The submission was based on the results of a Phase 3 trial with 15,000 volunteers in the UK and a 30,000-participant late stage trial in the US and Mexico. According to the US biotech, the candidate was shown to be 86.3% effective against the Alpha variant of the coronavirus and 89.7% across all strains as well as a displaying a favorable safety and tolerability profile.

In August this year, Novavax postponed its application to the US Food and Drug Administration yet another time and now expects to file in the upcoming fourth quarter. The company has said it will initially prioritize distribution to low-income countries that have a still unmet need for primary vaccination doses. In this effort, it is partnering with the Serum Institute of India.

To date, the UK has administered at least two doses of a Covid-19 vaccine to about 76% of its population, the Reuters news agency calculates. Boosters are now being rolled out as new infections rise.

After filing for authorization in India, Indonesia and the Philippines, Novavax now expects to complete additional regulatory filings in in Europe, Canada, Australia, New Zealand and the World Health Organization, in addition to the US.

FDA Panel Recommends Comirnaty Shot for Ages to 11

By a vote of 17 to 1 with one abstention, the US Food and Drug Administration’s advisory panel has recommended that the health agency approve the Pfizer/BioNTech Covid-19 vaccine Comirnaty for children aged 5 to 11. The benefits of inoculating this age group outweigh any potential risk, the shot could protect around 28 million who are now attending school in person again, the panel said.

If the FDA nods off on the advice, an advisory panel to the US Centers for Disease Control and Prevention will meet immediately to make technical recommendations for administering of the vaccine, whereby CDC director Rochelle Walensky will have the final word. According to data published by the American Academy of Pediatrics, more than 500 children have died from Covid-19 in the US to date, the eighth highest killer in this age group over the past year.  

Author: Dede Williams, Freelance Journalist