Through Operation Warp Speed, a partnership among components of the Department of Health and Human Services (HHS) and the Department of Defense, millions of COVID-19 vaccine doses of COVID-19 are being developed and distributed — all while ensuring the safety and effectiveness of the vaccines.
The Food and Drug Administration has issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccine. The FDA chooses to grant EUAs once studies have demonstrated the safety and effectiveness of a vaccine, but before the manufacturer has submitted or the FDA has completed its formal review of the license application. Johnson & Johnson and Oxford/AstraZeneca also have vaccines currently in phase 3 clinical trials.
The West Virginia Department of Health and Human Resources has established vaccinate.wv.gov to provide more information about the vaccine and distribution. An information hotline, 1-833-734-0965, is also available Monday through Friday from 8 a.m. to 6 p.m. and Saturday from 9 a.m. to 5 p.m.
Yes. COVID-19 vaccines have been evaluated in tens of thousands of individuals who volunteered to participate in clinical trials according to rigorous Food and Drug Administration (FDA) standards, the same ones that have been applied to other vaccines currently in use for years. The information from these clinical trials allowed the FDA to determine that the newly authorized COVID-19 vaccines meet its safety and effectiveness standards; therefore, the FDA has made these 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 will continue to monitor the safety of the vaccines now that they are in use.
The vaccine process is happening faster because vaccine research and development, clinical trials, manufacturing, and plans for distribution are occurring at the same time. This method removes delays that occur when these processes are carried out one after the other. Steps to ensure safety are not being eliminated.
The vaccines do not contain the full live SARS-CoV-2 virus and therefore cannot cause COVID-19. The first vaccines that will be available will either contain mRNA (non-infectious genetic material), viral vectors, (modified versions of live viruses), or protein subunits (parts of viral proteins) which cannot cause infection.
The Pfizer and Moderna mRNA 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 the provide protection if a person comes into contact with the virus. The mRNA vaccines are noninfectious and do not enter the human cell nucleus so it cannot be inserted into human DNA. Additionally, mRNA is rapidly broken down, and this theoretically reduces chances for long term side effects. The mRNA vaccines do not have the ability to cause cancer.
General reactions to the COVID-19 vaccine include fever, body aches, and headaches which typically last one to two days. This reaction simply means that the immune system is working.
There is no evidence the COVID-19 vaccine affects fertility. People who are trying to become pregnant or who are pregnant and for whom the vaccine is recommended may choose to be vaccinated. A discussion with her health care provider can help to make an informed decision.
In Phase 3 trials, the Pfizer vaccine showed a 95% efficacy rate 7 days after the second dose. The vaccine was 94% effective in adults >65 years old. The Moderna vaccine showed a 94% efficacy rate 14 days after the second dose. These results were consistent across gender, age, race and ethnicity. The length of immunity following vaccination is not yet known for COVID-19. Given the novel nature of this virus and vaccine development, long term data is not yet available to guide future vaccine protocols.
After receiving FDA authorization for use in the U.S., Pfizer and Moderna vaccines began arriving in West Virginia in early-mid December. West Virginia is dedicated to ensuring that all West Virginians have access to a COVID-19 vaccination as soon as possible. The guiding principles in decision making for allocating limited supplies include reducing hospitalizations, reducing the rate of deaths, protecting the most vulnerable West Virginians, and ensuring the state and local communities can maintain critical services.
The initial focus in vaccine distribution is to take care of the most vulnerable West Virginians. Vaccines will be in limited supply initially, so the first phase will be distributed to individuals in high-risk settings such as healthcare, emergency response, long-term care facilities, and community infrastructure. This approach is imperative to preserve critical infrastructure, such as making sure the West Virginia’s healthcare system can meet the state’s needs.
As West Virginia receives more vaccine supply and has vaccinated those identified for Phase 1, vaccinations will be made available for the general public. Decisions on moving to the next phase are made at a state/local level. Phases may overlap. It is not necessary to fully complete vaccination in one phase before beginning the next phase.
Vaccine doses purchased with U.S. taxpayer dollars will be given to the American people at no cost. However, vaccination providers will be able to charge an administration fee for giving the shot to someone. Vaccine providers can get this fee reimbursed by the patient’s public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration’s Provider Relief Fund.
You should continue covering your mouth and nose with a mask when around others, avoiding close contact with people who are sick, staying 6 feet away from others, avoiding crowds, and washing your hands often.
Wearing a mask, washing hands, and staying at least 6 feet away from others will remain important even after receiving the vaccine. Since there will be limited doses available initially, and people will be vaccinated in phases, it will take time to vaccinate enough of the population to stop the spread of COVID-19.