FDA Approval

FDA Approval

All vaccinations proven safe before delivery – even in the face of a pandemic

Any time that you receive a vaccination in the United States, you can rest assured that the vaccine withstood a rigorous set of trials and standards in order to reach you.

Each immunization – which is designed to provide herd immunity to a community that would otherwise be unobtainable – must pass detailed clinical trials before being approved by the Food and Drug Administration (FDA). Following that process, the Centers for Disease Control (CDC) makes recommendations to license the proposed vaccine – all of which happens before it is determined if the proposed vaccination should go into standard use.

It is a strict and involved standard that has produced extraordinarily useful and safe tools for physicians and patients alike – including those vaccinations so recently developed and adopted to address the novel coronavirus that causes COVID-19.

Initial steps

Any time that a company develops a vaccine – such as those that combat COVID-19, the flu, or measles – that vaccine undergoes a comprehensive set of clinical trials that determine the proposed immunization’s safety, side effects, and effectiveness.

A specially designated panel of experts known as the Vaccines and Related Biological Products Advisory Committee monitors and gathers all findings before advising the FDA whether the vaccine should be approved for licensing.

Immunizations only receive a license from the FDA if they are proven safe and effective and all benefits prove greater than any potential health risks.

Further study

Once the vaccine receives its license from the FDA, it faces further examination before being recommended for use. Next, the CDC steps in to add another layer of trials and study to ensure the immunization’s safety.

Conducted by the CDC’s Advisory Committee on Immunization Practices (ACIP), these reviews are handed over to the FDA – along with the CDC’s recommendation (or rejection) of the specific uses for a proposed vaccination.

And yet this is still not the end of the study. In fact, all vaccines are continuously monitored by the FDA and CDC to ensure supreme effectiveness and safety. This continuous monitoring allows for the identification of any rare side effects that may not reveal themselves even during numerous test trials.

It is a multi-faceted, safe, and proven procedure that has delivered improved health conditions throughout our nation for decades. In fact, this same procedure helped to almost eradicate mumps and measles – until recent skepticism over the validity of vaccinations helped usher in measles outbreaks in 2019. As fewer children began to receive the standard MMR vaccination, measles infections began to increase for the first time in decades.

Process maintained for COVID-19

Because of the aggressive and unique nature of the novel coronavirus pandemic that caused COVID-19, the FDA and CDC acted as fast as possible to respond to the work being done by companies such as Pfizer/BioN-Tech, Moderna, and Johnson & Johnson, in the creation of a vaccination for the virus.

But just because officials and scientists worked at a rapid pace did not mean that they cut corners – especially in terms of safety. In fact, officials conducted an extraordinary amount of research and clinical trials before licensing and recommending the vaccinations.

In fact, independent experts maintained their model of monitoring and studying 30,000-50,000 participants for this vaccine over an eight-week period – despite the anxiety gripping the globe in the face of the pandemic.

Since most side effects occur within six weeks of vaccine administration, officials knew well how the three vaccines would react when distributed. And because of their continued and detailed examination even after dissemination, officials reacted immediately when a minuscule number of patients did experience some issues with the Johnson & Johnson vaccine.

On April 13, 2021, the FDA and CDC recommended a temporary pause of the Johnson & Johnson vaccination to further explore a rare side effect of blood clots in certain groups. As of that date, only six cases in nearly 7 million doses had been reported. The result was that, approximately 10 days later, use of the single dose J&J vaccine was resumed.

And since Covid-19 vaccination includes booster shots, the FDA and CDC continue to monitor situations and are also keeping tabs on new developments with the virus itself.

What is in the Covid-19 vaccination?

Because scientists had vast experience with immunization processes from previous viruses, it helped them to work quickly and determine the safest yet most trustworthy method of ensuring that any novel coronavirus vaccination would be effective.

They did this by using a dead novel coronavirus in all Covid-19 vaccinations. That means that any vaccination – initial round or booster – cannot infect a patient and make them sick. What it does do, however, is give your body a blueprint of how to recognize and neutralize the virus that causes Covid-19. This process does not keep you from “getting” Covid-19, but it does mean that your body can respond as effectively as possible to keep you from experiencing the mortality or morbidity rates that characterized the early stages of the pandemic. In other words, the vaccination is designed to keep you alive and out of the hospital.

That does not mean that there is no reaction to the vaccination. While many do not experience any issues, some patients do in fact develop a sore arm that is red or warm to the touch. Some patients also experience temporary headaches, fever, or muscle aches – all of which are signs that the vaccine is causing a response in the body’s immune system and creating antibodies to fight off the virus. It does not mean a patient gets COVID-19. These minor side effects may last up to a week after vaccination, though usually no more than a few days.

Vaccination is long trusted and valued by doctors and scientists – and it continues to be a valuable weapon in the fight against disease. And while there is ample misinformation in circulation via online sources, the results and history of this science is there for all to see. And the process of immunization has done much to advance the health of the global population – certainly so for Americans and those living here in the C.S.R.A. And, thanks to the dedication and knowledge of governing bodies at the FDA and CDC, you can rest assured that any vaccination recommended by your doctor will be worth its utilization.

To learn more about where you can receive Covid-19 vaccination, click here.

To learn more about the full range of childhood and adult immunizations, click here.