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Q & A text source: U.S. CDC
Images supplied by Guidepost from various sources
Suddenly there is a light at the end of the long, dark, scary tunnel – and it isn’t a flickering light either. It is bright and will probably get brighter in the days to come. The world is excited! But at the same time, there’s some understandable reticence to embrace it with no questions asked. It is the fear of the still-unkown that’s making people hold back somewhat, though the scientific community is quite upbeat about them, about the coronavirus vaccines.
The Moderna biotech company announces that the efficacy of its vaccine against COVID-19 is 94.1%; vaccine efficacy against severe COVID-19 is 100%. Pfizer-BioNTech performance is about the same.
The United States is the leading country in developing the vaccines. So, therefore, the world takes its cue from that country. However, the UK stole a march over the USA. On 2 December 2020, Pfizer tweeted the news that spread like a wildfire around the world: “@MHRAgovuk issued a temporary authorization for emergency use of our #COVID19 vaccine with @BioNTech_Group in the United Kingdom. This marks the first authorization of a vaccine to help fight the pandemic following a worldwide trial.” [MHRA is the UK’s Medicines and Healthcare Products Regulatory Agency.]
Be that as it may, here are the frequent Q&A that the United States Centers for Disease Control and Prevention (CDC) has culled. Note that coronavirus information is subject to constant updates.
When will a COVID-19 vaccine be available in the United States? The goal for Operation Warp Speed is to deliver safe vaccines that work, with the first supply becoming available before the end of 2020. When a vaccine is authorized or approved in the United States, there may not be enough doses available for all adults. Supplies will increase over time, and all adults should be able to get vaccinated later in 2021. However, a COVID-19 vaccine may not be available for young children until more studies are completed.
What has been done to plan for the distribution of COVID-19 vaccines? The [U.S.] federal government will oversee a centralized system to order, distribute, and track COVID-19 vaccines. All vaccines will be ordered through CDC. Vaccine providers will receive vaccines from CDC’s centralized distributor or directly from a vaccine manufacturer.
Many COVID-19 vaccine candidates are in development, and clinical trials are being conducted at the same time with large-scale manufacturing. With first doses expected before the end of 2020, planning and preparing for a COVID-19 vaccination program is very important.
Planning efforts have focused on every step and detail of the process. . .
This situation continues to change, and planning will progress as more information about any authorized or approved vaccines becomes available. A safe and effective COVID-19 vaccine is a critical component of the U.S. strategy to reduce COVID-19-related illnesses, hospitalizations, and deaths and to help society function as it did before COVID-19. The goal of the U.S. government is to have enough COVID-19 vaccine doses for all people in the United States who choose to be vaccinated.
Will there be enough vaccines for everyone? When FDA [Food and Drug Administration] first authorizes or approves the use of one or more COVID-19 vaccines in the United States, there may be a limited supply. This would mean that not everyone will be able to be vaccinated right away. It is understandable how concerning this would be for people, especially for those who are at increased risk for serious illness from this virus and for their loved ones.
That is why, early in the response, the federal government began investing in select vaccine manufacturers to help them increase their ability to quickly make and distribute a large amount of COVID-19 vaccine. This will allow the United States to start with as much vaccine as possible and continually increase the supply in the weeks and months to follow. The goal is for everyone to be able to easily get a COVID-19 vaccine as soon as large quantities are available. Several thousand vaccination providers will be available, including doctors’ offices, retail pharmacies, hospitals, and federally qualified health centers.
How many COVID-19 vaccines are under development? Multiple COVID-19 vaccines are under development. As of November 24, 2020, large-scale (Phase 3) clinical trials are in progress or being planned for five COVID-19 vaccines in the United States.
How many shots of a COVID-19 vaccine will be needed? All but one of the COVID-19 vaccines currently in Phase 3 clinical trials in the United States need two shots to be effective. The other COVID-19 vaccine uses one shot.
Are there special considerations on who should get the COVID-19 vaccine first? At first, there may be a limited supply of COVID-19 vaccine. Operation Warp Speed will work to get those first vaccine doses out once a vaccine is authorized or approved and recommended, rather than waiting until there is enough vaccine for everyone. However, it is important that the initial supplies of vaccine are given to people in a fair, ethical, and transparent way. Learn how CDC is making COVID-19 vaccine recommendations, including recommendations if there is a limited supply, based on input from the Advisory Committee on Immunization Practices (ACIP).
If I had already had COVID-19 and recovered, do I still need to get vaccinated with a COVID-19 vaccine when available? There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this. Until we have a vaccine available and the Advisory Committee on Immunization Practices makes recommendations to CDC on how to best use COVID-19 vaccines, CDC cannot comment on whether people who had COVID-19 should get a COVID-19 vaccine.
Does immunity after getting COVID-19 last longer than protection from COVID-19 vaccines? The protection someone gains from having an infection (called natural immunity) varies depending on the disease, and it varies from person to person. Since this virus is new, we don’t know how long natural immunity might last. Some early evidence—based on some people— seems to suggest that natural immunity may not last very long.
Regarding vaccination, we won’t know how long immunity lasts until we have a vaccine and more data on how well it works.
Both natural immunity and vaccine-induced immunity are important aspects of COVID-19 that experts are trying to learn more about, and CDC will keep the public informed as new evidence becomes available.
What percentage of the population needs to get vaccinated to have herd immunity from COVID-19? Experts do not know what percentage of people would need to get vaccinated to achieve herd immunity to COVID-19. Herd immunity is a term used to describe when enough people have protection—either from previous infection or vaccination—that it is unlikely a virus or bacteria can spread and cause disease. As a result, everyone within the community is protected even if some people don’t have any protection themselves. The percentage of people who need to have protection in order to achieve herd immunity varies by disease.
How do I report if I have a problem or a bad reaction after getting a COVID-19 vaccine? CDC and FDA encourage the public to report possible side effects (called adverse events) to the Vaccine Adverse Event Reporting System (VAERS). This national system collects these data to look for adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns of occurrence. Learn about the difference between a vaccine side effect and an adverse event. Reports to VAERS help CDC monitor the safety of vaccines. Safety is a top priority.
Healthcare providers will be required to report certain adverse events following vaccination to VAERS. Healthcare providers also have to adhere to any revised safety reporting requirements according to FDA’s conditions of authorized use throughout the duration of any Emergency Use Authorization; these requirements would be posted on FDA’s website.
CDC is also implementing a new smartphone-based tool called v-safe to check-in on people’s health after they receive a COVID-19 vaccine. When you receive your vaccine, you should also receive a v-safe information sheet telling you how to enroll in v-safe. If you enroll, you will receive regular text messages directing you to surveys where you can report any problems or adverse reactions you have after receiving a COVID-19 vaccine.
What does it mean if a clinical trial is temporarily paused? Safety is a top priority during the vaccine approval process. It is not unusual for a clinical trial to be temporarily paused when a possible side effect (called an adverse event) is detected. Clinical trials are designed to pause when an unexpected health event (called a safety signal) is detected so scientists and physicians can investigate potential safety concerns. The approval process for COVID-19 vaccines is no different ― safety is always the focus.
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