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.

On September 24, 2021, the NYS Clinical Advisory Task Force endorsed CDC's statement recommending a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also a booster dose for those in high risk occupational and institutional settings.

On October 23, 2021, the NYS Clinical Advisory Task Force endorsed the CDC's recommendations to authorize booster injections of Moderna MRNA and Janssen.

On October 29, 2021, the FDA authorized Emergency Use of the Pfizer-BioNTech COVID-19 Vaccine in children ages 5 to 11 years old.

On November 19, 2021, the FDA and CDC approved a booster dose of the COVID-19 vaccine for all adults who have received the Pfizer-BioNTech or Moderna initial vaccine series at least six months ago or the Janssen/Johnson & Johnson at least two months ago. 

On January 6, 2022, the CDC and NYSDOH strongly encourages all New Yorkers 12 years and older who received their Pfizer-BioNTech initial vaccine series at least five months ago to receive the Pfizer-BioNTech booster. Also, 5-11-year-olds with certain immunocompromising conditions who received their Pfizer-BioNTech initial vaccine series at least 28 days ago are eligible for an additional dose of the Pfizer-BioNTech vaccine.

On January 7, 2022, the CDC and NYSDOH strongly encourages all eligible New Yorkers 18 and older who received a Moderna vaccination series at least five months ago are now eligible for a booster dose.

On January 31, 2022, the FDA fully approved the Moderna vaccine for people 18 and older. The approved vaccine will now be marketed as Spikevax.

On March 29, 2022, the FDA approved Emergency Use Authorization for a second booster and the updated recommendation from the CDC to allow adults 50 years and older to receive a second booster of an mRNA vaccine at least four months after their first booster. Additionally, adults ages 18 - 49 years who received the Johnson & Johnson vaccine for their primary vaccine and initial booster dose now may receive a second booster four months after their first booster dose. Also eligible for the second booster are New Yorkers 12 years and older who are moderately to severely immunocompromised.  

On May 17, 2022, the FDA endorsed the first booster dose of the Pfizer-BioNTech COVID-19 Vaccines for children ages 5 - 11 years old.

On June 15, 2022, the FDA fully approved the Pfizer-BioNTech and Moderna vaccines for children as young as 6 months old.  

On August 31, 2022, the FDA amended the Emergency Use Authorizations (EUAs) of the Moderna and the Pfizer-BioNTech vaccines to authorize bivalent formulations of the vaccines for use as a single booster dose. 

Development

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.

CDC Vaccine Safety 

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.

 

Vaccine Safety

Decades of research show that vaccines prevent disease. An overwhelming number of studies also show that they are safe and effective. The United States has the safest, most effective vaccine supply in its history. 

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