The Food and Drug Administration (FDA) has authorized this Monday the emergency use of the Pfizer and BioNTech coronavirus vaccine in children and adolescents between 12 and 15 years old. This is the first drug pre-approved for such a low age range in the United States where, of the more than 581,000 deaths from covid-19, around 300 have been people under 18 years of age. The FDA’s decision comes with a view to starting the next school year in September, which may increase confidence in the resumption of face-to-face classes and the long-awaited return to the new normal.
The announcement comes a month after the drugmaker learned that its vaccine, which is already licensed for young people 16 years and older, also protected the younger population. Health experts from the Centers for Disease Control and Prevention (CDC) are scheduled to meet Wednesday to recommend how the vaccine should be used among teens. As has happened on previous occasions, the CDC is expected to give the go ahead and, once that step is completed, the children will begin to receive the injections.
The other vaccine makers are likely to go the way of Pfizer, which last week announced that it hopes to submit an emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 in September. Most have launched or plan to start trials of their vaccines in adolescents and younger children. For now, Moderna and Johnson & Johnson’s COVID-19 vaccines are licensed for use in those 18 and older.
The Joe Biden Administration has ordered the purchase of at least 300 million doses of the BioNTech-Pfizer injection by the end of July, enough to vaccinate 150 million people. Almost half of the American adult population has already received at least a first dose, and about 115 million people (35% of the population) have already completed treatment. Although Ugur Sahin, co-founder of BioNTech, announced that a third dose will be necessary at nine months or at most a year after the second, to reinforce protection against the coronavirus.
Extending the authorization to people between 12 and 15 years of age opens vaccination to another 5% of the population, almost 17 million more people. With the impending recommendation of the CDC, the successful vaccination campaign will continue to accelerate. The agency based its authorization on a trial of nearly 2,300 adolescents between the ages of 12 and 15 that showed 100% efficacy in that age group. There were only 16 cases of Covid-19 in the trial, all of them among teens who received a placebo.
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Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.