Vaccination against Covid19 is starting! How will the vaccine be monitored for safety?


A: Healthcare workers and people in long-term care facilities are starting to get the Covid19 vaccine this week.

As vaccine supplies improve, more folks will start to get vaccinated in the coming weeks and months. While safety data from the clinical trials is very good, safety monitoring is ongoing and appropriately a priority. Several existing and some new strategies are being put in place to monitor the safety of the Covid19 vaccine. Below, get ready to wade through some acronyms and we’ll outline a few of these strategies.

➡️Vaccine Adverse Events Reporting System (VAERS): This is a biggie. Co-managed by the CDC and the FDA, VAERS has been around since 1990. The goal is to identify early warning signs of problems with vaccines or if new problems develop over time. Anyone can report possible side effects from a vaccine through VAERS and healthcare workers are required to report certain side effects. The CDC and FDA uses this data to monitor safety and make recommendation changes if needed.

➡️Vaccine Safety Datalink (VSD): This is a longstanding collaboration between the CDC and 9 healthcare organizations from across the country. The VSD uses electronic health record data to answer questions about safety. When they are evaluating a possible side effect of the vaccine, the VSD looks at information on the vaccine (like which vaccine was given and when) and patient characteristics (like other health problems and ER or hospital visits) to pick out patterns.

➡️V-Safe: This is the new kid on the block. V-Safe is a new smartphone-based tool developed for monitoring the safety of the Covid19 vaccine. Once you get vaccinated, you are offered the opportunity to sign up for V-Safe. It will serve as your vaccination record card, remind you when to get the second shot, and help you report to the CDC if you develop any side effects from the vaccine.

➡️Vaccine makers: The vaccine developers are still conducting their clinical trials and safety monitoring is a major part. The trials are going to continue for many months, and we can look forward to even more safety and efficacy data.

Of course, people want to make sure that any vaccine they take is safe. The clinical trial data available so far for the Pfizer-BioNTech vaccine did not show any serious side effects from the vaccine. There were some expected side effects, like headache, muscle aches, feeling tired, and fever. These typically lasted only a day or two. Vaccine safety monitoring is ongoing and continues to be top priority. The CDC and FDA use all the sources above (and more) to monitor for safety problems.

If you have questions about whether the Covid19 vaccine is right for you, please ask your primary care clinician. They can work with you to make sure that you have your questions and concerns addressed to help you make the right decision for you.


CDC Ensuring the Safety of Covid19 Vaccine in the US

Vaccine Adverse Events Reporting System

Vaccine Safety Datalink


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