By Kari Bray / Snohomish Health District
Multiple vaccine candidates are on track to be authorized for use in the U.S. by the end of the year. Planning efforts have been underway for months at the state and local level to get ready.
As Snohomish County faces an alarming third wave of COVID, the prospect of a vaccine is generating a lot of interest. Some people are eager to get vaccinated, while others are concerned about the process or the vaccine in general.
Last Tuesday, the Snohomish Health District and Snohomish County Department of Emergency Management published the local interim COVID-19 vaccination plan online. Anyone can see the plan on our Preventing COVID-19 webpage. The statewide plan also is available online.
This is a good time to start learning more about COVID vaccine. We want the people of Snohomish County to feel confident and make informed decisions about this key step in addressing the pandemic.
The purpose of vaccinating against COVID is to protect people against acquiring the virus and becoming severely ill. Based upon preliminary modeling and the results from clinical trials showing 90-95% effectiveness in preventing infection, we will need to vaccinate at least 70% of the population in order to interrupt transmission and loosen the grip COVID-19 has on society.
Here are five things to keep in mind.
1) THERE WILL BE A PHASED APPROACH TO VACCINATION.
Though multiple vaccines are getting closer to approval, most people won’t be vaccinated until months down the road.
Vaccine manufacturing, supply, distribution and administration won’t all fall into place on a massive scale overnight. It will take time, so the vaccination plan is tiered to focus on specific groups early on. The timing between tiers will be determined in large part by how much vaccine is available, when it is available, and the local capacity to vaccinate people. There has been extensive effort, both in the public and private sector, to set up a framework and phasing that will maximize the benefits of vaccination, minimize harm, promote justice and transparency, and mitigate health inequities.
The first phase of vaccination includes those who are essential to sustaining the ongoing response to the pandemic, including healthcare and emergency services workers who are at greatest risk of COVID exposure. Others who are at higher risk of being exposed to and becoming severely ill with COVID fall within a second tier of that first phase, such as long-term care residents, adults over the age of 65 with at least one underlying condition, and caregivers or workers in settings like long-term care facilities.
The second phase would expand to include more people, among them school and child care staff as well as people of any age who have underlying conditions that put them at higher risk of severe illness.
Most healthy adults shouldn’t expect to be vaccinated until later phases, likely summer or fall of 2021 at the earliest. We expect more information for groups such as children and pregnant women to be available in the coming months.
2) EXPECT TO NEED TWO DOSES.
The vaccine candidates that are closest to approval would require two doses spaced some length of time apart, maybe 3-4 weeks. It’s important to make sure you get both doses of the same two-dose vaccine brand in order for the vaccine to be effective.
Go into this with the expectation that you will have to make it to two appointments, and don’t be shy about asking questions of your medical provider. Discuss the best ways to make sure you are reminded to come back on time for your second dose.
3) VACCINES ARE THOROUGHLY VETTED BEFORE WIDE DISTRIBUTION.
We know safety of a new vaccine is among the top concerns for people. Unlike the flu shot, which has a 50-year track record, the COVID vaccine is new. New can be scary in general for some, and the speed of the vaccine development process may provoke mistrust among others. Washington State will only implement vaccination if the involved product is demonstrated to be safe and effective.
There is an extensive authorization process in place for vaccines before they are distributed. Here are a few terms worth knowing.
FDA Approval: The Center for Biologics Evaluation and Research within the Food and Drug Administration (FDA) regulates vaccines in the U.S. Vetting vaccines is a multi-step process. After clinical development of the vaccine, the vaccine’s sponsor must submit an application to the FDA prior to any human studies. Then vaccine clinical trials are done, typically in three phases. The first includes safety and immune response studies on a small number of closely monitored participants. More participants are added in the second phase, and by the third phase, the studies involve potentially thousands of individuals to document safety and effectiveness in preventing disease.
If all three rounds of trials are successful, an application for a biologics license may be submitted. The application must include efficacy and safety information, and a pre-manufacturing inspection is done at the facility where the vaccines would be made. The application is reviewed by a multidisciplinary FDA team that includes medical officers, microbiologists, chemists, and more. The team’s findings also may be reviewed by an additional advisory committee, the Vaccines and Related Biological Products Advisory Committee.
