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FDA Takes Further Action In Fight Against COVID-19 By Issuing Emergency Use Clearance For Second COVID-19 Vaccine

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For immediate release:

Today, the United States Food and Drug Administration issued an Emergency Use Authorization (EUA) for the second vaccine for the prevention of 2019 coronavirus disease (COVID-19) caused by the coronavirus 2 of severe acute respiratory syndrome (SARS-CoV-2). Emergency Use Authorization allows the Moderna COVID-19 vaccine to be distributed in the United States for use in people 18 years of age and older.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic which is causing a large number of hospitalizations and deaths in the United States every day”, said the commissioner of the FDA. Stephen M. Hahn, MD “Thanks to the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been cleared within an accelerated timeframe while meeting rigorous standards of safety, efficacy and manufacturing quality. necessary to support the emergency use clearance that the American people expect from the FDA. These standards and our review process, which are the same as we used to review the first COVID-19 vaccine and which we plan to use for any other COVID-19 vaccine, included input from scientific and health experts. independent public as well as an in-depth analysis of the data of the agency’s career staff. “

The FDA has determined that the Moderna COVID-19 vaccine meets the statutory criteria for issuing an EUA. All of the available data provides clear evidence that the Moderna COVID-19 vaccine may be effective in preventing COVID-19. The data also shows that the known and potential benefits outweigh the known and potential risks, which supports the company’s claim for the use of the vaccine in people 18 years of age and older. By making this decision, the FDA can assure the public and the medical community that it has conducted a thorough evaluation of the available information on safety, efficacy and manufacturing quality.

The Moderna COVID-19 vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of SARS-CoV-2 virus mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. Once a person receives this vaccine, their body makes copies of the spike protein, which does not cause disease, but causes the immune system to learn to respond defensively, producing an immune response against SARS- CoV-2.

“Guided by science and data, the agency’s career staff have determined that the known and potential benefits of the vaccine clearly outweigh its known and potential risks, and although this is not an FDA approval , the FDA expectations outlined in our June and October guidance documents have been met ”. said Peter Marks, MD, Ph.D., director of the FDA’s Biologics Assessment and Research Center. “Today’s clearance demonstrates our unwavering commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been upheld. This achievement is yet another testament to the dedication of FDA scientists and career physicians, who are urgently working to conduct comprehensive and rigorous evaluations of submitted vaccine data to prevent COVID-19.

FDA Assessment of Available Safety Data

Moderna COVID-19 vaccine is given in a series of two doses, one month apart. Safety data available to support the EUA includes an analysis of 30,351 participants enrolled in a randomized, placebo-controlled study conducted in the U.S. These participants, of which 15,185 received the vaccine and 15,166 received a saline placebo , were followed for more than two months after receiving the second dose. The most frequently reported side effects, which usually lasted for several days, were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as injection, nausea and vomiting and fever. It should be noted that more people experienced these side effects after the second dose than after the first dose, so it is important that vaccines and recipients expect that there may be side effects after the first dose. ‘one or the other dose, but even more after the second dose.

It is mandatory for ModernaTX, Inc. and vaccine suppliers to report the following to the Adverse Vaccine Event Reporting System (VAERS) for Moderna COVID-19 vaccine: all vaccine delivery errors, adverse events severe, cases of multisystem inflammatory syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.

FDA assessment of available efficacy data

Efficacy data supporting the EUA includes an analysis of 28,207 participants in the ongoing randomized, placebo-controlled US study who had no evidence of SARS-CoV-2 infection prior to the first dose of vaccine. Of these participants, 14,134 received the vaccine and 14,073 a placebo. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. At the time of analysis of these 196 cases of COVID-19, none in the vaccine group and 30 in the placebo group were classified as severe. Once the analysis of these 196 cases has been completed, a serious case from the vaccinated group has been identified and is awaiting confirmation. At present, data is not available to determine how long the vaccine will provide protection, nor is there any evidence that the vaccine prevents the transmission of SARS-CoV-2 from a person to person.

The American process

Based on the determination of the Secretary of the Department of Health and Human Services on February 4, 2020, that there is a public health emergency that has significant potential to affect national security or the health and safety of U.S. citizens living abroad, and has issued statements indicating that circumstances exist to warrant authorization of emergency use of unapproved products, the FDA may issue an EUA to permit the use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat or prevent COVID -19 when there are no adequate, approved and available alternatives.

Issuing an EUA is different from FDA approval (licensing) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA assesses the available evidence to determine whether the product can be effective and also assesses the known or potential risks and the known or potential benefits. If the product meets the efficacy standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA application for a COVID-19 vaccine to the FDA, the agency then assesses the application and determines whether the relevant regulatory criteria are met, taking into account all of the scientific evidence on the vaccine that are available to the FDA.

The EUA also requires that information sheets that provide important information, including dosing instructions, and information about the benefits and risks of Moderna COVID-19 vaccine, be made available to immunization providers and of the vaccinated.

ModernaTX, Inc. has submitted a pharmacovigilance plan to the FDA to monitor the safety of the Moderna COVID-19 vaccine. The pharmacovigilance plan includes a plan to supplement longer-term safety monitoring for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities to monitor the safety profile of the Moderna COVID-19 vaccine and to ensure that any safety concerns are identified and assessed in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional information on safety and efficacy and obtain approval (licensing).

The EUA for Moderna COVID-19 vaccine has been issued to ModernaTX, Inc. Authorization will be effective until the declaration of circumstances justifying the authorization of emergency use of drugs and biologics for prevention and treatment of COVID-19 be terminated. The EUA for the Moderna COVID-19 vaccine may be revised or revoked if it is determined that the EUA no longer meets the statutory criteria for issuance.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines and other biologicals for human use and medical devices for human use and veterinary. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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