Vaccines have been a hot-button issue for some time now. Many people believe they are the best defense against contracting a disease, while others hold onto the faulty, discredited claims that vaccines can cause certain conditions like autism in children and they hurt rather than help. We asked Dr. Jamie McCarthy, Chief Physician Executive for Memorial Hermann, and Dr. Angela Shippy, Chief Medical Officer and Chief Quality Officer for Memorial Hermann, to set the record straight and answer all of your most pressing questions about vaccines.
Q: How does a vaccine get FDA approved?
A: The process of getting a vaccine approved by the Food and Drug Administration (FDA) is a rigorous one, to ensure both safety and efficacy. Vaccines are approved by the FDA the same way other drugs are approved. A sponsor who wants to start a clinical trial must submit an Investigational New Drug (IND) application. Once the paperwork is complete, the trials begin. These are done in three phases:
- Phase 1 is designed to measure safety and to see if the antigen in the vaccine provokes an immune response in a small number of patients.
- Phase 2 is where different dosages are measured against each other to see what works best in a large group of people.
- Phase 3 studies thousands of people to document the effectiveness and important safety data required for licensing of the vaccine.
If the completion of all three phases of the clinical trial is successful, a Biologics License Application is filed. The application must provide all the efficacy and safety information to the FDA review team as well as other pertinent information about the manufacturing facility. Approval also requires adequate labeling of the product for healthcare workers to understand the proper use of the vaccine, and an explanation of the benefits and risks of the vaccine so healthcare workers can share those with the public and safely deliver the vaccine. Once the application is reviewed, the FDA and the sponsor can present their findings to a non-FDA expert committee that will present its thoughts on the safety and efficacy of the vaccine.
After all of these things are approved, the FDA will oversee the production of the vaccine to ensure it is being manufactured safely. After approval, in some cases, both new drugs and vaccines will undergo a Phase 4 trial to provide ongoing monitoring for safety and efficacy. The FDA also utilizes the Vaccine Adverse Event Reporting System (VAERS) to identify any concerns after marketing begins.
Q: How many potential vaccines will there be for COVID?
A: The Department of Health and Human Services and the Department of Defense have partnered on an initiative called Operation Warp Speed. The idea is to produce more than 300 million doses of COVID-19 vaccines that are safe and effective. Availability will be based on the final results of the Phase 3 trials. According to timeline estimates by federal sources, the hope is that the results of the trials will be complete towards the end of 2020 and the first doses will be administered sometime this January and more than two billion doses by the end of 2021. More than 150 COVID-19 vaccines are currently being worked on all over the world by companies like Johnson & Johnson, Pfizer, Moderna and Astra Zeneca. According to the New York Times, as of Nov. 4, 50 vaccines are currently in clinical trials on humans and 87 preclinical vaccines are under investigation in animals.
Q: How will we know if a vaccine is safe and effective?
A: Before a vaccine is distributed widely to the public, it is tested in pre-clinical and clinical trials. The information is used to determine whether the vaccine is safe to test on humans. This will normally start out with small groups, as few as 20 people, but will eventually be tested in tens of thousands of people. These clinical trials determine the vaccine safety, what the dosage should be, and how one’s immune system will react to it. Throughout this process, the FDA works closely with the company to make sure the vaccine is safe and effective. In other words, the vaccine is put through a rigorous evaluation by many scientists before it is widely distributed. That being said, the speed at which a vaccine is being accelerated to curb the COVID-19 pandemic should not worry the public. The FDA will closely evaluate these vaccines and will not rush one to market if they do not feel it is safe to do so.
Q: How do vaccines and herd immunity work together?
A: As we have all experienced during the COVID-19 pandemic, a virus can spread very quickly throughout a community infecting many people. However, if enough people get vaccinated, germs cannot spread from person to person as quickly and the vast majority of people will not get sick. This is what is known as herd immunity. Herd immunity protects everyone, especially those people who cannot receive a vaccine for one reason or another, those who do not have a strong immune response to vaccines, and those with serious allergies or weakened immune systems.
Q: Any myth busters about vaccines in general?
A: Many myths surround vaccines, and there are many people who simply don’t believe in vaccines. Here we bust some of the most common myths:
- I can get the flu from getting the flu shot.
This is simply not true because the vaccine does not contain a live virus. It might give you some minor aches and pains and a little discomfort at the site where the shot was administered, but it will not give you the flu. The nasal spray vaccine does contain live viruses that are attenuated (weakened) so that they will also not cause illness.
- Pregnant women shouldn’t receive the flu vaccine.
Pregnant women should always discuss any vaccines and medicines with their doctor to ensure they are safe during pregnancy. However, avoiding the flu vaccine could do more harm than good. The flu vaccine does not cause any damage to unborn children but if a pregnant woman catches the flu, it could potentially affect the baby. The CDC actually views pregnant women as a high-risk group for the influenza virus and advises them to receive the vaccine.
- Vaccines can cause autism.
This myth was started in the mid-1990s when a British surgeon published a paper that certain vaccines were causing autism in children. That paper has since been discredited and retracted. However, because of this paper, many additional studies have been performed and none have found a link between vaccines and autism.
- Vaccines can damage an infant’s immune system.
Believe it or not, an infant’s immune system is pretty strong. Only slightly more than 0.1 percent of a baby’s immune capacity would be used if they were given all 14 scheduled vaccinations at one time. Keep in mind, infants are exposed to bacteria and viruses all the time, so immunizations will not hurt them.
- Vaccines are too risky.
Vaccines are considered a mainstay in preventing communicable diseases. Children have been vaccinated for years and years, and there has not been one study that links vaccines to long-term health problems. Some might experience an allergic reaction due to a component of the vaccine or other side effects.
- The flu vaccine causes paralysis.
Paralysis is an incredibly rare side effect that has happened to less than one in one million individuals after receiving a flu vaccine.
It’s important to consult trusted healthcare professionals and scientific experts, and do your due diligence and research on any vaccine before you receive it. There are going to be a lot of questions and concerns because of the speed at which the COVID-19 vaccines are being studied and produced, but rest assured that the FDA will not release a vaccine to the public before it has been thoroughly checked and checked again. In the meantime, we are now in the midst of flu season — and still in the middle of a global pandemic – so it’s important to continue to wear a mask, practice social distancing and good hand hygiene. Taking these actions, along with getting a flu vaccine, will help you and those around you stay healthy during these crazy times.