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COVID Vaccines

FDA Grants Full Approval to Pfizer-BioNTech COVID Vaccine

The federal Food and Drug Administration has granted full approval to the COVID vaccine developed by Pfizer-BioNTech for people 16 and older, making it the first to move beyond emergency use authorization status.

FDA Grants Full Approval to Pfizer-BioNTech COVID Vaccine Read the full press release.

Who Needs an Additional COVID Vaccine?

The CDC recommends that moderately to severely immunocompromised people receive an additional dose.
This includes people who have:

  • Been receiving active cancer treatment for tumors or cancers of the blood
  • Received an organ transplant and are taking medicine to suppress the immune system
  • Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
  • Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection
  • Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

You do not need a doctor’s note to receive the vaccine. You may be vaccinated at the sites listed on the Finger Lakes Vaccine Hub website. UR Medicine is working on opening third-dose clinics, and hopes to announce details soon. Please check back. If you still have questions about receiving a third dose, talk to your healthcare provider. 

Pre-Procedure COVID Testing Resumes

Covid testing before medical procedures, regardless of vaccination status, resumes Aug. 23. Tests must be completed within a 5-day window prior to a procedure. If you are scheduled for a procedure, look for details coming from your healthcare provider.

Frequently Asked Questions

The most up-to-date information can be found on the Centers for Disease Control website. Below are answers to questions often posed by our patients and families:

The Centers for Disease Control has deemed COVID vaccines safe. You can find answers to commonly asked questions about COVID-19 vaccination on the CDC website. CDC also has information for busting common vaccine myths available in facts about COVID-19 vaccines.

The Centers for Disease Control recommends everyone 12 years and older should get a COVID-19 vaccination to help protect against COVID-19.

University of Rochester Medical Center scientists have been heavily involved in vaccine trials, so we have a good sense of how these vaccines were developed and how safe they are. While it’s true that they were developed much more quickly than past vaccines, they were still subject to large trials and strict review by independent scientists.

The process moved quickly in part because groundwork had already been done on vaccines for other, similar coronaviruses, meaning parts of the process that could otherwise have taken years were already completed. In addition, trials were combined and manufacturing began before the trials were done. "However, no steps were skipped and safety remained a top priority," said Angela Branche, M.D., who co-directs URMC’s Vaccine and Treatment Evaluation Unit where she has led research on many of the first coronavirus vaccines to be distributed. "More than 100,000 volunteers were injected with the vaccines to ensure they would not cause significant adverse effects."

Read more about coronavirus vaccine safety.

Getting a coronavirus vaccine will not give you COVID-19. None of the vaccines currently being developed, tested and distributed in the U.S. use the live virus that causes COVID-19; they use other methods to stimulate our bodies to recognize and fight the virus. Learn about how COVID-19 vaccines work.

Coronavirus vaccines are designed to teach our immune systems to recognize and fight the virus that causes COVID-19. This process can cause symptoms, such as fever, in some individuals. This is common and a sign that the body is building immunity. Learn about how COVID-19 vaccines work.

No serious side effects requiring hospitalization have been reported in clinical trials. In addition to fever, some trial participants reported fatigue, headaches, muscle and joint pain, and chills, all lasting about 12 to 24 hours.

As with any vaccine, an allergic reaction is possible but rare. If you know you have severe allergic reactions, you should make sure you receive the coronavirus vaccine in a medical setting where these rare reactions can be effectively treated.

Scientists don’t know for sure, but believe it will last at least for many months. It is too soon to know whether the coronavirus vaccine will need to be an annual shot, like the flu vaccine, and, if it is, whether the same vaccine will work every year.
It’s unclear at this time if coronavirus vaccines will be needed annually like the flu shot. Scientists at URMC and other institutions are studying the immune response to COVID-19 infection and vaccination; we will know more as they gather additional data. Read about URMC’s research on the immune response to coronavirus: Study 1 | Study 2
  • If you are pregnant or plan to become pregnant: Pregnancy is a high-risk condition for severe COVID-19 disease, hospitalization and death. Based on limited data and since the theoretical risk of fetal harm from mRNA vaccines (such as the Pfizer/BioNTech vaccine) is very low, the benefits from vaccination greatly outweigh these risks in anyone exposed to COVID-19. Please discuss COVID vaccination with your OB provider if you have questions.  
  • If you are breastfeeding: Based upon the limited information that is available, physicians and researchers believe it will be safe for use during breastfeeding.​ Please discuss with you OB provider if you have questions.

Please also see Maternal-Fetal Medicine's COVID-19 in Pregnancy page for more FAQs.

Dr. Eva PressmanQ&A with Dr. Eva Pressman About Pregnancy, the Vaccine and More

Eva Pressman, M.D., chair of the Department of OB/GYN and an expert in high-risk pregnancy, recently held an information session with the Department of Imaging to address concerns about the COVID vaccine in women who are pregnant, breastfeeding or are concerned about fertility impacts. See a summary of the discussion, grouped by topic.

Coronavirus vaccines should be safe for individuals with autoimmune disorders, but we don’t yet know how effective they will be.