NEW YORK: Pfizer announced Wednesday that its COVID-19 vaccine is safe and strongly protective in kids as young as 12, a step toward possibly beginning shots in this age group before they head back to school in the fall.
Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the coronavirus. Pfizer’s vaccine is authorized for ages 16 and older. But vaccinating children of all ages will be critical to stopping the pandemic — and helping schools, at least the upper grades, start to look a little more normal after months of disruption.
In the vaccine study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots, Pfizer reported.
It’s a small study, that hasn’t yet been published, so another important piece of evidence is how well the shots revved up the kids’ immune systems. Researchers reported high levels of virus-fighting antibodies, somewhat higher than were seen in studies of young adults.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Dr. Philip J. Landrigan of Boston College said the results are encouraging.
“It’s hard to get kids to comply with masking and distancing, so something that gives them hard protection and takes them out of the mix of spreading the virus is all for the good,” said Landrigan, who was not involved in the study.
It’s another positive development in the race against the virus even as U.S. cases, at 66,000 new infections a day, are rising again and deaths are averaging nearly 1,000 a day. Centers for Disease Control and Prevention director Dr. Rochelle Walensky warned Americans again Wednesday that “we can’t afford to let our guard down.”
Pfizer and its German partner BioNTech in the coming weeks plan to ask the U.S. Food and Drug Administration and European regulators to allow emergency use of the shots starting at age 12.
“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the start of the next school year” in the United States.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6-month-old.
“We are longing for a normal life. This is especially true for our children,” BioNTech CEO Ugur Sahin said in a statement.
AstraZeneca last month began a study of its vaccine among 6- to 17-year-olds in Britain. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.
While most COVID-19 vaccines being used globally were first tested in tens of thousands of adults, pediatric studies won’t need to be nearly as large. Scientists have safety information from those studies and from subsequent vaccinations in millions more adults.
One key question is the dosage: Pfizer gave the 12-and-older participants the same dose adults receive, while testing different doses in younger children.
It’s not clear how quickly the FDA would act on Pfizer’s request to allow vaccination starting at age 12. The agency has taken about three weeks to review and authorize each of the vaccines currently available for adults. That process included holding a public meeting of outside experts to review and vote on the safety and effectiveness of each shot.
The process for reviewing data in children could be shorter, given FDA’s familiarity with each vaccine. An agency spokeswoman said the FDA had no information to share on how the review would work, including whether additional public meetings would be required.
Another question is when the country would have enough supply of shots — and people to get them into adolescents’ arms — to let kids start getting in line.
Supplies are set to steadily increase over the spring and summer, at the same time states are opening vaccinations to younger, healthier adults who until now haven’t had a turn.
Children represent about 13% of COVID-19 cases documented in the U.S. And while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.
Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a Duke University pediatrician, presented the option. He doesn’t know if he received the vaccine or a placebo.
“Usually I’m just at home doing online school and there’s not much I can really do to fight back against the virus,” Caleb said in a recent interview. The study “was really somewhere that I could actually help out.”
His father, Dr. Richard Chung, said he’s proud of his son and all the other children volunteering for the needle pricks, blood tests and other tasks a study entails.
“We need kids to do these trials so that kids can get protected. Adults can’t do that for them,” Chung said.
AP Newsroom
Thu Apr 01 2021
Pfizer's logo is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS pic
Hyundai to invest RM2.16 bil in Malaysia through strategic partnership with INOKOM
This investment includes efforts to upgrade INOKOM's existing assembly capacity to meet Hyundai's automotive needs.
‘C4Cinta’ sets record as highest-grossing Malaysian Tamil film
'C4Cinta', directed by young filmmaker Karthik Shamalan, has set a new benchmark in Malaysian Tamil cinema.
Man charged with mother's murder, storing body in freezer
The court denied bail and scheduled case mention on Feb 7 for the submission of forensic, autopsy, and chemist reports.
Abolition of examination in schools to reduce pressure on pupils - Fadhlina
The classroom assessment approach offers a much more interesting learning ecosystem, says Fadhlina Sidek.
Google, Meta urge Australia to delay bill on social media ban for children
Google and Meta says the government should wait for the results of an age-verification trial before going ahead.
Judge tosses Trump 2020 election case after prosecutors' request
It represents a big legal victory for Donald Trump, who won the Nov. 5 US election and is set to return to office on Jan. 20.
DHL plane crash in Lithuania leaves authorities searching for answers
Rescue services said the plane hit the ground, split into pieces and slid over 100 metres (110 yards).
National squad to hold friendly matches for 2025 Indoor Hockey World Cup
The warm-up matches will involve matches against better ranked teams in the world, namely Austria (first) and Belgium (third).
G7 seeks unity on ICC arrest warrant for Netanyahu
The United States, part of the G7, has rejected the ICC decision, with President Joe Biden describing it as outrageous.
Francissca Peter remembers Tan Sri Ahmad Nawab: A tribute to a musical legend
A legend who has influenced our music for decades, was one of the highlights of my career, says Francissca Peter.
TikTok decision coming soon as Jan. 19 divestment deadline looms
Judges are reviewing TikTok's challenge to a law requiring ByteDance to sell its US assets by Jan. 19 or face a ban.
Lebanese sources: Biden, Macron set to announce Israel-Hezbollah truce
In Washington, White House national security spokesperson John Kirby said, "We're close" but "nothing is done until everything is done".
PM meets chaebol tycoon to attract more FDI to Malaysia
Chaebols are prominent figures from South Korea's family-owned conglomerates.
Govt won't allow non-citizen vehicles to enjoy RON95 subsidy - Economy Ministry
The implementation of the RON95 subsidy in 2025 is expected to provide savings of RM3.6 billion to government expenditure.
Ringgit opens lower as greenback gains ground
Dr Mohd Afzanizam says the market responded positively to news of hedge fund manager Scott Bessent heading the US Treasury Department.
Management of low-cost housing, gov't quarters, focus at Dewan Rakyat today
Also among the highlights, UNICEF report on 12.3pct of teenagers in Klang Valley's PPR face mental health issues and suicidal tendencies.
UN Resolution 1701, cornerstone of any Israel-Hezbollah truce
Here are the resolution's main terms, and a note about subsequent violations and tensions.
Record aid worker deaths in 2024 in 'era of impunity', UN says
So far this year there have been 281 aid worker victims, according to the Aid Worker Security database.
Why India's toxic farm fire counting method is disputed
Here's how India counts farm fires - a major contributor to severe pollution in the north - and why its method is being questioned.
Divisions on curbing plastic waste persist as UN treaty talks begin
South Korea is hosting the fifth and ostensibly final UN Intergovernmental Negotiating Committee (INC-5) meeting this week.