Updated May 11, 2021
Vaccine development usually takes years. However, in this case, scientists had already begun researching coronavirus vaccines during previous outbreaks like Severe Acute Respiratory Syndrome (SARS) in 2003, and Middle East Respiratory Syndrome (MERS) in 2012. SARS, MERS and COVID-19 are all members of the coronavirus family. Lessons learned from this earlier research provided a head start, allowing for rapid development of a COVID-19 vaccine.
The U.S. Food and Drug Administration (FDA) authorized Pfizer's COVID-19 vaccine for emergency use on Friday, Dec. 11, Moderna’s on Friday, Dec. 18, and Johnson & Johnson’s on Saturday, Feb. 27. Nearly 200 million doses of the COVID-19 vaccines have been administered in the U.S. as of April 12, 2021.
The Nebraska Department of Health and Human Services (DHHS) has paused administration of the Johnson & Johnson COVID-19 vaccine. The decision follows the joint Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) recommendation.
Emergency use authorization
During an emergency, the FDA can issue an emergency use authorization (EUA) to provide more timely access to critical medical products like medicines and tests.
The EUA process allows the FDA to authorize use based on less data than would be required for full approval, clearance or licensing.
Once the EUA is given, it is in effect until the emergency ends, but it can always be revised or revoked as the emergency evolves, or more data becomes available.
Ingredients will vary by vaccine type. As the FDA approves the vaccines, better answers will become available. The vaccine manufacturers are required to submit this information as part of the approval process.
The vaccines do NOT include:
- Fetal cells
- Blood products, like red blood cells, white blood cells, plasma or platelets
- COVID-19 virus cells
- Sometimes there are microchips on the outside of a syringe, so the health care professional can scan it quickly for digital records. The world’s tiniest microchip is still much too big to insert into an immunization shot.
Some of the COVID-19 vaccines, including the Pfizer and Moderna vaccines, use mRNA, or messenger RNA, to instruct your body to build the coronavirus’ spike protein. Once your body makes the spike protein, your immune system then produces antibodies to combat the coronavirus when it encounters it later. Learn more about mRNA vaccines.
Adenovirus vector technology
The Johnson & Johnson vaccine is an adenovirus vector vaccine. (Adenovirus is the virus that causes the common cold. The virus in this vaccine has been changed so that it does NOT cause illness.) With this type of vaccine, a carrier, in this case adenovirus, acts as a delivery vehicle. The adenovirus has had the coronavirus spike protein added to its DNA. The adenovirus carries that genetic material into your body, delivering its modified DNA to your cells. Your cells will then make the spike protein, activating your immune system. Once activated, your immune system creates antibodies to fight off the spike protein. Learn more about the Johnson & Johnson vaccine.
If you are pregnant or breastfeeding
There were no pregnant women included in the initial COVID-19 vaccine clinical trials.
The FDA’s EUA states: “Available data on Pfizer-BioNTech COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
The American College of Obstetrics & Gynecologists Practice Advisory states: “Pregnant and lactating women who otherwise fit the criteria for inclusion in high-priority population can be vaccinated alongside their non-pregnant peers based on shared clinical decision making with the patient and her clinician.”
The Society for Maternal-Fetal Medicine: “Strongly recommends that pregnant and lactating people have access to COVID-19 vaccines and that they engage in a discussion about potential benefits and unknown risks together with their health care providers regarding receipt of the vaccine.”
In the data submitted to the FDA from Pfizer’s COVID-19 vaccine clinical trial, eight women became pregnant during the trial, so they were removed. Eventually, 23 people became pregnant after receiving both doses of the vaccines. Pfizer reported one poor pregnancy outcome, but that person was in the placebo group, so they did not actually receive the vaccine.
We have no reason to believe any of the COVID-19 vaccines would harm a developing fetus or a nursing infant. What we do know: Data suggests that a pregnant woman who develops a COVID-19 infection is likely to become sicker than a non-pregnant woman who develops a COVID-19 infection.
We encourage women who are pregnant or breastfeeding to discuss the benefits and risks of receiving a COVID-19 vaccination with their doctor.
Officials recommend that breastfeeding women get the vaccine. We have no reason to think the COVID-19 vaccines will cause problems with lactation or breastmilk.
If you are immunocompromised
We recommend immunocompromised people get the vaccine.
If you have concerns, or a specific question related to your personal condition, we encourage you to speak with your doctor before getting the vaccine.
The Pfizer vaccine is approved for people who are 12 years of age and older. The Moderna and Johnson & Johnson vaccines are approved for people who are 18 years of age and older.
COVID-19 vaccine clinical trials are now including children. We will most likely have the results of these clinical trials sometime next year.
Blood clots in the brain, abdomen and legs, along with low levels of platelets – the blood cells that help your body stop bleeding – have occurred in a small number of people who have received the Johnson & Johnson COVID-19 vaccine.
Symptoms began approximately one to two weeks following vaccination. Most people who developed these problems were female, ages 18 to 49.
This outcome is very rare. In a joint statement, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) stated, “The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.”
If you recently received the Johnson & Johnson vaccine, please contact your doctor if you develop any of the following symptoms within three weeks of receiving your vaccine:
- Shortness of breath
- Chest pain
- Leg swelling
- Persistent abdominal pain
- Severe persistent headaches
- Blurred vision
- Easy bruising or tiny blood spots under the skin beyond the injection site