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What if a vaccine does not work?

What if a vaccine does not work?
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The White House reportedly tried to block new federal guidelines this week that would slow down production of a COVID-19 vaccine until after the election. As a physician who has spent 35 years developing biopharmaceutical products I have participated in or led many urgent programs, including for AIDS. I find the White House's rush to ram through a vaccine — and the administration’s all-consuming confidence in its potential efficacy — to be ill-advised.  

Most of the world is awaiting the results of clinical trials of vaccines for SARS-Cov-2, the virus that causes COVID-19. Vaccines are never a slam-dunk; look at the 33 years that have passed since the first clinical trial of a vaccine for AIDS, with none in sight. 

Some vaccines can even make things worse. Years of clinical trials are needed to get crucial safety information that can only be determined in patients who get the disease after receiving the vaccine. I have never seen a program where political factors have interfered as they are doing now. The political forces in the White House must not be allowed to stop the FDA from setting rules on the safety data needed to grant emergency access to an unapproved vaccine.

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None of the ongoing clinical trials will be able to provide this type of information at the first data readouts that are planned to drive early FDA approval. 

There are two ways that COVID-19 vaccines can fail: first, they may cause antibodies to form that do not prevent infection; second, they may make things worse for an important group of patients. 

Alternatively, a vaccine could work not by preventing infection, but by reducing its severity. In that case, the early readouts would be negative, but much later results could demonstrate a crucial benefit. 

Finally, a vaccine could work well enough to be approved, but not well enough to pass the stricter tests for early approval. The studies will be positive if they reduce infections by half, a test that will take six months or longer. To be positive after only two months, they will need to decrease infections by nearly four-fold.

What is the plan in case early readouts are negative? Is the nation prepared to continue on its current path until we achieve herd immunity? That will take years, and we have already seen the governor of Florida throw in the towel. The state with the third highest number of cases and the fifth highest of number of COVID-19 deaths has determined that it will no longer attempt to control this disease.

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Why do we want to control COVID-19 infections? Some political leaders seem to have forgotten the heroic struggles of Italian health care workers who faced more critically ill patients than there were ICU beds or ventilators. They have also forgotten how, after their leaders told New Yorkers to carry on and not worry, New York City barely kept things under control. Its ICUs operated near capacity, patient floors became COVID-19 floors, and the critical shortage of PPE risked the lives of medical personnel. Doctors and nurses flew in from all over the country to save New York City. The governor of Florida seems oblivious to the hard-won knowledge of COVID-19’s ferocity.

The strategy of the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) has been to make certain that our health care system is not overwhelmed. It is not to prevent everyone from getting sick. Even with a vaccine, that strategy remains essential; we may just need it for a shorter period. 

No group is immune to this disease. Though rare, babies have died from COVID-19. While younger people have a lower risk of death, as more are infected, more will die. 

COVID-19 is not even one year old. As our knowledge grows, so does our state of preparedness. Americans have adapted. In May, 45 percent of Americans refused to wear masks. By August, 85 percent of people wore them most or all of the time. 

Americans urgently need an organizing principle to appear in our national government — a move from chaos to order, from politics to science, from gut feelings to data. At the same time, Americans need to realize that science is always evolving. The best available answers today may be different in six months. We have already seen that happen with masks. 

Our leaders need to promulgate a shared, national policy supported by the data and a clear scientific consensus, that can evolve with our understanding. The focus of this policy must be to keep our health care system and our economy functioning well while minimizing the risk of death. It must recognize that distance learning, as implemented to date, is failing many of our students. And as hard as it is for students, it can be intensely stressful for their working parents. It must also recognize that life in sequestration may be worse than no life at all for some people. 

Most importantly, we need to base our plans on reality. There is no guarantee that even an effective vaccine will show safety and efficacy in October. We need a Plan B in case the initial results are not good enough and we're left having to wait another three, six or even 12 months. And we need a variant on that plan, in case the road to herd immunity is longer than we hope. 

Without planning, all we will have is chaos.

Kenneth Gorelick, MD, is a board-certified internal medicine and pulmonary disease specialist and a member of the Committee to Protect Medicare. He has more than 35 years of experience in the development of drugs, biologics, and medical devices in the health care sector.