What role do COVID-19 vaccinations play in helping to curb the pandemic?

COVID-19 vaccination will help protect ourselves, our families, and our communities from the disease and save lives. Vaccines can both prevent and reduce the severity of disease. Vaccines provide immunity without the serious risks associated with getting infected naturally. Wearing masks and physical distancing help reduce the chance of being exposed to the virus or spreading it to others, but these measures are not enough.

The COVID-19 vaccines are designed to work with our immune systems so the body is ready to fight the virus if we are exposed to it. When enough people in a community get vaccinated against COVID-19, immunity rates in our communities substantially increase, which reduces the spread of the virus.

Are the COVID-19 vaccines safe?

Yes. COVID-19 vaccines have been evaluated in tens of thousands of individuals who volunteered to participate in clinical trials. These clinical trials met the same rigorous standards set for all vaccines by the Food and Drug Administration (FDA).

 

The information from these clinical trials allowed the FDA to determine that the newly authorized COVID-19 vaccines meet its safety and effectiveness standards. Based on these findings, the FDA has made the vaccines available for use in the United States under what is known as an Emergency Use Authorization (EUA).

 

The Centers for Disease Control and Prevention (CDC) and the FDA is continuing to monitor the safety of the vaccines now that they are in use.

 

How effective will the vaccines be for disease prevention?

The COVID-19 vaccines currently authorized for use were found to be highly effective in preventing COVID-19 in clinical trials.

All authorized COVID-19 vaccines have high efficacy in protecting against severe COVID-19 disease as well as COVID-19 related hospitalizations and death. They all have been reviewed rigorously by the scientific experts and have met the FDA efficacy standards for emergency use authorization.

How do COVID-19 mRNA vaccines (Pfizer and Moderna) work?

The vaccines contain synthetic mRNA, which is genetic information used to make the SARS-CoV-2 spike protein. The spike protein is the part of the virus that attaches to human cells. The spike protein alone cannot cause COVID-19.

Once the spike protein is created, it causes the immune system to make antibodies against the virus. These antibodies can then provide protection if a person comes into contact with the virus.

Since the vaccine does not contain any virus, it is not possible to spread COVID-19 from receiving the vaccine. The mRNA does not enter the center of the human cell where DNA is made (the nucleus); so, it cannot alter the genetic material of the cell (DNA). The mRNA is rapidly broken down, making the chance for long-term side effects less likely. The mRNA vaccines do not have the ability to cause cancer.

Learn more here: https://www.cdc.gov/vaccines/covid-19/downloads/healthcare-professionals-mRNA.pdf

How do COVID-19 viral vector vaccines (Johnson & Johnson's Janssen vaccine) work?

As of April 13, 2021, out of an abundance of caution, use of the Johnson & Johnson's Janssen COVID-19 vaccine is temporarily paused in accordance with CDC and FDA recommendation.

The J&J/Janssen COVID-19 vaccine contains an inactivated 'common cold' virus called an adenovirus. This virus cannot replicate in the human body, will not cause an infection, and does not enter DNA. The adenovirus carries a gene for the coronavirus spike protein that allows it to be created and recognized by the immune system. The spike protein is the part of the coronavirus that attaches to human cells. The spike protein alone cannot cause COVID-19. Once the spike protein is created it causes the immune system to make antibodies against the virus. These antibodies can the provide protection if a person comes into contact with the coronavirus.

Can I get COVID-19 from a vaccine?

As of April 13, 2021, out of an abundance of caution, use of the Johnson & Johnson's Janssen COVID-19 vaccine is temporarily paused in accordance with CDC and FDA recommendation.

No. None of the COVID-19 vaccines currently authorized for use or in development in the United States use the live virus that causes COVID-19.

What many people experience as a result of receiving the vaccine are the body's immune system responding to the COVID-19 vaccine. All of the COVID-19 vaccines work with your immune system so it will be ready to fight the virus if you are exposed. Common immune responses are pain, redness, and swelling in the arm of the injection, along with possible tiredness, headache, muscle pain, chills, fever, and nausea.

It usually takes a few weeks for the body to build immunity after being fully vaccinated (that is, two doses for Pfizer and Moderna or one dose for J&J/Janssen). That means it is possible for an individual to be infected with the virus that causes COVID-19 if exposed just before or just after vaccination. The vaccine itself does not cause infection. Similarly, the vaccine cannot cause you to have a positive COVID-19 test.

