Will You Take The Vaccine?
Leonard Zwelling

         If there is one thing in short supply in America today, it is trust in our major institutions. This surely includes the government. Who can tell when the man in the White House is telling the truth or one of his 20,000 and counting lies? Not I.

         In the political arena, the Big Lie has a long history and has been used to control populations for centuries. Therefore, we should not be surprised by the use of lies by the president (Biden is not for defunding the police, for example) to get himself re-elected. I’m not talking about that trust at all. That’s politics.

         I am talking about whether or not the American people have trust in those agencies of government whose main role is to keep them safe—the police, health departments and most importantly, one federal regulatory agency currently in the spotlight—the FDA.

         We live in a country where the anti-vaccine movement is potent. Outbreaks of measles due to the reluctance or fear of many Americans to get their kids immunized has become the stuff of current events. There is pent up reluctance to get immunized already using vaccines known to be safe and effective. Now comes the 64-dollar question. Let’s say the Trump Administration and the FDA offers you a new anti-coronavirus vaccine on November 1. Would you take it?

         On the plus side, the pace of progress in developing such a vaccine appears to be remarkable. Major pharmaceutical firms using cutting-edge technology have rapidly pushed testing to the phase three trial point. Large-scale efficacy and safety testing has begun, but how fast will we know if it works and how sure will we be that it’s safe? Not by November 1.

         Efficacy could be known quickly if challenge testing were ethical as some people have espoused. This is where those getting the vaccine are purposefully exposed to the contagious agent to find out if the vaccine, putatively proven in these people to have elicited antibodies, actually protects those vaccinated. Given that the coronavirus is potentially fatal, this seems to have crossed the ethical line to me, but others disagree and believe that challenge testing is ethical. It would be quicker, but no one has put such plans into effect yet. The current trials use randomization between active vaccine and placebo and send the volunteers out to their communities to see who is protected. This cannot possibly be known in two months. Early 2021 seems more likely.

         Then there’s the issue of safety. Short-term safety (e.g., people contracting covid-19 from the vaccine or having fatal side effects) could be known quickly. But what about long-term side effects? What if those subsequently exposed to the coronavirus after having received the vaccine have an acute allergic response or go into cytokine storm. It is not likely that will be ruled out by November 1.

         Finally, are you sure you trust your friendly FDA any longer? It pushed through the use of hydroxychloroquin under what appeared to be political pressure. Ditto the benefits of convalescent plasma. Too many Americans who got sick with covid were not part of good clinical trials, while this was not the case in Great Britain which did a better job recruiting human subjects into ethical trials than we did. Where was the federal government’s leadership to use the country to make medical progress? Absent as it was with everything else about this pandemic.

         As with most things surrounding the coronavirus pandemic, the United States has gotten most things wrong. Lots of people (over 180,000) have died WITH covid. Who knows how many died FROM it?

         For a country that likes to take pride in its clinical research infrastructure and great progress in academic medicine, the United States is not really leading in the coronavirus crisis other than in deaths. Just say for me I will be the very second person to roll up my sleeve for any novel coronavirus vaccine that is using never before tried technology on the whole population. I don’t trust the regulatory agencies to be free of political pressure to have a vaccine by Election Day. It’s too fast. These things take time to be done right and with a vaccine that is proposed to be given to the population of the world, I will tend to be a little more patient.

         I still believe we will wearing masks on New Years Eve along with funny hats.

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