Updated May 23, 2022
Under the FDA's EUA, all children ages 5 through 11 years should now receive a COVID-19 booster vaccine 5 months after completing their primary series. Children ages 5 through 11 years who are moderately or severely immunocompromised should receive a booster 3 months after completing their primary series.
In anticipation of a pediatric vaccine for the under 5 population, CDC updated the Pediatric Operational Planning Guide. This can inform planning for all current COVID-19 vaccine programs and channels for distribution of the Pfizer and Moderna vaccine for children aged 6 months–5 year, should either or both vaccines receive FDA EUA and CDC recommendation.
The Pfizer-BioNTech vaccine EUA authorizes a single booster dose for children 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine. The AAFP is monitoring the authorization process and awaiting additional information from the CDC.
The Janssen vaccine is now only authorized for people 18 years and older when other COVID-19 vaccaines aren't accessible or clinical appropriate, or people 18 years or older who want the J&J COVID-19 vacccines because it's only one dose.
VRBPAC will meet in early June on expected EUA vaccine requests from several vaccine manufacturers. This includes the Novavax COVID-19 vaccine for people 18 years and older, and Pfizer-BioNTech and Moderna vaccines for children younger than 5. On June 28, VRBPAC will discuss if the SARS-CoV-2 strain composition should be modified for future strains.
The AAFP is encouraged the FDA will meet to discuss applications for COVID-19 vaccines for children under 5 and hope this timeline provides clarity to families. We will review the data and continue providing information to support our members in counseling and immunizing their patients and families.
On April 22, Dr. Ada Stewart was a featured speaker in the "We Can Do This Summit: Conversations on Encouraging COVID-19 Vaccinations." She shared her perspective as a family physician and how to have conversations when a patient or family is hesitant.
Data for Moderna's vaccine shows comparable immune responses to young adults, but a decision will be held until the FDA's advisory council meeting in June.
On April 15, the company announced it will ask the FDA to authorize a booster dose of its pediatric COVID-19 vaccine for children ages 5-11. The data shows an increase in immune response in the clinical trial.
On March 29, after an expedited FDA review of evidence, the CDC updated its recommendations to allow for the administration of a second booster dose of mRNA COVID-19 vaccine in individuals age 50 years and older and in people with certain types of immunocompromising conditions. These recommendations have been reviewed and approved by the AAFP.
In response to the Florida Department of Health announcement about healthy children not receiving the COVID-19 vaccine, the AAFP issues a statement by AAFP President Sterling Ransome, M.D. that reaffirms the likelihood of infection and the health risks associated with COVID-19 outweigh any potential risks associated with COVID-19 vaccines.
The updated interim clinical considerations include:
ACIP unanimously approved a recommendation for the FDA-approved Moderna (Spikevax) vaccine primary series for use in individuals 18 and older. This recommendation was endorsed by the CDC. These recommendations have been reviewed and approved by the AAFP.
Moderna's COVID-19 vaccine has been fully approved by the FDA for people 18 years and older. The approved vaccine will be marketed as Spikevax for the prevention of COVID-19. Full approval means Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval.
In a new white paper, the COVID-19 Vaccine Education and Equity Project is confronting issues that allow for COVID-19 vaccine disparities to persist. Ongoing gaps in vaccine access are creating vaccine disparities in communities nationwide.
On Jan. 13, the U.S. Supreme Court ruled on COVID-19 vaccine mandates. They struck the vaccine mandate for employers with 100+ employees, but upheld the vaccine mandate for health care workers. This decision sets a consistent COVID-19 vaccination standard for workers in facilities that participate in Medicare and Medicaid. Learn more on our Vaccine Mandates & Exemptions page.
On Jan. 7, the FDA amended the EUA for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least 5 months for individuals 18 years of age and older.
