Your Oct. 23 editorial about how to safely make vaccines, was typical of most of your recent editorials: Highly politicized.
Your bottom line was to protect from criticism those who are, in my opinion, "slow-walking" the release of at least several vaccines that are ready to go. Furthermore, as a result of the "Warp Speed" program authored by the Trump administration, and paid for by about $2 billion of taxpayer money, there are literally millions of doses stored up and ready for distribution.
President Trump has assigned the Army to be responsible for rapid distribution of the vaccines, correctly starting with those at most risk.
So, what’s the problem? After all, this is a pandemic. Would it not be good to get the vaccines out as quickly as possible? No, you say, we must be sure they are safe! Perhaps you are unaware that drugs must go through three phases of testing. They are now completing Phase 3, to ascertain degree of effectiveness.
Perhaps you are unaware that safety is the concern of Phase 1 and Phase 2 — but of course it continues to be monitored throughout Phase 3 as well. So, a high degree of safety has already been established. And remember, we are not re-inventing the wheel here: Vaccines in one form or another have been used since the 18th century. (Remember Edward Jenner? Look him up.)
I have been involved in numerous complex drug studies in the past, and I can tell you that these require regular monitoring by their sponsors, to assure a high degree of accuracy in patient selection. In all the drug studies in which my practice participated, recruiting was the biggest problem, as it has been with the vaccine studies.
But curiously, the vaccine studies required a "placebo group" equal to 50% of the group total. In most drug studies, the ratio is 75% active drug recipients and 25% placebo. This makes recruiting easier, since the odds of getting the real vaccine are much higher. So here is an example of "slow walking" the study that most people won’t catch because they are not familiar with drug research.
I would ask another question: Do we need a placebo group at all? I ask this because, during a pandemic, the entire population can be considered a "control group," since they are not getting the vaccine and are all at risk. But our drug-approval bureaucracy was not buying it: They know that if anything goes amiss, they will get the blame.
Will they accept the blame for the thousands of people who may die because they are slowing down approval of existing vaccines already in storage? Not from people like you, who are trying to justify the slowdown.
Finally, you wonder whether protection will require yearly "booster shots" like the flu vaccine. Influenza viruses mutate far more than most viruses. That is why yearly shots are given. But flu mutates so fast that even that isn’t always enough to ensure an effective vaccine.
But, in fact, mutation studies done on COVID-19 show that while it does mutate (like all viruses) its structure is such that rapid mutation, such as in the case of influenza, is highly unlikely. While it is too soon to know for sure, it is highly unlikely that controlling COVID-19 will require yearly treatment.
So vaccines on hand should be approved quickly and treatment started. The risk of unknown side-effects is minuscule, while the risk of death from COVID-19 in our elderly population and among persons with other diseases is high.
James H. Ransom is an emeritus physician at Topeka Allergy & Asthma Clinic in Topeka.