ACP Chapter Action Tool Kit
Prepared by ACP’s Division of Governmental Affairs and Public Policy
September 16, 2021
Why Is A Chapter Action Plan Necessary?
On December 14, 2020, the first vaccine to fight COVID-19 was administered in the U.S. to a nurse -- outside of clinical trials – under a Food and Drug Administration (FDA) emergency use authorization (EUA). Since then, efforts to vaccinate the U.S. population have been challenging, requiring a combination of both federal and state action. The federal government worked with manufacturers in the production and distribution of the vaccine, with guidance from key federal agencies, while the individual states were tasked with the planning and logistics of administering the vaccine to their populations. There have been ongoing challenges with equitable access and distribution of COVID vaccines, as well as educating the U.S. population about the efficacy of the COVID vaccine, which has contributed to vaccine hesitancy among certain segments of the population.
We encourage ACP chapters to engage with state officials to ensure the equitable distribution of COVID vaccines to all those eligible, including frontline physicians and health care workers, those with compromised immune systems, pregnant women, and incarcerated individuals regardless of immigration status. ACP also supports that the government may appropriately require employers (including health care and long-term care employers), schools, public agencies, and organizations to require their employees to receive the COVID-19 vaccine. States should also do their part in vaccine-related education and outreach campaigns, which includes information on quality protocols, storage and handing, documentation, and other requirements specific to COVID-19 vaccines.
What COVID vaccines have been granted Emergency Use Authorization?
Currently, the FDA has authorized and recommended three vaccines in the United States to combat COVID-19, all under Emergency Use Authorization:
- Pfizer-BioNTech – 2 shots for people ages 12 and older
- Moderna – 2 shots for people ages 18 and older
- Johnson and Johnson/Janssen – one shot for people ages 18 and older
On August 23, 2021, the FDA granted “full” approval of the Pfizer COVID-19 vaccine for the prevention of COVID-19 disease in people ages 16 years and older. The vaccine continues to be available under emergency use authorization for adolescents ages 12 to 15 years, and for the administration of a third dose in some immunocompromised people. This is the first of three COVID vaccines to receive full FDA approval. The other two vaccines are still authorized and recommended by the FDA to combat COVID-19 and are considered safe and effective at reducing the risk of severe illness. The Advisory Committee on Immunization Practices (ACIP) voted unanimously on August 30, 2021 to recommend use of the Pfizer-BioNTech COVID-19 vaccine for people 16 years of age and older under the FDA's Biologics License Application (BLA) approval. ACP supports the recommendation of ACIP.
Data on the Pfizer and Moderna vaccines have determined an efficacy rate of between 94-95 percent in preventing symptomatic COVID-19 after two doses, and the Johnson and Johnson/Janssen vaccine with an 85 percent efficacy rate. However, a recent report by the Centers for Disease Control and Prevention (CDC) states that the efficacy rate for these vaccines decreases against the Delta variant. The CDC said that the reduced protection may be due to both decreasing immunity over time and the highly contagious Delta variant.
To address the reduction in protection, on August 18, 2021, U.S. Health and Human Services public health and medical experts announced a plan to begin offering COVID-19 mRNA vaccine booster shots this fall. Booster shots are doses of vaccine that are given when the initial immune response to a vaccine is likely to have decreased over time.
The CDC says that the COVID-19 vaccines remain the most powerful tool we have against COVID-19, making it critical that all people get vaccinated as soon as they are eligible. To find a vaccine provider near you, visit vaccines.gov or your state or local public health department.
What is the Federal Government doing?
The Biden Administration has instituted a number of measures to increase the vaccination rate in order to curb the surge in COVID-19 cases. On September 9, 2021, President Biden announced his six-part "Path Out of the Pandemic" plan to combat the COVID-19 by increasing vaccination rates, protecting the vaccinated, ramping up testing and requiring masking, improving efforts to keep kids in classrooms safe, protecting the country's economic recovery, and improving care for those with COVID-19.
The administration will use its authority to do the following:
- Require COVID-19 vaccination for all federal employees, without an option for periodic testing as a substitute;
- Require COVID-19 vaccines for workers at Medicare and Medicaid participating health care settings;
- Require employers with more than 100 employees to require their workforces to be vaccinated or be tested weekly for COVID-19;
- Require paid time off for individuals to get vaccinated; and
- Provide COVID-19 booster shots, subject to authorization/approval by the FDA and a recommendation from the Advisory Committee on Immunization Practices.
The U.S. Department of Veteran Administration and U.S. Department of Defense have also announced mandatory vaccine requirements. In addition, on July 22, 2021, Health and Human Services Secretary Xavier Becerra announced 1.7 million in new funding for testing and vaccine outreach – $1.6 billion would go toward testing in prisons and homeless shelters, and around $100 million to support outreach in rural areas.
What are the States doing?
Since the U.S. Equal Employment Opportunity Commission announced that employers could require workers to be vaccinated against COVID-19 as long as they did not violate the Americans with Disabilities and the Civil Rights acts, several states have announced that they would require public employees and some health care workers to get vaccinated or submit to regular testing. As of September 2, 2021, nineteen states have implemented COVID-19 vaccine mandates.
