You are using an outdated browser. Please upgrade to the latest version for the best experience. Upgrade your browser now.
Skip Navigation

Second Opinion: What Does FDA Approval Really Mean For Vaccines? And Should I Get A Booster?

Blue Shield of California's chief medical officer shares the latest on COVID-19 vaccine developments

Dr. Susan Fleischman, chief medical officer for Blue Shield of California, answers questions — FDA approval, booster shots, masks, and more — and the latest developments in the battle against COVID-19.

What is Comirnaty?

This is the new, official brand name for the Pfizer and BioNTech COVID-19 vaccine. As of last week, it is fully approved for use in fighting the novel coronavirus by the U.S. Food and Drug Administration (FDA). As part of the approval process, the vaccine gets its own name for use in the U.S. According to Pfizer, the name "represents a combination of the terms COVID-19, mRNA, community, and immunity, to highlight the first authorization of a messenger RNA (mRNA) vaccine, as well as the joint global efforts that made this achievement possible with unprecedented rigor and efficiency — and with safety at the forefront — during this global pandemic."

Dr. Susan Fleischman


What does it mean for Comirnaty to get approved by the FDA?

The Pfizer vaccine had already met the FDA’s rigorous, scientific standards for emergency use authorization (EUA) starting at the end of 2020. However, this official approval for the vaccine means that it meets the high standards for safety, effectiveness, and manufacturing quality that the FDA requires of a fully approved product. 

Many non-vaccinated people waited for this kind of approval to give them the confidence and reassurance to receive their vaccines. There is hope that the full approval will increase vaccination rates. Having more people vaccinated will help us mitigate the surging Delta variant, as well as other mutations that could surface as a result of not having herd immunity. 


What ages are approved to use the Comirnaty vaccine? 

Sixteen years of age and above. However, under the emergency use authorization, the vaccine continues to be available for 12- to 15-year-olds. 


What is the status for a vaccine for younger children -- infants to teens? Which brand will be releasing that vaccine?

At this time, no vaccine is approved or authorized for emergency use for infants to 11-year-olds. However, recent announcements suggest possible approval down to age 5 by the end of the year. Both Pfizer and Moderna vaccines are currently in clinical trials for 5- to 12-year-olds.


Where are Moderna and Johnson & Johnson vaccines in the FDA-approval process? 

The COVID-19 vaccines from Moderna and Johnson & Johnson are still seeking full approval for use by the FDA. They entered the pipeline for full approval after Comirnaty. 


If Comirnaty is FDA-approved for two doses, why are booster shots needed?

We continue to learn about COVID-19 over time. Scientists are currently working to understand how long immunity lasts after the standard two doses. Studies suggest there is some waning immunity over time, and that a booster shot “boosts” immunity.  The U.S. government has committed to moving forward with boosters for Pfizer and Moderna vaccines. Originally this was planned at eight months after the second dose, by late September 2021. There is some current discussion at giving a booster as early as six months after the 2nd dose.  This will depend on FDA and Centers for Disease Control and Prevention (CDC) authorization for the booster dose. 

The current boosters under consideration are the same vaccines used for the initial doses.  Boosters are recommended now for immunocompromised individuals (see the list of who qualifies now in the next question).  Many vaccines that prevent other illnesses require boosters, for example we should all have a tetanus shot every 10 years, flu shots are an annual event.


Who needs the COVID-19 vaccine booster?

The FDA recently amended the Emergency Use Authorizations (EUAs) for both the Pfizer and the Moderna COVID-19 vaccines to allow for the use of an additional dose in certain immunocompromised individuals. If you meet the following criteria, contact your provider to discuss getting your booster shot:

  • Active or recent treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ or recent hematopoietic stem cell transplants
  • Severe primary immunodeficiency
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids, alkylating agents, antimetabolites, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory
  • Chronic medical conditions such as asplenia and chronic renal disease that may be associated with varying degrees of immune deficit

Depending on FDA and CDC approval, boosters for anyone who received the Pfizer or Moderna vaccines will be available after Sept. 20, either at six or eight months after the second dose. Johnson & Johnson boosters are under discussion.


When should I get a booster shot?

If you are immunocompromised, and a recipient of a Pfizer or Moderna vaccine, you are likely eligible now. Otherwise, we expect boosters to be available by late September, and to be given six to eight months after the second dose.


Where should I get vaccinated (first time and booster shots) in California?

There is ample vaccine available now. You can search for vaccine appointments in your area on the MyTurn.Ca.Govwebsite. 


What is the latest recommendation about wearing masks now that the Delta variant is surging?

Whenever you are in close contact with others who are not a part of your household, you should be masked. Many counties in California now require masking for indoor activities such as restaurants. Additionally, masking is helpful in crowded outdoor settings. Eating and drinking are much safer outside. Please follow federal, state, and local guidance.