STONY BROOK, NY, October 19, 2020 – It’s still unknown when a COVID-19 vaccine might be available in the United States. Some early trials have shown promising results in the global effort to develop a vaccine for COVID-19, which has killed more than 200,000 people in the United States and more than 900,000 worldwide.
Pfizer just announced that it received FDA approval to enroll children as young as 12 years old in its COVID-19 vaccine trial. They will start testing to better understand whether the vaccine would be safe and effective for our kids. Until now, children under 16 have not been included in any of the COVID-19 vaccine trials in the U.S., and the average age of participants has skewed much older.
We asked Sharon Nachman, MD, Chief of the Division of Pediatric Infectious Diseases at Stony Brook Children’s Hospital and an investigator/principal investigator on more than 30 clinical trials, including vaccine trials, about the Pfizer vaccine trial and the future of a COVID-19 vaccine.
What happens before a vaccine is approved to be given to the american public?
- “In order for a vaccine to get licensed and out to the US public, there are a multitude of steps that have to happen. Prior to review by the FDA, the phase 3 clinical trial (where it is compared to placebo) has to be reviewed by a Data Safety Monitoring Board. The people on this board are all conflict free, and include statisticians, basic scientists, clinicians and community advisory individuals and they have to look at the safety and the effectiveness of the vaccine. Once its been reviewed and approved by the Data Safety Monitoring Board, then it goes to the FDA where a completely different group of individuals look at the data. As part of that process, the FDA will have an open forum so people can ask questions. This review of the study doesn’t happen behind closed doors and is open for public comment. After that, the FDA will then vote on it. If approved it will move on to another group, the Advisory Council for Immunization practice (ACIP), who will then decide what age groups and which populations in those age groups the vaccine is best for. That is why it will be important for these large studies to include similar populations to the US, so that FDA and ACIP can determine if the vaccine will be safe and effective in that population.”
Can someone get sick if they take part in the Pfizer COVID-19 vaccine trial?
- “What’s important to remember about the Pfizer trial is that it is not a live vaccine, thus no one can get COVID from getting this vaccine. While people who do get the vaccine may have local reactions (very common in pretty much every vaccine we use) and some people will get some systemic reactions like low grade fever or feeling under the weather, none of these symptoms represent COVID infection and the person is never contagious.”
If people refuse to get the vaccine when available, will the country ever reach herd immunity?
- “We will not. Herd immunity expects that 80% at least will be immune to the virus. If we do the math and let the virus go unchecked, we would have just in Nassau and Suffolk County alone, another 60,000 deaths, and untold hospitalizations. Herd immunity or community protection will only happen after use of a vaccine.”