On June 30, the U.S. Food and Drug Administration (FDA) issued guidelines for new crown vaccines to assist bidders in clinical development and licensing of new crown vaccines. According to the guidelines, the new vaccine should be able to prevent or reduce the severity of the disease in at least 50 percent of vaccinated people. Earlier, the U.S. media reported, according to a summary of the guidelines, that the vaccine alone causes the patient to produce antibodies in the blood, the vaccine will not be approved because there is no known level of antibodies to protect patients.
Originally published as FDA releases new generic vaccine guidelines that require at least 50% efficiency
Screenshot of the U.S. Food and Drug Administration’s (FDA) Official Guidelines for New Crown Vaccines
“We recognize the urgent need to develop a safe and effective vaccine to prevent new coronaviruses, but instead of taking shortcuts in our decision-making, we will not take a shortcut in our decision-making, but instead make clear through the guidelines what data should be submitted to meet our regulatory standards,” said Dr. Stephen Hahn (MD), commissioner of the U.S. Food and Drug Administration. This is particularly important because we know that some people are skeptical of vaccine development efforts. “
The FDA will consider ways to accelerate approval of vaccine licenses as the FDA learns more about SARS-CoV-2 immunology and vaccine immune responses, the FDA said, although the use of specific candidate vaccines will require the identification of immune responses or other measures that reasonably predict clinical benefits.
In addition, due to the current public health emergency, the guidelines also address considerations regarding the Authorization for Emergency Use (EUA) for research vaccines, making it clear that data on the safety and efficacy of the new crown vaccine will be assessed on a case-by-case basis for data on the safety and efficacy of the product, based on the sum of target populations, product characteristics, and related, available scientific evidence, including preclinical and human clinical studies.
With approval, the FDA will continue to use various existing surveillance systems to closely monitor the safety of all vaccines, including the new crown vaccine, and may require post-marketing studies to further assess known or potentially serious risks. The guidelines also mention that follow-up to COVID-19 results by study participants (especially for the performance of severe COVID-19 disease) should be as sustainable as possible, preferably for at least one to two years.
The guidelines encourage the inclusion of diverse populations at all stages of clinical development, including those most affected by the new coronavirus, particularly ethnic and ethnic minorities, and fully representative in older patients and late-stage trials with comorbidities. In addition, new vaccine sponsors are encouraged to include pregnant women and children in their development plans, and these studies will provide data to support use during pregnancy and to assess the safety and effectiveness of pediatrics.
The FDA said the guidelines reflect the FDA’s recommendations to companies, researchers and other agencies over the past few months, describing the agency’s current recommendations for recommended data that could help produce, clinically develop and approve new crown vaccines.
Peter Marks, director of the FDA’s Center for Biological Product synodry, stressed that “in this particular crisis, we need to do our utmost to help speed up vaccine development without sacrificing quality, safety, and efficacy standards.” “
Peter Mark also says that at present, neither the FDA nor the scientific community can predict how quickly vaccine clinical trials will produce data. Once the data is generated, the FDA is committed to evaluating all data thoroughly and quickly.