US biotech firm Moderna said on Thursday it had submitted a request for an emergency use authorisation in the US for its Covid-19 vaccine for babies aged 6 months to children under 6.
Very young children are the only group that are yet to be eligible for the Covid-19 vaccine in the US and in most countries — a source of concern for many parents.
“We believe [this vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against Covid-19 and will be especially welcomed by parents and caregivers,” the company's chief executive Stephane Bancel said.
In March, the company announced results from a trial that showed the two-shot regimen was found to be safe and produced a strong immune response.
The trial featured 4,200 children aged 2 to 6 years and 2,500 babies aged 6 months to 2 years.
Side effects were generally mild and consistent with those seen in older age groups, said Moderna.
It did, however, find relatively low efficacy, with its trial taking place during the Omicron variant wave.
The current generation of vaccines were designed against the original strain of the virus.
Vaccine efficacy in children 6 months up to age 2 was 51 per cent, and efficacy was 37 per cent in the 2 to 5 years age group, when limiting the analysis to only cases confirmed positive on a positive PCR test.
Moderna said these were similar to vaccine efficacy estimates in adults during Omicron, and it is also currently studying booster doses for all paediatric cohorts.
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People ride a New Jersey bus after the US government announced it would no longer enforce a mask mandate on public transport. Reuters -
People arrive at a New Jersey transit station after the nationwide public transport mask mandate is repealed. Reuters -
A healthcare administrator checks paperwork at a mobile Covid-19 testing centre outside Pennsylvania Station in New York City. Reuters -
A person carries a sign protesting Covid-19 vaccines in Washington. AFP -
A sign urges passengers to wear masks at Logan International Airport in Boston, Massachusetts. Bloomberg -
Travellers wait for transport outside of the Los Angeles International Airport. AP -
President Joe Biden receives his second Covid-19 booster shot on March 30, 2022, in Washington. AP -
A nurse registers people for second booster shots of the Covid-19 vaccine in Waterford, Michigan. Reuters -
A woman gets a haircut as the indoor mask mandate is temporarily reinstated in Philadelphia, Pennsylvania. Reuters -
Travellers walk to their destinations at the Los Angeles International Airport. AP -
A nurse administers a Covid-19 booster vaccination at a clinic in San Rafael, California. AFP -
A medical worker administers Covid-19 tests in Brooklyn, New York. AFP -
A Covid-19 testing site stands on a Brooklyn street corner in New York City. AFP -
US President Joe Biden removes his face mask before delivering remarks at the White House in Washington. Reuters
In February, the Food and Drug Administration postponed a meeting of a panel to consider the Pfizer-BioNTech Covid vaccine for children younger than 5, saying it wanted to see data on how three doses performed before considering the matter.
Pfizer's vaccine, when given as two doses of three micrograms to children aged 6 months to 2 years elicited a similar level of antibodies to the full 30 micrograms given to people aged 16-25, but the same was not true for children between 2 and 4.
This week, Pfizer chief executive Albert Bourla said in an interview that his company was aiming to get the vaccines out by June if regulators agree.
Scientists evaluating a vaccine for infants must closely consider the risk-benefit balance.
New CDC data shows that 75 per cent of US children have had coronavirus so far in the pandemic.
Even when unvaccinated, children under 5 are at very low risk for severe disease, with only 476 US deaths occurring in this age group, according to official data.
Among all US children, there have also been almost 8,000 cases of MIS-C, a post-viral inflammatory condition, resulting in 66 deaths.
Emergency physician Jeremy Faust, of Brigham and Women's Hospital, in Boston, Massachusetts, tweeted that Moderna's results were very positive news, despite the mediocre-sounding efficacy estimates.
“What these vaccines have been shown to really do, over and over, is protect against severe disease and hospitalisation, long-term consequences,” he said, adding the immune response outcomes predicted success on these measures.
“I'll be quite comfortable getting my 4-year-old vaccinated with Moderna.”
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Students wearing face masks arrive with their parents on the first day of classes for the 2021-22 school year at Baldwin Park Elementary School in Florida. Getty Images -
Nurse Alisa Ellis-Balogun tests 7-year-old Thomas Byrd for coronavirus at Seneca High School a day before returning to school in Louisville, Kentucky, US, on August 10, 2021. Reuters -
Crossing guard Kelly Linder helps a masked mother and son cross a road as they make their way to Loretto Elementary School on August 10, 2021, in Jacksonville, Florida, for the first day of the new school year. AP -
A school worker wipes down tables after students finished eating breakfast, on August 10, 2021, during the first day of school at Washington Elementary School in West Palm Beach, Florida, AP -
Fifth-grade students wearing masks to help prevent the spread of Covid-19, listen during class, on August 10, 2021, during the first day of school at Washington Elementary School in Riviera Beach, Florida. AP -
A parent adjusts her son's visor on the first day of school at Enrique Camarena Elementary School in Chula Vista, California, on July 21, 2021. AP -
Nurse Celeste Moore, tests 11.5 years old Samira Javed for coronavirus at Seneca High School a day before returning to school in Louisville, Kentucky, US, on August 10, 2021. Reuters -
A student waits in the cafeteria after eating breakfast, on August, 10, 2021, during the first day of school at Washington Elementary School in Riviera Beach, Florida. AP -
Charlie Gonzalez holds up a sign during the first day of school at the new Hannah Marie Brown Elementary School in Henderson, Nevada, US, on August 9, 2021. AP -
A sign hanging in the hallway reads "Keep Henry Healthy, wash or sanitize your hands, repeat the personal space of others and masks are optional" at Tussahaw Elementary school on August 4, 2021, in McDonough, Georgia, US. AP -
Victoria Dickens wears a mask and face shield as she waits for her class assignment at Summit Elementary School in Summit, Mississippi on August 5, 2021, during the first day of the 2021-22 school year. AP -
Lucie Phillips, 6, and her brother David Phillips, 3, join parents and students during a rally at Utah State School Board Office calling for mask mandate on August 6, 2021, in Salt Lake City. AP -
A 17-year-old receives a first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic during a back to school event offering school supplies, Covid-19 vaccinations, face masks, and other resources for children and their families at the Weingart East Los Angeles YMCA in Los Angeles, California on August 7, 2021. AFP
AFP contributed reporting
