Here's what you need to know about the first COVID-19 vaccine to be fully approved by the FDA.
By Drew Kartos | drew.kartos@state.co.us | August 25, 2021, 1:30 p.m. MST
The summer may be coming to an end, but there are plenty of ‘firsts’ to get excited about — the first day of kindergarten, the first day of college, the first dusting of snow in the mountains, and the first COVID-19 vaccine to gain full approval from the U.S. Food and Drug Administration (FDA). On Monday, August 23, the FDA fully approved the Pfizer vaccine for use in individuals 16 years of age and older; it continues to be available for 12–15-year-olds and for the administration of a third dose for immunocompromised individuals under the existing Emergency Use Authorization (EUA).
Why is full FDA approval important?
Before we get into the details of the FDA’s full approval of Pfizer’s COVID-19 vaccine, let’s take a quick history lesson. The concept of authorizing a vaccine or treatment without going through the FDA’s full review process was first introduced in 2004 through what is called the Emergency Use Authorization program. EUA allows medical products or treatments to be used during a declared emergency when the known and potential benefits outweigh the known and potential risks. Before the COVID-19 pandemic, EUAs had only been used a handful of times, including during the response to H1N1 in 2009 when the FDA authorized the use of medical equipment and influenza drugs. Before a medical product or vaccine can be authorized for emergency use, it must undergo a rigorous safety and efficacy review process that includes large clinical trials. While the regulatory process for COVID-19 vaccines was streamlined, enough data were collected to ensure vaccine safety and effectiveness, and benefits far outweighed risks.
Full FDA approval of Pfizer’s vaccine is an important milestone that will help build confidence among those who may be hesitant about getting vaccinated, but the true impact of the vaccine has already been observed. We’re aware of many, if not all, of the potential side effects of vaccination, and the data show the vaccines’ ability to protect against severe disease, hospitalization, and death. As expected, areas with higher rates of vaccination are seeing fewer cases, and vice versa.
What’s the difference between EUA and full approval?
It comes down to the amount of data available. The more time that passes, the more data that are available to review for full approval. No vaccine can receive EUA or full approval without meeting rigorous scientific standards for safety and efficacy. FDA needs to see enough data to support the safety and efficacy of a vaccine. The number of people who participated in the initial COVID-19 vaccine safety studies was similar to those used for tetanus, diphtheria, whooping cough, and meningitis safety studies.
EUA requires at least two months of data for at least 3,000 vaccine recipients from clinical trials. (Note: The initial EUA for Pfizer’s vaccine was based on about 20,000 vaccine recipients and 20,000 placebo recipients ages 16 years and older.)
FDA approval requires six months of data from the original vaccine trial recipients. (Note: About 12,000 Pfizer vaccine trial recipients were followed for at least six months.)
Overall, the Pfizer vaccine was found to be 91% effective in preventing COVID-19 disease. The most common side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
What can you do to prevent the spread?
No vaccine is 100% effective, and with the rapid rise of the delta variant we still need to be safe — vaccinated or not. Here are some layers of protection we should all remember:
- Stay home if sick.
- Wear your mask.
- Practice physical distancing.
- Avoid touching your face.
- Wash your hands often.
- Practice cough etiquette.
- Provide accessible testing.
- Spend limited time in crowds.
- Sign up for CO Exposure Notifications.
- Complete contact tracing.
- Ensure adequate ventilation, time outdoors, and air filtration.
- Quarantine if exposed, isolate if sick.
- Help others get vaccinated.
- Share fact-based information.
- Get vaccinated – including receiving booster dose(s) when indicated.
The stories behind the data
While most COVID-19 hospitalizations have been among adults, we’ve seen a small increase in hospitalizations among younger age groups.
Among younger age groups, there are increases. Most of what we’re seeing suggests that the increases are primarily due to increased transmissibility of delta. As we look at hospitalizations, we see increases in COVID-19 and other hospitalizations due to other respiratory viruses, such as respiratory syncytial virus (RSV).
Rates of hospitalizations are seven times higher among unvaccinated individuals vs. those who are fully vaccinated.
While we’ve seen an increase in ICU bed use from 72% to 80%, we still have significant surge capacity across the state.
The positivity rate is at 6.48%. When percent positivity increases above 5%, it indicates that there is more transmission happening in the community, and there are probably people infected who haven’t been tested. When community transmission is high, it is even more important to follow recommendations for testing if you are symptomatic or after you are exposed or think you might have been exposed.
Remember, you can get tested at a free community testing center near you if you are exposed to someone with COVID-19 or if you experience any of these symptoms:
- Cough.
- Fever or chills.
- Shortness of breath or difficulty breathing.
- Fatigue.
- Muscle or body aches.
- Headache.
- New loss of taste or smell.
- Sore throat.
- Congestion or runny nose.
- Nausea or vomiting.
- Diarrhea.
Other news:
- Booster doses of mRNA COVID-19 vaccines could be available as soon as September 20, 2021, pending FDA evaluation and an official recommendation from the Advisory Committee on Immunization Practices (ACIP).
- The self-reporting feature is now available through CO Exposure Notifications to allow users to share their test results right away, including results from an at-home test. It gives users another option to more quickly and conveniently anonymously notify people who were possibly exposed.
- Chipotle gift cards and Parks and Wildlife vouchers are available for those who receive their first or second dose of the COVID-19 vaccine.
- Back-to-school vaccinations are more important than ever.
The bottom line: It will be interesting to see how much the FDA’s approval affects COVID-19 vaccination rates as it should inspire more confidence in COVID-19 vaccines and the safety and efficacy review process as well as support the adoption of vaccine mandates both in Colorado and nationally. We are also anticipating how much the back-to-school period will impact the COVID-19 situation in the state. It usually takes about two weeks before we start seeing new cases, followed closely by hospitalizations. As we battle this pandemic wave, please be safe, and don’t let your guard down.