Monitoring by the FDA continues after an approved vaccine is in production, as well. Many vaccines also undergo a fourth phase of studies documenting efficacy and safety in the general population after approval, since extremely rare side effects may not be detected in phase 3 trials. There is a system in place to report any adverse reactions, called the Vaccine Adverse Event Reporting System (VAERS).
Emergency Use Authorization (EUA): This authorization by the FDA, when granted, allows for a vaccine or medicine to be used in the event of an emergency even if it has not yet gone through the full approval process. It can also allow an existing product to be used in a way other than its previously approved uses. This doesn’t mean the vaccine isn’t vetted – it still must go through the FDA and an independent panel of experts who advise the FDA on safety and efficacy. For example, all currently available tests and new treatments for COVID-19 are operating under an EUA.
Advisory Committee on Immunization Practices (ACIP): This is a panel of scientists and health care providers convened by the Centers for Disease Control and Prevention (CDC). The members all have expertise in various aspects of immunizations. They review the data for any FDA-approved vaccine and make the final recommendations for use of the vaccine. State and local health departments then promote those recommendations and health care providers implement them. ACIP provides such guidance on virtually all vaccines and has done so with great integrity for decades.
COVID Vaccine Scientific Safety Review Workgroup: In coordination with California, Oregon and Nevada, Washington is participating in this multi-state workgroup to review the safety and efficacy of COVID-19 vaccines once they have been approved by the FDA and recommended by ACIP. This is an added layer of independent expert review including local and regional experts who are nationally-recognized scientists with expertise in immunization and public health.
4) THE TRIALS OF THE VACCINE CANDIDATES SUGGEST MILD-TO-MODERATE SIDE EFFECTS ARE COMMON. SEVERE SIDE EFFECTS (HOSPITALIZATION, LIFE-THREATENING ILLNESS OR DEATH) HAVE NOT OCCURRED.
Even safe, effective vaccines can have side effects. So far, indications are that people who receive a COVID vaccine may have soreness around the injection site and potential headache, fatigue or fever lasting up to 48 hours in up to one-third of recipients—especially after the second dose. Though some of these side effects also are on the list of COVID symptoms, this does not mean a vaccine will give you COVID. Vaccines are used to prepare the body to defend against an infection. Reactions like headache or soreness are not uncommon with other vaccines, as well, even routine ones like the flu shot.
If you have concerns about side effects or the COVID vaccine in general, we encourage you to talk through them with your medical provider when the time comes to get vaccinated.
Local and state health departments and the CDC have included reporting and monitoring for severe side effects in the vaccine implementation plan in order to detect any rare safety concerns that were not detected in the clinical trials. If a safety concern were to arise from this monitoring, that information would be made public and use of the vaccine would be modified accordingly.
5) WE STILL NEED TO KEEP UP WITH OUR GOOD HEALTH AND COVID PREVENTION HABITS.
Yes, even the ones we are ready to be rid of.
A COVID vaccine is a big step on the path out of this pandemic. It is not, however, an instant solution.
Even after the vaccine is available, we need to behave as though we are in the thick of a pandemic. Frankly, we are and still will be during the anticipated months-long effort to vaccinate people.
If all goes smoothly, it likely will take about 9-12 months to vaccinate most of the population. That’s another 9-12 months of fighting COVID with the same measures we’re relying on now.
Wear a face cover when you’re around people who aren’t part of your household. Stay home if you feel sick. Avoid large gatherings, or any gatherings that are indoors and unmasked. Wash your hands, and clean and sanitize high-touch surfaces frequently. Keep your distance – at least six feet – from people you don’t live with. Don’t let your guard down until reliable sources indicate it is safe to do so.
We know there will be a lot of information circulating about COVID vaccine in the coming weeks and months. Please turn to trusted sources for health information, including your healthcare provider and public health experts. We’ll continue to provide updates on COVID at www.snohd.org/covid.
The Public Health Essentials! blog highlights the work of the Snohomish Health District and shares health-related information and tips.