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Observations From a Family Doctor

The COVID-19 Vaccines are Coming:

Here’s 4 things that are different from past vaccines.

Speed of the process. In early April the Trump administration created a program called Operation Warp Speed (OWS) which created temporary programs to unite government, scientists and businesses without much of the typical red tape to develop a rapid response to the pandemic. One of the components was creating the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines), a partnership between NIH (US National Institutes of Health) and 18 biopharmaceutical companies. ACTIV is searching for both vaccines and drugs to combat the pandemic.

By eliminating the existing regulating components, the scientists were able to start the process of vaccination development within a few days, and within a few weeks began the first steps of specific vaccines. These steps are the Exploration stage (lab testing only) and Pre-Clinical stage (tissue and animal testing), which normally take 3 to 6 years, were done within the month. Then the human studies began. These also take several years to complete and consist of Phases I-IV. Phase I is done with 20-80 volunteers to check on basic safety and efficacy (will it kill or seriously harm people and does it trigger the immune response). Phase II uses several hundred volunteers and repeats safety and efficacy tests but also adds the best dose and schedule of the vaccine. Phase III is the same as II but uses tens of thousands of volunteers. Phase IV is started after the public is allowed to get the vaccine and is the long-term monitoring of the vaccine’s effectiveness.

Phase’s I-III usually take several years, but 3 vaccines as of August 15, 2020 are in phase III and 2 are in phase II. Since Phase’s I-II went very well, it’s reasonable to expect Phase III on these 3 vaccines will go well and, in a few weeks, will be ready for mass production. Around the world there are over 150 COVID-19 vaccines being developed. Russia has decided to skip Phase III on a vaccine they named Sputnik V and will already start giving it to the public.

Type of vaccines. All of the current vaccines are using the modern technology never done before on such a wide scale. These techniques are only a couple of decades old and used only in small scale programs, but indeed are the future of vaccines. Basically, we’re going from horse and buggy to the automobile with these types of vaccines.

One type is using a known virus that is not lethal to humans and attaching material from the lethal virus, COVID-19. To be clear, no live COVID-19 virus will be used. Only particles of the virus will be in the vaccines, so there is no way you will get COVID from the vaccine.

The other type is using genetic code from the virus that allows our cells to accept the package of another genetic code that makes our cells produce antibodies against the virus.

Funding for the vaccines. One of the most frustrating things for scientists is getting money for breakthrough ideas. A scientist needs to get other people’s money to go forward on any project, unless you’re Bill Gates or Elon Musk. ACTIV eliminated this by having the government paying the companies early on in the process, either by granting money or purchasing vaccines before Phase III.

Moderna and Astra Zeneca/University of Oxford received grants of 1 billion and 1.2 billion dollars respectively. Pfizer and BioNTech each got 1.95 billion dollars for 100 million doses of vaccine. And Johnson & Johnson got 1 billion for 100 million doses.

This process of funding has eliminated months to years of lobbying and negotiations.

Distribution of the vaccines. Another move made by the Trump administration was to have the Department of Defense be the distributor of the vaccine. Typically, the CDC will coordinate with private and public distribution systems. This works fine when it’s either small scale or the same vaccines that have been given to the public for decades, like the flu shot or children’s vaccines. The CDC has wisely agreed to step aside and let the DoD be the distribution network. The generals, with the assistance of the CDC, have already started planning who will be the first to get the vaccines and how they will be getting them from the factories to the people in the fastest way possible.

There are still some questions about the vaccines that will not be answered before they begin giving them to the public. One is the duration of immunity, or how long will you be protected before needing another shot/booster. Another is how many doses to begin with, although most companies are assuming two shots with a few assuming it will just be one. A third question is the short- and long-term risks of the vaccine. We are such a diverse population and only after millions of us get the vaccine will we really have an idea of side effects. Of course, it will take years before we truly can be sure of any adverse effects these new vaccines will have. And finally, will the vaccines actually have an impact on reducing the transmission of COVID-19.

During times of urgency or when the medical needs are overwhelming, doctors have developed a system of triaging. This is an imperfect method that saves more lives but does eliminate the thoughtful process that is used to treat an injury or disease. There will be flaws in the process of these vaccinations. There will be some resistance and protesting about the vaccines. But overall, this process is what must be done if we want to minimize the damage this pandemic has done and will do over the next year if left alone.

Be safe, be happy, and be healthy,

Dr. Stinson

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