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Updated April 15, 2o21

Update: On April 13, 2021, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) released a statement recommending a pause in distribution of the Johnson & Johnson/Janssen COVID-19 vaccine out of caution as they investigate reported cases of Americans who developed a rare and serious blood clot after receiving the J&J vaccine. Currently, these blood clots appear to be rare. The pause will allow federal health officials to investigate the cases and make further recommendations. 

At UPMC, we are committed to the safety of our communities in our vaccination efforts. We are following federal guidance in the distribution of the J&J vaccine. We are pausing our distribution of the J&J vaccine pending the CDC investigation.

If you or a loved one received the J&J vaccine, do not panic. The reported adverse effects are extremely rare given the number of J&J vaccines distributed. Call your doctor if you experience side effects related to blood clots, including severe headache, arm or leg swelling, and/or shortness of breath. You do not have to start any medicines like aspirin to thwart blood clots.

As the distribution of COVID-19 vaccines begins 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 granted EUA to the Pfizer-BioNTech and Moderna vaccines in December 2020. A third vaccine, developed by Johnson & Johnson/Janssen, received EUA in February 2021.

Data show that the Pfizer, Moderna, and J&J vaccines are safe for use in humans.

“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.”

On April 13, 2021, the CDC and FDA recommended a pause in the distribution of the J&J vaccine as they investigate reports of a rare, serious blood clot some Americans developed after getting the vaccine. This adverse effect appears to be very rare.

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.

The Pfizer and Moderna vaccines are reported to be at least 94% effective in preventing symptomatic COVID-19 in humans. The Johnson & Johnson vaccine is reported to be about 70% effective in preventing mild to moderate COVID-19 and 85% effective in preventing severe COVID-19.

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 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.

On April 13, 2021, the CDC and FDA recommended a pause in the distribution of the J&J vaccine as they investigate reports of a rare, serious blood clot that some Americans developed after getting the vaccine. This adverse side effect appears to be extremely rare. The same side effect has not been linked to the Moderna or Pfizer vaccines.

“Most people, regardless of the vaccine they receive, should not expect severe side effects like this,” says Donald Yealy, MD, chief medical officer, UPMC. “It’s exceptionally rare.”

Myth: The COVID-19 vaccine could cause women to become sterile.

Fact: There is no evidence that the COVID-19 vaccine could cause sterility.

Rumors that the Pfizer vaccine results in female sterilization because it contains a spike protein known as syncytin-1 are false. The vaccine does not contain this protein.
There is no evidence that the Pfizer vaccine would result in sterilization of women.

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.

EUAs for the Pfizer, Moderna, and J&J vaccines have allowed millions of people to get vaccinated. Still, there are many millions of people who have not yet been vaccinated.

The ACIP recommended that the first doses of vaccine go to health care workers and residents of long-term care facilities like nursing homes. As the United States gets more vaccines from manufacturers, more people will receive them.

It likely will take months for enough people to get vaccinated to fully slow the spread of COVID-19.

In the meantime, it’s important to follow other preventive measures, like wearing facemasks, following good hand hygiene, and maintaining social distancing.

“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.”

Will There Be Enough Vaccine for Everybody?

Myth: There will not be enough doses of vaccine for everyone to get vaccinated.

Fact: Having more than one potential vaccine should increase availability.

Early supplies of the vaccine are not enough for everyone to be vaccinated, but more will become available in the coming months.

The speed at which Pfizer, Moderna, and J&J developed their vaccines — plus the knowledge that there are multiple other vaccines now in development — also makes broad availability more likely.

“They have made these vaccines faster than has ever been done in history,” Dr. Snyder says. “That gives us a lot of confidence that we’ll have enough vaccine.”

However, it will take time for enough vaccines to be produced and distributed. Until that time, it’s important to slow the spread of COVID-19 by masking, social distancing, handwashing, and avoiding large crowds.

Sources

Centers for Disease Control and Prevention, People at Increased Risk. Link

Denise Grady, New York Times, Early Data Show Moderna's Coronavirus Vaccine Is 94.5% Effective. Link

About UPMC

Headquartered in Pittsburgh, UPMC is a world-renowned health care provider and insurer. We operate 40 hospitals and 700 doctors’ offices and outpatient centers, with locations in central and western Pennsylvania, Maryland, New York, and internationally. We employ 4,900 physicians, and we are leaders in clinical care, groundbreaking research, and treatment breakthroughs. U.S. News & World Report consistently ranks UPMC Presbyterian Shadyside as one of the nation’s best hospitals in many specialties and ranks UPMC Children’s Hospital of Pittsburgh on its Honor Roll of America’s Best Children’s Hospitals.