As new infections continue to climb globally and our collective COVID-19 fatigue builds, it’s clear that we’re all itching for some good news right about now. And that’s why the COVID-19 vaccine advancements announced recently is offering renewed hope that a return to normalcy may not be that far off.
So, what do we know about the race to develop a vaccine? And what should your organization be doing now to prepare for a highly anticipated COVID-19 vaccination campaign in 2021? Let’s take a quick look.
Positive Signs Ahead for COVID-19 Vaccines
On November 30, Moderna applied to the U.S. Federal Drug Administration (FDA) for emergency approval of its candidate vaccine mRNA-1273 developed to fight COVID-19. This announcement comes just 10 days after a similar application was filed by Pfizer/BioNTech for emergency approval of their vaccine BNT162b2. Both companies reported recently that their respective vaccines were shown to be 94% and 95% effective in late-stage trials, and there’s hope that with fast-tracked approval, the first doses of these vaccines could be delivered to essential health care workers before the end of the year.
In fact, the UK government has recently directed NHS hospitals to be prepared to receive the first lots of vaccine as early as December 7, as it expects its Medical & Health Care Products Regulatory Agency (MHRA) to expedite vaccine approval in the coming days, meaning it’s time for organizations to start preparing now for their COVID-19 vaccination campaigns.
Understanding the Vaccine Approval Process
So, what’s driving the timeline to get vaccines into the market? To obtain FDA approval, candidate vaccines need to meet 3 key criteria:
- Firstly, vaccines must be at least 50% effective. Vaccine efficacy is defined as the proportionate reduction in disease among the vaccinated group. In other words, the candidate vaccine is administered to a specific number of test subjects, with another subset receiving a placebo. Researchers then measure the percent reduction in disease amongst the vaccinated group relative to the placebo group. 90% vaccine efficacy means that 90% of the individuals who received the vaccine did not contract the virus. The higher the efficacy, the better.
- Secondly, drug manufacturers must be able to demonstrate that the candidate vaccine is safe. Since serious adverse reactions generally occur in the first 6 weeks following vaccination, researchers can only declare the vaccine is safe if 50% of the trial participants do not to show adverse symptoms in the 2 months following vaccination. If serious reactions are discovered, those cases must be thoroughly investigated, and another trial will likely need to be conducted. It’s important to note, however, that researchers are concerned with serious or life-threatening complications. These complications are much more serious that the mild side effects most would experience following vaccination, including fatigue, muscle aches or even a low-grade fever for 1-2 days afterward.
- Thirdly, pharmaceutical companies seeking regulatory approval must be able to demonstrate they have the capacity to assure product quality and consistency in the mass manufacture of the vaccine. This step is critical to ensure that vaccine quality doesn’t deviate during production, which could ultimately impact its overall safety or efficacy within the larger population.
How do COVID-19 Vaccines Work?
Most vaccines we receive are manufactured from inactivated virus strains that illicit an immune response when injected into the body. The body recognizes the inactivated virus as foreign and triggers the immune system to attack the invading material. What’s different about the COVID-19 candidate vaccines developed by Pfizer/BioNTech, Moderna, and AstraZeneca/Oxford is that they’re mRNA vaccines. mRNA is molecule that “reads” cellular DNA to synthesize proteins used in other cellular functions. The COVID-19 mRNA vaccines have been designed with a specific genetic code that instruct the cells to synthesize the “spike” proteins that are found on the outer surface of the SARS-CoV-2 virus. By essentially training the body’s immune system to recognize and attack the spike proteins, it’s thought that the immune system will be able to swiftly detect and destroy COVID-19 virus cells if/when they enter the body.
It’s important to note that drug makers admit that they cannot say with absolute certainty how long the vaccine will provide protection against COVID-19. While we all hope it provides long-lasting protection, there remains a possibility that inoculation may become a seasonal activity, similar to the flu. In that case, individuals will need to be prepared to receive boosters to maintain their immunity to the virus and organizations will need to plan for ongoing COVID-19 vaccination campaigns.
What are the COVID-19 Vaccination Distribution Challenges?
All three manufacturers indicate that immunization will require 2 vaccine doses, administered roughly 3 weeks apart. But there’s a catch: mRNA is an extremely unstable molecule, and consequently the vaccines must be preserved at extremely cold temperatures up to the point they’re administered. While the Pfizer/BioNTech vaccine is the most unstable, and must be stored at temperatures of -70oC (-130oF), vaccines by Moderna and AstraZeneca are more stable and may be refrigerated for up to one month or more before use.
The storage requirements are particularly critical when we consider the logistics of a national immunization strategy. Whereas some hospitals and government labs may have the infrastructure to store vaccines for long periods at extremely cold temperatures, health networks in more remote and rural locations, as well as non-healthcare employers may not have the same capacity, which may limit their ability to use the Pfizer/BioNTech vaccine. Consequently, these areas would need to wait for vaccines from other manufacturers before COVID-19 vaccination campaigns are kick-started. And since individuals need to receive 2 doses within a 3-week period, it may result in a longer rollout of the vaccine than initially thought.
