COVID-19 Vaccine Policies Should Reflect the Best Available Scientific Evidence in Order to Improve Vaccine Access & Uptake

August 19, 2021

The Biotechnology Innovation Organization (BIO) believes that legislation and public health policies to address this pandemic and the use of FDA authorized and approved COVID-19 vaccines should reflect the best available scientific evidence in order to improve access to and uptake of COVID-19 vaccination.

• In the U.S., vaccination requirements for school entry, daycare entry, and employment are set by each state and vary from state-to-state. These vaccination requirements can be changed by legislation or regulation, depending on the state. Additionally, in certain instances, requirements also may be determined by private institutions.
• Policies to address this pandemic and the use of FDA authorized and approved COVID-19 vaccines should reflect the best available scientific evidence in order to improve access to and uptake of COVID-19 vaccination services. The scientific evidence on SARS-CoV-2 is still emerging, and policies to address this pandemic should reflect the current state of knowledge and adapt to incorporate new relevant evidence as it emerges.
  • Vaccine companies have committed to upholding high scientific standards throughout the COVID-19 vaccine development process. In September, CEOs of nine companies researching COVID-19 vaccines pledged to “follow the science” in conducting clinical trials and seeking FDA review.1 1 BusinessWire, “Biopharma Leaders Unite to Stand with Science,” available at https://www.businesswire.com/news/home/20200908005282/en/.
• Policymakers should consider the following factors in determining whether, when, and how to implement requirements for COVID-19 vaccination:
  • The Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority exists specifically for cases such as this pandemic – when a medical product is needed more expeditiously due to great public health need. Such products are considered investigational and are subject to robust safety monitoring. Last Fall, FDA released guidance outlining the high scientific standards and robust review process for seeking an EUA for COVID-19 vaccines.
  • Any requirement decision must consider system capacity. Supply only just became sufficient to open vaccination up to the general public.
    • Current trials are researching the safety and efficacy of COVID-19 vaccines in adolescents and adults. Additionally, based on the preliminary prioritization framework of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), children are not likely to among the first populations for vaccination against COVID-19.
  • Policies that promote vaccination among the risk-based priority groups, including requirements, need to consider the evidence specific to these populations.
• When States consider policies related to COVID-19 and vaccination, transparency in the decision-making process is critical for fostering public confidence in these vaccines and how they are used. Building vaccine confidence and ensuring a communications plan to increase public understanding of the vaccines and the scientific evidence and rigor of the review processes is of the highest importance.

Beyond requirements, there are other policies and practices that States should considered to help to improve access to and uptake of vaccination services, including for COVID-19 vaccines. Planning and a proactive response in advance of the broad use of a COVID-19 vaccine is critical. In the interim, opportunities to prepare for COVID-19 vaccination and strengthen the immunization infrastructure include:

• Educational communications, including engagement with community leaders and trusted voices: A COVID-19 vaccine will only be impactful if 2 Recommendations are in part adapted from Vaccinate Your Family (https://www.vaccinateyourfamily.org/wpcontent/uploads/2020/05/State-Vaccine-Policy-Suggestions-during-COVID-May-2020.pdf) and the American Academy of Pediatrics (https://www.aap.org/en-us/about-the-aap/aap-press-room/campaigns/call-yourpediatrician/Pages/default.aspx) . people are willing to take it. State policymakers can play a role in educating constituents and spreading good information about the clinical trials process, high standards of safety and efficacy these products are being held to, and the importance of a vaccine to ending the pandemic. This outreach is especially important to communities hit hard by the pandemic.
• Immunization Information System (IIS) improvements to accommodate multiple COVID-19 vaccines with potentially different dosing schedules: There will likely be multiple COVID-19 vaccines in use, each with different intervals between doses. It may be that certain COVID-19 vaccines are more effective in certain populations (i.e., for older adults, for those with chronic conditions). Vaccinations will be given at a variety of sites including provider offices, pharmacies, public health clinics, and community events. Therefore, tracking which vaccine was received by whom, when, and where, and having reminder-recall for subsequent doses of the correct vaccine series will be complex but crucial. IIS vary from state to state in terms of critical capabilities such as data sharing among providers. States should examine the capability of their IIS system and make any necessary improvements necessary for COVID-19 data and functionality.
• Pharmacy scope of practice for adult vaccinations: To prepare for a COVID-19 vaccine, states should examine their scope of practice laws and ensure that pharmacists – as well as other immunizers – are adequately trained in vaccine administration and have the ability to administer vaccines to, bill for reimbursement, and input immunization information into IIS systems for all adults age 18 and older.
• Prepare health, public health, and immunization departments: States are currently preparing for allocation and distribution of COVID-19 vaccines. In many localities, health care and public health have been stretched beyond capacity by the pandemic. Fully funding health, public health, and immunization departments and ensure these departments are fully staffed to meet the need of a COVID-19 vaccination campaign.
• Encourage your constituents to remain up-to-date on all routine immunizations including influenza: During the COVID-19 pandemic, vaccine administrations for both children and adults have steeply declined. While pediatric vaccines have begun to rebound, significant declines in adolescent and adult vaccinations have not rebounded. Individuals should contact their providers to see what safety measures are in place and to make an appointment for missed routine vaccinations. Additionally, constituents who became unemployed during the pandemic may have coverage for vaccines under Medicaid or the Vaccines for Children (VFC) program.

BIO is a national trade association for the biotechnology industry, representing over 1,000 companies and academic institutions involved in the research and development of innovative healthcare, agriculture, industrial, and environmental biotechnology products. BIO members include companies working on vaccines and therapeutics to combat the COVID-19 pandemic. Our member companies are committed to rigorous science; the safety of our vaccine and therapeutics is our top priority.