MRNA shares after the withdrawal of the FDA submission of the Covid flu combo shot

Shares of Moderna The mRNA decreased by almost 8% yesterday after it announced that it had voluntarily withdrawn regulatory registration, in which the FDA approval for mrNA-1083, whose investigation mRNA-based combination vaccine was aimed at. According to the company, the decision was made in consultation with the agency.

This announcement was not surprising, since the MRNA had already announced at the beginning of this month, together with its Q1 results that the FDA had requested “Data from Phase 3 -Gripee effectiveness”. This setback has derailed the company’s first plans to secure a potential FDA approval for the vaccine before this year.

Moderna plans to enable this to be submitted later this year after the effectiveness data of the vaccine from the current phase III study to its seasonal influenza vaccine in the phase III, mrna-1010. Intermediate data from this study are expected this summer.

This decision is also made for a day after the FDA has published new guidelines for Covid vaccine booster. As part of this guide, Covid vaccine manufacturers must carry out randomized, placebo-controlled clinical studies that demonstrate the real benefits of annual covid vaccine boosters in people under 65 years.

The initial FDA registration, which requested the approval for use in older adults aged 50 and over, was supported by data from a phase -III study announced last year. Data from this study showed that mRNA-1083 compared to licensed independent influenza and covid vaccines were triggered higher immune responses to influenza and covid.

To date, the Moderna shares have decreased by 38% compared to 4%.

Image source: Zacks Investment Research

Apart from Moderna, Novavax Nvax, Pfizer PFE and Sanofi SNY also develops her respective vaccines with covid/flu.

NVAX started a late stage study last year, in which the CIC candidate of the experimental Covid Influenza combination (CIC) was evaluated. This study compare the immunogenicity and security of the CIC vaccine with separate administrations of the currently authorized Covid vaccine from Novavax and a licensed seasonal influenza vaccine. The first data from this study will be expected later this year.

Pfizer suffered a big setback in this area last year when it reported data from a phase III study on the Covid/GLI combination of mRNA-based investigation mRNA base. The study missed one of the two primary immunogenicity goals. PFE is currently evaluating the adjustments to its combination vaccine program to improve immune responses against influenza b and plans to discuss the next steps with the health authorities. Pfizer develops this vaccine in cooperation with Biontech.