TGA Provisionally Approves Pfizer Vaccine for Children aged 5-11 yrs

Synopsis:

  •  The Therapeutic Goods Administration has provisionally approved the Comirnaty (Pfizer) vaccine as safe and effective for use among 5 to 11-year-old children in Australia.

Australia’s medical regulator, the Therapeutic Goods Administration (TGA), on Sunday provisionally approved Pfizer’s  Coronavirus vaccine for children aged between 5 and 11.

Health Minister Greg Hunt said the federal government now expects the vaccine rollout for that cohort to start on January 10 pending approval from the Australian Technical Advisory

Group on Immunisation (ATAGI).

 TGA Approves Pfizer Vaccine for Kids 

“The vaccine dose approved by the TGA for children aged 5 to 11 is the same safe and effective vaccine used for other age cohorts, however is one-third the dose approved for those aged 12 and over,” according to a media release from Hunt.

“As with other age groups, the use of this vaccine in children aged 5-11 years should be given in two doses at least 3 weeks apart.”

There are approximately 2.3 million Australians in the 5-11 age bracket.

As of Saturday, about 88 per cent of Australians aged 16 and over and 67.5 per cent of 12-15 year-olds were fully vaccinated against Covid.

On Sunday, Australia reported more than 1,200 new locally-acquired coronavirus cases and eight deaths as the country continues to battle the third wave of the infection.

The majority of them — 980 cases and seven deaths were in Victoria, the country’s second-most populous state with Melbourne as the capital city.

The number of cases of the Omicron variant in Australia has increased to 18 after more cases were reported in the Australian Capital Territory (ACT) and New South Wales (NSW).

Parliament House in Canberra was closed on Sunday after a staffer to Greens leader Adam Bandt, tested positive for Covid.

The Government has an agreement in place with Pfizer to receive sufficient supply of the paediatric vaccine for the entire population of children aged 5 to 11 in Australia.

The first shipment of children’s doses are due to arrive in Australia by early January 2022 and will undergo the same rigorous batch testing processes in the TGA laboratories as other batches of COVID-19 vaccines.

The TGA is also currently evaluating an application from Moderna for its COVID-19 vaccine to be used in Australia for children aged 6 to 11 and the Government already has supply deals in place to make it available should it be approved by the TGA and recommended by ATAGI.

This two step TGA and ATAGI assessment and approval process is the same rigorous process followed for all COVID-19 vaccine approvals in Australia.

 

 

For more Information: Sign in Websites for Agrochemical & Pharmaceutical Databases:

Website : https://www.chemrobotics.com/ (Agrochemical Databases)

Website : https://chemroboticspharma.com/  (Pharmaceutical Databases)

Related posts

GSK and Wave Life Sciences Establish a Partnership to further the Identification and Development of Therapeutic Oligonucleotides that Target Novel Genomic Targets.

Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for relapsed or Refractory Multiple Myeloma

National CDC-Funded Study Confirms that mRNA Vaccines Protect Against Serious COVID-19 During Pregnancy