By Cynthia Pearson

The NWHN is far from alone in embracing efforts to develop a vaccine for COVID-19, which is critical to being able to return to something even resembling a normal life. We are, however, disappointed that full disclosure of all of the important data isn’t happening as yet—and that, in some circumstances, federal officials are ignoring the need to guard against financial conflicts of interest during vaccine development. But the basic idea that the federal government is spending lots of money to develop and produce a vaccine? That sounds good to the NWHN.

Full disclosure. I’m a white Baby Boomer, raised by parents who trusted doctors and thought vaccinations, especially against polio, were a miracle of modern science. I’m also a feminist health activist who is skeptical of Big Pharma, and more comfortable sharing decision-making with my doctors than simply trusting them. I choose my vaccinations depending on the evidence and my personal risk factors. I recognize that others — especially Black, Latinx, and Indigenous folks, whose communities’ health was knowingly undermined by the federal government — may start from a very different place when considering getting vaccinated. For those who want to evaluate whether to get the novel coronavirus vaccine, once one exists, here are a few things the NWHN will use to assess the safety and effectiveness of any new vaccine.

Did the vaccine study include women? People of color?

Vaccine trials should include both women and people of color in proportion to their share of the population. In fact, because people of color are more likely to be diagnosed with and die of COVID,  it’s fair to argue that Black, Indigenous, and other people of color (BIPOC) should be over-represented in these trials. But, it’s not appealing to volunteer to test something you might not be able to afford once it’s for sale. For this reason, members of Congress and the executive branch should start implementing policies that guarantee the vaccinations will be free to consumers, and that profits are limited. This is not only the right thing to do but will also help encourage broader participation in vaccine trials.

Did the study include enough people over 65?

While the likelihood of getting infected after being exposed may not be worse for older folks, the likelihood of developing severe symptoms is; and, once older folks are sick enough to go to the hospital, their outcomes aren’t good. 2 Here at the NWHN, we won’t accept excuses that older folks are “too difficult” to recruit, or that they can’t be relied on to return for follow-up visits. Those excuses are just laziness on the part of researchers. Tens of thousands of older men and women have participated in trials of menopause hormone therapy and shingles vaccinations, among other things. Their participation in COVID-19 vaccination trials is crucially important.

Was the vaccine tested against a placebo?

All of the coronavirus vaccine effectiveness trials seem to be randomizing volunteers to get either the experimental vaccine or a shot with inactive ingredients (placebo). 3 That’s the way it should be done. Other approaches, like comparing folks who’ve been vaccinated to others in the same neighborhood or school aren’t reliable. We won’t trust the results of a vaccine trial that isn’t both randomized and placebo-controlled, and nor should you!

What do the researchers mean by “effectiveness?”

Do they mean people who got the vaccine were less likely to report symptoms? Less likely to be diagnosed with COVID by a physician? Less likely to get a positive test result? Less likely to be hospitalized? We’ll be looking for a study that includes both test results and symptoms. Knowing whether or not people who got the vaccine were less likely to be hospitalized is also important. If a vaccine prevents some of the milder cases, but doesn’t protect against serious
cases, that’s important to know.

How effective is the new vaccine in preventing what was measured?

The Food and Drug Administration (FDA) has announced that the agency wants any new vaccine to be at least 50% effective in preventing laboratory-confirmed COVID. 4 We’ll be watching carefully to determine if an approved vaccine actually met this minimum standard.

What do we know about safety?

Well-run trials identify the most common risks and side effects. Their limited size means, however, that a vaccine’s rarer risks and side effects can’t be identified until after the vaccine is in widespread use in the population (see box). If you are eager to get a COVID vaccine as soon as possible, and aren’t worried about less-common risks, getting vaccinated will help you and also help generate population-level information about rare side effects. If you don’t want to risk experiencing a rare and potentially serious complication, hold off on getting the vaccine until we have more information.

Finally, does it look like political pressure led to premature approval of a vaccine?

As health activists, we know the FDA is our shield, protecting us against unsafe products and ensuring that consumers can get information that drug companies would rather bury. But, we also know that the FDA has caved in response to political pressure before. It took a lawsuit to prove that FDA officials were doing the White House’s bidding when they overruled their own scientists and refused to allow Plan B to go over-the-counter without age limits. 5 We lack that kind of proof that the FDA was following Donald Trump’s directives when it approved an emergency use authorization for hydroxychloroquine as a potential COVID-19 treatment — but the agency’s action looks suspicious to us and to many others. 6 Consumers must trust that a new vaccine has been fully and rigorously reviewed. Approval on an emergency basis or that’s announced just a few days before the November 3rd elections, will raise warning flags for us.

When a COVID-19 vaccine is closer to fruition, we will be closely examining the details about the composition of the study groups and the study methodology; the trials’ outcomes, particularly with respect to efficacy, and the potential impact of any undue political influence. We’ll let you know what we think about the vaccine’s potential to help respond to the pandemic. Until then, stay safe.

It’s unusual for a vaccine that looked reasonably safe in a large clinical trial to cause serious complications once in widespread use, but it has happened. In the 1990s, the FDA approved the first-ever vaccine against rotavirus (RotaShield), which causes serious, even deadly, diarrhea in infants. The vaccine had been tested in more than 7,000 infants and appeared to be safe. Once in wide-spread use, however, it quickly became clear that the vaccine caused a rare type of bowel obstruction. RotaShield was withdrawn and new, safer vaccines are now used. But, the numbers are illustrative. RotaShield increased the likelihood that infants experienced bowel obstruction by 20-30 times, an extreme increase in risk. Still, the complication only occurred in 1-2 of every 10,000 infants who were vaccinated. These numbers make it clear that it’s almost impossible to uncover rare but serious complications before vaccines are approved.

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1 The Atlantic, The COVID Racial Data Tracker, New York (NY): The Atlantic Monthly Group, no date. Online:
https://covidtracking.com/race.
2 The Centers for Disease Control and Prevention (CDC), COVID-19 Hospitalization and Death by Age, Atlanta (GA):
CDC, August 10, 2020. Online: www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-
discovery/hospitalization-death-by-age.html.
3 www.clinicaltrials.gov information on phase 3 COVID-19 vaccine trials NCT04368728 (BioNTech & Pfizer) and
NCT04470427 (Moderna). Accessed 8/15/2020.
4 Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, Development and Licensure of
Vaccines to Prevent COVID-19 Guidance for Industry, Washington, DC: FDA, June 2020. Online:
www.fda.gov/media/139638/download.
5 Hamilton MA, “The Recent Federal District Court Decision Regarding the ‘Morning After’ Pill: How It Reveals
Evidence of the Bush White House's Interference with the FDA, Where Religion Displaced Science to the Detriment
of the Public Good,” Find Law, April 2 2009. Online: https://supreme.findlaw.com/legal-commentary/the-recent-
federal-district-court-decision-regarding-the-morning-after-pill-how-it-reveals-evidence-of-the-bush-white-houses-
interference-with-the-fda-where-religion-displaced-science-to-the-detriment-of-the-public-good.html.
6 Kaplan,S, “Stephen Hahn, F.D.A. Chief, Caught Between Scientists and the President,” New York Times, August 10,
2020, page A-1 (August 11). Online: www.nytimes.com/2020/08/10/health/stephen-hahn-fda.html.