The US Food and Drug Administration (FDA) has revealed that Moderna's COVID-19 vaccine candidate is safe and highly effective, which increases the shot's chances to get regulatory approval for emergency use.
FDA released a 54-page report on Tuesday, which concurred with the biotechnology firm's claim of a 94 percent efficacy rate. While deeming the vaccine safe, there are really no concerns that could prevent FDA from approving its emergency use authorisation.
This development comes a few days ahead of FDA's vaccines and related biological products advisory committee meeting on Thursday, wherein the agency is expected to recommend the emergency approval. Post this, Moderna will become the second company to have its vaccine approved in the USA, after the collaborative duo of Pfizer and BioNtech managed to do so earlier this month. The first jabs of the latter's vaccine were received by Americans on Monday.
Likewise the Pfizer vaccine, the FDA confirmed Moderna's shot to be equally effective across races, ethnic groups, and gender groups. The vaccine has also shown to be working decently well on people suffering from previous medical issues who are prone to severe COVID-19 infections; the efficacy rate in people older than 65 was found to be a little lower at 86.4 per cent.
Moderna had also come out with an 84-page analysis report for its vaccine candidate, saying that "the known and potential benefits of the Moderna COVID-19 vaccine outweigh the known and potential risks."
FDA also likened the side effects of Moderna's vaccine to that of Pfizer's. The report revealed that for the former's vaccine trials that had 30,000 participants, side effects such as headache, fatigue, muscle aches and pain were observed. Similar symptoms were observed for Pfizer's shot.
According to the Wall Street Journal, the FDA had approved the emergency use of Pfizer's vaccine just a day after the vaccine panel's recommendations, and is likely to expedite the clearance for Moderna's vaccine as well.
Another similarity shared by the vaccine candidates of Pfizer and Moderna is their use of the mRNA technology, wherein the genetic material injected prompts an immune response to the virus by instructing the body to create a miniscule amount of COVID-19 spike proteins. Having said that, the former's shots have led to a few cases of severe allergic reactions in the UK, and the FDA's vaccine panel is going to be more circumspect in studying the signs of unwanted reactions for Moderna's jab.