Moderna Inc (NASDAQ: MRNA) Will Approach FDA For Full Approval For Its Covid Vaccine To Stay In The Market

Moderna Inc (NASDAQ: MRNA) will seek the full approval of the US FDA for its covid vaccine. The move allows the company to stay in the market even after the COVID-19 pandemic ends.

The vaccine is effective in kids

Full approval from the US FDA allows the company to increase the price of the Covid vaccine. It could also market the vaccines to the consumers directly. Moderna covid vaccine is effective in kids aged between 12 and 17 years. 

Seeks EUA for covid vaccine

Moderna seeks EUA (Emergency Use Authorization) for its covid vaccine for children aged 12 and 17. 

Moderna’s CEO, Stéphane Bancel, is thrilled to announce that it applied for EUA of its covid vaccine to inoculate adolescents in the US. 

Bancel said the company is pleased its covid vaccine is highly effective in adolescents in preventing SARS-CoV-2 infection and COVID-19. 

Applies to EMA for authorization of covid vaccine

Modern already submitted its application to EMA (European Medical Agency) and Health Canada seeking authorization for its COVID-19 vaccine. The company will also seek authorization for its vaccine in other nations worldwide for use in adolescents.

Moderna is committed to helping all populations worldwide to end the pandemic. In a Phase 2/3 TeenCOVE trial conducted using its covid vaccine in May 2021, the vaccine improved immune responses and bridged the gap with adults. 

The patients are administered two doses of the Moderna vaccine and have not been affected by the coronavirus.

Around 2,500 subjects in the trial proved that coronavirus is 100% effective. Moderna vaccine showed improved safety and tolerability in the subjects in the clinical trials. Its data is consistent with the tolerability profile observed in the Phase 3 COVE clinical trial in adults.

People who are administered a second dose of the covid vaccine experienced mild symptoms like myalgia, fatigue, headache, and chills. An independent safety committee regularly monitors the safety data of the Moderna covid vaccine.

The company will supply an easy to store covid vaccine to pediatricians and healthcare providers to inoculate children in the fall before returning to the school. 

Moderna is the second biotech company to seek approval for its vaccine to inoculate young people. Its vaccine is already in use in the US, Canada, and the EU.