Is there a vaccine for COVID-19?
Two manufacturers (Pfizer/BioNTech and Moderna) are anticipated to be granted Emergency Use Authorization (EUA) for their recently developed COVID-19 vaccines. An EUA is issued by the U.S. Food and Drug Administration (FDA) if and when clinical studies demonstrate safety and effectiveness. The EUA process differs from an FDA approval. As of the morning of December 14, 2020, only the Pfizer vaccine has been approved by the FDA. An EUA allows for emergency use of a product based on the best available evidence, carefully considering the benefits versus the risks, but not the entire body of evidence that is required for FDA approval. EUAs can be revised or revoked by the FDA at any time.
Both the Pfizer/BioNTech and Moderna vaccines are a new type of vaccine, but the technology behind them has been studied for decades. These vaccine types teach our cells to make the “spike protein” necessary to protect us from infection when the real virus enters our body. This type of vaccine cannot give you COVID-19 and does not impact or interact with your DNA (genetic material).
What is the Emergency Use Authorization (EUA) process?
During the EUA submission process, there are multiple checkpoints. An independent data safety monitoring board reviews data from the clinical trials and the FDA’s career scientists and physicians evaluate the manufacturer’s submission. A committee consisting of external scientific and public health experts discusses the safety and effectiveness data. The FDA’s career professional staff considers the committee’s input and continues the evaluation to determine if the safety and effectiveness and manufacturing data supports an EUA. Even after EUA approval, manufacturers are continuing to provide clinical data, as well as their clinical trials.
How were these COVID-19 vaccines developed so quickly?
Coordinated efforts by public and private partnerships helped accelerate vaccine development, but these accelerated efforts have not sacrificed scientific standards, integrity of the vaccine review process, or safety. Prior knowledge in vaccine development and advances in bioengineering was critical to the timeline, as well as government funding which decreased the monetary risk to companies, allowing them to develop and manufacture the vaccine concurrently with clinical studies.
Who is receiving the vaccine first?
Based on national guidance, a “tiering” system is being used to prioritize those at greatest risk of exposure, particularly healthcare workers and long-term care facility residents. On December 1, 2020, the Centers for Disease Control and Prevention (CDC) recommended that healthcare personnel with direct or indirect exposure to patients or infectious materials receive a COVID-19 vaccine first. The CDC has identified that healthcare personnel are at a high risk of exposure to and infection by COVID-19, and therefore can inadvertently spread the virus to patients with co-existing medical conditions, thus increasing the patients’ risk for a severe COVID-19 illness. Learn more about the CDC’s vaccination recommendations.
What is Tiering?
“Tiering” is the term used to describe the phased allocation of COVID-19 vaccines. Several expert groups, including the National Academy of Medicine (NAM) and the CDC, have offered guidance on how to make the greatest and best use of the supply by determining which populations are at highest risk and/or are most critical to maintaining the effective functioning of society. NAM and CDC have both made similar policy recommendations on a phased allocation of the COVID-19 vaccines, which prioritizes healthcare personnel, as well as those living in long-term care facilities.
When will the general public receive the vaccine?
Experts began working during the summer of 2020 on a strategy for distributing these limited vaccines in a fair, ethical and transparent way. Vaccines have been allocated to each state based on population. Each state is responsible for developing a distribution plan. Therefore, distribution plans and timelines will vary by state. Check with your local health department for updates.
Do I have to receive the vaccine?
No, the vaccines are not mandatory at this time. This aligns with national guidance from organizations such as the Society for Healthcare Epidemiology of America. According to World Health Organization (WHO), immunization through vaccination is the safest way to protect against disease, and we do believe vaccination is a major step towards ending the pandemic. However, the choice to vaccinate is a personal decision and should be discussed with your healthcare provider
What are the benefits of getting the COVID-19 vaccine?
Below is a summary of the benefits of COVID-19 vaccination based on what we currently know.
COVID-19 vaccination will help keep you from getting COVID-19
- All COVID-19 vaccines currently available in the United States have been shown to be highly effective at preventing COVID-19.
- All COVID-19 vaccines that are in development are being carefully evaluated in clinical trials and will be authorized or approved only if they make it substantially less likely you’ll get COVID-19.
- Based on what we know about vaccines for other diseases and early data from clinical trials, experts believe that getting a COVID-19 vaccine may also help keep you from getting seriously ill even if you do get COVID-19.
- Getting vaccinated yourself may also protect people around you, particularly people at increased risk for severe illness from COVID-19.
- Experts continue to conduct more studies about the effect of COVID-19 vaccination on severity of illness from COVID-19, as well as its ability to keep people from spreading the virus that causes COVID-19.
COVID-19 vaccination will be a safer way to help build protection
- COVID-19 can have serious, life-threatening complications, and there is no way to know how COVID-19 will affect you. And if you get sick, you could spread the disease to friends, family, and others around you.
- Clinical trials of COVID-19 vaccines must first show they are safe and effective before any vaccine can be authorized or approved for use. The known and potential benefits of a COVID-19 vaccine must outweigh the known and potential risks of the vaccine for use under a EUA.
- Getting COVID-19 may offer some natural protection, known as immunity. But experts don’t know how long this protection lasts, and the risk of severe illness and death from COVID-19 far outweighs any benefits of natural immunity. COVID-19 vaccination will help protect you by creating an antibody response without having to experience sickness.
- Both natural immunity and immunity produced by a vaccine 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.
Ensuring the safety of COVID-19 vaccines in the United States
The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Safety is a top priority while federal partners work to make a coronavirus disease 2019 (COVID-19) vaccine(s) available.
- The Food and Drug Administration (FDA) carefully reviews all safety data from clinical trials and authorizes emergency vaccine use only when the expected benefits outweigh potential risks.
- The Advisory Committee on Immunization Practices (ACIP) reviews all safety data before recommending any COVID-19 vaccine for use.
- FDA and CDC will continue to monitor the safety of COVID-19 vaccines, to make sure even very rare side effects are identified.
Is it true that clinicians don’t have to wear gloves to administer the COVID-19 vaccine?
Safety and Health Administration (OSHA) regulations do not require gloves to be worn when administering vaccinations, unless there are extenuating health risks. Per the CDC, persons administering vaccinations should cleanse their hands with an alcohol-based waterless antiseptic hand rub, or wash with soap and water before preparing vaccines for administration and between each patient contact.
As we manage an increase in COVID-19-positive patients, we continue to pay careful attention to the conservation of Personal Protective Equipment (PPE) when necessary and in accordance with guidance. This may include any use of gloves or other equipment that is not deemed necessary by the CDC.
Is there any reason to avoid one brand’s vaccine over another?
Based on information coming from the UK, any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline auto injector) should not receive the Pfizer BioNtech vaccine.
Visit the Centers for Disease Control’s web site for the latest frequently asked questions about vaccination for COVID-19