An adult sits on an exam table with a bandage after getting vaccinatedThere has been much vaccine-related news about third doses, boosters, the Pfizer approval and more. We thought it’d be helpful to give a quick overview of where things stand. (Keep in mind information changes quickly, so this is current as of this posting!)

Pfizer (Comirnaty) Vaccine Granted Full FDA Approval

On August 23, the FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine. The vaccine will now be marketed as “Comirnaty” and is now fully approved for everyone 16 years old and older.

The Pfizer-BioNTech COVID-19 vaccine was first issued Emergency Use Authorization on December 11, 2020 based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. To support the decision for full approval, the FDA reviewed updated data from the clinical trials, including analyzing effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older.

We wrote an entire blog post about this full approval!

Third Doses for Severely Immunocompromised People

On August 13, the CDC’s immunization advisory committee voted to change guidelines for severely immunocompromised people to receive an additional dose of Pfizer or Moderna vaccine. This third shot will be available to a very small and specific group of people who were unlikely to have a strong immune response to their first two doses.

The CDC shared that about 40% of fully vaccinated people hospitalized with severe COVID-19 were previously severely immunocompromised. Keep in mind that “severely immunocompromised” isn’t just having a chronic condition, like diabetes; it’s at the level of receiving an organ transplant.

Healthcare providers in the area are vaccinating patients who meet the criteria for a third dose. See our blog post for more information.

Boosters for General Population (Yes, they are different from third doses!)

The third dose mentioned above for severely immunocompromised people is not a booster dose, but rather part of the normal vaccination course for severely immunocompromised people. This is because people in this group are unlikely to have had a strong immune response to their first two doses.

However, there has also been news recently about the possibility of booster doses for the general population. A booster dose could be used if there is evidence of waning immunity among people who are fully vaccinated.

On August 30, the CDC’s immunization advisory committee met and very briefly discussed the possibility of booster doses. At this time, they did not have enough safety data to evaluate booster doses for the general population. At their next meeting in mid-September, they will be discussing the data they do have before any action would be taken.

Because booster doses are not recommended by the committee at this time, providers are strictly prohibited from giving them under penalty of law.

Vaccines for Kids Under 12

Both Pfizer and Moderna vaccines have been in clinical trials with children under 12 since March of this year. In July, the FDA requested that more children be enrolled in the clinical trials for examining the dosing for Pfizer and Moderna vaccines. They made this request to increase the chances identifying possible rare side effects.

We don’t have a firm timeline for when any vaccine for a child under 12 will be authorized, but many federal health officials have suggested authorization for children 5-11 years old may come closer to the end of 2021. While we are all anxious for kids to have access to vaccination, it’s important to remember that kids aren’t just little adults; the dosing that’s appropriate for a 50 year old may not be the same for a five year old. The trials are pinpointing what amounts of the vaccine are safe and effective for kids, and that takes time.

Still need to get your dose? Visit our vaccination page to find a vaccine provider near you!

This content is free for use with credit to the City of Madison - Public Health Madison & Dane County and a link back to the original post.