The U.S. Food and Drug Administration (FDA) has announced the approval of Moderna’s COVID vaccine, the second vaccine to get approved this month after Pfizer’s, prompting officials to ramp up the distribution across the nation.
On Friday, the FDA issued emergency use authorization (EUA) for the vaccine use among adults. Now, the U.S. has two vaccines available to the public, a historic effort that accomplished in less than a year.
Other vaccine candidates, such as AstraZeneca and Johnson & Johnson’s, have also received federal government support. The companies are expected to submit a review next year.
On December 11, the FDA approved the Pfizer-BioNTech vaccine, which is based on mRNA technology. Also, Moderna’s vaccine is based on mRNA technology. On Thursday, FDA advisers voted 20-0 to back the Moderna’s vaccine, which is not yet approved in any other nations.
Moderna said in a statement that the distribution of the vaccine in the U.S. will begin immediately.
Stéphane Bancel, CEO of Moderna, said, “I am proud of what the Moderna team has achieved in collaboration with our partners. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”
Like Pfizer-BioNTech vaccine, Moderna’s vaccine is given in a two-dose regimen, with a four-week gap between two shots. The company said some of the most common mile side effects of the vaccine included injection site pain, swelling, and swollen lymph nodes.
Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, told reporters that the agency is investigating five allergic reactions related to Pfizer’s vaccine in the U.S.
He said, polyethylene glycol, an ingredient that is in both Pfizer and Moderna’s vaccine, “could be a culprit here, adding the compound is “uncommonly associated” with allergic reactions, though “those allergic reactions could be more common than the uncommon we thought.”
Unlike Pfizer’s vaccine that needs ultracold freezers for storage, Moderna’s vaccine does not require special equipment to be kept cold. However, Moderna’s vaccine can be kept in a standard freezer.
Moderna claimed that its vaccine is more than 94% effective at preventing COVID and can prevent the most severe infections. Pfizer-BioNTech’s vaccine has been found to be 95% effective.
FDA Commissioner Dr. Stephen Hahn said, “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.”
Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a statement that he hopes “that all Americans will protect themselves by getting vaccinated when the vaccine becomes available to them. That is how our country will begin to heal and move forward.” President-elect Joe Biden called the FDA’s authorization “another milestone in our battle to overcome the crisis our country is facing today.”
