• COVID-19 Vaccine

    Updated July 27, 2021

    Almost 189 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 problems that happen after vaccination.

    The Latest: CDC Issues New Masking Guidance for Fully Vaccinated Individuals 

    The COVID-19 Delta variant is widely prevalent and more infectious than prior strains. Currently, the Delta variant accounts for more than 80% of all COVID-19 cases in the U.S. It is also significantly more infectious than prior SARS-CoV-2 variants and has led to a rapid rise in COVID-19 cases. Emerging evidence suggests that fully vaccinated people are at risk for transmitting the Delta variant to others. The CDC’s COVID Tracker is continually updated to rates of community transmission and vaccination. 

    Vaccination against COVID-19 remains the most effective means to achieve control of the pandemic. In the short-term, to minimize preventable morbidity and mortality, additional strategies are needed. The CDC recommends in areas with substantial and high transmission, fully vaccinated individuals wear a mask in public indoor settings to help prevent spread of Delta and protect others. CDC also recommends universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status to allow for full-time in-person learning in the fall with proper prevention strategies in place. Read more in the AAFP article, CDC Recommends Masks in Schools, COVID-19 Hot Spots.

    Please note that guidance for healthcare settings has not changed at this time. The CDC has and continues to recommend use of source control for everyone in healthcare settings (patients, residents, visitors, and healthcare personnel) regardless of vaccination status and community incidence. 

    The CDC has issued a Health Alert Network Advisory urgently encouraging vaccinations and the updated masking guidance. The CDC has also updated its guidance for fully vaccinated individuals and provided an MMWR with guidance for local jurisdictions on implementation of prevention measures based on differing levels of transmission and vaccination rates. 

    FDA Updates Janssen (Johnson & Johnson) Vaccine Labels

    The FDA has updated its fact sheet for the vaccine to include information on an observed increased risk for Guillain-Barré Syndrome. There is no established causal link at this time, but there have been 100 reported cases of the syndrome out of over 12 million doses of the vaccine given the U.S. The CDC and FDA are monitoring the issue and will provide updated information as available. The CDC’s ACIP will discuss these reported cases at their next meeting on July 22, 2021.

    Booster Shots Not Needed at This Time

    The CDC and FDA released a joint statement encouraging individuals to get vaccinated to protect themselves from severe disease and hospitalizations, particularly with the increase in circulation of variants like the delta variant. Fully vaccinated individuals do not need booster shots. However the CDC, FDA, and HHS are collecting data from multiple sources to determine if/when additional doses are needed. AAFP staff will monitor the situation and provide updated information.

    Myocarditis and Pericarditis after mRNA COVID-19 Vaccination

    FDA releases updated COVID-19 vaccine fact sheets: The FDA revised the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis and pericarditis following vaccination. 

    Joint statement from June 23 CDC ACIP meeting: “We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated, as the benefits of vaccination far outweigh any harm. Especially with the troubling Delta variant increasingly circulating, and more readily impacting younger people, the risks of being unvaccinated are far greater than any rare side effects from the vaccines."

    Concern: Since April 2021, there have been increased reports to the Vaccine Adverse Event Reporting System (VAERS) of cases of inflammation of the heart—called myocarditis and pericarditis—following receipt of the mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna). Reported events have been rare and most cases have been mild, and observed in adolescents and young adults within a few days after vaccination. There is no established link that the vaccines caused myocarditis or pericarditis in these individuals. Most cases resolved with minor treatment and rest.

    COVID-19 vaccines are still recommended for eligible individuals aged 12 years and older. Individuals should seek medical care if any of the following symptoms occur after vaccination: chest pain, shortness of breath, and any feelings of fast-beating, fluttering, or pounding heart. Family physicians are strongly encouraged to report potential cases of myocarditis and pericarditis to the VAERS system. AAFP will monitor the situation and update members as information becomes available. 

    CDC’s ACIP Recommends Pfizer/BioNTech COVID-19 Vaccine for Adolescents Aged 12-15 

    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.

    Identifying, Disposing and Reporting COVID-19 Vaccine Wastage

    As demand for vaccination slows, you have questions about wasting vaccines. The CDC's guidance states that wastage does not negatively impact a provider but is simply a means for accounting for inventory. Providers should not miss any opportunities to vaccinate every eligible person who presents at a vaccination site, even if it means puncturing a multidose vial to administer vaccine without having enough people available to receive each dose. 