On Jan. 5, the CDC’s ACIP issued updated interim recommendations for the Pfizer-BioNTech COVID-19 vaccine to recommend a single booster dose for individuals aged 12-17 to be given at least 5 months following completion of the primary series. This recommendation was based on data showing that the rates of myocarditis and other adverse reactions remain low in this age group in addition to data showing that booster doses increased vaccine effectiveness against the Omicron variant. View the evidence to decision framework. The CDC issued two additional updated recommendations specific for the Pfizer-BioNTech mRNA vaccine:
These recommendations have been reviewed and approved by the AAFP. Staff are working to update AAFP resources.
On Jan. 3, the FDA amended the EUA for the Pfizer-BioNTech mRNA vaccine to allow for expanded use in adolescents and shorten the interval between the primary series and booster dose for all ages. The amendment includes:
Decisions were based on review of laboratory and real-world data supporting the safety and efficacy of the vaccine in adolescents. The EUA fact sheets have been updated to reflect these changes.
The CDC and AAFP support the ACIP's recommendation, “mRNA COVID-19 vaccines are preferred over the Janssen (J&J) COVID-19 vaccine for individuals aged 18 and older.” This is based on safety data related to cases of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with the Janssen COVID-19 vaccine. The updated EUA fact sheet has information and a contraindication for individuals with a history of TTS. The CDC also released updated clinical considerations.
As of Dec. 10, individuals 16 and 17 years of age can receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine at least six months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. These individuals should only receive the Pfizer-BioNTech COVID-19 Vaccine as their booster dose.
On Dec. 8, the FDA issued an Emergency Use Authorization (EUA) for the use of the monoclonal antibody combination of tixagevimab and cilgavimab (EUVASHELD) for the pre-exposure prophylaxis of COVID-19 in immunocompromised individuals aged 12 and older. The EUA is specific for the following individuals:
IMPORTANT: EUVASHELD is not authorized for treatment of COVID-19 and is not a substitute for vaccination against COVID-19.
Clinical info: The product contains two vials of 150 mg of tixagevimab and cilgavimab which should be administered consecutively via intramuscular injection.
The EUA was based on 2 Phase III clinical trials that enrolled over 6,000 participants. Only one trial showed a reduction in symptomatic cases of COVID-19 (77%, 95% CI 46-90). There were cases of serious cardiovascular events, particularly myocardial infarction and heart failure, observed in the larger trial. Clinicians should inform patients about these increased risks prior to administration of the product.
The omicron variant has been identified in the U.S. Scientists are still working to understand the effect of this variant. The AAFP strongly recommends everyone get vaccinated against COVID-19. Additional prevention strategies, such as wearing masks in public indoor settings or crowded public areas, physical distancing, and hand washing are encouraged to hope prevent the spread of COVID-19 and its variants. View the CDC's Omicron Variant web page for the newest information.
All individuals age 18 years and older who received an mRNA COVID-19 vaccine primary series should receive single booster dose. These booster doses are given at least six months after the primary series. Recommendations for individuals in long-term care facilities and for those who received the Janssen vaccine are unchanged.
On Nov. 14, the FDA amended the emergency use authorizations (EUA) for both the Moderna and the Pfizer-BioNTech COVID-19 vaccines, authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or -approved COVID-19 vaccine.
The CDC approved the use of the COVID-19 vaccine for children 5-11 years old. They agreed the clinical trial demonstrated the Pfizer-BioNTech COVID-19 vaccine is safe and effective in this age group, and can reduce the devastating impact of COVID-19 on children. The Pfizer-BioNTech vaccine (10ug) will be available for all children in this age group under the FDA’s EUA.
The AAFP quickly signed off on the child COVID-19 vaccine recommendations. The CDC's endorsement clears the way for family physicians and other health care professionals to begin administering the vaccine to children starting the week of Nov. 8.
On Oct. 29, the FDA authorized use of the Pfizer-BioNTech COVID-19 vaccine for children 5-11 years old. The AAFP applauds the actions by the FDA protect children from the devastating effects of COVID-19. The authorized vaccine is at a different dose and will be shipped separately from adult doses. It will still be a 2-dose series with 3 weeks between doses. In data presented to the committee, this dose induced comparable antibody levels as seen in adolescents and young adults, and was 90% effective at preventing symptomatic COVID-19. Side effects were similar, if not lower, than those in adults. No cases of myocarditis, anaphylaxis, or death were observed. More information can be found on the COVID-19 Vaccines for Children and Adolescents web page.
