What Is the Vaccine FDA Approved?
With the COVID-19 pandemic making its way around the globe and cases growing in numbers, vaccines are being developed and tested to combat it. People are eager and desperate for the pandemic to be over. This has led to many questions about the latest vaccines and when they will be available. One of the biggest questions involves whether they have been given the green light by the Food and Drug Administration (FDA) or not. In this article, we will discuss what it means for a vaccine to be FDA approved and how the process works.
What Does It Mean if a Vaccine Is FDA Approved?
When a vaccine is FDA approved, it means that it has gone through rigorous testing to make sure that it is safe, effective, and of the highest quality. This approval ensures that the vaccine is suitable for public use. It also means that the vaccine can be legally sold and distributed in the United States.
The FDA approval process takes many months, often years, and can involve thousands of data points. This indicates the strict and thorough standards the FDA uses to evaluate a vaccine, which is why people often rely on their judgment to decide whether a specific vaccine is suitable for their use.
How Does the FDA Approval Process Work?
Before a vaccine can be FDA approved, it must go through a lengthy process that involves many steps to make sure it meets all the required safety, effectiveness, and quality standards. The first step in the process is pre-clinical testing, during which laboratory tests are conducted to evaluate the safety and efficacy of the vaccine. The vaccine then enters clinical trials in which it is tested on human volunteers to see how it works, if it has any side effects, and if it is effective in preventing the disease for which it is intended.
After satisfactory results in the clinical trials, the vaccine is then evaluated by the FDA, which may take several months. A Vaccines and Related Biological Products Advisory Committee made up of medical experts, scientists, and patient representatives provide an expert review of the data and recommend whether the vaccine should receive approval.
Finally, the FDA reviews the vaccine data and makes a final decision about approval. If the vaccine is approved by the FDA, it can then be legally sold and distributed in the United States. It is important to note that even after the vaccine is approved, the FDA continues to monitor its safety and efficacy to ensure its safety and effectiveness.
What Vaccine Has the FDA Approved So Far?
Currently, the only vaccine that is FDA approved is the Pfizer-BioNTech vaccine. This vaccine is authorized for use in people aged 16 and older. It is a two-dose vaccine and is administered 21 days apart. To date, over 100 million doses of this vaccine have been administered in the United States.
The FDA has also granted Emergency Use Authorization to the Moderna and Johnson & Johnson vaccines. These vaccines are currently in the process of being approved, which could take several months. Additionally, the FDA is currently evaluating other vaccine candidates in clinical trials, so more vaccines could be approved in the near future.
Are There Any Risks with FDA Approved Vaccines?
Like any medical product, there is a small chance of risks associated with any vaccine. Some of the common side effects of the COVID-19 vaccine include pain, redness, and swelling at the injection site, fatigue, headache, muscle pain, joint pain, and fever. Most of these symptoms are mild and go away on their own within a few days.
However, if any of these side effects become severe or last for an extended period of time, it is important to contact your healthcare provider right away. Additionally, it is important to know that the COVID-19 vaccines were developed under extraordinary circumstances and were given emergency approval by the FDA, which means that the exact long-term risks and benefits are still being studied and that the safety profile of the vaccine is unclear at this time.
The FDA approval process is vital in ensuring the safety and effectiveness of vaccinations before they can be sold and distributed in the United States. To date, the only vaccine that has been given full approval by the FDA is the Pfizer-BioNTech vaccine, and the Moderna and Johnson & Johnson vaccines have been granted Emergency Use Authorization (EUA). It is important to be informed about the risks that come with any FDA approved vaccine before being vaccinated.
Despite the possible risks, vaccinating against COVID-19 remains the best way to protect yourself and others against the virus. It is important to get vaccinated as soon as you are eligible and to follow all the provided guidelines to ensure that you and those around you stay healthy and safe.