KUALA LUMPUR, Oct 2 — Moderna Therapeutics will seek an emergency-use authorisation from the United States’ Food and Drug Administration (FDA) for its Covid-19 vaccine after November 25 once it gets enough safety data, Forbes reported.
Emergency-use authorisation by the FDA allows the use of unapproved medical treatments in public health emergencies, when there are no available alternatives.
“November 25 is the time we will have enough safety data to be able to put into an emergency authorisation file that we would send to FDA,” Moderna CEO Stephane Bancel was quoted saying.
However, Bancel said that an approval wouldn’t be expected until late first quarter or early second quarter of 2021.
CBS News reported that Moderna, the first pharmaceutical firm to conduct human trials for a coronavirus vaccine, said earlier this month that it would seek an emergency authorisation as soon as November 1.
Public health experts then argued that a vaccine could be found to be safe and effective by the end of the year at the earliest, but widespread distribution wouldn’t occur until 2021.
As reported by Financial Times, Bancel said that Moderna, a US-based pharmaceutical company, is not able to file a limited emergency authorisation before November 1 as the guidelines by the FDA show that at least half of the trial participants have to undergo two months of screening following their final injection.
Moderna injected their mRNA-1273 coronavirus vaccine into 15,000 out of 30,000 participants last Friday, which makes November 25 the earliest it could complete the two-month screening.
This means that the vaccine will not be ready before the US presidential election on November 3. President Trump claimed that a coronavirus vaccine could be ready in a matter of weeks before the election, which he repeated last Tuesday during his debate with Democratic presidential nominee Joe Biden, citing Moderna’s vaccine.
The mRNA-1273 Covid-19 vaccine, which uses messenger ribonucleic acid (mRNA) to trick the body into producing viral proteins to fight a disease, may require two shots to protect one from the Covid-19 infection.
WebMD reported that Phase One trial data on the experimental Moderna vaccine suggested that the mRNA-1273 vaccine can generate neutralising antibodies in older and elderly people, which means the group that has been hit the hardest by Covid-19 could receive strong protection from the shot.