Vaccine-maker will apply for FDA authorisation in June
US biotech firm Moderna said Tuesday that trials had shown its Covid-19 vaccine is “highly effective” in adolescents aged 12-17 and the company would seek regulators’ approval in June.
This study, known as the TeenCOVE study, enrolled more than 3,700 participants ages 12 to less than 18 years in the US.
“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents,” CEO Stephane Bancel said in a statement.
“We will submit these results to the US FDA and regulators globally in early June and request authorization.”
Research by US scientists has shown that the Pfizer and Moderna Covid vaccines should remain highly effective against two coronavirus variants first identified in India.
The lab-based study was carried out by the NYU Grossman School of Medicine and NYU Langone Center and is considered preliminary because it has not yet been published in a peer-reviewed journal.
“What we found is that the vaccine’s antibodies are a little bit weaker against the variants, but not enough that we think it would have much of an effect on the protective ability of the vaccines,” senior author Nathaniel “Ned” Landau told AFP.