COVID-19 Vaccine

Over 228 million people have received at least one dose of COVID-19 vaccine in the U.S., and the Centers for Disease Control (CDC) continues to monitor the safety of COVID-19 vaccines for any health issues after vaccination. 
 

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

The CDC recommends a single booster dose for individuals age 18 years and older who received an mRNA COVID-19 vaccine primary series. These booster doses are given at least six months after the primary series. This change replaces the previous recommendation for individuals with underlying conditions. The AAFP agrees with these recommendations. 

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.

OSHA, CMS Issue New Health Care Worker Vaccination Requirements

A new emergency regulation requires COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. Staff must be fully vaccinated by Jan. 4, 2022. Here's what we know and how this applies to your practice. 

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.