Moderna on Tuesday announced that it has sought full approval of its Covid-19 vaccine from the US Food and Drug Administration.
Moderna Seeks Full FDA Approval For Its Vaccine
The vaccine is in use after the Emergency-use Authorization (EUA) from the US-FDA, which was granted in December along with other vaccines. The EUA fact sheet mentions that the Moderna Covid-19 vaccine is an unapproved vaccine used to prevent Covid-19.
EUA is issued when no adequate or alternative medications are available, and it does not have the same review process of full approval. With just two months of clinical data, EUA can be issued. Hence Moderna and other vaccines essentially bypassed submitting long-term data to seek emergency use approval, thereby helping in inoculating millions of Americans.
Now that more than 50% of the US population are inoculated with at least one dose, and millions of data has been gathered for more than six months from vaccinated people, it could be submitted for full approval. And since it is a vaccine, it requires a Biologics License Application (BLA)
Moderna is the second vaccine that has started to gain full approval after Pfizer/BioNTech, which sought approval in early May for people 16 years and above. Both Moderna and Pfizer are mRNA vaccines that require two shots spaced several weeks apart.
After the application for approval is submitted, Moderna must continue to send data to support its application. However, as far as vaccine public data is seen, the vaccine has shown more than 90% efficacy and hence CEO of Moderna, Stephane Bancel is positive that the approval is not far. But the review process of the FDA takes few weeks to few months. Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee, says the process done by the scientists is very meticulous where they see the clinical trials data and their safety concerns before the approval is given. They would seek the data submitted from the Phase 3 study to complete the process.
This comes as a boost to the vaccination drive in the country as more people would be encouraged by the approved drug in the market. Some Americans had shown concern about the still unapproved use of the vaccines. Many educated people were concerned about the long-term effects of the vaccine and this review process of the FDA could help people make informed choices and help bring them forward to vaccinate themselves.
Full approval would allow the vaccine to stay on the market even after the pandemic is over and hence help during future pandemics if the case arises. This would also lead the way to advertise the drug on TV to increase awareness to the people, which is not permitted currently. It makes it easier for companies, schools, and other areas where social gatherings are inevitable to mandate compulsory vaccination.
Furthermore, the company is also expected to seek EUA approval for vaccine use in adolescents after trials proved that it was 100% effective in children aged 12 to 17. This could act as a deterrent as recently many believe that mutant strains could affect children more acutely.
In anticipation of increased demand, Moderna has entered into an agreement with Thermo Fisher Scientific for manufacturing and packaging its COVID-19 vaccine in order to scale up the production. The manufacturing site in Greenville, North Carolina, will be provided for manufacturing and packaging services and supply millions of vaccine doses.
In March, Thermo Fischer had started working with Pfizer/BioNTech to produce their vaccines in Italy.
Though Moderna has demonstrated great results, there are chances of variant strains to wreak havoc on their production plans. But they are still ready for booster candidates who may come out as soon as fall itself.