There’s also the question of manufacturing. With Pfizer committing nearly 100 million doses of the vaccine to the US government in 2021 and Moderna committing another 80 million, seamless and uninterrupted vaccine manufacturing will be critical to support this massive public health effort. Considering the current trajectory of infections in the US alone, it means that pharmaceutical companies will need to maintain strong workplace infectious disease protocols for the foreseeable future to ensure that infections and workplace outbreaks do not compromise their manufacturing capacity.
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How to Prepare for your Mass COVID-19 Vaccination Campaign in 2021
With so many unanswered questions, it’s difficult to know exactly if and/or when vaccine lots may be available to allow employers to conduct COVID-19 vaccination campaigns. Nonetheless, even if your organization cannot administer the vaccine yourselves, there are several questions that your organization should consider when preparing for your COVID-19 vaccination campaign:
- How will we keep track of which employees have been vaccinated and which have not?
- How will we monitor when an employee is due for their second dose to ensure it isn’t missed?
- If we administer vaccinations, how will we do so as efficiently as possible?
- How will we be able to monitor COVID-19 vaccination campaign program performance and detect issues early for corrective action?
Fortunately, EHSQ software solutions are extremely effective at helping organizations manage immunization campaigns efficiently and cost-effectively. Let’s see how they help:
Launching Your COVID-19 Vaccination Campaign: How to Manage Vaccination Schedules
Any effective vaccination campaign is centered around knowing who needs the shot, and who’s already received it. Maintaining this information on paper records or a spreadsheet is not only time-consuming, but susceptible to errors that could result in someone falling through the cracks, missing a dose, or possibly receiving the wrong dose. Digitizing your COVID-19 vaccination campaign with software enables you to create a vaccination roster to give your business the confidence that every applicable worker will be captured in the COVID-19 vaccination campaign. Moreover, by integrating your immunization program with risk assessment and similar exposure group (SEG) management tools, your clinicians can create priority groupings based on any selected criteria, including age, pre-existing health conditions, or occupational risk factors that will help identify which at-risk workforce populations should be immunized first.
Process automation offered through software is a huge benefit to any immunization campaign. Users can configure business rules in the back-end of the solution to automate processes for greater efficiency. For instance: your business can automate the delivery of a digital questionnaire that a worker would complete ahead of their vaccination appointment, identifying any health issues that could affect their receipt of the vaccine, or simply to obtain their consent for treatment. Similarly, automated alerts and notifications can be sent out to workers and their supervisors to remind them of their upcoming appointment, ensuring that those meetings are not forgotten. Plus, business rules can even be used to auto-schedule the next vaccination appointment based on the vaccine and date administered, to ensure additional doses are received at the appropriate time.
While it’s likely that most employers will not be administering the COVID-19 vaccine themselves, they will still need to collect vaccination records from employees to confirm their immunization status, certainly before companies consider removing current physical distancing restrictions in the workplace. Even when vaccinations are received outside the workplace, employers can still benefit from software that helps them streamline information gathering, manage records, or even remind employees when they’re due for their next dose.
Optimize Clinician Efficiency and Inventory Management Throughout Your COVID-19 Vaccination Campaign
For clinicians, a digital solution can dramatically improve efficiency, by reducing the time spent to chart and maintain health records, and in turn provide more time to deliver more vaccinations. User-defined pick lists, drop downs and calendar icons in software layouts are all designed to reduce the time it takes users to navigate and update medical records. By integrating barcode readers, software can help reduce keystrokes even further. By scanning 2D barcodes on vaccine vials, clinicians can not only create vaccine inventories associated with a specific health center, but can also auto-populate fields in the employee health record in a matter of seconds when administering the vaccine, reducing charting time and errors and allowing them to see the next employee much more quickly. And in this respect, when a dose is administered, the solution will automatically adjust the vaccine inventory to reflect what’s been used. By attaching automated alerts to pre-set vaccine inventory thresholds, the software solution will even send a notification out advising when the next vaccine order must be placed so supplies don’t run out.
COVID-19 Vaccination Campaign: Performance Oversight and Benchmarking
Organizational leaders know that immunizations can protect the company from costly business interruptions, productivity losses, and absenteeism. They also know that it takes money to run an effective COVID-19 vaccination campaign. Consequently, these leaders need access to accurate, real-time information to help them evaluate program success, identify gaps that could be compromising objectives, or even benchmark performance across locations to determine where additional resources may be required.
Most software platforms now offer extensive business intelligence tools and advanced analytics to enable organizations to slice and dice their data, identify key trends and insights, and help guide more effective and timely decision-making. Users can leverage many purpose-built dashboards and reports right out of the box to keep senior leadership apprised of program performance, or customized key performance indicators (KPIs) to provide clarity on what’s working well, what needs to improve, and to help quantify the overall ROI of immunization efforts.
Final Thoughts: Prepare for Your COVID-19 Vaccination Campaign Now
There’s growing optimism that the end of COVID-19 may be forthcoming, and vaccines will almost certainly play a leading role. But launching an effective COVID-19 vaccination campaign will require a great deal of coordination, strong communication, and efficient data sharing to ensure employers are positioned for success. While drug makers are tweaking their vaccines for maximum effectiveness, now is the time all businesses should look at how they can do the same with their EHSQ programs.