Moderna (MRNA) Gets EMA Authorization for SpikeVax Third Dose


Zacks Equity Research Zacks

via Nasdaq - Oct 6, 2021


Moderna, Inc. MRNA announced that the European Medicines Agency (EMA) has authorized the third dose of its mRNA-based COVID-19 vaccine, Spikevax (mRNA-1273), for use in certain immunocompromised individuals aged 12 years or older. The additional dose needs to be administered after at least 28 days from the completion of the initial two-dose regimen.


The immunocompromised individuals include patients with weakened immune systems, such as organ transplant recipients whose initial responses to vaccination were low.


Data from the recent clinical study conducted by the company in 120 participants who had undergone solid organ transplant demonstrated that the third dose of mRNA-1273 improved immune response compared to placebo.


The data from a few clinical studies demonstrated...


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Sweden suspends Moderna vaccine for those 30 and under


By Associated Press

via New York Post - October 6, 2021


COPENHAGEN, Denmark — Swedish health authorities on Wednesday suspended the use of Moderna’s COVID-19 vaccine for those ages 30 and under, saying the move was done out of precaution.


The reason for the pausing is “signals of an increased risk of side effects such as inflammation of the heart muscle or the pericardium” — the double-walled sac containing the heart and the roots of the main vessels, Sweden’s Public Health Agency said in a statement. “The risk of being affected is very small.”


Anders Tegnell, Sweden’s chief epidemiologist, said they “follow the situation closely and act quickly to ensure that vaccinations against COVID-19 are always as safe as possible and at the same time provide effective protection” against the disease.


In July, the European Medicines Agency recommended authorizing Moderna’s COVID-19 vaccine for children ages 12 to 17, the first time the shot has been authorized for people under 18.


Moderna’s vaccine was given the green light for...