An investigational vaccination against COVID-19 has now been approved under FDA Emergency Use Authorization and is available to designated groups.

This will be the quickest scientists have ever been able to develop a new vaccination for a major disease. It typically takes years to create a new vaccine, but sometimes despite the best efforts of scientists, success eludes them.  As a result, we have no vaccination against HIV, hepatitis C, or malaria, to name just three examples.

The technology used for the first COVID-19 vaccinations being brought to market by Pfizer and Moderna uses a mRNA or messenger RNA technique. Significantly, this is the first time that an mRNA mechanism is being used in a vaccine. For the most part, mRNA technology is used in cancer therapy. It has had some success in producing various proteins to attack and disrupt certain cancer cells. Most of the commentary so far suggests that it may not be too much of a leap to use this approach in vaccinations as well.

The vaccine developed by AstraZeneca for COVID-19 uses a different mechanism. The good news is the AstraZeneca vaccine can be stored at normal refrigerator temperatures for up to six months. The bad news is it is only about 70 percent effective. This vaccine, however, may become the preferred one in third-world countries because of the storage issues.

Is there controversy connected with the use of these new vaccines? Yes. Here are some of the areas of concern:

• The trial data on the vaccinations released so far have not addressed the issue of transmission of the virus. That is, the data are based only on symptoms and COVID-19 testing, not on transmission to others. Could the vaccine create asymptomatic carriers who can unknowingly transmit the virus?

• Most other previous efforts to develop vaccines have used animal studies first to assure safety in humans. This was not done with these new COVID-19 vaccines.

• The 90 to 95 percent efficacy of a controlled study may be very different from the experience in the real world when massive numbers of people are involved. For example, data from the Centers for Disease Control and Prevention show that the influenza vaccination efficacy for the 2017-18 season was approximately 38 percent; only 20 percent was achieved in the 2018-19 season; and just 39 percent for the 2019-20 season. When the influenza vaccination was first introduced in 1938, the efficacy was expected to be much higher than current numbers suggest.

• The CDC data show that the survival rate of those contracting the disease goes up as age goes down. If you are less than 70 years old -- 99.5 percent; if you are less than 50 years old -- 99.98 percent; and if you are under 20 years old, the chance of surviving COVID-19 is 99.997 percent. Seasonal influenza is a greater risk to the young than is COVID-19. Weighing the benefits versus the risks of accepting the COVID-19 vaccine could be very difficult, especially for the young. It is unlikely, therefore, that I will recommend vaccinations for my young patients to protect them against a virus that more than 99 percent of them would survive should they contract it.

• The same companies (and executives) that look to profit from this vaccine are also immune from all liability. In 1986, Congress passed the National Childhood Vaccine Injury Act (NCVIA). It provides immunity from liability to all vaccine manufacturing companies. Many people are working to change this law. Rather than blanket immunity, I would propose establishing national limits to damages along the lines of California’s  Medical Injury Compensation Reform Act (MICRA).

• Will enough people get the vaccination to help reduce the spread of COVID-19? At best, only 50 percent of us choose to get an annual influenza vaccination despite the fact that it is widely available, inexpensive, and safe. In 2018 only 45 percent of those older than 18 received the flu vaccination. In 2017 that number was 37 percent. Even for seniors older than 60 this number reaches only 68 percent.

• Minorities tend to be skeptical of the government and especially vaccinations administered by the U.S. Public Health Service. The USPHS and the CDC carried out 40 years of secret experiments in a study of syphilis, using blacks as test subjects. Can we overcome such a  history to get the vaccine to the most vulnerable?

• We know very little about the longevity of the immunity acquired for COVID-19 from natural infections or from the vaccines. Will the vaccinations give long-lasting immunity or will a booster be needed? We have no lasting immunity from influenza, for example. Since the virus is constantly mutating, we have to get a new flu shot annually.

• The detailed safety data for the vaccines have not been released as of this writing. Are two months of trials enough time to be certain of the safety of the vaccines now being presented to the public? I am against a mandate to force this vaccination on anyone. In light of the limited safety data, it must be a voluntary prevention strategy.

• In 1976 we attempted a mass vaccination of the population with a newly created swine flu vaccine. The vaccination program was aborted, however, after some 450 people came down with Guillain-Barré syndrome, a rare neurological disorder. How will the memory of this epic government failure affect the rollout of a new mass vaccination program?

• We are now hearing rumblings that the COVID-19 vaccination could be made mandatory for air travel, international border crossings, or other activities such as entering a theme park or government building. What could possibly go wrong with that requirement?

I am not opposed to vaccinations, per se, including the COVID-19 vaccination. I am very hopeful that the vaccines will be safe and effective for those at highest risk.

But I am opposed to any government requirement for the vaccination or any private or public dictate about the vaccine that infringes on a citizen’s freedom of choice. I strongly support informed consent for all vaccinations, which currently is not the U.S. standard.  

While these questions are being answered and the other caveats mentioned above are resolved, we have to note that we are getting better and better at treating COVID-19: the death rate in terms of population continues to fall, hospital stays for COVID-19 get shorter, and hospital mortality from COVID-19 plummets.

A COVID-19 vaccine, in other words, should be viewed as one of many tools to combat the pandemic but not as the savior that many believe has arrived.

Image: Pxhere