In her column at the Washington Post Leana Wen identifies two scenarios that could “derail vaccination efforts”. The two scenarios she identifies are the known side effects and the attribution of deaths from other causes to the vaccine. Her proposed mitigation for these is openness:
It must be made clear from the outset that side effects are normal and expected. Downplaying them can only backfire. Both the Pfizer and Moderna vaccines require two doses — a primer and booster shot — and someone who experiences an unpleasant side effect after the first shot may not return for the second. It’s important to hear from people such as Froehlich and Yamane about what they went through and why they remain huge proponents of the vaccine. Those receiving vaccines also must be advised on home care (for example, take Tylenol or ibuprofen for fevers and aches); otherwise, many may go to the ER and further strain an overtaxed health-care system.
To be clear, my nightmare scenario isn’t the side effects themselves, but rather the misinformation about them that could dissuade people from getting vaccinated.
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Let’s say that someone receives a vaccine and then — unrelated to it — succumbs to a heart attack. Heart disease is the No. 1 cause of death in the United States, and the individual may have had long-standing conditions that led to the tragic outcome. Still, the time course could raise questions. What happens if several people have heart attacks in the days after they receive a vaccine — how does one prove that the vaccine was not the cause?
There are ways to anticipate and mitigate this concern. In advance of mass vaccinations, the Centers for Disease Control and Prevention can provide baseline numbers for expected illness and death among nursing home residents. If, say, 50 people in a given time period would be predicted to die of heart disease, that provides statistical context for interpreting individual tragedies. In addition, every possible adverse event must be investigated immediately, with full transparency and complete rationale provided to the public. Otherwise, disinformation will fill the void.
I’d like to propose a few others, none of which can be mitigated proactively by openness. First, what is being proposed is that two or even three orders of magnitude more people will have been inoculated over the next several weeks than have participated in the clinical trials. Using the rule of thumb employed in such things that is actually quite likely to reveal side effects that did not appear during the trials. It could be among a small number of those being inoculated or a larger number. We just have no way of knowing.
Second, even if the virus itself was not a weapon of war, which I believe is a reasonable conclusion, that active disinformation campaigns associated with the vaccination will be deployed by Russia, China, North Korea, Iran, and who knows what other countries is practically a certainty. There may also be domestic politically-inspired disinformation campaigns. With 20% of people getting most of their news from social media which is practically synonymous with saying that they can’t tell a reliable source from an unreliable one, it’s hard to see how openness can mitigate this particular risk.
Third, both Moderna and Pfizer may be overstating their abilities to deliver the vaccine in quantity. They have multiple reasons for doing so including goosing their stock prices and warding off competitors. That’s something else we have just no way of knowing.
And then there are the unknown unknowns. Both the Moderna and Pfizer vaccines employ mRNA, a novel approach with which we’ve had very little experience. I point these things out not to discourage people from getting inoculated or to throw cold water on the process but in the hope of ensuring that we all have a realistic assessment of the issues.
Here’s one question I have for Ms. Wen. Why do 40% of physicians and 60% of nurses say they don’t plan to take the vaccine? If openness is the solution, wouldn’t you expect the best-informed to be less reluctant to get inoculated?
She must do only administrative medicine. She expresses real concerns and issues, but not worried about side effects? Really? Fever is a sign of Covid. If people get fever from the vaccine, sounds like they do, with any frequency it is going to be hart to sort things out especially with our lack of testing ability. Someone is going to get sent home being told it is just a reaction to the shot then do poorly when it is really Covid. I am less worried about heart attacks. Not a normal side effect and I doubt people will see it that way. A few cases of GBS would be another story.
As to docs and nurses first, a lot of them really arent that well informed. Many of them are influenced by their politics, religion or whatever they believe in. Second, some of us have seen drugs that dont work so well or that cause problems. A lot of us understand that when it comes to vaccines the safest course, usually, is to make sure everyone else but you takes the vaccine. That way you get all of the benefits with none of the risk. Now we arent even sure of all the risks and we really dont know the benefits. How long will the vaccine last? Can you still be infectious? Not really an easy decision.
Steve
Or narcolepsy as was caused by the adjuvant in one form of the H1N1 vaccine used in Sweden and Finland.
Yep. Those are among the questions I’ve been asking. It also doesn’t help that all interests are not aligned.
And, as I pointed out in the body of the post, there are the unknown unknowns. 20 million people inoculated is virtually guaranteed to be different from inoculating 50,000 people. If that weren’t the case, trials would only need to involve a handful of volunteers.
And inoculating 7 billion people will be that much different again.
And I didn’t even delve into the complication of a dozen different vaccines. If problems arise with one of whatever sort, what effect does it have on the rest? How much can we trust the Chinese or Russian vaccines? They may not be used here but news of their effects could reach here whether they’re used or not.
I’m not sure what Ms. Wen’s credentials are other than she writes on public health issues. So do I 😉 But I’ve never seen a vaccine given without an information sheet (I believe from CDC) about known side-effects, and when to seek medical care.
I think she’s blurring things together in a nonsensical fashion. The symptoms she is describing are common to all vaccines, why credit this vaccine as different?
The flu vaccine produces the most common serious side effects, which is an apparent increased risk of Guillain-Barre Syndrome (injury to nerve cells from immune response that is rare, typically followed by full recovery, but in extreme cases can leave permanent nerve damage). The increased risk the vaccine poses of GBS is extremely slight, and one is more likely to get GBS from a bad case of the flu than the vaccine.
Which I think points to an issue that does not seem to be discussed much — vaccine injuries tend to mimic injuries caused by the disease being vaccinated against because the vaccine is seeking in some safer way to trigger the body’s immune response to the disease. The person with the atypical response to a vaccine is likely to be a person with an atypical response to the virus.
Does COVID-19 cause heart attacks? We know heart attacks are up in 2020, either because people are avoiding medical treatments during a pandemic or in severe cases the virus is causing myocardial injury that may lead to heart attack or continued risk of heart attacks after release. I don’t know what statistical elaboration she thinks would help here. People afraid of heart attacks should consider getting vaccinated and encourage others to get vaccinated in order to reduce your own risk.
And I wrote this before reading steve’s post mentioning GBS.
A Mississippi nurse commentor at Marginal Revolution reported that about 25% of nurses said they didn’t want to be vaccinated in response to a survey the hospital sent around. If the nurse said “don’t know” or “maybe later” it was treated as not wanting to be vaccinated presumably because they were preparing to prioritize how to distribute the initial doses. The commentor said that he/she responded positively to vaccination, but those nurses who didn’t expressed the view that they hadn’t gotten it so far, so there’s no hurry.
One more comment, then back to work:
The Pfizer briefing tomorrow apparently shows efficacy of the vaccine after the first dose was 88.9%. This is more effective than most vaccines, so they are apparently studying whether it makes sense to go with a single dose or delay the booster for longer than the initial plan. Could be doubling vaccine coverage and I don’t think Wen’s concern about people not coming back for a booster poses that significant of a public health risk (perhaps it increases the individual’s risk, but if the vaccine goes to another person, it increases community safety). Also, the second shot was the one that hurt more:
“Severe adverse reactions occurred in 0.0-4.6% of participants, were more frequent after Dose 2 than after Dose 1 and were generally less frequent in older adults (>55 years of age) (<2.8%) as compared to younger participants (≤4.6%)."