COVID-19 Vaccine
Updated February 27, 2021
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 (J&J) COVID-19 vaccine, which uses a non-replicating adenovirus vector. More information can be found at https://www.fda.gov/media/146305/download.
The two mRNA vaccines have been recommended by the CDC’s Advisory Committee on Immunization, which was reviewed and approved by the AAFP. The ACIP will be discussing the Janssen COVID-19 vaccine on Feb. 28. The session is open to the public, and AAFP expert staff will provide an efficacy and safety data overview, plus updated resources and patient education from the FDA and the CDC’s ACIP.
Similar to current recommendations, the AAFP will review and determine approval. View the CDC's Interim Clinical Considerations for information on the different vaccines, including clinical considerations, preparation and storage.
New Criteria: Quarantine 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:
- 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)
- Are within 3 months following receipt of the last dose in the series
- 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.
- What do we know so far about the variants and their impact on vaccines? Read more below.
- Concerned about adverse events? Learn about CDC updates to anaphylaxis guidance.
- Need an easy resource to support staff conversations? Borrow slides from our sample COVID-19 presentation.
- Thinking about what patients will ask? Our COVID-19 Vaccine FAQs and COVID-19 Vaccine Myths can help.
Variants and Impact on COVID-19 Vaccines: What We Know So Far
Virus mutations are common, so it's not surprising that SARS-CoV-2 variants have been detected. The CDC is monitoring these variants and tracking their spread across the U.S., as well as the effect on infection and disease. Researchers are also rapidly checking vaccine effectiveness against the different variants. Read this short summary of each variant identified in the U.S.
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.
B.1.1.7 (United Kingdom)
- 50-70% more efficient in spreading from person to person
- Multiple mutations: a change in the receptor binding domain of the spike protein, a deletion in the spike protein that causes a conformational change, and a substitution mutation near the S1/S2 furin cleavage site(a site with high variability in coronaviruses).
- To date, there is no evidence of any impact on disease severity or vaccine efficacy for the two vaccines authorized for use in the U.S.
B1.351 (South Africa)
- Individuals infected with this strain showed higher viral loads which may increase transmissibility.
- Multiple mutations in the spike protein, most importantly one mutation that may impact the ability for antibodies to neutralize the virus.
- Early studies with several COVID-19 vaccines resulted lower neutralizing antibody titers against this variant. However, titers were still well within the expected range to be effective.
P.1 (Brazil)
- This strain was identified more recently so data are still needed to determine impacts on transmission, disease severity, and vaccine effectiveness.
- Contains 17 mutations including three mutations in the spike protein receptor binding domain that may impact neutralizing antibodies.
Distribution Plans and Issues
The CDC and other federal agencies are working to distribute vaccine doses to states and jurisdictions. At this time, limited vaccine quantities are available, so priority is being given for certain populations, such as frontline health care workers and those at greatest risk of morbidity and mortality from COVID-19.
The ACIP issued recommendations to guide prioritization for initial allocations of the vaccine, as supply is limited. Healthcare workers and residents in long-term care facilities were prioritized for phase 1a of vaccine distribution. Phase 1b includes persons aged 75 and older and frontline essential workers. Phase 1c includes individuals aged 65-74, persons aged 16-64 with high-risk medical conditions, and other essential workers not captured in phase 1b.
- A list of state-by-state distribution plans, and a map from the National Academy of State Health Policy, is available on the COVID-19 Vaccine Distribution page.
- The CDC's COVID-19 Data Tracker is also tracking the number of vaccines distributed and administered by state.
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.
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.
- First COVID-19 Vaccine CPT Codes Published
- More new CPT codes approved for COVID-19 vaccines
- COVID-19 Vaccine Coverage Requirements and Preliminary Payment Guidance: information on coverage for vaccine administration and related services.
CDC's COVID-19 Vaccine Resources
Check out information on the CDC's COVID-19 site, including:
- COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians
- COVID-19 Vaccine Training Module
- COVID-19 Vaccine Facts
- Understanding mRNA Vaccines
- CDC Process for Vaccine Recommendations
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.