 1.6 percent of recorded covid cases have resulted in recorded covid deaths. We can now compare that to the risks from vaccination.

Risk of death from covid in the US as a whole. As of 10/18/21 the cumulative rate of deaths from covid hit 224.5 per 100,000 people. That means that on average, a US resident is 2.1 times more likely to have died from covid since the start of the pandemic to date than to have risked any negative reaction to a vaccine, and 8.3 times more likely to have died as a result of covid than to have risked one of the serious reaction to the vaccine.

Risk of covid deaths state by state. As of 10/18/21, five states had cumulative covid death rates less than 105 deaths per 100,000 population. Those are Oregon (99), Utah (96), Hawaii (87), Alaska (59) and Vermont (55). For residents in those states, which comprise just three percent of the US population, the odds of having died from covid so far in the pandemic are somewhat less than the risk of having any negative reaction to the vaccine, but still two to three times higher than the risk of one of the serious vaccine side-effects. Even in those states, however, the risk of hospitalization from covid is significantly higher than any of the risks from the vaccine.

The remaining 97 percent of Americans live in states where the risks of contracting covid, becoming seriously ill, being hospitalized or dying from covid are greater than the risks of any negative sequelae from the vaccines.

Risk of covid deaths county by county. You can check your county's cumulative covid death rate on this map. If you're in one of the darker blue counties--most of which have very small populations--the cumulative death rate per 100,000 people is less than the risk of side-effects from the vaccine. Still, unless your county's cumulative death rate is less than 12 per 100,000, as it is in Orange County, Vermont (population 29,000) or Skamania County, Washington (population 11,066), your risk of hospitalization from covid is higher than any risk from the vaccine.

Risk of covid deaths from breakthrough infections: We now know that vaccine-induced immunity fades over time, and that the delta variant in particular is causing a significant number of fully vaccinated people to fall ill. However, the vaccines are still highly protective against severe illness and death. Perhaps the most striking statistic is that out of 187,000,000 fully vaccinated Americans, 7,178 have died from covid, or just 3.8 per 100,000. That's less than 6 percent of the 124,000 Americans who have died from covid since mid-July, when the delta variant became predominant.

In summary, for the large majority of Americans, the risks of getting covid, suffering one or more of the serious impacts of covid, having to be hospitalized because of covid, or dying from covid are all far higher than the risks of any side-effect of the mRNA vaccines, and, even against the delta variant, the vaccines remain highly protective against severe illness or death.

What about children?

There is one group, however, for whom this may not be true. As many critics of covid vaccination have pointed out, the risks from covid are significantly lower for young people. For example, the cumulative covid death rate for children under 15 is less than 5 per 100,000, comparable to the death rate for fully vaccinated adults. For 16 and 17 year-olds it's 9 per 100,000, and from 18 through 29, 16 per 100,000. If we were just comparing the risk of dying from covid to the much less serious but documented risks from the mRNA vaccines, one could potentially come down on the side of not vaccinating young children and teenagers.

The picture changes if we include the risk of children needing to be hospitalized because of covid. The cumulative covid hospitalization rate for children 0 through 4 is 87 per 100,000, and from 5 through 18, 51.8 per 100,000. These are less than the risk of any side effects of the vaccines, but higher than the risks of serious side effects. Luckily, young children are less likely to be severely sickened or to die from covid than adults, but a significant number do need to be hospitalized.

Safety and efficacy trials of covid vaccines for children from 5 through 11 are currently taking place, and the White House has announced plans to promote vaccination of children ages 5 through 11 once a children's vaccine is approved. We should have more data specific to that age group within the next few months.

Individual risks vs. social responsibility

The risk ratios discussed above refer to individual risks. That is, one could decide to be vaccinated or not based only on comparing one's own risk of contracting covid, or of requiring hospitalization, or of dying vs. the known risks from the vaccine. However, public health authorities point out that, much like choosing to wear a mask, getting vaccinated doesn't just protect the person getting the jab, it also protects others by reducing the likelihood that that person will infect others. This multiplicative factor becomes significant when large numbers of people in a population remain unvaccinated, and so provide a continuing medium for the virus.

Currently, 43 percent of the US population remain unvaccinated, or more than 143 million people. Around half of those are adults who would incur low risks from vaccination yet could protect themselves and others by doing so. As long as they choose not to get vaccinated, they remain a big, wide playing field across which the coronavirus can continue its advance.