    About the COVID-19 Vaccines

    To date, no COVID-19 vaccine candidates have been approved (licensed) by the FDA. The FDA issued emergency use authorizations for three vaccines. EUAs were given for mRNA vaccines from Pfizer/BioNTech and Moderna in December 2020. The third EUA was issued on February 27, 2021 for the Janssen (Johnson & Johnson) COVID-19 vaccine, which uses a non-replicating adenovirus vector. Read more. 

    All three of the authorized COVID-19 vaccines have been recommended by the CDC’s Advisory Committee on Immunization Practices, which was reviewed and approved by the AAFP. All three vaccines are effective at preventing COVID-19 disease, hospitalizations and death. 

    • Updated COVID-19 Vaccine FAQs: Use our COVID-19 Vaccine FAQs to answer your patients' most common questions about the vaccines. We'll continue updating as new information is released. 
    • Tools to educate patients: Dr. Ada Stewart shares patient-friendly resources from the "We Can Do This" campaign aimed at fighting vaccine misinformation.
    • An additional tool to support patient conversations: Use the Vaccine Confidence Toolkit from Ariadne Labs to discuss the COVID-19 vaccine with hesitant patients.
    • Need an easy resource to support staff conversations? Borrow slides from our sample COVID-19 vaccine presentation. (updated July 2021)
    • What are the guidelines for vaccinated patients? The CDC 's Guidance for Vaccinated People outlines what activities fully vaccinated people can participate in.

     

    Variants and Impact on COVID-19 Vaccines 

    Virus mutations are common, and SARS-CoV-2 variants have been 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. 

    Update: The Delta variant is accounting for a growing number of new COVID-19 infections. According to the CDC, it has 

    • Increased transmissibility29
    • Potential reduction in neutralization by some EUA monoclonal antibody treatments 7, 14
    • Potential reduction in neutralization by post-vaccination sera 21

    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.

    Vaccine Availability

    The CDC and other federal agencies continue to distribute vaccine doses to states and jurisdictions. As supply continues to increase, jurisdictions will be expanding vaccination sites into small primary care offices and community centers. Find where vaccines are being given in your area.

    CDC has provided a vaccine finder to assist in finding locations with available vaccine. Additionally, many jurisdictions have provided phone numbers to aid individuals without access to internet. 

    Interested in how we're advocating on vaccine distribution issues? The AAFP is working to ensure that family physicians are prioritized in federal and state vaccine strategies. Learn more about these efforts on our Vaccines and Immunizations Advocacy Hub. 

    Quarantine Criteria for Vaccinated Persons

    Additionally, the CDC has issued updated guidance on quarantining after an exposure for vaccinated individuals. Note that while mRNA COVID-19 vaccines have demonstrated high efficacy at preventing severe and symptomatic COVID-19, there is currently limited information on how much the vaccines might reduce transmission and how long protection lasts. In addition, the efficacy of the vaccines against emerging SARS-CoV-2 variants is not known. 

    At this time, vaccinated persons should continue to wear a mask, practice physical distancing, practice hand hygiene and other public health measures. However, vaccinated persons with an exposure to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria: 

    1. Are fully vaccinated (i.e., ≥2 weeks following receipt of the second dose in a 2-dose series, or ≥2 weeks following receipt of one dose of a single-dose vaccine)
    2. Are within 3 months following receipt of the last dose in the series
    3. Have remained asymptomatic since the current COVID-19 exposure

    Persons who do not meet all three should continue to follow current quarantine guidance after exposure to someone with suspected or confirmed COVID-19. 

    FDA Approval Process

    The FDA released guidance for manufacturers to request approval for EUA of a COVID-19 vaccine. The standards for EUA for the vaccine will be stricter than those for other products and vaccine candidates must meet prespecified efficacy and safety data with at least two months of follow up. Additionally, under an EUA, the FDA will continue to collect safety and efficacy data as the vaccine is made available to the public. All data will be reviewed by experts in vaccinology and the CDC’s Advisory Committee in Immunization Practices. 

    Find a list of other vaccine candidates and phase of development in a World Health Organization report.

    AAFP member, Jennifer Middleton, MD, MPH, also wrote a blog on what's ahead with additional vaccines in "Here come the COVID vaccines". 

    Coding and Payment

    The American Medical Association published the first set of COVID-19 vaccine and administration codes. Their unique structure allows for tracking and accommodating multiple COVID-19 vaccines.  

    CDC's COVID-19 Vaccine Resources

    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.

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