On Oct. 21, the CDC’s ACIP reviewed analyses of potential benefits and harms of a booster dose given 6 months after the primary two-dose series of Moderna and a booster dose given 2 months after the initial dose of the J&J vaccine. The committee voted to support the following recommendations, which the CDC and AAFP quickly approved.
These recommendations replace those issued in September and mean there are now booster recommendations for all three COVID-19 vaccines. The committee also discussed clinical considerations for heterologous (mix and match) boosting, but did not make a formal recommendation. Additional guidance will be included in clinical considerations accompanying the formalized CDC recommendations.
On Oct. 20, the FDA authorized the following uses:
These amendments to the authorizations for use of the COVID-19 vaccines come after votes by the FDA’s VRBPAC recommending booster doses for Moderna and Janssen vaccines in the populations indicated above. The committee reviewed data for heterologous boosting but did not take a vote. More detail is available in the FDA press release.
On Sept. 24, the CDC approved the ACIP recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings. The use of the terms “should” and “may” are based on the level of evidence and the differences in the balance of benefits and harms for different populations. The CDC issued the following recommendations:
The AAFP has approved the recommendations and has updated resources for our members, including the COVID-19 Vaccine FAQs and COVID-19 Vaccine Booster FAQs. All recommendations are issued under the parameters of the Emergency Use Authorization and only apply to those who have completed a primary series of the Pfizer-BioNTech vaccine. The CDC and FDA are committed to reviewing data related to boosters from other manufacturers as soon as it is available.
COVID-19 vaccines have been recommended by the CDC’s Advisory Committee on Immunization Practices, which was approved by the AAFP. All three vaccines are recommended by the CDC and AAFP, and are effective at preventing COVID-19 disease, hospitalizations and death.
Virus mutations are common, and SARS-CoV-2 variants continue being detected. The CDC is monitoring these variants and tracking spread across the U.S., as well as the effect on infection and disease. Researchers are also checking vaccine effectiveness against the different variants.
As of Nov. 30, the CDC recognized Omicron as a new variant of concern. There aren't a lot of details at this time. They will continue tracking the mutation and its impact.
This past summer and fall, the Delta variant spread faster and caused more infections. According to the CDC, it has
It is important to note that all the variants appear to have increased efficiency in spreading from person to person so the use of mitigation measures like masks, ventilation, hand washing, physical distancing, and quarantine are paramount. A Variant Classification scheme that defines three classes of SARS-CoV-2 variants has been developed and information for the different variants is provided at the links below:
The B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.427 (Epsilon), B.1.429 (Epsilon), and B.1.617.2 (Delta) variants circulating in the United States are classified as variants of concern. Use the CDC's map to see where the different variants are found in the U.S.
The committee voted to recommend the vaccine for individuals aged 12 – 15 in the U.S. under the Emergency Use Authorization (EUA). The ACIP recommendation followed the FDA amending its EUA to include individuals 12 to 15 based on safety and efficacy data, which showed 100% effectiveness in the vaccine group (0 cases) compared to the placebo group (16 cases). The EUA Fact Sheets reflect the changes.
Curious about increased risks of myocarditis and pericarditis? See Myocarditis and Pericarditis after mRNA COVID-19 Vaccination on the News Archive page.
The American Medical Association continues publishing COVID-19 vaccine and administration codes. Their unique structure allows for tracking and accommodating multiple COVID-19 vaccines.
Check out information on the CDC's COVID-19 site, including:
Expect updates to this site, plus CDC’s Vaccination and Immunization site, as more information is available. It's critical that jurisdictions and federal entities receiving vaccine have information to implement an effective COVID-19 vaccination program.