FDA Approves Second Dose of Moderna’s COVID-19 Vaccine

March 31, 2022 - FDA recently amended the emergency use authorization of Moderna's COVID-19 vaccine to allow for a second booster dose at the 50 microgram level in adults 50 years of age and older. 

The application to amend the emergency use authorization (EUA) included data from Israel indicating the safety and effectiveness of administering a fourth dose of the vaccine during the Omicron variant surge.  

"The FDA's endorsement of a second booster dose will allow millions of Americans to build and maintain protection against SARS-CoV-2," Stéphane Bancel, CEO of Moderna, said in the announcement.  

"Data continue to show that mRNA boosters remain the best defense against severe infection and death, and vaccines are a foundational part of our public health protection. Now, healthcare providers have the opportunity to advise higher-risk people about when and how to get boosted and build immunity in advance of future outbreaks," Bancel continued.  

In December 2020, FDA issued the second EUA for a COVID-19 vaccine to Moderna. Then in June 2021, Moderna initiated the rolling submission process with FDA for a biologics license application for its vaccine. 

READ MORE: Pfizer Submits for EUA of Additional COVID-19 Vaccine Booster

And most recently, FDA approved the biologics license application for the vaccine to prevent coronavirus in individuals 18 years of age and older. Moderna stated that it will continue collecting and monitoring real-world data on its COVID-19 vaccine.  

FDA Expands EUA for Pfizer, BioNTech's COVID-19 Vaccine  

FDA recently expanded the EUA for Pfizer and BioNTech's COVID-19 vaccine, Comirnaty, to include a second booster dose in adults 50 years of age and older who previously received the first booster of any authorized vaccine.  

At the same time, the agency authorized a second booster dose of Comirnaty for individuals 12 years of age and older with certain kinds of immunocompromise. Providers can administer the additional dose at least four months after the first booster.  

FDA based the authorizations on the totality of scientific evidence, including immunogenicity data from an ongoing study of 154 healthcare workers 18 years of age and older at a single center in Israel.  

In the study, all patients received two booster doses of Comirnaty during the period when the Omicron variant was predominant. Individuals experienced an 11-fold increase in geometric mean neutralizing antibody titers two weeks after the booster dose compared to five months after the first.  

READ MORE: Pfizer Initiates Phase 2/3 Clinical Trial of COVID-19 Treatment

Notably, there were no new safety concerns.  

"Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in the announcement. 

"Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so," Marks continued.  

FDA fully approved the Pfizer-BioNTech COVID-19 vaccine In August 2021 for individuals 16 years of age and older. The vaccine is also currently available under emergency use authorization, including for individuals 12–15 years of age.  

Novavax's COVID-19 Vaccine Included in 2 Booster Trials  

Novavax recently announced the inclusion of its COVID-19 vaccine, NXV-CoV2373, in two booster clinical trials.  

READ MORE: GSK, Sanofi Seek Approval of COVID-19 Vaccine for Adults

The first ongoing Phase 1/2 trial is assessing homologous and heterologous boosting regimens of NVX-CoV2373 in 1,130 healthy participants who received a primary series of a COVID-19 vaccine. Providers will administer either a third dose of the vaccine or one of the three FDA-approved or emergency use authorized vaccines.  

The second Phase 3 vaccine is taking place in the United Arab Emirates (UAE) and is assessing homologous versus heterologous boosting in 1,000 participants who previously received Sinopharm's COVID-19 vaccine.  

The trial aims to provide data to support an NVX-CoV2373 booster shot in many individuals already vaccinated with inactivated vaccines globally.  

Researchers will follow participants in both studies for 12 months. Topline results are expected later this year, and full results are expected in 2023.  

"Additional COVID-19 booster studies are important to support vaccine choice for individuals, healthcare providers, and public health authorities," Filip Dubovsky, MD, chief medical officer at Novavax, said in the announcement.  

"Our COVID-19 vaccine has already been recommended by multiple national policy bodies for both primary vaccination and booster settings in individuals 18 years of age and older. We look forward to adding to this body of evidence to support the expanded use of our protein-based vaccine," Dubovsky continued.