US authorises Pfizer-BioNTech COVID vaccine for children 12 to 15
US regulators on Monday (May 10) authorised Pfizer and BioNTech's COVID-19 vaccine for use in children as young as 12, widening the country's ...
BookmarkWASHINGTON: US regulators on Monday (May 10) authorised Pfizer and BioNTech's COVID-19 vaccine for use in children as young as 12, widening the country's inoculation program as vaccination rates have slowed significantly.The vaccine has been available under an emergency use authorisation (EUA) to people as young as 16 in the United States. The vaccine makers said they had started the process for full approval for those ages last week.
AdvertisementAdvertisementThe US Food and Drug Administration said it was amending the EUA to include the millions of children aged 12 to 15.It is the first COVID-19 vaccine to be authorised in the United States for this age group, seen as an important step for getting children back into schools safely. US President Joe Biden has asked states to make the vaccine available to the younger adolescents immediately.
"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 Dr Janet Woodcock said in a statement.AdvertisementAdvertisement headtopics.com
"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."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 in this age range.
'A GODSEND'Dr William Gruber, a top vaccine scientist at Pfizer, said the EUA would help the United States reach further immunity and protect an age group that has not been completely spared from severe disease.Advertisement"I hear from paediatricians 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.
READ: US parents excited over prospect of COVID-19 vaccine shots for childrenVaccines are crucial to ending the pandemic. But many health officials are concerned vaccine hesitancy in some adults will be even more pronounced when it comes to their children.
Parents may question the risks versus benefits, given the unknowns about the vaccines' long-term impact on childrens' development and data on how few young kids have been hit hard by COVID-19.The companies said in March that they found the vaccine produced robust antibody responses and was safe and effective in 12- to 15-year olds in a clinical trial. headtopics.com
In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of COVID-19 in the group that got a placebo and none among those who received the actual vaccine, resulting in 100 per cent efficacy in preventing the illness, the companies said at the time.
Pfizer and BioNTech asked the FDA to expand their EUA to include the younger age group in early April.Nearly 46% of people in the United States had received at least one shot of a COVID-19 vaccine as of Sunday, according to data from the U.S. Centers for Disease Control and Prevention (CDC).
But the pace of US vaccinations has slowed significantly since topping out at a 7-day average of more than 3.3 million doses a day in mid-April. That average had fallen by more than a third to around 2.1 million shots a day as of May 4, according to CDC data.
Pfizer's vaccine is the only one authorised for 16 and 17 year olds in the United States. Nearly 2 million people in that age group have received at least one shot, according to CDC data. Many states only opened to non-high risk individuals in that age group in early April. headtopics.com
Widely vaccinating 12- to 18-year olds could allow US schools to relax masking and social distancing measures suggested by the CDC. Read more: CNA »
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US authorises Pfizer/BioNTech Covid-19 vaccine for children 12 to 15
US authorises Pfizer-BioNTech COVID-19 vaccine for children 12 to 15US regulators on Monday (May 10) authorised Pfizer and BioNTech's COVID-19 vaccine for use in children as young as 12, widening the country's ...
Sri Lanka approves Pfizer COVID vaccine for emergency useSri Lanka on Saturday approved Pfizer's COVID-19 vaccine for emergency use in Sri Lanka, as the island nation battles a third wave of the virus, while suffering a restricted supply of vaccines from neighboring India. Dr. Sudharshani Fernandopulle, the minister overseeing the fight against the epidemic, said in a statement the government would order 5 million doses of the Pfizer vaccine. Sri Lanka is seeking to secure other vaccines as the Serum Institute of India, the world's largest vaccine manufacturer, has suspended the delivery of AstraZeneca's Covishield vaccine due to spiraling coronavirus infections in India.
U.S. children ages 12 to 15 could begin COVID-19 vaccinations Thursday(Reuters) -U.S. regulators authorized Pfizer and BioNTech's COVID-19 vaccine for use in children as young as 12 and said they could begin receiving shots as soon as Thursday, widening the country's inoculation program as vaccination rates have slowed significantly. This is the first COVID-19 vaccine to be authorized in the United States for ages 12 to 15. Vaccinating younger ages is considered an important step for getting children back into schools safely.
US FDA to hold advisory panel meeting on use of COVID-19 vaccines in childrenThe US Food and Drug Administration said on Monday (May 10) it will hold a meeting of its independent panel of advisers on June 10 to discuss the ...