Build Vaccine Trust: Publicize *all* risks and data

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Millions of people are lining up to get Pfizer’s COVID-19 shot without being told the FDA sees a risk they will get a more severe case of COVID-19 after the initial protection fades. Testing hasn’t lasted long enough to find out. If the public isn’t warned about *all* risks now, they may not trust vaccines even if full testing demonstrates them to be safe.

Author’s view:  Vaccines for other diseases have saved hundreds of millions of lives. [Those signing can disagree with that estimate]. If people lose trust in the vaccine approval process they may not take those vaccines either, putting many lives in jeopardy.

The UK, US and Canadian governments provide documents for patients and health care workers explaining the vaccine. Yet as of Dec. 12th, 2020: none of those mention this important issue acknowledged by the US government only in sources most people will never read.

 The non-partisan US government’s Congressional Research Service explained: “experts are concerned about the potential for vaccine enhanced disease, in which vaccination could worsen the health effects of COVID-19 infections […]. Animal studies of other coronavirus vaccines have found some potential for vaccine enhanced disease”

medical journal says after the dengue vaccine’s initial effect faded “vaccinated children in the 2–5 year age group, were found to be nearly 8 times likely to be hospitalized for severe dengue, compared to children in the placebo group”.

The  FDA’s initial review of the Pfizer and BiNTech vaccine says its makers “identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk.” and the FDA adds “risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies”. Unfortunately the short testing period wasn’t long enough to assess the risk.

Media in countries hit hard by COVID-19 haven’t called attention to the issue to date. In contrast a Japanese paper quoted the director of the Japanese  Society of Clinical Virology: “Concerns over ADE still remain. I am an elderly person myself, but if I were asked, I would say I don’t want to get a shot.” Elsewhere he explained: “In the past, a dengue vaccine proved effective in tests and was widely used, but then it worsened symptoms for people who were still getting infected.”. A leading professor of Immunology testified to Japan’s House of Representatives: “There’s no doubt that their effectiveness is quite high, but their safety is not guaranteed at all”.

Hopefully continued testing will discover COVID-19 vaccines are safe over the long run, but they don’t understand COVID-19 well enough to predict that.

Many people are impatient for a vaccine and will get it regardless of potential risks. However polls show others won’t yet risk getting inoculated. Governments and manufacturers need to earn the public’s trust by being completely transparent about all known  risks of every vaccine and letting the public decide for itself when they feel its safe enough.

Experts who feel the vaccine is already worth the risk need to explain their reasoning and evidence in a way the public can understand. Alternatively they need to educate front line healthcare professionals, government officials and journalists who have more experience communicating with the general public.

There is a natural temptation to downplay risks to not worry the public. That may backfire and lead   people to lose trust  if the risks aren’t addressed clearly upfront. They may react as if it were a “cover up” even if the risks were acknowledged, but were buried in the fine print of documents most people won’t read in the hope people wouldn’t notice . 

The FDA’s “FACT SHEET FOR RECIPIENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE” explicitly includes: ” INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS” which advises giving people “The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.”

Yet the vaccine enhanced disease risk isn’t mentioned. The government needs to follow its own advice. If not: the public may wonder what else they aren’t being told.

Dr. Fauci in the US and regulators in the EU critiqued the UK as having moved too quickly to approve a vaccine. How is the general public to assess whether any countries, including the US, moved too quickly, or perhaps not quickly enough? The process needs to be as transparent as possible so people trust that politics, wishful thinking, or impatience don’t interfere with scientific judgement.

In general all relevant data and evidence relevant to evaluating every vaccine should be made public for every expert around the world to “peer review” on an ongoing basis. If not: the public should be informed exactly why this isn’t possible. Millions of people in free countries don’t see why they should be required to trust  their lives and health to a secret process performed by a limited number of people, no matter how qualified they are. They’d rather trust the combined expertise of the entire world.

Limited exceptions are understandable to maintain patient privacy and protect the integrity of ongoing trials. Shareholders of companies producing vaccines should consider that earning the public’s trust will benefit them in the long run. for more info and to spread word.