Real-World Evidence Confirms J&J COVID-19 Vaccine Protection

FDA Decreases Between Moderna’sModerna’s COVID-19 Vaccine, Booster

FDA recently amended the emergency use authorization for Moderna’sModerna’s COVID-19 vaccine to shorten the time between completing the primary series and a booster dose.

Specifically, the agency shortened the time between primary and booster for Moderna’sModerna’s vaccine to at least five months for adults 18 years and older.

In October, FDA approved Moderna’sModerna’s booster dose at the 50 microgram dose level for individuals 65 years of age and older and individuals 18 to 64 at high risk of severe COVID-19 or who have frequent exposure to the virus.

And in December, the booster increased neutralizing antibody levels against the Omicron variant.

At Day 29 post-boost, the 50 microgram booster of mRNA-1273 increased neutralizing geometric mean titers (GMT) against the variant to 850. And at Day 29 post-boost, a 100 microgram100-microgram dose booster of the vaccine increased neutralizing GMT to 2228.

“The country is in the middle of a wave of the highly contagious omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” Peter Marks, MD, PhD, director of the FDA’sFDA’s Center for Biologics Evaluation and Research, said in the recent announcement.

"Vaccination is our best defense against COVID-19, including the circulating variants, and shortening the length of time between completion of a primary series and a booster dose may help reduce waning immunity,” Marks concluded.

Novavax Submits COVID-19 Vaccine Data to FDA for EUA

Novavax recently submitted the final data package to FDA for emergency use authorization of its COVID-19 vaccine. The data package includes the complete chemistry, manufacturing, and controls module to fulfill the prerequisites for authorization of the protein-based COVID-19 vaccine with Matrix-M adjuvant.

“Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” Stanley C. Erck, president and CEO of Novavax, said in the announcement.

“We thank the US Government for its ongoing support of our COVID-19 vaccine program, as well as our clinical trial participants and those who have supported the development and manufacturing of our vaccine,” Erck continued.

Novavax filed the complete data package to FDA with its manufacturing partner, the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer.

The company expects to submit the emergency use authorization request for its vaccine next month.