A COVID-19 vaccine is on the way

What you should know about it (as we wait)

The race to develop a safe vaccine against COVID-19 has led to the development of more than 50 clinical trials of vaccines in people around the world1, with many offering real hope for long-term protection in the near future. In the United States, the Centers for Disease Control and Prevention (CDC) is working closely with state health departments and partners to develop vaccination plans based on years of preparing for a pandemic. While it may take time for a vaccine to be available to everyone, it is important to remember the following:

• The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Any vaccines deemed ready for distribution to the public will have been tested by the rigorous standards set forth by the Food and Drug Administration.
• While many vaccines are being developed and tested, some may be ready before others. The CDC and other healthcare organizations plan for flexible COVID-19 vaccination programs that can accommodate different vaccines and scenarios.
• The goal is for everyone to get a COVID-19 vaccine as soon as large quantities are available. The plan is to have several thousand vaccination providers available, including doctors’ offices, retail pharmacies, hospitals and federally qualified health centers.
• There may be a limited supply of COVID-19 vaccines at first, but the supply will increase in the weeks and months that follow. Experts are planning to distribute these limited vaccines in a fair, ethical and transparent way. Some groups, like healthcare workers and first responders, can get a COVID-19 vaccine first. People with health concerns and those over age 65 will also be given priority.
• While these vaccines may potentially prevent infection, they cannot cure the disease. It is still essential to protect yourself and your business until you can get the vaccination. Keep wearing a mask in public, washing your hands often and staying at least six feet from those outside your immediate family. Review our tips for returning to work safely.
• You won’t have to pay for the vaccine or the administration fee for the vaccine for yourself or employees on your health plan, no matter where you get it. If you have questions, you should check your health plan or call customer service.
• The two vaccines likely hit the market first will both require two doses around 21 days apart. It is extremely important that you get the second dose of the vaccine. The provider who administers your first dose will provide you with the information that you need for your second dose.

Vaccine safety measures

People have expressed concerns about vaccine safety for years prior to the COVID-19 pandemic. However, when the federal government launched Operation Warp Speed in March 2020 with drug makers to produce 300 million vaccine doses for Americans by the first of 2021, those concerns deepened as many questioned whether a safe vaccine could be produced so quickly.

Measures do exist to ensure that all vaccines authorized in the United States, including COVID-19 vaccines, are as safe as possible.

Clinical trial phases 1, 2, 3 and 4

Before a vaccine is authorized for public use, it must go through clinical trials. Vaccine clinical trials have phases, each designed to answer different questions about a drug’s efficacy. Phase one investigates the safety of a treatment in humans. Phase two examines whether a treatment works. Phase three compares a new treatment with standard treatments to see if it works better, has fewer side effects, etc. Phase four examines the long-terms risks and/or benefits of the drug.

Safety monitoring

After a vaccine is approved for public use, it is monitored by additional groups for accurate and timely reporting of adverse side effects and other concerns. Along with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), other groups that monitor vaccine safety include but are not limited to the following:

• General public – Centers for Medicare and Medicaid Services
• Military – Defense Medical Surveillance System
• Tribal groups – Indian Health Services
• Veterans – Adverse Drug Event Reporting System

Public health is a top priority when companies and the government develop vaccines like the ones underway for COVID-19. Concerns about vaccine safety are normal. However safety measure are in place to reduce health risk. Please tell employees to talk with their healthcare provider about specific concerns.

The COVID-19 pandemic is moving quickly to impact essentially every country in the world. We all want our lives to return to normal as soon as possible. The collective knowledge of the scientific community has never been more robust. The ability to understand and quantify the genetic code of the virus is a recent development that is allowing the discovery of vaccines that will be extraordinarily targeted to this menace. Do not equate “new” with “unsafe.” Manufacturers of vaccines must follow well-established guidelines to assure something designed to help us does not place us at an unreasonable risk. We need to take full advantage of all the brilliant scientific brains working in this project around the world by letting them figure this out, make sure it is safe and available, then strongly consider getting vaccinated to protect you and your business.

Sources: CDC, Arkansas Department of Health

Mark T. Jansen, M.D., joined Arkansas Blue Cross and Blue Shield in July 2019. He serves as vice president and chief medical officer for Arkansas Blue Cross. Dr. Jansen, who has been board-certified in Family Medicine since 1984, spent 29 years as a primary care physician in Arkadelphia, Arkansas, before joining the UAMS faculty in 2013. Most recently he served as chief medical officer for Regional Programs for the UAMS Area Health Education Centers (AHEC) program. He is a member of the American Academy of Family Practice and Arkansas Medical Society. In April 2016, Dr. Jansen was invested as the inaugural recipient of the Arkansas Blue Cross George K. Mitchell, M.D., Endowed Chair in Primary Care. In 2015, he was named Teacher of the Year in the UAMS Department of Family & Preventive Medicine.