Globally, more than 150 vaccines are in development to ease the COVID-19 pandemic. Five vaccine candidates have emerged as the most promising, all reaching phase 3 and beyond in clinical trials. Though the current administration is pushing for a vaccine to become available by the end of the year, many experts think the middle of 2021 is a realistic expectation for most Americans to receive the vaccine. The CDC has communicated that vaccine distribution will occur in a phased approach, with high-risk populations receiving the vaccination first.
Here’s a rundown on the current vaccine candidates, provisional CDC requirements, and procedures healthcare facilities will want to consider as they prepare to distribute mass amounts of the COVID-19 vaccinations in the coming months.
Name of vaccine: mRNA-1273
In partnership with the National Institutes of Health (NIH), Moderna Therapeutics is developing a vaccine that inserts small pieces of the novel coronavirus’s genetic material into human cells. This vaccine promotes an immune response as the body becomes familiar with the presence of the virus. It is a new technology, and approval is still pending for the treatment of humans. The vaccine is administered in two doses, four weeks apart. Early results have shown that healthy individuals, including older adults, have produced coronavirus antibodies. As of September 25th, the company was nearing the end of its phase 3 trial. Moderna’s chief executive said the earliest the biotech company can apply for emergency use authorization would be November 25th.
Name of Vaccine: BNT162b2
Pfizer, a New York-based pharmaceutical company, collaborates with a German biotech company called BioNTech to produce an mRNA coronavirus vaccine. If the vaccine is successful and approved for use, they plan to distribute 1.3 billion doses by the end of 2021 globally. September 12th, Pfizer announced that they expanded their phase 3 trial to include around 44,000 participants. They hope to seek regulatory approval by the end of 2020. The vaccine produced antibodies in injected individuals during phase 1 and phase 2 trials.
Name of Vaccine: AZD1222
To create an effective COVID vaccine, Oxford University, located in the U.K., has partnered with a leading pharmaceutical company, AstraZeneca. The duo’s candidate is a viral vector vaccine. The vaccine works by placing the genetic material of the SARS-CoV-2 into a weakened version of the adenovirus (usually causes the common cold) to stimulate an immune response when injected. Early clinical trials produced favorable immune responses with minimal side effects of fatigue and headaches. On September 8th, due to an adverse reaction among a U.K. trial participant, phase 3 testing experienced a temporary pause. As of October 2nd, the trial had resumed in the U.K., Brazil, South Africa, India, and Japan, while still on hold in the U.S.
Johnson & Johnson
Name of Vaccine: JNJ-78436735
Johnson & Johnson, a New York-based healthcare and pharmaceutical corporation, is testing an adenovector vaccine. The candidate introduces SARS-CoV-2 DNA to the body via a genetically modified adenovirus. This technology is similar to what the company used to develop and manufacture the Ebola vaccine. The company announced on September 23rd that they have entered into Phase 3, which will include 60,000 volunteers across three continents. This vaccine is a single dose. Vaccine storage is held at 2° to 8° C with a shelf life of up to three months. Johnson & Johnson hopes to have the vaccine produced for emergency use authorization in early 2021.
Name of Vaccine: NVX-CoV2373
A Maryland-based biotech company used its nanoparticle technology to create a vaccine engineered from the genetic sequence of SARS-CoV-2. The company announced that they were entering phase 3 of their study, in the U.K, on September 24th. Ten thousand participants will participate in the study and require two vaccinations 21 days apart. Also, 400 participants will receive an influenza vaccine in addition to the COVID-19 vaccine as part of a co-administration sub-study. Novavax hopes to be able to manufacture 2 billion doses per year by mid-2021.
When will a COVID-19 vaccine be ready?
Typically a vaccine would take years to develop, test, approve, and manufacture. During the world COVID-19 pandemic, researchers are attempting to compress that timeline into just a few months. Many health experts and leading-manufactures listed above believe mid-2021 is a realistic time for the general population to receive COVID-19 vaccines. Since initial vaccine supplies will be limited, the CDC has indicated that healthcare workers, high-risk populations, and the elderly will receive priority.
How do healthcare providers receive COVID-19 vaccine shipments?
The CDC COVID is currently working with state, local, and tribal health departments to zero in on existing plans for vaccine distribution and administration. To receive and administer the COVID-19 vaccine and ancillary supplies, all interested healthcare providers and organizations must enroll in the United States Government (USG) COVID-19 vaccination program. Dispensing locations must sign and agree to conditions outlined in the COVID-19 Vaccination Program Provider Agreement in coordination with their local immunization program.
The CDC COVID-19 Vaccination Program Provider Agreement requires the administering facility to provide necessary information regarding the organization.
Required information includes:
- Clinic hours/days of operation
- Provider type and setting
- Patient population served
- Demographic logistical information for receiving COVID-19 vaccine shipments
- The number of patients the clinic can vaccinate weekly
- Vaccine storage capacity (refrigerated/frozen/ultra-cold temperature).
COVID-19 vaccine allocation to jurisdictions will depend on various factors, including:
- Populations recommended by the Advisory Committee on Immunization Practices
- Current local spread/prevalence of COVID-19
- COVID-19 vaccine production and availability
Get more information here.
How will COVID-19 vaccines be stored?
Cold chain storage and handling requirements for each COVID-19 vaccine product will vary from refrigerated (2°C) to frozen (-20°C) to ultra-cold (-60° to -80°C) temperatures, and ongoing stability testing may impact these requirements.
As pharmacies, health departments, doctor’s offices, and hospitals prepare to vaccinate, it is essential to consider cold storage capacity. Currently, Pfizer and Moderna’s vaccine candidates require sub-zero temperatures. Vaccines from AstraZeneca, Johnson & Johnson, and Novavax require 2-8°C temperatures - the same requirement for the seasonal influenza vaccine.
Planning for your vaccine freezers and refrigerators is crucial since a cold storage shortage may be on the horizon. K2Scientific currently has pharmaceutical-grade refrigerators, freezers, and ultra-low temperature freezers available. Many are available to ship the same day. Lead times for back-ordered items are improving daily as K2 Scientific is ramping up production to accommodate the impending demand.
Who will eligible for the COVID-19 vaccine?
The initial supply of the vaccine may be limited. The CDC indicates at-risk-populations will receive priority status as long as vaccines remain in short supply. The primary focus will be on vaccinating:
- Healthcare workers and other critical workforce
- Staff and residents in long-term care and assisted living facilities
- Elderly and other at-risk populations
When enough vaccine supply is available for expanded groups among the general population, a national COVID-19 vaccine finder will be open online through the CDC’s website.
What are the dosing requirements for the COVID-19 vaccine?
The majority of the current vaccine candidates require two doses with 21 or 28 days between successful immunity injections. Reminders to patients to come back to receive their second dose will be a critical logistic to iron out. Text reminders, calls, or emails sent to patients will be vital in making sure they return to get their second injection.