Moderna says has completed filing process for FDA's full approval to its Covid-19 vaccine
Two days after the US Food and Drug Administration (FDA) granted full approval in the United States to Pfizer-BioNTech’s coronavirus vaccine, Moderna announced on Wednesday that it, too, has completed the real-time review process needed for full approval of its jab. The American drugmaker has, so far, released 300 million doses of its vaccine to the US government.
“The completed submission process includes data from a late-stage study that showed 93% efficacy, even through six months after the administration of the second dose,” Moderna said in a statement. The company’s submission includes a priority review designation for its vaccine, for which an Emergency Use Authorisation (EUA) was granted by the FDA in December last year. Currently, the shot is administered to people aged 18 and above.
The White House, in its statement welcoming the full FDA approval for Pfizer, had also mentioned it is looking forward for the same authroisation to the other two vaccines as well. “The Moderna and Johnson & Johnson vaccines remain safe and effective options. Both have undergone rigorous and methodical scientific testing before being authorised for emergency use,” the White House had said.
Moderna's messenger RNA (mRNA)-based jab, called mRNA-1273, is among the three vaccines that are currently being administered in the US, the other two being those of Pfizer and Johnson & Johnson, respectively. It is administered in two doses, within a 28-day gap, while a third or booster shot is recommended for people who are immunocompromised.
According to Fox News, Moderna announced on June 1 the beginning of its rolling admission process with the top drugs panel for a full approval for its vaccine.
In medical terms, a full approval is called “Biologics License Application” (BLA). For a successful BLA, a company needs to provide a comprehensive document with information on specific requirements to the regulator. An EUA, as the name suggests, is authorised for use in emergency situation. It is given on the basis of interim clinical trial results, if the regulator is of the opinion that benefits “far outweigh” risks.