“Out of an abundance of caution,” the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) have urged a pause on using the Johnson & Johnson COVID-19 vaccine after six women developed rare blood clots days following the single-dose shot.
The reported blood clots, called cerebral venous sinus thrombosis, were all among women ages 18 to 48, the FDA and CDC said in a joint news release. The agencies said the cases seem to be extremely rare, but that the pause is important so that healthcare providers can be made aware of such reactions, and properly recognize and manage them. This development should not deter anyone from getting vaccinated, the U.S. agencies and medical experts say.
The three U.S.-approved vaccines — produced by Moderna, Pfizer-BioNTech and Johnson & Johnson — work by teaching your immune system how to recognize and fight the coronavirus — effectively protecting you from getting sick or dying from COVID-19.
Extensive research has found all of them to be significantly safe and effective. But even before the pause on the Johnson & Johnson vaccine, falsehoods persisted via social media or traditional word-of-mouth or other means that might deter some from getting vaccinated.
“As a pharmacist, it is amazing to see how quickly the scientists have created these vaccines,” said Madeline Camejo, M.S., Pharm.D., chief pharmacy officer and vice president of pharmacy services for Baptist Health South Florida. “With that being said, we want people to understand that even though the vaccines have been developed in record time, it does not mean that it is not safe or effective. The type of technology we have today has allowed scientists to create a vaccine that safely helps your body to fight COVID-19.”
Crucial Facts to Consider
Initial trials considered by the FDA before issuing “emergency use authorizations” found the Moderna and Pfizer vaccines to be up to 95 percent effective in preventing COVID-19 illness in those without prior infection. That effectiveness covered a wide range of types of people and variables, including age, gender, race, ethnicity, and body mass index (BMI) — or the presence of other medical conditions.
The Johnson & Johnson vaccine was found to be 86 percent effective against severe disease, including protection against at least one variant of COVID-19 circulating in the U.S.
Several trials have been are underway or completed since the initial research. The findings continue to be remarkably positive. The CDC found “strong evidence” that the Moderna and Pfizer-BioNTech vaccines are highly effective in preventing COVID-19 infections “in real-world conditions among healthcare personnel, first responders, and other essential workers,” according to a study published last month.
“Being protected from getting sick is important because even though many people with COVID-19 have only a mild illness, others may get a severe illness, have long-term health effects, or even die,” states the CDC. “There is no way to know how COVID-19 will affect you, even if you don’t have an increased risk of developing severe complications.”
The Top 3 Vaccine Myths/Falsehoods
1. Falsehood: The COVID-19 vaccine will make me sick with COVID-19.
None of the current COVID-19 vaccines approved by the U.S. Food and Drug Administration (FDA) contain the live virus that causes COVID-19. This means that a COVID-19 vaccine cannot make you sick with COVID-19.
All of vaccines essentially teach our immune systems to recognize and fight the virus that causes COVID-19. Both the Pfizer-BioNTech and Moderna vaccines are made of a laboratory manifested agent called mRNA that causes the body to make a substance to which your body’s immune system responds. Both vaccines require two doses for the highest immunity. And both vaccines have proven to be extremely safe and effective in trials. Sometimes, this process can cause symptoms, such as fever. It typically takes at least two weeks for the body to build maximum immunity after getting the second shot. This means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination. This is because the vaccine has not had enough time to provide protection.
If you get a COVID-19 vaccine that requires one shot, you are considered fully vaccinated two weeks after your shot. The Johnson & Johnson vaccine, which requires only one shot, does not use the mRNA technology. It is known as a “vector vaccine” that utilized a harmless cold virus to deliver a gene that carries the blueprint for the “spike protein” found on the surface of the coronavirus. The vaccinated person’s cells then adopt this blueprint to create a replica of the coronavirus spike protein. The person’s immune system uses these replicas to recognize and fight the real coronavirus.
2. Falsehood: The COVID-19 vaccine will alter my DNA.
None of the current COVID-19 vaccines approved by the FDA affect your DNA. There are currently two types of COVID-19 vaccines that have been authorized by the FDA: messenger RNA (mRNA) vaccines (from Pfizer-BioNTech and Moderna), and a viral vector vaccine (from Johnson & Johnson). The mRNA vaccines train the body’s cells to make a protein that creates an immune response. The mRNA from a COVID-19 vaccine never enters the nucleus of the cell, which is where most DNA is located. This means the mRNA cannot affect or interact with a person’s DNA. The mRNA vaccines safely team up with the body’s natural defenses to fight the coronavirus.
The Johnson & Johnson’s viral vector vaccine also safely educates a person’s immunity to fight COVID-19, without any interference with a person’s DNA. This type of vaccine uses a modified version of a different, harmless virus (the vector) to instruct the body’s cells to build its own natural protection. It does so by delivering a type of genetic material that helps the cell to produce a harmless component of a virus that causes COVID-19. It is referred to as a “spike protein” and it is only found on the surface of the virus that causes COVID-19. This enables your immune system to recognize the virus that causes COVID-19 and to begin producing antibodies, and triggering other immune cells, to fight off what it believes to be an infection.
3. Falsehood: I have already had COVID-19 and recovered, so I don’t need to get vaccinated with a COVID-19 vaccine.
You need to be vaccinated, even if you’re already had COVID-19. Many studies are looking into the length of time that COVID-19’s antibodies, or natural immunity, protects a person from reinfection or illness from the coronavirus. But experts do not yet know how long you that natural protection lasts. It is possible — although at this time it’s rare — that you could be infected again. It is unknown at this time how long immunity obtained from vaccines will last; ongoing studies are looking into this question — and whether repeat vaccinations — or booster shots are needed. Pfizer-BioNTech recently announced that its vaccine continues to be effective against COVID-19 up to six months after getting its second dose, according to an ongoing late-stage study of more than 44,000 volunteers. If you were treated for COVID-19 with monoclonal antibodies or convalescent plasma, you should wait 90 days before getting a COVID-19 vaccine. Talk to your doctor if you are unsure what treatments you received or if you have more questions about getting a COVID-19 vaccine.
Trust the Science
Dr. Camejo emphasizes that the public should trust the medical science that made the vaccines possible, despite apprehensions among certain groups or outright misinformation being distributed.
“We do have some cultural issues where people have distrust in vaccines, but the population needs to realize that this pandemic is not like a regular flu or other illnesses,” says Dr. Camejo. “This is a virus that affects people in many different ways. We’ve seen everything from elderly patients who experienced minor symptoms to seemingly healthy young people who have had serious complications. It is a disease that we are still learning about, and the impact on long term effects Covid-19 will have on the population.”