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As the distribution of COVID-19 vaccines continues worldwide, there has been much discussion about the vaccines and the development process. Following is an analysis of some of the myths and facts about the COVID-19 vaccine.
Was the COVID-19 Vaccine Approval Process Rushed?
Myth: The vaccine could be dangerous because it was rushed through approvals.
Fact: Although the vaccine process went quickly, the vaccines went through large trials.
The development of vaccines for COVID-19 occurred more quickly compared to previous vaccines in history. However, all vaccines must go through extensive clinical trials. Developers must show that their vaccines are both safe for use and effective against the disease.
The same holds true for the emergency use authorization (EUA) process. As part of the EUA review, expert advisers from the U.S. Food and Drug Administration (FDA) review safety data and how well the vaccine works.
The FDA, Centers for Disease Control and Prevention (CDC), and Advisory Committee on Immunization Practices (ACIP) evaluate COVID-19 vaccine candidates.
The FDA has authorized or approved four different COVID-19 vaccines: developed by Pfizer-BioNTech, Moderna, Johnson & Johnson/Janssen, and Novavax. Data show that they are safe for use.
“Each has gone through the usual scientific rigor,” says Graham Snyder, MD, medical director, Infection Control and Hospital Epidemiology, UPMC.
“An EUA means a vaccine is getting emergency use authorization before it gets full approval, but that doesn’t mean we lack data. We have clinical trial data. We have data on safety and efficacy. And, as with any new drug or vaccine, there will be more data collected in the future.”
Even after EUA, federal health officials monitor the safety and effectiveness of vaccines as distribution occurs.
In April 2021, the CDC and FDA recommended a pause in the distribution of the J&J vaccine to investigate cases of a rare, serious blood clot. After investigation, federal health officials lifted the pause. Federal health officials determined these adverse effects are extremely rare and the benefits of the vaccine are greater than the risk. The vaccine is safe and effective in preventing COVID-19.
Have the COVID-19 Vaccines Been Tested Enough?
Myth: The vaccines haven’t been tested rigorously enough on humans.
Fact: The vaccines have followed safety protocols, including human testing.
Again, while COVID-19 vaccine development has operated on a faster timeline, manufacturers still must follow the usual process. That includes rigorous testing that measures safety and efficacy.
Before issuing an EUA, the FDA weighs whether the benefits of the vaccine outweigh the risks — including the risk of waiting too long.
Those risks include thousands more infections and deaths from COVID-19.
“What we’re really asking now is, ‘Do we have enough data to feel confident that these vaccines are safe and effective?’ without asking for so much data that we delay the benefit,” says Dr. Snyder.
It is important to note that when the FDA issues an EUA for a vaccine, that does not mean the vaccine is fully approved. It will continue to be monitored for safety and efficacy as it is widely distributed.
The FDA has previously issued EUAs for other COVID-19 treatments, including remdesivir and monoclonal antibodies.
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Why Are Multiple Companies Releasing COVID-19 Vaccines?
Myth: There must be one vaccine that’s better than the others.
Fact: Having more than one safe, effective vaccine is a good thing.
Throughout the COVID-19 pandemic, scientists and pharmaceutical companies have invested significant time and money in trying to find treatments and cures. Multiple vaccines have been developed or are now in development, which means that more safe, effective vaccines could be available more quickly.
Dr. Snyder says a benefit of having multiple vaccines is that one vaccine potentially could be better for a particular group of people, while another vaccine could be better for different group.
“We’re much better off having multiple options, so we can tailor the way we can use these vaccines,” says Dr. Snyder.
More vaccines can help with the supply of available vaccines, too.
Another benefit of having different people working on vaccines is that it may result in the discovery of even better vaccine technology, says Dr. Snyder.
Is the COVID-19 Vaccine Dangerous?
Myth: The vaccine contains harmful ingredients.
Fact: There is no evidence of the vaccine containing harmful ingredients.
