The baseball legend Yogi Berra noted that “It ain’t over ‘til it’s over” in connection with the 1973 pennant race. This observation has inspired many to keep fighting in the face of almost certain failure. In 2020 the fight has been against a virus that seems intent on killing or crippling a large segment of the human population. Many of our fellow humans decided it did not exist and refused to fight. Others chose to wear masks, avoid large gatherings, etc. and support efforts to develop a vaccine.
Unfortunately, the leaders of the U.S. government failed their constituents for reasons I still cannot fathom and left a quarter million of the people they swore to protect dead and several million more permanently injured. As private industry worked to develop vaccines, the government promised to buy whatever they came up with but made no other substantial contribution to the effort to slow or stop the spread of Covid-19. Senator Ted Cruz even predicted that no one would be talking about Covid-19 after the presidential election. Well, the election came and went, and the only people who are not talking about the virus and the accelerating toll it is taking on our country are the invertebrate (that is, spineless) politicians who have ignored it from the beginning.
Private industry claims it has developed at least three good vaccines and more are in the pipeline. These vaccines will undergo “Emergency Use Authorization” reviews by the FDA, after which they will be distributed to hundreds of millions of people at taxpayers’ expense. Unlike a routine FDA review, the emergency review allows for a fairly cursory examination of the materials provided by the drug companies. Customarily the FDA review would take several months at a minimum, and the hundreds of thousands of documents provided by the drug company applying for safety and efficacy certifications for its vaccines would face considerable scrutiny. Questions would be raised, additional documents requested, and internal audits performed. With emergency use reviews, this assessment is impossible.
The FDA assumes the industry applicant is rushing its product to market for humanitarian reasons and that the applicant has performed due diligence on its own. Of course, there are financial rewards for being first or even the first to be second, but, truth be told, the financial rewards associated with vaccine developments have been relatively meager. A $2 billion contract for a company like Pfizer, the vaccine maker most likely to get the first emergency use authorization, has no real impact on its bottom line.
Obviously, there is concern that the vaccines will not work in the real world and may even prove dangerous. People enrolled in clinical trials are not as diverse as the general population. To be enrolled in the trial you must meet numerous predetermined criteria. The objective is to eliminate distracting noise that may confound the interpretation of the results. This is wise and appropriate, but when the vaccine is distributed to tens of millions or hundreds of millions, there will be surprises. History has taught us that many of these surprises may be worrisome. No, I am not saying that vaccines cause autism. That widely circulated myth has been repeatedly debunked as nonsense. Nonetheless, when the vaccine is injected into millions of people, the unexpected should be expected.
Friends, relatives, and other nosey people have asked me if I would step up to get the vaccine as soon as it is available. Yes, I would. No, I do not intend to wait to see if the first few million survive the injections before I get into line for a shot. Given my negative view of the drug industry and my disappointment with government oversight of that industry, you may wonder why I recommend vaccination as soon as possible. It is simple math: the virus is moving too quickly to advise caution. If the drug companies have deluded or failed us and the vaccines are not as safe or effective as they have claimed, much of the elderly population of the U.S. will die and much of the not so elderly population will be left crippled.
We do not have the luxury of time to wait and see. Operation Warp Speed fired its warp engines about nine months too late. Even after the government reported its launch of this program, the impact of the cleverly named initiative was imperceptible. Pfizer actually declined to accept government financing for their vaccine development. The company apparently saw no advantage in letting the current administration “help” it. Pfizer had been working on vaccine development for several months before the government decided it might lend a hand with a Star Trek-inspired moniker.
Why do I say the government effort was too little too late? This virus is called Covid-19 because it appeared in 2019, not 2020. We had many months to mount a defense against this killer. Those months were wasted by the politicians hired by us to protect us. They made speeches, held super-spreader rallies, and played golf while we died. They reassured us that this was a hoax, even after they themselves had trouble breathing and their friends and supporters (remember Herman Cain, laid to rest Aug. 7) died from the virus.
And so should we wait to see how are neighbors fare after getting vaccinated? Hell, no. Our government may be inept at addressing emergencies, but it is fairly good at keeping track of casualties. The infection rate is skyrocketing. Hospitals are overflowing. Funeral homes are overwhelmed. If you do not know someone who has been ravaged by this virus, you must be in a coma or in Congress.
We have been bloodied by this plague, and it is not over yet. “It ain’t over ‘til it’s over” still applies to this pandemic. The vaccines may slow or stop the spread of this misery, but we are left not knowing how we shall we be at the end of it all. If the vaccines work, we shall have a future and, hopefully, shall be wiser and more prepared for catastrophe than we were a year ago. If the vaccines work, we shall have cause to quote a real statesman who earned his salary by fighting to protect the people who elected him and observed, “… this is not the end. This not even the beginning of the end, but it is perhaps the end of the beginning.” For the challenge we currently face, we need a Winston Churchill, not a Yogi Berra.
Dr. Lechtenberg is an Easton resident who graduated from Tufts University and Tufts Medical School in Massachusetts and subsequently trained at The Mount Sinai Hospital and Columbia-Presbyterian Medical Center in Manhattan. He worked as a neurologist at several New York Hospitals, including Kings County and The Long Island College Hospital, while maintaining a private practice, teaching at SUNY Downstate Medical School, and publishing 15 books on a variety of medical topics. He worked in drug development in the USA, as well as in England, Germany, and France.
