COVID-19: Is the vaccine safe? Should I get it? – Perspectives from the US

Given the evolution of the pandemic and the news about vaccines, many of us may be asking ourselves these questions right now, which we will try to answer with a double approach: technical and social, individual and collective.

Is the vaccine safe?

Despite the deep concern for our physical and mental health and for the economic situation, many citizens confess not wanting to be vaccinated, now that we almost touch the first version of that coveted vaccine with our fingers. The main concern: side effects. Nobody wants to be “first.” 

These beliefs reflect a significant gap in the information that is distributed each day. Society is bombarded with efficacy data (70%, 90%, 95%, 96%) and technical details (RNA, DNA, attenuated viruses, viral vectors) while pharmaceutical companies (Pfizer-BioNTech, ModeRNA, AstraZeneca-Oxford, Johnson & Johnson…) compete for the biggest piece of the pie. However, little effort has been invested in disseminating the safety data of these vaccines (and the basic knowledge to be able to interpret them) and, at the last minute, doubts assail us.

Medicines, vaccines and diagnostic devices are subject to complex regulations. Each country has its own laws, but the great economic powers (the US, Europe, and Japan, among others) are aligned to ensure high quality standards. The major regulatory agencies (FDA in the US and EMA in Europe) have maximized their cooperation with pharmaceutical companies to ensure optimal efficiency in the development and regulation of new products to diagnose, treat or prevent COVID-19, without mortgaging the quality that is required by law.

A fundamental and mandatory part before marketing a new drug is the set of clinical studies. They assess its safety (identifying types and likelihood of possible adverse effects) and its efficacy (ability of the drug to produce the desired effect). While “efficacy” refers to the benefit observed in the strictly optimal conditions of a clinical trial, “effectiveness” refers to the benefits the drug provides in the not-so-perfect “real world.”

Clinical trials are designed by pharmaceutical companies in collaboration with medical institutions and approved by regulatory agency (s) prior to initiation. Prior to clinical trials, by law, drugs must have been tested on animals (toxicity or preclinical studies). The first clinical phase is carried out with several dozen healthy volunteers highly monitored before, during and after the administration of the new drug. If the drug meets the required safety, the second clinical phase begins with hundreds of volunteers in which not only safety but also efficacy of the drug is evaluated. For its objective evaluation, a group of patients receives an inert substance or placebo and is compared with those who received the drug (without knowing who received what until the end of the study). The third and final phase involves thousands (even tens of thousands) of participants at various clinical centers (often several countries) and vast amounts of clinical data are collected to demonstrate safety and efficacy. So, none of us (even if we want to) is going to be “the first” anymore.

Also by law, the clinical data obtained during these studies are confidential until the drug is approved. As a former FDA regulator, I attest to the strict confidentiality with which this information is treated. However, due to the great public interest in the development of vaccines against COVID-19, pharmaceutical companies are issuing press releases to share their progress (to the extent possible).

Efficacy data are more difficult to interpret and the case of vaccines is especially complicated. The objective of a vaccine is not to cure but to prevent, therefore, efficacy studies are carried out with healthy volunteers, not with patients. By law (and ethics), participants cannot be deliberately exposed to the pathogen to evaluate the efficacy of a vaccine. It takes months for these volunteers to become infected (or not) in a natural and random way. It is a matter of time and numbers. After 2 months, 170 volunteers have been confirmed positive for COVID-19 out of the nearly 42,000 participants in the Pfizer-BioNTech study. Of these 170 infected, 162 had received placebo and only 8 had received the vaccine, indicating that it protects 95% of immunized volunteers. However, 170 is frankly a low number for solid statistical data.

My years of experience with the FDA provides me with great peace of mind as a patient. We are in a scenario with multiple vaccines in development, and the regulatory agencies have the last word to approve (by law) only those whose benefit (effectively preventing COVID-19) is shown to be greater than their inherent risk (non-severe adverse effects and / or infrequent). The most common adverse effect of the Pfizer vaccine: fatigue (3.8% of participants).