There are no harmful ingredients associated with the COVID-19 vaccines, says Dr. Snyder.
Instead of containing weakened or inactive portions of the virus, like previously traditional vaccines, the Pfizer and Moderna vaccines contain messenger RNA (mRNA). Using genetic code, these vaccines teach your body how to make select components of the virus, which triggers the immune system to attack and destroy it.
Although these are the first examples of mRNA vaccines, the technology surrounding mRNA is not new. Data surrounding the Pfizer and Moderna vaccines suggest they are safe, but they will continue to be monitored.
The Novavax vaccine is a traditional, protein-based vaccine. Protein-based vaccines have been used globally for decades to prevent many different diseases. This vaccine contains a synthetic version of the coronavirus’ spike protein, along with an “adjuvant,” an ingredient that boosts your immune response. The synthetic spike protein is lab-created: It contains no genetic material and cannot cause disease.
The J&J vaccine is a viral vector vaccine. It uses a substitute virus that has been modified with some of the genetic material of the coronavirus to deliver instructions to your body about how to fight COVID-19.
Although the substitute virus contains part of the genetic material of SARS-CoV-2, it has been modified so that it can’t create an infection. You cannot get COVID-19 from the vaccine.
In rare cases, people who received the J&J vaccine developed a rare, serious blood clot. After investigation, the CDC and FDA determined these adverse effects are extremely rare. The vaccine is safe and effective in preventing COVID-19. The Moderna and Pfizer vaccines have not been linked to this side effect.
The Moderna, Pfizer, and Novavax vaccines have been linked to the inflammatory heart conditions pericarditis and myocarditis. These are rare side effects of vaccination that occur mostly in adolescent and young adult males.
The CDC continues to recommend vaccination for Americans 6 months old and up.
Can the COVID-19 Vaccine Affect Fertility?
Myth: The COVID-19 vaccine could cause women to become sterile.
Fact: There is no evidence that the COVID-19 vaccine could cause sterility.
Can the COVID-19 Vaccine Cause Miscarriages or Menstrual Cycle Changes in Others?
Myth: Being around fully vaccinated people can cause miscarriages or menstrual cycle changes.
Fact: You cannot cause others to have miscarriages or changes in their menstrual cycles by getting the COVID-19 vaccine.
A rumor circulating online claims that unvaccinated women can have miscarriages or develop menstrual cycle changes after being in contact with people who are vaccinated. This is a false, baseless rumor.
The COVID-19 vaccine only affects the person receiving it. You cannot cause others to have miscarriages or changes in their menstrual cycles by choosing to get vaccinated.
Vaccines are not contagious. Your vaccine will not impact the health of those around you. A person with COVID-19 sheds virus particles when coughing, sneezing, or talking. However, you cannot “shed” or transfer your vaccine to other people.
There is no evidence that the COVID-19 vaccines cause infertility. Some people have reported menstrual changes after getting the vaccine, but there is no data to suggest that these changes were caused by the vaccine.
Is There a Tracking Microchip in the COVID-19 Vaccine?
Myth: There is a microchip in the vaccine that will track people who get it.
Fact: This is totally false and baseless.
Widely circulating online discussion alleges that the COVID-19 vaccine contains a tracking microchip. This is completely false. There is no basis in fact.
Can I Be Allergic to the COVID-19 Vaccine?
Myth: Vaccine allergies are common and severe.
Fact: Although it’s possible to be allergic to vaccine ingredients, it is uncommon and does not usually cause a severe reaction.
There have been isolated reports of allergic reactions to the COVID-19 vaccine in the United Kingdom, and scientists are investigating. They appear to happen in people with pre-existing allergies that require them to carry the EpiPen®.
Vaccine allergies are uncommon, and reactions are not typically severe, says Dr. Snyder.
If you have underlying allergies and are concerned about the COVID-19 vaccine, talk to your doctor for guidance.
Do I Need the COVID-19 Vaccine?
