COVID Vaccine Testing and Approval
Many people are astonished by the unprecedented speed of COVID vaccine testing.
The vaccine development process — for COVID and any vaccine —involves many layers of study, testing and review. According to The College of Physicians of Philadelphia, vaccines usually take an average of 10-15 years to create.
And yet, the COVID vaccines were developed in less than a year.
The vaccines for the novel coronavirus went through the same layers of review and testing as other vaccines. Due to the dire nature of the pandemic, certain barriers to development, related to funding and manufacturing, were removed.
To understand how this is possible, it is important to know how the vaccine development process typically works and how the COVID vaccine was created.
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The Traditional Vaccine Testing Process
Testing vaccines is a complex process. There are many layers of study and review that need to take place before a vaccine can be administered to a member of the general public.
Before any vaccine testing or development begins, scientists study the structure of the virus and how it causes disease in the body. This allows them to identify potential ways of creating an effective vaccine.
This process usually takes several years. In contrast, new technology allowed the genetic makeup of novel coronavirus to be shared with researchers worldwide just a few weeks after the first case of COVID-19.
Once scientists select the type of vaccine that looks the most promising, the vaccine is then created in the lab.
In a laboratory setting, scientists study the vaccine looking at the safety and efficacy of the vaccine in animals before moving to testing in humans.
If enough research supports a vaccine candidate, it can then be tested using clinical trials involving people. These clinical trials, which have three phases, are tightly regulated by the Food and Drug Administration (FDA).
In the case of the COVID-19 vaccine, all three phases were planned simultaneously to prevent delays if a vaccine candidate was proven effective.
Usually, each phase is planned after the previous one is completed since companies don't want to put time and money behind a vaccine if it won't be successful. This may result in 1-to-2-year gaps between clinical trial phases.
The three phases are:
Phase 1 Clinical Trial
A study, of usually less than 100 people, is designed to determine if the vaccine is safe, the best dosage and if there are any serious side effects.
Phase 2 Clinical Trial
A larger study with a few hundred volunteers focuses on how well the vaccine works. These studies also continue to investigate its safety and side effects.
Phase 3 Clinical Trial
An even larger study, often including thousands of volunteers, allows scientists to compare people who receive the vaccine to those who did not. They can better determine if the vaccine is safe and effective in a larger population of individuals.
Volunteers are randomly selected to receive either the vaccine or an alternative "control" medication. The control medication is usually a placebo or another vaccine that is already FDA-approved.
FDA Review of Clinical Trials
The FDA looks for evidence that the vaccine is unsafe, ineffective or has side effects that outweigh the benefits of receiving the vaccine.
If there is substantial evidence that the vaccine is effective and it does no harm, then the FDA approves the vaccine for general public use. If a vaccine is not proven safe, has significant side effects or does not show efficacy, the vaccine is not distributed to the public.
Traditionally, vaccines manufacturing begins when Phase 3 of clinical trials are being planned. In the case of the COVID-19 vaccine, manufacturing began in parallel with the clinical trials to ensure that FDA-approved vaccine candidates could be distributed quickly.
Throughout the manufacturing process, batches of vaccine are tested to ensure that they're packaged and distributed in a way that maintains their effectiveness. The FDA routinely reviews the results of these tests.
Additionally, all manufacturing facilities are routinely inspected and expected to meet strict quality and safety standards.
Continued Safety Monitoring
After a vaccine is approved, both the Centers for Disease Control and Prevention and the FDA continue monitoring the safety of the vaccine.
While extremely rare, if it happens, experts quickly determine if the vaccine recommendations need to be reevaluated. According to the World Health Organization, adverse effects from vaccines are so rare that often their risk cannot be accurately assessed statistically.
How COVID Vaccine Testing Moved So Fast
The speed of COVID vaccine development has given some people pause, but this vaccine was created under unique circumstances.
Here are some of the factors that sped up the COVID vaccine testing process.
Vaccine Research Funding
Vaccines can be expensive to create. Each step of the testing process requires significant financial investment from companies.
To minimize the chance of losing money, companies usually want to see overwhelming evidence that the vaccine will ultimately be effective and worthy of FDA approval before moving into the next step of testing. This can lead to gaps in funding, as well as an overall hesitancy to fund vaccine development efforts.
In the case of the COVID-19 vaccine, public and private entities united to pour money into development efforts. Billions of dollars from the government and nonprofits allowed development to take place unimpeded by cost constraints.
Pre-Approval Vaccine Manufacturing
To cut costs, companies usually wait until a vaccine is FDA-approved before manufacturing and distribution can begin.
In the case of the COVID-19 vaccine, companies received funding from the government and federal agencies to cover manufacturing costs upfront. Millions of potential vaccine doses were created before they were actually approved. This ensured that FDA-approved vaccine candidates would be distributed significantly faster.
Vaccine candidates that are not proven safe and effective during clinical trials and aren't approved by the FDA will not be distributed.
Developing a vaccine is a top priority for the government, FDA and other regulatory bodies. To speed along the review of vaccine efficacy data, a number of administrative changes were made that prioritized COVID vaccine work. For example, all COVID-19 vaccine clinical trial phases were planned at once to prevent the delay that can usually occur.
None of these changes have affected the way scientists or the FDA evaluate vaccine safety.
When a safety concern arises at any stage of the process, scientists halt the study to investigate further before continuing the study. A few times during the development process of developing a COVID vaccine clinical trials were paused so questions could be safely addressed.
A Familiar Virus
While SARS-CoV-2, also known as the novel coronavirus, was new to the world, the family of viruses it came from was familiar to infectious disease scientists.
Scientists were already researching potential vaccines for other coronaviruses, such as SARS and MERS, so they could apply much of what they had already learned to develop a COVID vaccine.
Additionally, SARS-CoV-2 causes an acute illness. This makes it inherently easier to vaccinate against. Vaccines against viruses that cause chronic illnesses, such as HIV, are usually more difficult to develop.
Global Communication and Collaboration
More advanced ways of communicating and sharing information globally have also significantly sped up the vaccine creation process. Nations across the globe have united to develop an effective COVID-19 vaccine as quickly and safely as possible.
For example, the discovery phase of vaccine development is usually a very long process. However, the genetic makeup of novel coronavirus was shared with researchers worldwide just a few weeks after the first case of COVID-19. This allowed researchers and health organizations around the world to begin researching the best type of vaccine quickly.
New Vaccine Development Technologies
There are many different ways to develop a vaccine, but in the last decade, scientists have made significant advancements in this area.
For example, older vaccines were typically created by using weakened or inactivated viruses. Today, companies can simply read a virus's genetic code and synthesize it in a lab, significantly shortening development times.
Other recent advances in immunology, genetics and other fields have enhanced scientists' understanding of how to create an effective vaccine quickly.
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