The US has authorised the Pfizer vaccine for 12- to 15-year-olds amid a push to get the shot into more Americans’ arms.
The Food and Drug Administration (FDA) said it was “a significant step in the fight against the Covid-19 pandemic”.
FDA Commissioner Dr Janet Woodcock said the move was aimed at “bringing us close to returning to a sense of normalcy and to ending the pandemic”.
Some 260 million doses have been given in the US, but demand has been falling.
Ms Woodcock added in her statement: “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 authorisations.”
Monday’s announcement expands an emergency use authorisation that already allowed the Pfizer jab to be administered to people as young as 16 in the US.
The decision follows a clinical trial by Pfizer and BioNTech involving 2,260 children aged 12-15. The participants received either two doses of the vaccine, or a placebo.
There were 18 cases of symptomatic coronavirus infection in the placebo group and none among the children who received the vaccine, found the trial.
The FDA’s seal of approval is not the final regulatory hurdle. An advisory panel of the Centers for Disease Control and Prevention (CDC) will review the data soon.
Immunisations could begin straight away if, as expected, the CDC committee approves the vaccine’s use in adolescents.
Some of New York and Oregon’s biggest universities have meanwhile joined a growing number of higher education institutions requiring students and staff to have Covid-19 vaccinations before they can return to classes this autumn.
The rules were announced on Monday by State University of New York, the City University of New York, the University of Oregon and Western Oregon University.
Last week, US President Joe Biden announced a plan to get at least one dose of vaccine administered to 70% of the nation’s population by 4 July.
Mask mandates are being loosened across the country, and most states have reopened their economies, or are doing so within the next month.
But dwindling demand for the shot has been prompting states across the country to refuse their full allocation of doses from the federal government.
Wisconsin, Iowa, Connecticut, South Carolina, North Carolina and Washington are all among states that reduced their requests.
The risk of children becoming seriously ill from the virus is tiny, health data shows.
According to the American Academy of Pediatrics (AAP), as of this month 3.85 million US children have tested positive for Covid-19 since the onset of the pandemic, just over 10% of total cases nationwide.
Between 0.1%-1.9% of all child Covid-19 cases resulted in the patient being admitted to hospital, found the organisation’s report.
No more than 0.03% of all child Covid-19 cases resulted in death, according to the AAP.
The risk of complications for healthy children is higher for flu compared with Covid-19, according to the CDC.
Pfizer has been one of a number of vaccine manufacturers testing jabs on children. The aim of vaccinating them – particularly older children – would be to keep schools open, reduce the spread of coronavirus in the community and protect vulnerable children with conditions which put them at increased risk.
Moderna and Johnson & Johnson are currently testing their vaccines on those aged 12-18, with Moderna’s data expected soon.
Moderna and Pfizer are also testing their jabs on younger children between six months and 11 years old.
In the UK, AstraZeneca is testing its vaccine on 300 child volunteers. Researchers will assess whether the jab produces a strong immune response in children aged between six and 17.
Last week President Biden said he planned to back a World Trade Organization waiver that would take away intellectual property rights from vaccine manufacturers. If approved, the waiver would allow production of vaccines to be ramped up and provide more affordable doses for less wealthy countries.
The head of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, described Mr Biden’s backing as a “monumental moment in the fight against Covid”.
Total doses per 100 people
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This information is regularly updated but may not reflect the latest totals for each country. Total vaccinations refers to the number of doses given, not the number of people vaccinated. It is possible to have more than 100 doses per 100 population as some vaccines require two doses per person.
Source: Our World in Data, ONS, gov.uk dashboard
Last updated: 10 May 2021, 13:03 BST