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According to the CDC’s Advisory Committee on Immunization Practices, because supplies of the vaccines are currently limited, they are initially being offered to those in the healthcare community within the Phase 1A First and Second Tier designation.
According to the CDC, vaccine safety is its top priority. These vaccines were developed and tested in record time, using the FDA’s rigorous expedited evaluation process. The clinical data on the vaccines is also reviewed by the CDC and non-government academic groups. The FDA will continue to collect and monitor the safety data on the vaccines as more people are immunized.
It is important to note that the COVID vaccine is an addition to our pandemic response and not a replacement for any existing efforts. Deployment of the COVID vaccine will not change our foundational COVID infection prevention practices, including use of PPE, patient placement, and screening at entrances.
Until these vaccines are readily available and we achieve significant rates of vaccination in our communities, the most effective safety measures we can take against COVID-19 continue to be wearing a mask, washing our hands, getting a flu shot, and maintaining social distance.
The state of Texas has asked that we offer vaccinations for those that are in Phase 1B. This group is aged 65 and/or has specific chronic conditions. Given the current limited supply of vaccine, at this time, we are not providing community vaccinations. However, we are actively planning to offer this service, and when the supply of vaccine is available, an announcement will be made to those that are eligible with instructions on location and how to schedule an appointment to receive the vaccine.
Q: The approval process was so quick when it has taken years for other vaccines to be approved, so how do we know these vaccines are safe? A: According to the CDC, vaccine safety is its top priority. These vaccines were developed and tested in record time, using the FDA’s rigorous expedited evaluation process. The emergency use process has been followed for potential authorization of the COVID-19 vaccines as with other vaccines. According to the Department of Defense’s Operation Warp Speed, the difference is some of these processes have been conducted simultaneously, which shortened the timeline, and manufacturers are sharing data with the FDA in real time. In addition, the government has provided $10 billion in funding to support vaccine development. Also, new bioengineering and vaccine technologies have evolved in recent years. The safety of vaccines is paramount, and safety monitoring will continue beyond the approval process. For more information about the accelerated vaccine process, go to https://media.defense.gov/2020/Aug/13/2002476369/-1/-1/0/200813-D-ZZ999-100.JPG
Q: What role does the FDA play in vaccine approvals? A: The FDA evaluates the vaccine’s safety, efficacy and ability to produce an immune response. The agency also studies the design of the vaccine trial and looks at other clinical factors. Additionally, it evaluates the manufacturing rigor deployed by the manufacturer and assesses the quality of its manufacturing processes.
Q: What are the potential side effects of the vaccines? A: According to Pfizer and Moderna, the potential side effects are mild to moderate and similar to those of the flu vaccine. Typical side effects could such things as fever, chills, fatigue and muscle ache.
Q: Do the Pfizer and Moderna vaccines require one or two doses? A: The Pfizer and Moderna vaccines require two doses, with the second one given after 21 or 28 days, depending on which vaccine is used.
Q: What happens if I receive the first dose but not the second one? A: According to the vaccine manufacturers, it’s important to follow up with the second dose or you will only receive a fraction of the protection you need. The effectiveness of the vaccine is dependent on a two-dose strategy.
Q: Can I get one dose of the Pfizer vaccine and a second dose of the Moderna vaccine? A: No. The two vaccines are not interchangeable. You must get two doses of the same vaccine.
Q: How are the Pfizer and Moderna vaccines different? A: The two companies have taken different approaches to immunity development. Both vaccines have been shown to be over 90% effective.
Q: Is there a pediatric version of the vaccines? A: Currently, there are no vaccination dosages for pediatric patients and a pediatric vaccine has not yet received FDA approval. The current vaccines are approved for those 18 years of age and older.