New Delhi, May 11:
US health regulators have approved Pfizer-BioNTech’s Covid-19 vaccine for people between 12 and 15 years of age, making it the first for children.
It’s the same vaccine that is being administrated to people 16 years and older and will be delivered in two separate shots of primer and a booster. In a trial involving 2,260 participants, none of those given the vaccine contracted Covid-19 while 16 among those given a saline placebo tested positive.
Calling the emergency use authorisation “significant step” in the fight against the epidemic, Janet Woodcock, acting head of the Food and Drug Administration (FDA), said, “Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic.”
She added: “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorizations.”
The health regulator said that Pfizer-BioNTech Covid-19 vaccine has “met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.
More that 152 million Americans — 57% of the eligible population of those 16 and older and 46% of the total population — have received at one dose of a Covid-19 vaccine. Only 12% of Indians have been vaccinated thus far in comparison, an estimated 170 million doses have been administered.
“This is a promising development in our fight against the virus,” President Joe Biden said in a statement. “If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today’s decision is a step closer to that goal.”
The Biden administration plans to expand the programme with a new focus on children. The US president said last week that 20,000 pharmacies will be involved in the roll-out of vaccines for children. Vaccinating children is key part of his strategy to get the United States back on track.
Moderna, the other major maker of Covid-19 vaccines, is also working towards an authorisation of its vaccine for children. And Pfizer-BioNTech vaccine is up for authorisation in Europe.
