COVID-19 vaccine information can quickly, but we know you may still want access to previous updates that are still relevant. Below you can find past news and updates to support your patient care efforts.
On Sept. 22, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose in the following populations:
These doses would be administered at least six months after completion of the primary series.
In August, the CDC reported the highest number of COVID-19-related deaths in pregnant people since the pandemic began. Evidence suggests that about 97% of pregnant people hospitalized with SARS-CoV-2 infection were unvaccinated. The CDC and AAFP strongly recommends that all people who are pregnant, recently pregnant, are trying to get pregnant or might become pregnant get vaccinated now.
Pfizer-BioNTech vaccine is approved for use in individuals over the age of 12. For most individuals, this is a two-dose series unless they have moderate to severe immunosuppression or are eligible for a booster dose under the amended EUA as outlined by the FDA. Unlike most FDA-licensed medications, off-label use in younger individuals or as a booster dose in immunocompetent individuals who received a non-Pfizer-BioNTech vaccine is strongly discouraged.
CDC recommends the Pfizer-BioNTech vaccine following FDA approval of the Biologics Licensure Application (BLA) for individuals 16 years and older under the BLA. This means that the vaccine is recommended outside of the public health emergency for this age group. The recommendation was based on extensive data from post authorization safety data and an extended length of follow up compared to the previous recommendation for this vaccine in December 2020. The ACIP recommendations for use in individuals aged 12-15 and for use of an additional dose in immunocompromised individuals are still valid under the conditions of the Emergency Use Authorization. Read more in FDA Gives Full Approval to Pfizer-BioNTech COVID-19 Vaccine.
An Aug. 18 joint statement outlined plans for mRNA COVID-19 vaccines booster doses, pending authorization by the FDA, and review and recommendation from the CDC’s ACIP. This is in response to data published by CDC showing a decline in vaccine effectiveness in preventing infection over time. This decline coincided with the increase in the Delta variant in the U.S., along with relaxation of masking and physical distancing recommendations.
The FDA and CDC are reviewing data on the efficacy of booster doses and the ACIP plans to meet on Aug. 23 to discuss considerations for booster doses. As we have throughout the pandemic, AAFP expert staff will continue to participate in meetings with the CDC and FDA and provide updated information as it becomes available.
The committee voted unanimously to recommend an additional dose of Pfizer/BioNTech COVID-19 vaccine (≥12 years) and Moderna COVID-19 vaccine (≥18 years) is recommended following a primary series in immunocompromised people under the FDA’s Emergency Use Authorization. The AAFP has reviewed and approved this recommendation. The CDC has updated its clinical considerations to include information for individuals with moderate to severe immunosuppression.
This recommendation follows an amendment by the FDA that allows for an additional dose of either mRNA COVID-19 vaccine (Pfizer/BioNTech or Moderna) to be given to certain individuals who are immunocompromised. The additional dose is only authorized for certain immunocompromised individuals, specifically solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Studies demonstrated only a moderate increase in immune response following a third dose, so immunocompromised individuals are strongly encouraged to continue risk mitigation strategies including masks and distancing to reduce their exposure to the virus.
This amendment does not apply to recipients of the Janssen (Johnson & Johnson) vaccine at this time due to insufficient evidence. Please note: Other fully vaccinated individuals do not need an additional (booster) dose at this time.
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.
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.
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 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.
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.
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.
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.