Moderna to begin testing COVID-19 vaccine candidate on children
Fox News correspondent Alex Hogan has the latest on ‘Special Report’
A Food and Drug Administration committee review of Moderna’s coronavirus vaccine emergency use authorization application found “no specific safety concerns” in subgroup analyses by age, race, ethnicity, medical comorbidities or prior SARS-CoV-2 infection, potentially paving the way for a second COVID-19 jab to enter the scene.
In documents posted ahead of Thursday’s Vaccines and Related Biological Products Advisory Committee meeting, the panel also found that the vaccine reduced the risk of confirmed COVID-19 – including severe cases – occurring at least 14 days after the second dose.
The committee was careful to note that there wasn’t enough data to evaluate the duration of protection in relation to the vaccine, effectiveness in certain high-risk populations such as immunocompromised individuals, effectiveness in individuals who have previously been infected with SARS-CoV-2 or effectiveness in pediatric populations. There also wasn’t enough data for the committee to evaluate future vaccine effectiveness in relation to changes in the virus, effectiveness against asymptomatic infection, and effectiveness against long-term effects of COVID-19, effectiveness against mortality or effectiveness against transmission of SARS-CoV-2.
ALLERGIC REACTIONS TO VACCINES ARE RARE, SHORT-LIVED
Not unlike Pfizer and BioNTech’s vaccine, the Moderna jab did elicit non-serious adverse reactions such as pain at injection site, fatigue, headache, muscle pain, joint pain and chills. The reactions were characterized as generally mild to moderate.
Should the panel endorse Moderna’s vaccine on Thursday, the vote will then go before FDA officials who will decide whether to grant emergency use authorization (EUA) based on the committee’s findings. Such approval would come about a week after the regulatory agency granted EUA to Pfizer’s COVID-19 vaccine, which states have begun rolling out to health care workers.
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