Updated April 13, 2021
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.
Throughout the COVID-19 pandemic, scientists worldwide have been working to find treatments and cures.
Below are some frequently asked questions about vaccines and the status of COVID-19 vaccines.
What Is a Vaccine?
Simply put, a vaccine can prevent disease. When you get a vaccine for a certain disease, it stimulates your immune system to create antibodies against the disease. Those antibodies can give you immunity against a disease without ever becoming sick.
Vaccines have been around for more than 200 years, and there are currently vaccines for more than 20 life-threatening diseases. According to the World Health Organization, vaccines prevent the death of between 2 million and 3 million people each year.
Where Do Vaccines Come From?
From scientific study and research. Scientists study an infectious disease in the laboratory and break down its components. They attempt to find out what component causes the disease. They then create a vaccine to neutralize the disease-causing portions. The goal is for a vaccine to be both safe for people who get it and effective at preventing the disease.
Vaccines go through extensive clinical trials to determine their safety and effectiveness — first in animals, then in humans. The FDA monitors the trials. If a vaccine is shown to be both safe and effective, the FDA can approve the vaccine for widespread use in humans.
Never Miss a Beat!
Subscribe to Our HealthBeat Newsletter!
Get Healthy Tips Sent to Your Phone!
What Is the Status of the COVID-19 Vaccine?
In December 2020, the FDA granted emergency use authorization (EUA) to two vaccines: one developed by Pfizer-BioNTech and another produced by Moderna. In February 2021, the FDA issued an EUA for a vaccine produced by Johnson & Johnson/Janssen.
Other vaccine candidates are in the clinical trial phase and could seek FDA approval for use in the future.
What Is an Emergency Use Authorization?
During a public health crisis like the COVID-19 pandemic, the FDA can issue an Emergency Use Authorization (EUA) for medical treatments that have not yet received final approval.
Manufacturers can submit a request for an EUA to the FDA. The FDA evaluates the EUA request on several criteria, including the safety and effectiveness of the treatment. If the treatment is shown to be safe and effective, and if there are no other adequate approved treatments, the FDA can issue the EUA.
While an EUA means a treatment can be used during an emergency, that does not mean the treatment has final, full FDA approval. The regular clinical trial and approval process will continue even after an EUA is issued.
When Can I Get the COVID-19 Vaccine?
The Centers for Disease Control and Prevention (CDC) provides guidance to states about which groups should get the vaccine and when. Hospital systems like UPMC are working alongside state officials to offer vaccination.
As of April 13, 2021, all Pennsylvanians 16 and older are eligible for vaccination. For more information, visit the Pennsylvania Department of Health website.
You might also like…
Do I Need to Get the COVID-19 Vaccine?
A vaccine is the best way to reach herd immunity against COVID. Herd immunity occurs when a large portion of a population is immune to the disease, which can slow or stop the disease’s spread.
Scientists estimate that 70% to 90% of the population will need to become immune to COVID-19 for herd immunity to be reached. For that to happen, getting the vaccine is crucial.
Is the COVID-19 Vaccine Safe?
All reported data on the COVID-19 vaccines suggest their vaccines are safe.
All vaccine candidates are rigorously monitored for safety during the trial and approval process. For the FDA to issue an EUA, the manufacturer must prove it is safe in humans. The potential benefit must outweigh the risk.
These vaccines and other candidates will continue to be monitored for long-term side effects and other safety concerns.
On April 13, 2021, the CDC and FDA recommended a pause in the distribution of the J&J vaccine to investigate reports of Americans who developed a rare, serious blood clot after getting the J&J vaccine. This side effect appears to be extremely rare and has not been reported with the Moderna or Pfizer vaccines.
If you received the J&J vaccine, do not panic. Call your doctor if you experience symptoms related to blood clots, including severe headache, arm or leg swelling, and/or shortness of breath.
“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. This issue with J&J shouldn’t be construed as a negative for COVID-19 vaccines in general. It is just a pause to better analyze what’s going on right now with this specific vaccine.”
Does the COVID-19 Vaccine Work?
The goal of the COVID-19 vaccine is to prevent the disease.
No vaccine is 100% effective. However, both Pfizer and Moderna have reported that their vaccines are more than 94% effective in preventing symptomatic COVID-19. Johnson & Johnson has reported its vaccine is about 70% effective against mild and moderate illness and 85% effective against severe disease.
All of the authorized vaccines are very effective in preventing hospitalization and death from COVID-19.
Those figures far exceed FDA requirements for vaccine effectiveness.
How Does the COVID-19 Vaccine Work?
Both the Pfizer and Moderna vaccines include messenger RNA (mRNA). Vaccines with mRNA give your body instructions on how to fight the disease — in this case, COVID-19.
The Pfizer and Moderna vaccines both require two doses, given weeks apart, to be effective.
The J&J vaccine is a viral vector vaccine. It uses a substitute virus that has been genetically modified to deliver instructions to your body about how to fight the disease. It is currently a single-dose vaccine.
Will UPMC Be Providing the COVID-19 Vaccine?
UPMC is currently distributing the COVID-19 vaccine in accordance with guidelines from state and federal health officials.
On April 13, 2021, in accordance with recommendations from the CDC and FDA, UPMC paused our distribution of the J&J vaccine. We are following all guidance from federal, state, and local health officials.
We believe fully in the importance of vaccination in ending the COVID-19 pandemic. We are continuing to use available doses of the Pfizer and Moderna vaccine and encourage people to sign up for vaccination if they are eligible. We continue to monitor for safety in all of our vaccination efforts.
If you are eligible for the vaccine, you can schedule an appointment to receive the vaccine from UPMC. To sign up, visit Vaccine.UPMC.com.
UPMC’s goal is to provide the vaccine to as many people as possible, as quickly as possible, using all vaccine supply made available to us. We are actively providing vaccinations throughout our communities.
Centers of Disease Control and Prevention, Vaccines: The Basics. Link
Food and Drug Administration, Emergency Use Authorization for Vaccines Explained. Link
Denise Grady, New York Times, Early Data Show Moderna's Coronavirus Vaccine Is 94.5% Effective. Link
Lena H. Sun and Isaac Stanley-Becker, Washington Post, Health Care Workers and Nursing Home Residents Should Be the First to Get Coronavirus Vaccines, CDC Advisory Group Says. Link
Katie Thomas, New York Times, New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective. Link
World Health Organization, Vaccines and Immunization. Link
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.