The top concern among Missourians is whether a COVID-19 vaccine will be safe.
The US has a long history of assuring vaccines are safe through the use of specific, detailed, and time-tested protocols. The Food and Drug Administration (FDA) announced on October 6, 2020 that before approving a potential COVID-19 vaccine, it will need to see two months of follow-up data after volunteers get their second vaccine doses in a clinical trial. This is a sign that the FDA is taking every precaution to ensure the safety of a COVID-19 vaccine.
Clinical development for vaccines is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In the case of COVID-19 vaccines, Phase II trials in the U.S. should have a demographic makeup similar to that of the country, spanning a wide range of ages, races, ethnicities, and any other factors that would affect risk and efficacy. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety. During clinical development, a trial vaccine’s effectiveness is determined by comparing outcomes of patients who have received it with outcomes of patients who received the placebo.
In the U.S., the findings from clinical trials are presented to and reviewed by the FDA. The FDA also inspects manufacturing facilities to ensure safety and reviews product labels to ensure clarity. After approving a vaccine, the FDA continues to monitor and oversee its production to ensure that all safety protocols are followed. In addition, many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed. The FDA and CDC also collect and analyze information from reports of any side effects that may occur after a vaccine has been licensed.
So before any new vaccine is brought to market, it has been given to thousands of people under stringent monitoring for safety. Sometimes, very rare side effects are recognized only after the vaccine is licensed because they occur so infrequently, but such side effects are very rare and must be weighed against the good the vaccine will do.
Careful and thoughtful planning for a COVID-19 vaccination campaign is very important and will take months. The Delta region has already begun planning how to offer COVID-19 vaccinations in our communities.
Vaccine planning underway
It will be very complicated to vaccinate hundreds of millions of people in stages based on risk criteria provided by scientific oversight agencies. Plans will require accurate estimates of the dates and quantities of vaccine available, clinic scheduling, training, public information campaigns, and careful monitoring of the process and outcome.
Special efforts will be necessary to reach populations at highest risk and to develop trust with people who have concerns about vaccine safety. The process must be transparent and fully grounded in science..
Because there won't be enough vaccine for everyone at first, people who are at highest risk of infection with COVID-19 will need to be prioritized.
Missouri has identified the following priority groups for vaccination as vaccine becomes available:
Long term care facility staff and residents
Front-line health workers
People at increased risk for severe COVID-19
Critical infrastructure workers
Employer-defined essential employees
Don't lean on herd immunity
Herd immunity is achieved when a virus stops circulating because a large segment of the population has already been infected or has been vaccinated against the virus. Since 9 in 10
Missourians are still at risk for getting COVID, this strategy to just let millions more people get sick instead of focusing on proven infection control methods would lead to many more deaths. It would put all of us at risk.
A herd immunity strategy was attempted in Sweden, only to be quickly ended when COVID-19 deaths sharply increased.