Myth: If I don’t get the COVID-19 vaccine, it is my choice and won’t affect people around me.
Fact: The vaccine will play an important role in protecting people around you.
Like other COVID-19 preventive measures, getting the vaccine is your choice. However, not getting the vaccine could affect people around you.
If you don’t get the vaccine and become infected with the coronavirus, you potentially could spread it to others — including people who have not yet been vaccinated.
“It is each person’s choice. We should all pay attention to what’s reported about the safety and how well it’s working in order to make an informed choice,” says Dr. Snyder. “But there’s definitely an advantage to all of us getting the vaccine.”
Myth: I’m healthy and have a good immune system. I don’t need the vaccine.
Fact: COVID-19 can have lasting health effects on anyone, not just certain groups.
Older adults and people with underlying health conditions are more at risk for severe effects from COVID-19. However, the disease can have a significant and potentially life-threatening impact on anyone. Many people, even those without previous health problems, have experienced long-term effects.
That makes every preventive effort — including a vaccine — important.
Also, getting a vaccine to protect against COVID-19 could help keep you from spreading the coronavirus to other people. While the vaccine’s effectiveness in preventing transmission of the coronavirus is not fully known, it does make spreading the disease less likely.
“Part of the benefit of the vaccine is to protect the most vulnerable in our population,” says Dr. Snyder.
“For COVID-19, that especially means people who are elderly. One of the advantages of these vaccines is they can help stop the virus — and therefore transmission — which protects those around us. Even if you’re healthy, it is a benefit to society to get the vaccine.”
Myth: I don’t need to be vaccinated because COVID-19 only kills 1% of people.
Fact: Getting the vaccine is important to protect yourself and others.
Even if you are not in a high-risk group, getting the vaccine can help protect you from COVID-19’s potentially severe and life-threatening effects.
And the vaccine may prevent you from spreading the virus to other people, particularly those in high-risk groups.
When Will Life Go Back to Normal?
Myth: Vaccines against COVID-19 will make life go back to normal.
Fact: Even with a vaccine, other preventive methods are crucial.
Millions of people have gotten vaccinated. Still, there are many millions of people who have not yet been vaccinated.
The virus that causes COVID-19 continues to mutate, causing variants that may be more transmissible or cause more severe disease.
Immunity to COVID-19 wanes after time, even after vaccination. Many people are eligible for additional or booster doses of the vaccine.
For these and other reasons, other COVID-19 mitigation efforts like masking and social distancing also can help prevent the spread of disease. That’s especially the case if you live in an area with high disease spread.
“A vaccine alone is not going to work,” says Dr. Snyder. “A vaccine has to be paired with us still doing distancing and masking, making sure we’re washing our hands, and avoiding large groups of people. That’s why transmission of the virus has become so intense.”
Can’t Herd Immunity Take Care of COVID-19?
Myth: Because of herd immunity, a vaccine is not necessary to slow the spread of COVID-19.
Fact: A vaccine is a crucial step in reaching herd immunity.
Herd immunity occurs when a significant enough part of the population is immune to a disease to slow its spread. Immunity can come through previous infection or vaccination.
The exact percentage of people who need to be immune to COVID-19 to slow the spread is not known. However, estimates range from 70% to 90%.
That makes a vaccine the biggest step in reaching herd immunity.
“We have an intense amount of COVID-19 circulating in the United States right now,” says Dr. Snyder. “But we’re nowhere near having enough people infected naturally to make this go away. We can’t count on natural herd immunity to make COVID-19 go away.”
Editor's Note: This article was originally published on , and was last reviewed on .
The UPMC Adult Congenital Heart Disease (ACHD) Center is a joint program between UPMC Children’s Hospital of Pittsburgh and UPMC Heart and Vascular Institute. We provide long-term care for adolescents, young adults, maternal patients, and adults with congenital heart disease. Our goal is to provide complete care from your childhood all the way through your life. Our team of experts has a wide knowledge of heart conditions.