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    Home > Medical News > Medical World News > The FDA issues guidelines for new crown vaccines that require 50% effectiveness.

    The FDA issues guidelines for new crown vaccines that require 50% effectiveness.

    • Last Update: 2020-07-24
    • Source: Internet
    • Author: User
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    On Tuesday, the FDA issued an immediate and effective guideline called "Prevention of the Development and Licensing of the COVID-19 Vaccine" to help and facilitate the timely development of safe and effective vaccines involving production, non-clinical and clinical studies, as well as post-licensing recommendations and requirementsFDA said it hopes the sponsors will prove that the vaccine is at least 50 percent effective in placebo-controlled trials for a vaccine widely used against COVID-19the same day, at a hearing of the Senate Health, Education, Labor and Pensions Committee, FDA Director Stephen Hahn testified that the FDA will maintain its standards and independence in its decision to approve any COVID-19 vaccine:"While the FDA is committed to helping speed up this work, we will not take shortcuts in the decision-making process, and we made it clear in our guidelines what data needs to be submitted to meet regulatory standards for approval."in a press release issued by the guidelines, DrPeter Marks, director of the FDA's Center for Biological Assessment Research (CBER), responded to Hahn's statement by saying, "Don't get me wrong: the FDA will only approve or authorize the COVID-19 vaccine if we determine that it meets high standards."in the guidelines, the FDA said current development plans should aim to obtain traditional approvals because "there is no recognized alternative endpoint that can reasonably predict the clinical benefits of the COVID-19 vaccine" to support accelerated approvalthe guidelines read,"once a further understanding of SARS-CoV-2 immunology has been obtained, in particular the possible prediction of a vaccine immune response that could prevent COVID-19, it is possible to consider accelerating the approval of the COVID-19 vaccine..."It is important to note that the potential replacement endpoint will vary depending on the characteristics of the vaccine being discussedFDA also allows the issuance of an Emergency Use Authorization (EUA) for THE COVID-19 vaccine in certain circumstances, but cautions that "issuing EUA for the COVID-19 vaccine before large randomized clinical efficacy trials are completed may reduce the ability to demonstrate experimental vaccine efficacy in clinical end-of-life efficacy trials, which will support final listing permits."FDA said it may consider issuing EUA as a temporary measure for the COVID-19 vaccine after the study has shown safety and efficacy, but before submitting or formally reviewing a biologic licensing application (BLA)"Any assessment of EUA will be evaluated on a case-by-case basis based on the target population, the characteristics of the target population, preclinical and human clinical studies data for the product, and available scientific evidence," the FDA addedfor clinical development, the FDA encourages sponsors to consider adaptive or seamless clinical trial designs, which it believes can speed up developmentThe FDA added that late-stage trials may need to recruit thousands of participants, including comorbidities, to demonstrate the protective effects of severe COVID-19The FDA strongly encourages the inclusion of diverse populations at all stages of clinical development, including those most affected by COVID-19, especially ethnic and ethnic minorities, as well as in older patients and people with complications, who are adequately represented in the trialFDA stressed that late-stage trials should be subject to randomized, double-blind and placebo-controlled trials Although the FDA says that "1:1 randomization between vaccines and placebo groups is usually the most effective research design to demonstrate the efficacy of the vaccine," other types of randomization are acceptable If properly designed, studies of multiple candidate vaccines can also be evaluated using a single placebo group the guide also provides detailed recommendations on test design, efficacy and statistical considerations, as well as efficacy, statistics and safety issues Despite the urgency of the COVID-19 pandemic, the FDA said any COVID-19 vaccine "must meet legal and regulatory requirements for vaccine development and approval, including quality, development, production and control." FDA explains that vaccines must be properly characterized and produced in accordance with the current GMP, and that sponsors must have a well-defined and properly controlled production process to ensure consistency FDA added, "To the extent legally and scientifically permissible, development can be accelerated based on knowledge gained from similar products produced using the same proven platform technology." In addition, the FDA says that product-specific data requirements can be reduced based on certain areas of production and control on its platform the guide provides more than a dozen specific recommendations for the production of API and pharmaceuticals, including recommendations to demonstrate that the raw material is fully controlled; while pre-approval screening is "part of a review of biological product licensing applications," the FDA acknowledged that its ability to conduct inspections could be affected by the pandemic and said it would rely on alternative tools "to decide whether to conduct on-site inspections to support the application assessment." "
    provides a series of recommendations for non-clinical data types that sponsors should collect to support their vaccine development, and specific recommendations for assessing vaccine relevance to increase the risk of respiratory diseases the FDA, the type and extent of non-clinical data required for the first human (FIH) trial varies depending on the vaccine candidate FDA says non-clinical safety studies are necessary for new vaccines without non-clinical or clinical data to refer to, and non-clinical safety studies based on feature-based platforms may not require non-clinical safety studies: "if the candidate COVID-19 vaccine is made using platform technology for the production of licensed vaccines or other previously researched vaccines, and has sufficient characteristics, it is possible to use toxicological data (e.g., repeated dose toxicity studies, biologically distributed data) the FDA allows sponsors to submit unaudited draft final toxicology reports as data for toxicity studies to speed up the conduct of FIH clinical trials, but says full quality assurance reports should be submitted within 120 days of clinical trials FDA also recommends that the initiators need to study developmental and reproductive toxicity (DART) before enrolling pregnant or women of childbearing age who have not actively avoided pregnancy in clinical trials The FDA said sponsors may rely on data from DART studies using similar products, provided the FDA believes the data is scientifically sufficient suggests when to conduct biodistributive studies and to characterize immune responses in animal models .
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