What is an EUA and how is it different from FDA approval?
When there is an emergency, such as a global pandemic, the Food and Drug Administration (FDA) can issue an Emergency Use Authorization (EUA) to provide more timely access to critical medical interventions, when there are no other available alternatives. An EUA allows the FDA to authorize the emergency use of COVID-19 vaccines that meet safety and effectiveness criteria within weeks, rather than months to years. The EUA process is different from FDA approval, clearance or licensing because the EUA standard may permit authorization based on less data and in less time. EUAs are in effect until an emergency declaration ends, but can be revised or revoked as more data becomes available or as products become approved, cleared or licensed by the FDA. Remdesivir is an example of a drug to treat COVID-19 that recently went through this process, and now has FDA approval.
What does the COVID-19 vaccine review and approval process look like?
Vaccines are tightly regulated in the U.S. and go through a rigorous evaluation process to ensure safety and effectiveness. The FDA has a strict protocol that outlines very specific safety, effectiveness and study requirements for drug and vaccine manufacturers to follow. These requirements must be met for a drug or vaccine to pursue approval, even on a limited, emergency use basis. Boards of leading academic experts review the drug or vaccine data at various check points throughout the process, and have the authority to stop the study or require additional studies of the drug or vaccine to further evaluate its safety or effectiveness. Once these monitoring boards and the FDA see evidence that the drug or vaccine meets safety and efficacy benchmarks, they can grant it EUA to provide timely access to critically-needed medical interventions. The FDA will not grant an EUA until at least half of all vaccine study participants have been tracked for at least two months.
What is an mRNA vaccine?
Messenger RNA or mRNA vaccines – found in two COVID-19 vaccine candidates – help to protect against infectious diseases. mRNA teaches our cells how to trigger an immune response. This immune response produces antibodies that help protect us from getting infected, if we come into contact with the COVID-19 virus. mRNA vaccines are held to the same rigorous safety and effectiveness standards as other types of vaccines in the U.S. and cannot give you COVID-19 or affect or interact with your DNA.
Is the COVID-19 vaccine safe and effective?
The COVID-19 vaccine has been determined safe and highly effective in preventing COVID-19 by the FDA, the government agency that oversees and regulates vaccine development and approval. Other countries, including Canada and the United Kingdom, also found the vaccine safe and effective after extensive evaluation. To help reassure the public, additional precautions are being taken to validate the vaccine’s safety and efficacy. Some U.S. states have developed another review process, following emergency use authorization from the FDA. At Providence, we are also carefully reviewing the data prior to making it available at our facilities. We will always put the safety and well-being of patients and caregivers first.
What are the side effects of the COVID-19 vaccine?
We know there is a small risk of side effects associated with all vaccines, but often the side effects are less serious than the diseases themselves. The COVID-19 vaccine is no different. It may cause mild to moderate symptoms for some people. These symptoms can include pain at the injection site, fatigue, headache and fever. During initial testing, the COVID-19 vaccine resulted in no significant safety concerns. Recently, a very small number of other side effects, including allergic reaction, have been reported in the United Kingdom, where the vaccine is already being administered. We are monitoring these situations carefully and continuing to follow FDA and CDC guidance on administering the vaccine.
Who will have access to the COVID-19 vaccine first?
The COVID-19 vaccine will be rolled out in phases to ensure the most vulnerable and high-risk populations have access to it first. In line with state and federal requirements, the COVID-19 vaccine will first be made available to certain high-risk health care workers, and patients and residents in long-term care facilities. Public health authorities indicate that it will be made available to the
Why is the COVID-19 vaccine important?
Vaccines are one of the best, most effective ways to prevent disease. Thanks to vaccines and their scientific advancements, some diseases have been eliminated across all or most of the globe. For example, smallpox sickened and killed millions of people before a vaccine was created. Because the disease was eliminated following the creation of a vaccine, we no longer need to get immunized for it. Once proven safe and effective, a COVID-19 vaccine will help us to protect the health of our communities, whether the disease is eradicated or remains a public health challenge in the future.
What are the benefits of getting the COVID-19 vaccine, when available?
Like all vaccines, the COVID-19 vaccine is being designed to protect you from contracting the virus or to limit the severity of the disease should you contract it. We know from other diseases and their vaccines that we can slow or stop the spread of disease when roughly 60 to 80 percent of a population gets vaccinated. A vaccine can limit the spread of the disease by helping to protect you and those around you.
How would a COVID-19 vaccine work?
Vaccines allow the body to produce an immune response (e.g., antibodies), which help you to fight the virus should you come into contact with it. After getting vaccinated, you develop some level of immunity to that disease. A COVID-19 vaccine may be like a flu shot in that you may need to get it annually or in more than one dose to maintain protection.
Do I need the vaccine if I wear PPE as part of my job?
Caregivers are highly encouraged to get the COVID-19 vaccine, when available. Like PPE, vaccines are an important line of defense against this highly contagious virus. A COVID-19 vaccine, in combination with other measures such as wearing appropriate PPE, frequent hand washing and social distancing, is the best way to protect yourself and those around you. We know that on average, one person with COVID-19 can infect another 2.5 people. Immunizing is a critical step in changing the trajectory of this pandemic and finally getting it behind us.