Who is eligible for an additional dose of the COVID-19 vaccine?
On August 12, 2021, the U.S. Food and Drug Administration
(FDA) expanded the emergency use authorization for both mRNA vaccines, Pfizer-BioNTech and Moderna, for immunocompromised individuals. This authorization covers people ages 12 and up receiving treatments associated with moderate to severe immune compromise. This includes individuals who have:
- Been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
People should talk to their healthcare provider about their medical condition and whether getting an additional dose is appropriate for them.
Why isn’t everyone eligible for an additional vaccine dose?
The FDA and federal Centers for Disease Control and Prevention(CDC) have carefully reviewed data from recent vaccine trials related to antibodies in specific individuals. The results from these trials have shown people who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases. They are especially vulnerable to infections, including COVID-19. The administration of additional vaccine doses has been shown to increase protection in this population.
At this time, given the effectiveness of the vaccines, there is no recommendation for those who are fully vaccinated (2 doses of mRNA vaccine or one dose of J&J vaccine) and are NOT moderate or severely immunocompromised to receive an additional dose. However, CDPH has been planning for and is ready to begin administering booster doses in California, once recommended by our federal partners and the Western States Scientific Safety Review Workgroup.
What if I’m not eligible and still want to get an additional dose because I have other pre-existing medical conditions?
At this time, additional vaccine doses are only authorized for individuals with moderate to severe immune compromise. Research has shown that two doses of the mRNA vaccines or one dose of the Johnson & Johnson vaccine still offers protection for other populations.
Pending review of the evidence and approval by our federal partners and the Western States Scientific Safety Review Workgroup, booster shots for healthy individuals may become available in the near future to help maintain immunity to COVID-19 as announced by the U.S. Department of Health and Human Services.
What is the difference between an additional dose and a booster dose?
An “additional dose” of a COVID-19 vaccine is administered to individuals with weakened immune systems who have not responded fully to initial doses.
A “booster” dose is administered when the response to initial vaccination might have decreased to levels that increase vulnerability.
Q: How many Californians will be eligible?
There are approximately 800,000 Californians who will be eligible for additional vaccine doses under the FDA authorization and CDC recommendation. Only two to three percent of people in the United States are eligible for additional doses of COVID-19 vaccines.
How is the state defining ‘immunocompromised,’ and will Californians be required to verify they are immunocompromised?
California will follow the guidance of the Advisory Committee on Immunization Practices (ACIP) and CDC. ACIP will take the FDA modifications to the vaccine’s Emergency Use Authorizations and create current channels based on current evidence of effectiveness and safety.
This authorization covers people ages 12 and up who are solid organ transplant recipients or those who are diagnosed with conditions that are considered to have a moderate or severe level of immunocompromise. Verification of immunocompromised status will not be required. Your medical provider can help clarify if you meet the threshold for immunocompromised or not.
When will additional doses be available for immunocompromised individuals in California?
Additional vaccine doses are available as of August 16, 2021.
How does someone find and receive an additional vaccine dose?
Additional vaccine doses will be available through all current vaccination channels, including healthcare providers, clinics, and neighborhood pharmacies. Immunocompromised Californians can visit myturn.ca.gov to make an appointment or find a walk-in clinic.
When should I receive my additional vaccine dose?
The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after completion of the primary mRNA COVID-19 vaccine series. Whenever possible, mRNA COVID-19 vaccination doses (including the primary series and an additional dose) should be given at least two weeks before initiation of immunosuppressive therapies.
Which vaccines are covered by the emergency use authorization?
The FDA expanded the emergency use authorization for Pfizer-BioNTech and Moderna vaccines only for immunocompromised individuals.
What if someone received a Johnson & Johnson vaccine initially? Should they still get a Pfizer or Moderna vaccine?
The EUA amendment for an additional dose does not apply to the Janssen COVID-19 vaccine or individuals who received Janssen COVID-19 as a primary series. The CDC and FDA are actively engaged to ensure that immunocompromised recipients of the Janssen COVID-19 vaccine have optimal vaccine protection.
Can a person get an additional vaccine dose from a different vaccine brand, or do they need to stay with the brand for their original supplier?
