Like many of you, I am closely following the progress on the coronavirus vaccine as we continue to experience a significant burden on the health care system and a staggering loss of life. It was certainly encouraging to hear that the Pfizer Inc. and BioNTech messenger RNA (mRNA) vaccine BNT162b2 received emergency authorization in the United Kingdom on December 2, 2020. Following less than a year of research and development, inoculations against coronavirus disease-19 (COVID-19) could begin as early as next week in Europe. Approximately 40 million doses, enough to vaccinate 20 million people, have been ordered by the UK. Are they ready to immunize the masses? When will the vaccine be available in the U.S.? How will these vaccines be distributed? Who will be first in line? How can health care personnel prepare?
When will the vaccine be available in the U.S.?
On November 20, 2020 Pfizer Inc. and BioNTech submitted their vaccine application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The FDA undergoes a much lengthier, independent evaluation (compared to the U.K.) of the clinical trial results to ensure integrity of the data. Once approval is granted, vaccinations can begin, potentially within a few weeks. Pfizer and BioNTech believe they can produce approximately 50 million doses by January. The U.S. government signed an agreement in July with Pfizer and BioNTech to receive 100 million doses of their vaccine once approved (U.S. Department of Health & Human Services, 2020) and will then have the option to acquire up to an additional 500 million doses (Pfizer, 2020a).
How will the vaccine be distributed?
While most large vaccine manufacturers have extensive experience in the production and distribution of large quantities of vaccines worldwide, significant logistical challenges exist given the extremely cold temperature under which these new biologics must be maintained. The Pfizer-BioNTech vaccine is a two-dose regimen administered 21 days apart. In anticipation of EUA approval, Pfizer (2020b) has developed procedures to support vaccine transport, storage and continuous temperature monitoring. The company has designed temperature-controlled thermal shippers using dry ice to maintain temperatures of -70°Celsius (-94° Fahrenheit) +/- 10°C for up to 10 days. Pfizer will also use GPS-enabled thermal sensors to track the location and temperature of each vaccine shipment.
Once the shipment arrives, the clinic will have three options for storage:
- Ultra-low-temperature freezers that can extend the shelf life for up to six months; these units are costly and difficult to procure.
- Refrigeration units typically available in hospitals where the vaccine can be stored for five days at 2-8°C (36°-46°F), a short-term solution.
- Thermal shippers can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. Dry ice however is a hazardous material, may be in short supply in some areas and can be very expensive. After 15 days in the thermal shipper, the vials can be transferred to 2-8°C refrigeration units for an additional five days, or a total of 20 days. However, once thawed and stored at 2-8°C, the vials cannot be re-frozen.
Moderna Inc. (2020) announced that their coronavirus vaccine mRNA-1273 will be reviewed by the FDA on December 17th
and anticipates distribution will begin after EUA is granted. According to the company, the mRNA-1273 vaccine is stable at 2-8°C which can be maintained by a standard home or medical refrigerator for 30 days. Additionally, the vaccine can remain stable at -20°C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours (Moderna, 2020). This allows for storage at most pharmacies, hospitals or providers’ offices. Dozens of other vaccines are in various stages of the clinical development process
. Johnson & Johnson and AstraZeneca are next in line as both companies are currently conducting Phase 3 trials.
Who will be first in line for the vaccine?
The Advisory Committee on Immunization Practices (ACIP), a federal advisory committee consisting of medical and public health experts, held an emergency meeting on December 1st
to discuss who should be first to receive the COVID-19 vaccine. They are reviewing all clinical trial information including study participant demographics (age, race, ethnicity, medical conditions), how different groups respond to the vaccine and side effects that have been reported (CDC, 2020a). Studies began in September in teenagers and in October for adolescents as young as age 12. Those results are not yet available. Additional studies in younger children will be needed since their immune systems and immune responses are different than those in adults. There are also no study data on pregnant and lactating women to date.
Once the COVID-19 vaccine is authorized by the FDA, the ACIP will recommend vaccinations be prioritized in Phase 1a to health care staff and residents of long-term care facilities (CDC, 2020a). It is expected that the next phase of vaccination will include workers in essential and critical industries, individuals at high risk for severe COVID-19 illness due to underlying medical conditions and individuals 65 years and older. For the majority of us, we can anticipate vaccine availability next Spring, 2021 at the earliest.
It is important to note that while the ACIP guidelines are recommended, each state can determine their own protocols and make decisions based on their specific population. Similar to the influenza vaccine, COVID-19 inoculations will be administered at hospitals, outpatient clinics, community vaccination locations and pharmacies.
How can health care staff prepare?
When the vaccine does become available in the U.S., a carefully coordinated effort will be needed and extensive training and education of health care personnel will be critical. Local health departments will play a major role in providing information on vaccine management, administration, and reporting. Primary objectives should include (CDC, 2020b):
- ACIP COVID-19 vaccine recommendations
- How to order and receive COVID-19 vaccine
- COVID-19 vaccine storage and handling (including transport requirements)
- How to administer the vaccine (preparation, reconstitution, needle size, anatomic location for vaccine administration)
- Documentation and reporting of vaccine administration
- Managing and reporting vaccine inventory
- Managing temperature deviations
- Documenting vaccine waste/spoil
- Reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS)
- Enrolling patients in v-safe, a smart-phone application that asks patients about side effects after receiving the COVID-19 vaccine
- Providing fact sheets or information sheets to patients
- How to submit facility information for COVID-19 vaccination clinics to CDC’s VaccineFinder which helps individuals find providers who offer specific vaccines
The public will rely on nurses and health care providers for information on COVID-19 vaccines and how they work. Pfizer-BioNTech and Moderna both utilize messenger RNA (mRNA) technology which carries instructions for the cell on how to make a segment of the “spike protein” that is unique to severe acute respiratory coronarvirus-2 (SARS-CoV-2) (CDC, 2020c). Once on the cell surface, the protein or antigen will induce the immune system to produce antibodies that are specific to the SARS-CoV-2 virus, protecting the body from infection. Both Johnson & Johnson and AstraZeneca employ a different technology that genetically modifies adenoviruses, preventing their replication and therefore illness. The virus is then used as a vector or carrier of the genetic code for the antigen.
The CDC (2020c) outlines key points to share with patients regarding mRNA vaccines as these will be approved first:
- Similar to other vaccines, COVID-19 mRNA vaccines have been rigorously tested for safety prior to approval.
- While mRNA technology is new, it has been in development for over ten years.
- mRNA vaccines do not contain live virus and will not increase the risk of disease in a vaccinated individual.
- mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person’s DNA.
Vaccinating the masses
Health care workers continue to shoulder the burden of the pandemic in caring for the hundreds of thousands of individuals who require hospitalization. They will also play a major role in educating patients and the public about the vaccine and be responsible for its safe and efficient administration. Until a vaccine is widely distributed, we must remain vigilant and continue to follow public health guidance to wear masks, physically distance, wash our hands often and refrain from gathering with individuals outside of our own household.