U.S. FDA Pre-Announced Moderna COVID-19 Vaccine Booster Concerns

The US Food and Drug Administration (FDA) published a Briefing Document on October 13, 2021, for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for October 14, 2021.

This VRBPAC meeting is being held to discuss whether the data Moderna has submitted to the FDA are sufficient to support emergency use authorization of a booster dose of Moderna (SpikeVax) COVID-19 Vaccine (50 ug), administered at least six months after the primary two-dose series in specific populations.

As described in Section 4.2.5, 38 cases of COVID-19 infection occurred after booster vaccination among the 171 booster vaccine dose participants in the 100 µg-primed group of study P201, through the data cutoff date for the EUA amendment submission.

Due to limitations in study design (no control group, exploratory COVID-19 endpoint, lack of case definitions, lack of systematic collection of COVID-19 symptoms, and differences in transmission rates in Part A vs. Part B of study P201), no inferences can be made based on these data from P201 Part B, stated the FDA report.

Moderna also proposes to conduct one or more post-authorization observational studies to evaluate the association between Moderna COVID-19 Vaccine and pre-specified list of adverse events, including myocarditis and pericarditis, along with deaths, hospitalizations, and severe COVID-19.

In recent days, Nordic countries have released data on the increased incidence of myocarditis and pericarditis after vaccination with Moderna vaccines.

These heart issues appear to be related to mRNA vaccines given as the first dose, reported Norway.

And in Sweden, the use of Moderna's SpikeVax vaccine has recently been restricted to individuals born before 1991.

Overall, 'data indicate that US-licensed or Authorized COVID-19 vaccines still afford protection against severe Covid-19 disease and death. In addition, there are many potentially relevant studies, but the FDA has not independently reviewed or verified the underlying data or their conclusions,' said the FDA report. 

The SpikeVax COVID-19 Vaccine Moderna (mRNA-1273) is an Authorized mRNA vaccine against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form of the Spike protein.

Since its founding in Massachusetts in 2010, ModernaTX has worked to build the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and early development, a rapidly expanding pipeline, and a world-class team.