When possible, individuals should receive an additional vaccine dose from the same vaccine manufacturer as their original series. Meaning, if an individual received the Pfizer-BioTech vaccine initially, they should receive an additional dose of Pfizer-BioNTech if available. When the same brand is not available, a person may receive the other brand.
Why would I want to get an additional vaccine dose? (Are additional doses really necessary?)
People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases. They are especially vulnerable to infections, including COVID-19. The FDA determined that the administration of additional vaccine doses may increase protection in this population. These patients should be counseled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection to their loved ones.
Can I get multiple additional doses?
Currently, additional vaccine doses are only authorized for immunocompromised individuals by the FDA and recommended by the CDC.
If a person is eligible for an additional dose, does that mean they are not considered fully vaccinated under current public health guidelines?
A person is still considered fully vaccinated if they have received their dose(s) prior to the availability of this new dose for certain individuals.
How are we vaccinating some with additional doses when not everyone has received their two-dose series?
mRNA COVID-19 vaccine supply in the United States is sufficient to make additional doses for immunocompromised people feasible. Everyone who wants to get vaccinated will still have vaccines available.
Will digital vaccine records be updated to show that individuals have received the additional dose of vaccines?
Yes, the Digital COVID-19 Vaccine Record has been updated and will show the additional dose.
If I get an additional dose, will it show on my digital vaccine record?
Your digital vaccine record does not automatically update. If you receive an additional dose of the COVID-19 vaccine, you'll have to get a new QR code through the Digital COVID-19 Vaccine Record portal.
Does this mean California and the United States are going against the World Health Organization’s call to wait on boosters?
Officials with the WHO emphasized they were not referring to the extra doses that may be needed now for certain groups, like those with weakened immune systems.
Will an antibody or other test show whether I need an additional dose?
We do not recommend using antibodies or any other tests to determine protection from the virus at this time. There is significant variability from one antibody test to another, and we simply do not know enough about what antibody levels really mean in terms of protection. Boosters are an area of intensive research, and we hope to understand them better in the future.
Does receiving an additional vaccine dose eliminate the need for further harm-reduction precautions?
No, even with an extra dose of mRNA vaccine, not everyone with a compromised immune system appears to mount a normal immune response. Since we are still learning about this, it is prudent to protect yourself by taking extra precautions. Friends, family, and caretakers who you interact with should also continue to take harm-reduction precautions, such as wearing a mask when indoors.
Is there a test to determine who qualifies as an immunocompromised individual?
No, if you think you qualify but are not positive, please check with your medical provider to confirm you are eligible for an additional dose.
Is the state going to set aside doses specifically for additional doses for immunocompromised persons? Will they be administered from the same amounts allocated for the first doses?
California is no longer allocated doses from the CDC but is ordering on an as-needed basis. There are enough doses available on hand or in additional orders, so doses do not need to be set aside.
The CDC estimates more than 1 million Americans have received unauthorized additional doses. How many Californians have already received an additional dose?
There are approximately 100,000 people who have received three vaccine doses.
As a person with a weak immune system, once I get an additional dose, can I reduce the use of other precautions such as masking, distancing, and avoiding groups and crowds.
No, because even with an extra dose of mRNA vaccine, not everyone with a compromised immune system appears to mount a normal immune response. We are still learning about this, but at this time, we consider it prudent to continue taking extra precautions.
How do providers order an additional supply of vaccine doses?
Vaccine providers don’t need specific vaccines for additional doses. It is the same dose as used in the original vaccination.
How are additional doses recorded in a series?
All doses administered to an individual are recorded in CAIR in the same way.
How are additional doses recorded in CAIR?
All doses administered to an individual are recorded in CAIR in the same way.
Western States Scientific Safety Review Workgroup: Statement
CDC: COVID-19 Vaccines for Moderately to Severely Immunocompromised People
CDC: Statement on Additional COVID-19 vaccine dose for Immunocompromised People
FDA: Authorization of Additional Vaccine Dose for Certain Immunocompromised Individuals
ACIP: Presentation Slides, August 13, 2021 Meeting