FDA Issues Emergency Use Authorisation for Second COVID-19 Vaccine

December 21, 2020

The US Food and Drug Administration (FDA), on December 18, 2020, issued an emergency use authorisation (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The EUA allows Moderna’s mRNA-1273 COVID-19 vaccine to be distributed in the United States for use in individuals aged 18 years and older.

The authorisation will be effective until the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for the mRNA-1273 COVID-19 vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

“With the availability of 2 vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalisations and deaths in the United States each day,” said Sttephen M. Hahn, MD, Rockville, Maryland. “Through the FDA’s open and transparent scientific review process, 2 COVID-19 vaccines have been authorised in an expedited time frame while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorisation that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential risks, supporting the company’s request for the vaccine’s use in people aged 18 years and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.

The mRNA-1273 COVID-19 vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive spike protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

Moderna COVID-19 Vaccine is administered as a series of 2 doses, 1 month apart. The available safety data to support the EUA include an analysis of 30,351 participants enrolled in an ongoing randomised, placebo-controlled study conducted in the United States. These participants, 15,185 of whom received the vaccine and 15,166 of whom received placebo, were followed for a median of more than 2 months after receiving the second dose.

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 the analysis of these 196 COVID-19 cases, none in the vaccine group and 30 in the placebo group were classified as severe. After the analysis of these 196 cases was completed, 1 severe case in the vaccine group was identified and is awaiting confirmation. At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.

It is mandatory for ModernaTX, Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Moderna COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalisation or death.

The issuance of an EUA is different from an FDA approval (licensure) 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 evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits. If the product meets the effectiveness standard and the benefit-risk assessment is favourable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

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

Moderna has submitted a pharmacovigilance plan to the FDA to monitor the safety of the mRNA-1273 COVID-19 vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the mRNA-1273 COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorised under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

Reference: https://www.fda.gov/news-events/press-announcements/fda-takes-additional...

SOURCE: US Food and Drug Administration