The FDA Approved Moderna COVID-19 Vaccine for Emergency Use
On December 18, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the second COVID-19 prevention vaccine produced by Moderna. The EUA allows the Moderna company to distribute its vaccine in the USA for use in individuals of 18 years old and older, the company explained in a press release. The EUA lets the FDA sign off products faster than the normal review process during an emergency such as now.
Today, FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. https://t.co/w4BQVg0n2G pic.twitter.com/cw5JwYqxsh
— U.S. FDA (@US_FDA) December 19, 2020
Moderna is an American biotechnology company that focuses on drug development and vaccine technologies based on messenger RNA, which instruct the patient’s cells to produce proteins that prevent or cure diseases.
“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 that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D., in a press release.
Moderna is now the second COVID-19 vaccine to be approved for the emergency use by the FDA, following the Pfizer and BioNTech products that were authorized for the use in the USA earlier.
We just announced that the FDA has authorized the Moderna COVID-19 Vaccine in the U.S. for emergency use to prevent COVID-19 in individuals 18 and over. The Moderna COVID-19 Vaccine has not been approved or licensed by the FDA. https://t.co/zyd6dfJr53 pic.twitter.com/oNeB3DXazu
— Moderna (@moderna_tx) December 19, 2020
This means that the vaccine can now be given to adults who are 18 years of age or older in the country. The Moderna vaccine proved 94% efficacy against symptomatic COVID-19 in clinical trials. Besides, it can also protect against severe cases of the disease.
The data provided by Moderna also shows that its vaccine can be used to prevent not only symptomatic COVID-19 but also asymptomatic infection with COVID-19. During the clinical trial, the company tested every participant between the two doses of the vaccine. The placebo group had 38 cases without symptoms, and the vaccination group had 14 cases.
Just like Pfizer and BioNTech, Moderna made its vaccine using gene-based technology. After the virus RNA (genetic code) gets inserted into human cells, they learn to build copies of the coronavirus spike protein to then prompt immune responses when the actual virus enters the body.
The Moderna COVID-19 vaccine candidate mRNA-1273 showed 94% efficacy in preventing the disease with minor flu-like side effects, including tiredness, headache, pain at the injection site, chills, swollen lymph nodes, nausea, and fever.
Unlike the vaccine made by Pfizer and BioNTech, the Moderna vaccine can be kept at not so ultracold temperatures (Pfizer’s vaccine should be kept at -75C, while Moderna’s – at -20C up to 6 months), making it easier to distribute to places that cannot maintain the ultracold environment.
The US has already ordered 200 million doses of the vaccine, which will be enough to vaccinate 100 million people. Health care workers will be the first to receive the vaccine.
Vice-president Mike Pence and the House speaker Nancy Pelosi have already received the Pfizer vaccine on Friday.