The U.S. Food and Drug Administration ( FDA ) has issued an emergency use authorization ( 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 emergency use authorization allows the Moderna COVID-19 vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
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 has provide clear evidence that the Moderna COVID-19 vaccine may be effective in preventing COVID-19.
The data have also shown that the known and potential benefits outweigh the known and potential risks, supporting the request for the vaccine’s use in people 18 years of age 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 Moderna COVID-19 vaccine contains messenger RNA ( mRNA ), which is genetic material. The 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 has received 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.
FDA evaluation of available safety data
Moderna COVID-19 vaccine is administered as a series of two doses, one month apart.
The available safety data to support the EUA include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S.
These participants, 15,185 of whom received the vaccine and 15,166 of whom received saline placebo, were followed for a median of more than two months after receiving the second dose.
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 Moderna 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 hospitalization or death.
FDA evaluation of available effectiveness data
The effectiveness data to support the EUA include an analysis of 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine.
Among these participants, 14,134 received the vaccine and 14,073 received 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 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, one 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 EUA process
The issuance of an EUA is different than 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 favorable, 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 Moderna 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 Moderna COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner. ( Xagena )
Source. FDA, 2020