World Health Organization chief welcomes US announcement that it will support waivers for coronavirus vaccines.
Coronavirus vaccines will be made available to more children in the United States as regulators on Monday expanded use of the Pfizer-BioNTech jab to those as young as 12, sparking a race to protect students before they head back to class later this year.
Shots could begin as soon as Thursday, after a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds. An announcement is expected Wednesday.
Most COVID-19 vaccines worldwide have been authorised for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up.
Parents, school administrators and public health officials elsewhere have eagerly awaited approval for the shot to be made available to more children.
US President Joe Biden issued a statement hailing the authorisation as “a promising development in our fight against the virus”.
“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,” he said.
Most children with COVID-19 only develop mild symptoms or no symptoms at all. However, children are not without risk of becoming seriously ill, and they can still spread the virus. There have been outbreaks traced to sporting events and other activities for children aged between 12 and 15.
Dr William Gruber, a top vaccine scientist at Pfizer, said the authorisation of the vaccine for young teens would help the US expand its immune population and protect an age group that has not been completely spared from severe disease.
“I hear from pediatricians and people out in the community, what a godsend this is going to be for the adolescent population who have been restricted in terms of sports activities, drama club and the other sorts of things that naturally we want them to engage in,” Gruber said.
“This is a watershed moment in our ability to fight back the COVID-19 pandemic.”
Vaccinating children of all ages will be critical to a return to normalcy.
The US Food and Drug Administration (FDA) declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 volunteers ages 12 to 15.
WATCH LIVE at 7pm ET: Join Acting FDA Commissioner @DrWoodcockFDA and @FDACBER Director Dr. Peter Marks as they discuss Pfizer-BioNTech's #COVID19 vaccine for use in adolescents 12-15 years of age. https://t.co/PDF95M3LX7
— U.S. FDA (@US_FDA) May 10, 2021
The study found no cases of COVID-19 among fully vaccinated adolescents compared with 18 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.
The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.
Pfizer’s testing in adolescents “met our rigorous standards”, said FDA vaccine chief Dr Peter Marks.
“Having a vaccine authorised for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” Marks said.
Pfizer and its German partner BioNTech recently requested similar authorisation in the European Union, with other countries to follow.
The latest news is welcome for US families struggling to decide what activities are safe to resume when the youngest family members remain unvaccinated.
“I can’t feel totally comfortable because my boys aren’t vaccinated,” said Carrie Vittitoe, a substitute teacher and freelance writer in Louisville, Kentucky, who is fully vaccinated as are her husband and 17-year-old daughter.
The FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son who would be unvaccinated.
Pfizer is not the only company seeking to lower the age limit for its vaccine.
Moderna Inc recently said preliminary results from a study in 12- to 17-year-olds show strong protection and no serious side effects. Another US company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds, as well.
Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun US studies in children ages six months to 11 years.
Those studies explore whether babies, pre-schoolers and primary school-aged children will need different doses than teens and adults. Pfizer expects its first results sometime after September.
Outside of the US, AstraZeneca is studying its vaccine among 6- to 17-year-olds in the United Kingdom. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as three years old.