US Food and Drugs Administration declares Pfizer vaccine safe for children

An announcement from the FDA has marked a world first as the US hurries to inoculate its 332 million-strong population against COVID.

The Pfizer vaccine has been approved for use in 12 to 15-year-olds. Picture: Jens Schlueter/Getty Images

The US Food and Drug Administration has declared the Pfizer vaccine safe for children as young as 12.

The American-developed jab is the first vaccine available to children under 16.

As US President Joe Biden works to inoculate the nation’s population against coronavirus, it is expected the vaccine rollout will now quickly include children from the age of 12.

The US recently passed 100,000 positive COVID-19 cases per million, or one in 10 of the population, making it the hardest-hit country in the world since the beginning of the pandemic.

Now, with the US heading towards its school summer holidays, the new move suggests the government is planning to have a large amount of teenagers inoculated against COVID-19 in time for the coming school year.

“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,” acting FDA commissioner Janet Woodcock said in a statement.

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The FDA says the vaccine could be administered to children as soon as this week.

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Up until today, the Pfizer vaccine was only available to people aged 16 and over.

“Today’s expansion of our EUA represents a significant step forward in helping the US government broaden its vaccination program and help protect adolescents aged 12 to 15 before the start of the next school year,” Pfizer CEO Albert Bourla said.

Peter Marks, the FDA’s top vaccine regulator, says the vaccine could be administered to children as soon as this week as the Biden government pushes for more comprehensive vaccine coverage. Dr Marks says the regulation of the vaccine’s administration would still be left for the states to decide.

“We don’t regulate the practice of medicine at FDA, we regulate these products,” Dr Marks said. ”How they are administered may be regulated different in some states in terms of who can give a vaccine to a 12-year-old.”

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A Miami woman receives a dose of the Pfizer vaccine. Picture: Joe Raedle/Getty Images/AFP

Trial leads to green light for Pfizer vaccine

Positive results from a trial of 2300 US children aged 12 to 15 led to the FDA’s decision. The study conducted by Pfizer and development partner BioNTech revealed the vaccine was slightly more effective for that age group than for adults, claiming it was 100 per cent effective in preventing COVID-19.

According to Politico, the study also revealed that younger teens developed higher antibody levels post-vaccination than adults.

The FDA will meet in June to discuss further plans to vaccinate children aged 11 and below.

“As we get down to younger children age 11 and below, different doses of the vaccine will need to be used,” Dr Marks said. “There are also different risk-benefit considerations because we know that younger children have been susceptible to this interesting multi-inflammatory syndrome with COVID-19, and we have to make sure we’re not going to see anything untoward in the youngest children.”

The new move came after the World Health Organisation approved the Sinopharm COVID-19 vaccine for emergency use – the first Chinese jab to receive the WHO’s green light.

“This afternoon, WHO gave emergency use listing to Sinopharm Beijing’s COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality,” the UN health agency’s director-general Tedros Adhanom Ghebreyesus told a news conference.