What are 'variants' and what do they mean for individuals considering vaccination?

 

Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Sometimes new variants emerge and disappear. Other times, new variants emerge and stay. Multiple variants of the virus that causes COVID-19 have been documented in the United States and globally during this pandemic. Scientists are studying these variants to understand whether they:

 

 

Preliminary data concerning vaccine effectiveness and variants indicates the B.1.1.7 (first detected in the United Kingdom) has had minimal impact on vaccine effectiveness. The B.1.351 (first detected in South Africa) has shown to have moderate impact on vaccine effectiveness, and the P.1 (first detected in Brazil/Japan) is still be studied to evaluate the potential impact on vaccine effectiveness. Current public health actions such as wearing a mask, staying at least 6 feet apart, avoiding crowds, and getting vaccinated when it is available combined are the best protection against variants of the virus that causes COVID-19.

 

For more information on variants of concern please visit: https://www.cdc.gov/coronavirus/2019-ncov/variants/index.html.

 

What is an Emergency Use Authorization (EUA)?

During a public health emergency, the FDA can use a process called 'Emergency Use Authorization' (EUA). This process allows the use of medical products that are not yet approved to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met.

Several additional COVID-19 vaccines are currently being developed and tested for their safety and effectiveness in clinical trials (efficacy). Once vaccine manufacturers submit for authorization, the FDA evaluates the EUA request and determines whether they are safe and effective, taking scientific evidence into account. For a vaccine to receive an EUA, the FDA must determine if the vaccine's benefits outweigh its risks based on data from rigorous clinical trial(s).

Additional information on EUAs: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

How does the FDA Assess Safety and Effectiveness of a COVID-19 Vaccine Submitted for Emergency Use Authorization (EUA)?

COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to gather required safety and efficacy data, in the same way as many other currently approved vaccines. The FDA evaluates the information submitted by a vaccine manufacturer and uses all available tools and information, including records reviews, site visits, and previous manufacturing compliance history.

For an EUA to be issued, the FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.

Link: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

Which COVID-19 vaccines have been authorized for use by the FDA?

As of April 13, 2021, out of an abundance of caution, use of the Johnson & Johnson's Janssen COVID-19 vaccine is temporarily paused in accordance with CDC and FDA recommendation.

At this time, there are three COVID-19 vaccines authorized for use by the FDA. The Pfizer-BioNTech mRNA COVID-19 vaccine received FDA authorization December 11, 2020 for individuals ages 16 and older. It is a 2-dose vaccination series, given intramuscularly, recommended at least 3 weeks apart. For the full FDA statement on the authorization of this vaccine: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

The Moderna mRNA COVID-19 vaccine received FDA authorization December 18, 2020 for individuals 18 and older. It is a 2-dose vaccination series, given intramuscularly, recommended at least 1 month apart. For the full FDA statement on the authorization of this vaccine: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

Johnson & Johnson's Janssen vaccine received FDA authorization February 27, 2021 for individuals ages 18 and older. It is a 1-dose vaccination, injected into the muscle, typically of the upper arm. For the full FDA statement on the authorization of this vaccine: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

Why have vaccines been developed so quickly?

The vaccine process has happened faster because vaccine research and development, clinical trials, manufacturing, and plans for distribution have occurred at the same time. This method removed delays that occur when these processes are carried out one after the other. Steps to ensure safety were NOT eliminated.

 

What can individuals do to protect themselves and others until COVID-19 vaccines are more widely available?

It is vital that each person uses all tools available to stop the pandemic. Tools include:

Why do we need a vaccine if we can take other COVID-19 precautions, like masking and physical distancing, to slow or prevent the spread?

It is vital that each person uses all tools available to stop the pandemic. Vaccines work with the immune system and allow a strengthened response to the virus if exposed.

Other steps, like covering the mouth and nose with masks/face coverings worn properly, washing hands, and staying at least 6 feet away from others, help reduce chances of exposure to the virus or spreading it to others.

Together, COVID-19 vaccination and following recommendations for self-protection and to protect others will offer the best prevention for further spread of COVID-19. For more information: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html