Safe and Effective
Safety is a top priority in the development of any vaccine and COVID-19 vaccines are no exception. The U.S. has a robust vaccine safety system in place to ensure that all vaccines are as safe as possible. Safety is always closely monitored during clinical trials of vaccine candidates. After a vaccine is authorized or approved for use by the FDA, many vaccine safety monitoring systems watch for adverse events (possible side effects). This ongoing monitoring can pick up on adverse events that may not have been seen in clinical trials. If an unexpected adverse event is seen, experts quickly study it further to see if it is a true safety concern. Experts then decide whether changes are needed in U.S. vaccine recommendations.
In New York State, an added level of review was established to help ensure the safety of any COVID-19 vaccine. Experts on New York State's independent COVID-19 Clinical Advisory Task Force will thoroughly review all vaccine research before recommending a vaccine to New Yorkers. This review occurs concurrently with the FDA's own review process to ensure a comprehensive review, but one that does not slow down the distribution process.
On December 10, 2020, the FDA's vaccine advisory panel voted to recommend that the FDA authorize the Pfizer vaccine. Following that, also on December 10, New York's COVID-19 Clinical Advisory Task Force voted unanimously in approval of the FDA panel's decision. On December 11, the FDA formally authorized the Pfizer vaccine for emergency use.
On December 17, 2020, the FDA's vaccine advisory panel voted to recommend that the FDA authorize the Moderna vaccine. On December 18, New York's COVID-19 Clinical Advisory Task Force voted unanimously in approval of the FDA panel's decision and the FDA formally authorized the Moderna vaccine for emergency use.
On February 27, 2021, the FDA issued an emergency use authorization for the Janssen/Johnson & Johnson Pharmaceuticals COVID-19 vaccine. On March 1, New York's COVID-19 Clinical Advisory Task Force unanimously recommended use of the Janssen/Johnson & Johnson’s vaccine in New York State.
On May 12, 2021, the CDC endorsed the use of the Pfizer COVID-19 vaccine for adolescents 12 to 15 years of age. This followed a thorough review of data and FDA's expansion of the emergency use authorization on May 10. On May 12, New York's COVID-19 Clinical Advisory Task Force unanimously recommended to immediately implement expanded use of the Pfizer COVID-19 vaccine for 12 to 15-year-olds.
On August 23, 2021, the FDA fully approved the Pfizer-BioNTech vaccine for the prevention of COVID-19 disease in individuals age 16 and older. The FDA-licensed vaccine will now be marketed under the name Comirnaty.
There are many factors that combined to allow the COVID-19 vaccine to be developed quickly and safely:
- Researchers got a head start on developing a vaccine because the virus that causes COVID-19 is similar to other existing viruses.
- Research about the new virus was shared almost immediately with scientists all over the world, which allowed work to begin on a vaccine right away.
- Some researchers were able to run different phases of the trials at the same time.
The federal government allowed manufacturing of the most promising vaccines to begin while the studies were ongoing. That means that once a vaccine is authorized it can be offered to the public almost immediately. It’s important to note that all vaccine developers are required to go through each stage of the development process and meet all safety and efficacy (how well something works) standards.
Learn about the many steps in the typical vaccine testing and approval process.