What’s on the Horizon for Public Health

By Marcia Schroeder, RN, Horizon Public Health

The words “safe and effective” have been used over and over in reference to COVID-19 as well as other routine vaccines. It struck me that people might be interested in knowing what the “vaccine world” means exactly when that phrase is used. First and foremost it’s important to understand that “safe and effective” language is applied to all recommended vaccines. For the purpose of this article, the focus is on COVID-19 vaccine.  

Before being offered to the public, COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines must meet the Food and Drug Administration’s (FDA’s) rigorous scientific standards for safety, effectiveness and manufacturing quality in order to be granted emergency use authorization status.  

COVID-19 vaccines underwent the most intensive safety monitoring in U.S. history. Both well established and new safety monitoring systems are being used ongoing, to make sure the vaccine is safe. For COVID-19 and all other vaccines this means:

• After a vaccine is approved for use, vaccine safety systems monitor and continually watch for potential safety problems.

• Continued monitoring can identify harmful incidents that may not have been seen in clinical trials. If an incident is identified, experts quickly study it further to assess whether it is a true safety concern and if changes in clinical guidance and recommendations are needed.

• Monitoring is critical to help ensure that the benefits continue to outweigh the risks for people who receive vaccines.

More than 612 million doses of COVID-19 vaccine have safely been given in the U.S. from Dec. 14, 2020, through Sept. 14, 2022. Serious side effects, that could cause a long-term health problem, are extremely rare following any vaccination. The benefits of routine vaccines and COVID-19 vaccine outweigh known and potential risks. (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html).

The Centers for Disease Control and Prevention (CDC) continues to closely monitor the safety of COVID-19 vaccines. You can be part of ongoing safety monitoring. If you experienced a side effect following COVID-19 vaccination, you can report it to the Vaccine Adverse Event Reporting System (VAERS) by going to www.vaers.hhs.gov.

Effectiveness is a measure of how well a vaccine works to protect communities as a whole. Although clinical trials include a wide range of people, effectiveness in the real world can differ from the effectiveness measured in a trial, because scientists can’t predict exactly how effective the vaccine will be for a much bigger and more varied population.

When you hear a vaccine has an 80% efficacy rate, you might think the vaccine only works 80% of the time. That is not the case. If a vaccine has an 80% efficacy rate, it means in a vaccinated population, 80% fewer people will contract the disease when they come in contact with the virus. As more people get vaccinated it is expected that fewer people will come in contact with the virus (World Health Organization). 

Vaccines can stop most people from getting sick with COVID-19, but not everyone. Even after someone has all of the recommended doses and waits a few weeks for immunity to build up, there is still a chance that they can get infected. Vaccines do not provide full (100%) protection, so breakthrough infections, in spite of being fully vaccinated, will occur. But if vaccinated people do get sick, they are likely to have milder symptoms and not be hospitalized. In general, it is very rare for a vaccinated person to experience severe illness or die.

All vaccines, not just COVID-19 vaccine, given in the U.S. are “safe and effective.” Visit this website for more information https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html. If you or your children are due or overdue, for vaccines, call your health care provider.