. . World News – US – Emergency Use Approval becomes part of RiverBender talk about COVID-19 vaccines. com

The phrase « Emergency Use Approval » will become part of our talk about COVID-19 vaccines awaiting final government approval for distribution. But what is an emergency?

Sandy Salverson, vice president of pharmacy services at OSF HealthCare, says the procedure was designed for situations where the country lacks drug therapies to support rapidly and extensively needed treatment. It can be used to respond quickly to any number of situations threatening the nation, such as:. B.. chemical warfare or a health-related pandemic as we are currently experiencing with COVID-19.

According to Salverson, the Emergency Use Authorization (EUA) procedure was first used in 2009 during the H1N1 flu season.

« One of the drugs we know today as Tamiflu was not approved for use in infants at the time, and H1N1 was really affecting our child population (pediatrics), so they went (the Food and Drug Administration (FDA)) and evaluated the evidence they had of efficacy and safety, and at that point decided to implement emergency approval, « explains Salverson.

The Food and Drug Administration may make a judgment that something is worth releasing for use without the typical schedule for a new vaccine or drug.

The process described by Salverson includes making sure that there is enough research to support the use of a treatment or vaccine.

« You weigh what the benefit is (to address), what is happening and what data we have, outweighing the risk of not acting at all. For this purpose, all available data on effectiveness and safety are checked and then the current situation is assessed. « 

The FDA uses an independent review team of career scientists to review the science and ensure that the research results are valid. The Advisory Committee on Immunization Practices (ACIP), part of the Centers for Disease Control and Prevention (CDC), also sets guidelines for immunization and makes recommendations on dosage and the need for a booster shot.

Both EUA-approved vaccines, one from Pfizer and the other from Moderna, require two doses several weeks apart. According to Salverson, when supplies are limited, the CDC provides additional recommendations for prioritization based on several factors until production can be ramped up.

« Who gets sick, who is at the highest risk of dying from COVID, who is at the highest risk of long hospital stays or health problems from the disease and these are decisions that will affect how that Nation sets priorities who gets. « the vaccine first. « 

The CDC Advisory Panel recommended that the very first group of Americans to be vaccinated should be frontline health workers and residents of long-term care facilities. In Illinois, the first shipments will be in the 50 counties with the highest per capita death rate in the state.

In Michigan, the first phase of distribution will include health care workers, and then Phase 1B will expand to key education, nutrition, care and transportation workers. Phase IC includes seniors and other high risk individuals, according to a news release from the Michigan governor.

The FDA is not only empowered to issue an emergency approval, it can also revoke an EEA. This recently happened with hydroxychloroquine and chloroquine used to treat COVID-19. Salverson said the FDA used new data in revoking the EEA, including a large, randomized clinical trial in hospital patients.

« It didn’t really look like it had much of an impact on the disease itself. There were also some drug interaction concerns we used to treat conditions like pneumonia, and the combination of effectiveness and safety really got rid of the EEA for COVID-19, « she explained.

The two leading vaccines from Pfizer and Moderna that are being evaluated for EUA use a new technology called messenger RNA. Unlike other vaccines, the new approach gives the immune system a preview of what the real virus will look like without causing disease. This preview gives the immune system time to develop antibodies that can neutralize the real virus in case the individual ever becomes infected.

« There are other vaccines in Operation Warp Speed ​​or in the pipeline that may not take the same approach, but that doesn’t mean they aren’t (effective). It’s just a different approach, and we’re thinking that this messenger RNA will be faster and more specific to the virus, ”said Salverson.

Salverson says the FDA’s criteria for EUAs specifically state that vaccines cannot pose a risk that would hospitalize someone or cause serious side effects. The process also includes assessing manufacturing safety, skills, and the ability to produce enough vaccine to significantly prevent the virus from spreading.

The Food and Drug Administration will review emergency use approval for Pfizer’s coronavirus vaccine candidate in December. 10 and Moderna’s vaccine candidate on Dec.. . 17th. Distribution is expected to begin the next day when EUA is granted.

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Emergency Authorization, Vaccine, Food & Drug Administration, Healthcare