Alternatively, several states have introduced legislation to ban COVID-19 vaccine mandates for work and schools, and vaccine passports. To date, governors in seven states have signed legislation banning state agencies from requiring COVID-19 vaccinations as a condition of work and three states have banned mandates for health care workers. Fifteen states have introduced legislation or issued executive orders banning school COVID-19 vaccination mandates.
Vaccinating the Public and Health Care Workers
On September 15, 2021, ACP issued two new policy statements – on immunization policies to protect the public and the immunization of health care workers – that support the promotion of vaccines in the interest of public safety and health.
In the policy statements, ACP states that employers and schools may appropriately require proof of vaccination for recommended immunizations for highly transmissible diseases, this would include COVID-19 vaccines while we are dealing with a public health emergency due to the COVID-19 pandemic. ACP also opposes state laws, regulations or executive orders that prohibit employers and schools from instituting such requirements. ACP further says that the requirements imposed by employers and schools should be complemented by offering support through education, outreach, and paid time off for vaccinations and to deal with short term side-effects. This support is particularly important to offer to historically marginalized populations who are subject to racism and discrimination. ACP further states that while those who have clear medical contraindications should be exempt from requirements, that allowing exemptions based on non-medical reasons poses a risk to public health.
ACP also recommends that all health care workers should be immunized, as recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, for the safety of patients and the public unless there is a clear medical contraindication or other exemption under applicable law. ACP supports employers who require that all health care workers be vaccinated against highly transmissible diseases as a condition of employment. ACP has previously supported requirements for COVID-19 vaccines for health care workers.
Vaccine Administration, Distribution, and Payment
ACP recommends an “all-hands-on-deck” approach to COVID-19 vaccine administration, utilizing trained, certified community-based vaccinators in coordination with the patient’s primary care team. In many areas, non-physician clinicians, such as pharmacists and retail health clinic personnel, will administer vaccines, educate patients about vaccine safety, and perform other duties. However, community-based vaccinators do not always coordinate care with the patient’s primary team, which could result in duplicative care or other problems. In the context of the COVID-19 pandemic, ACP recommends non-physician vaccinators, including pharmacists and clinicians working in retail health clinics, must communicate, coordinate, and collaborate with the patient’s primary care team, inform the patient of the need for post-vaccine follow-up care, and provide a referral to a primary care physician if the patient does not have one.
The CDC’s COVID-19 Vaccination Program requires participating organizations to record vaccine information in the patient’s record and report to the relevant public health authority.
In many jurisdictions, vaccinators will use the Immunization Information Systems (IIS) or other reporting system that collects vaccination records from physician offices, hospitals, health clinics, pharmacies and other settings. Physicians can check the IIS to determine their patient’s vaccination history.
The CDC’s COVID-19 Vaccination Program also ensures that patients can get the vaccine at no cost. As a result, vaccinators must agree to vaccinate patients regardless of their ability to pay and cannot seek reimbursement or balance billing the patient. Payers are responsible for reimbursing vaccinators for administering the vaccine. Private and public payers (including Medicaid) should inform care teams of all billing, coding, and other information necessary to obtain prompt reimbursement for administering the vaccine and providing related counseling and follow-up care to patients. ACP supports requirements that COVID-19 vaccine be provided at no cost to all patients, regardless of coverage status.
On Aug 9th, ACP joined with the American College of Obstetricians and Gynecologists (ACOG) and other medical organizations to encourage COVID-19 vaccination among pregnant women along with women who were recently pregnant, are planning to become pregnant, or are lactating. Soon thereafter, the Centers for Disease Control and Prevention urged all pregnant women to get vaccinated. The ACP vaccine policy follows the Advisory Committee on Immunization Practices recommendations, which recommend vaccinations for everyone ages 12 and above, including pregnant women.
ACP also joined with the American Academy of Pediatrics (AAP) and ACOG in a letter to the secretary of U.S. Homeland Security urging that the agency take further action and administer COVID-19 vaccinations to all eligible immigrants in Customs and Border Protection custody. The organizations note, “All individuals held in federal custody, regardless of immigration status, should have access to timely, evidence-based comprehensive health care -- including vaccinations protecting against COVID-19.”
ACP Chapters should contact their state’s governor and recommend:
- That the government may appropriately require employers (including health care and long-term care employers), schools, public agencies, and organizations to require their employees to receive the COVID-19 vaccine; with exceptions for employees with identified medical reasons.
- Equitable distribution of COVID-19 vaccines to all those eligible, including frontline physicians and health care workers, those with compromised immune systems, pregnant women, and incarcerated individuals regardless of immigration status.
- Community-based primary care physicians and their team members receive clear information on when and where they can be vaccinated, including for any planned rollout of vaccine boosters.
- Stakeholders widely distribute to vaccinators all vaccine-related educational and outreach materials, quality protocols, storage and handing information, documentation, and other requirements specific to COVID-19 vaccines authorized under an Emergency Use Authorization or with full FDA approval. A sample letter that chapters can customize is available.
- National Academy for State Health Policy: States Plan for Vaccinating their Populations against COVID-19
- COVID-19: An ACP Physician’s Guide + Resources - Vaccinations
- CDC COVID-19 Vaccination Program Interim Operational Guidance for Jurisdictions
- CDC Information about Immunization Information Systems
- CDC Report on the Effectiveness of COVID-19 Vaccines on the Delta Variant
- Key Questions About COVID-19 Vaccine Mandates
- KFF State COVID-19 Data and Policy Actions