COVID-19 Vaccine

More than 219 million people in the U.S. are now fully vaccinated against COVID-19. The Centers for Disease Control (CDC) continues to monitor the safety of COVID-19 vaccines for any health issues after vaccination. Vaccination remains a priority as the Delta and Omicron variants are more infectious than prior strains.
 

The Latest: CDC Updates COVID-19 Vaccine Planning Guide for Children

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.

FDA Expands Eligibility for Pfizer Vaccine Booster Dose to Children 5-11 Years

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.

FDA Limits Use of J&J COVID-19 Vaccine to Certain Individuals

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. 

FDA Announces Tentative Advisory Committee Meetings Schedule for COVID-19 Vaccines

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. 

AAFP Board Chair Speaks on White House and HHS Summit to Encourage COVID-19 Vaccinations

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. 

Moderna to Ask FDA to Authorize Vaccine for Kids Under 6 Years 

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. 

Pfizer-BioNTech Will File for Kid Booster Dose EUA

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.

CDC Updates Recommendations for Second Booster to Further Protection

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.

Family Physicians Urge All Eligible Children and Adults to Get Vaccinated Against COVID-19

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.  

CDC Updates Vaccine Timing for mRNA Primary Series

The updated interim clinical considerations include: 

• Option for extending interval between 1^st and 2^nd dose of mRNA vaccines for individuals 12 years and older. Based on the data from other countries showing increased immune response and decreased risk of myocarditis, some individuals can choose to extend the interval, except if they are need to have rapid protection (increased risk of COVID) or are immunocompromised.
• Removal of recommendation to defer vaccination after receipt of monoclonal or passive antibody treatment. The only caveat is the recommendation of delaying providing EVUSHELD for preexposure prophylaxis until 2 weeks after vaccination.
• Clarification of dosing schedule for individuals who are immunocompromised: 

Moderna Vaccine Gets Full Approval From FDA, CDC

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.

FDA Gives Full Approval to Moderna's COVID-19 Vaccine

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. 

Vaccine Education And Equity Project Issue Brief Addresses Vaccine Disparities

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.  

Supreme Court Upholds CMS Vaccine Mandate for Health Care Workers

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. 

CDC Updates Recommendations for mRNA COVID-19 Vaccine Boosters, Additional Doses for Children Who Have Immunosuppression

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: 

• booster doses should now be given at 5 months following completion of the primary series of Pfizer-BioNTech for all other eligible individuals
• children aged 5-11 who have moderate to severe immunosuppression can receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine using child-specific dose/formulation

These recommendations have been reviewed and approved by the AAFP. Staff are working to update AAFP resources. 

FDA Authorizes Boosters for Adolescents, Third Doses for Children Who Are Immunosuppressed  

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: 

• Use of a single booster dose for individuals 12 through 15 years of age.
• Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
• Allow for a third primary series dose for children aged 5-11 who have moderate to severe immunosuppression.

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.  

AAFP Approve New Preferential Recommendation for mRNA COVID-19 Vaccines

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.

CDC, AAFP Approve Pfizer-BioNTech Vaccine for Ages 16-17

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.  

FDA Issues EUA for Monoclonal Antibody Combination to Support Immunocompromised Individuals

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:

• Those who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure
• AND who have moderate to severe immune compromise
• AND who may not mount an adequate immune response to COVID-19 vaccination
• OR who is unable to receive a COVID-19 vaccine due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine or its components

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.  

Monitoring Omicron Variant, Promoting COVID-19 Vaccinations

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. 

CDC Approves mRNA Booster Doses (Pfizer-BioNTech and Moderna) of COVID-19 Vaccine for All Adults 

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. 

FDA Authorizes Booster Doses of Pfizer-BioNTech and Moderna COVID-19 Vaccines for All Adults

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.

CDC Recommends Pfizer-BioNTech COVID-19 Vaccine for Children Aged 5-11

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.

FDA Authorizes COVID-19 Vaccine for Children Ages 5-11

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.

CDC Approves ACIP Booster Dose Recommendations for mRNA and Janssen (J&J) COVID-19 Vaccines

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. 

•  A single COVID-19 booster dose is recommended at least 6 months after completion of an mRNA primary series in the same risk groups recommended by CDC for the Pfizer-BioNTech vaccine, under the FDA’s emergency use authorization.
• A single COVID-19 booster dose is recommended for persons aged 18 and older at least 2 months after receipt of the initial J&J dose, under the FDA’s emergency use authorization.

View a simple booster dose table to compare criteria for each booster dose. You can find some of the most common questions on the COVID-19 Booster Dose FAQs.

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.  

Moderna and Janssen (J&J) Booster Doses and Heterologous (Mix and Match) Boosting

On Oct. 20, the FDA authorized the following uses:

• A single Moderna COVID-19 vaccine booster dose may be administered at least 6 months after completion of the primary series to individuals who are:
  • 65 years of age and older
  • 18 through 64 years of age at high risk of severe COVID-19
  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
• A single Janssen (Johnson and Johnson) COVID-19 vaccine booster dose may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
• Each of the available COVID-19 vaccines can be used as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different COVID-19 vaccine.

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.

CDC Issues Recommendations for Pfizer-BioNTech Booster Doses

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: 

• people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
• people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
• people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.
  
  

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.