In contrast, the “secondary” effects of COVID-19 are mortality (variable probability according to multiple factors still under study), and short, medium and long term sequelae that include fatigue, respiratory failure, thrombosis, heart problems, lung damage, neurological and psychological issues, neuralgia, anosmia, hair loss, and a more extensive etcetera every day. As potential patients, we will soon be able to decide whether we prefer the side effects of the vaccine or those of COVID-19.

Should I get the vaccine?

We all have medical and illness experiences. But this “disease” is of viral origin and is transmitted by air; it is a pandemic, a “collective disease” that, as such, has to be diagnosed and “cured”. 

The world has changed since the 1917 pandemic. It has become very democratic -individuals decide-, education is no longer elitist -people know what they say and decide-, and women, finally, have a relevant voice -democracy has been duplicated-. Even the most autocratic leaders have to justify their decisions. More people want to decide what will happen to them. Each of us has much more power than in 1917.

Our Western mental model is dominated by our “independent” education. We want to “be better than the other” so that our life, even more in crisis, goes better for us. But the world is now multipolar, finally the “leaders” depend on the citizens. Trump could not build his wall, Obama could not close Guantanamo, they are “only” US presidents.

And here the dissociation between reality and our thoughts jumps. Bill Clinton said that interdependence is saying “we can’t get divorced.” In big problems (climate change, inequality, pandemic) we cannot “divorce” ourselves from others; we will only solve them jointly. But now we think that everything that affects us can be decided and resolved individually: “we have the right” (we forget the obligations).

We feel “empowered”, that we can make all the decisions about ourselves for ourselves. If we do not like the doctor’s decision, we search the Internet, ask for a second opinion or, more usually, challenge the doctor with what we “know”, with information, but without sufficient criteria to interpret it. If we don’t like the result, we demand it; we have a “right to health”. But we are saturated with fake news (Bill Gates is going to place a microchip inside us, a Soros plan, COVID-19 doesn’t exist, etc.). Before, information was power; now disinformation is power. We cannot trust the information, we lack judgment.

Anti-vaccine sentiment is widespread. It is no longer that “Americans are stupid”; the “smart” Europeans too: either they don’t want to be vaccinated or they don’t want to be the first, they distrust. Before COVID-19, the number of vaccinations in measles, in flu was decreasing; Health workers are the risk group that is least vaccinated against influenza. And of course there is limited and partial information about COVID-19 vaccines, and RNA vaccines are very innovative and we do not know the consequences, positive and negative, in the long term.

A student of mine from the University, when he saw that his grade was below average, complained because “no one should be below average”…. If 80% of the population want to be the “last” to be vaccinated, we will all suffer; before, vaccination would be declared mandatory. And in times of populism, authoritarianism and personal leadership, another government involvement can carry even greater risks for democracy, which is hard to come by and easy to lose. Democracy, freedom and health: we only appreciate them and fight for them when we don’t have them. We believe that we are smart and independent.

Ronald Heifetz, my leadership professor at Harvard, defines technical challenges (eg. otitis) that require technical solutions (antibiotic) and adaptive problems (eg. terminal cancer) that require adaptive solutions (you are going to die, the doctor cannot change it, you decide what you are going to do) and mixed problems (e.g. heart attack, it has treatment, but if you don’t change your lifestyle, it will relapse). But we want technical solutions to adaptive problems, where we are the ones who have to change our way of thinking and acting in order to solve them. There is no technical solution.

In 2050 there will be more deaths from bacteria that are multi-resistant to antibiotics than from cancer, and this is because we all abuse them. If you want more antibiotics for your son, my grandson could die. Your individual decision affects others. We cannot “divorce” from others.

A West Point manual defines leadership today as “everyone jumping out of a plane without a parachute, but each with a piece of the plane that we have to build to avoid crashing.” If someone doesn’t jump, we won’t be able to save ourselves. Do you want to get vaccinated?