ATAGI recommendations on the use of Spikevax (Moderna) COVID-19 vaccine in children aged 6 to 11 years
Following the TGA’s provisional approval, ATAGI has put forth a guideline that recommends the use of Moderna’s COVID-19 vaccine (Spikevax) in children aged 6 to 11 years.
Clinical data supports that Spikevax produces a strong immune response and reduces the likelihood of children in this cohort developing COVID-19.
This statement addresses the recommendations, considerations and rationale for the use of Moderna’s COVID-19 vaccine in children aged 6 to 11.
To read the full statement, follow the link below.
The Conversation: The Moderna vaccine is now available for 6 to 11 year olds. Here’s what parents need to know
The Moderna COVID-19 vaccine is now approved for use in children aged 6 to 11 years. With just under half of Australian primary-school-age children having received their first COVID vaccine dose, the approval of Moderna’s COVID vaccine provides parents with an additional opportunity to protect their children against severe disease.
Following the KidCOVE clinical trial, this article explores the ongoing safety and efficacy as well as the considerations and administrative recommendations for the use of Moderna’s COVID-19 vaccine in the 6 to 11 years cohort.
To read the full article, follow the link below.
ATAGI update following weekly COVID-19 meeting – 16 February 2022
ATAGI held their weekly meeting on Wednesday 16 February to discuss the latest developments and recommendations relating to COVID-19 immunisations.
The meeting addressed the use of Moderna’s COVID-19 vaccine in children aged 6 to 11 years, as well as, the use of Novavax’s COVID-19 vaccine as a booster and recommendations regarding the vaccine dose interval for children.
To read the full update, follow the link below:
ATAGI update following weekly COVID-19 meeting – 16 February 2022
Moderna's COVID-19 vaccine (SPIKEVAX) provisionally approved for use in individuals 6 years and older
The Therapeutic Goods Administration (TGA) has provisionally approved the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 years and older. This follows provisional approvals granted by the TGA to Moderna for the use of SPIKEVAX in individuals aged 12 years and older on 3 September 2021, and on 7 December 2021 the SPIKEVAX booster dose for use in adults 18 years and older.
The TGA carefully assessed the data following the KidCOVE clinical trial which included up to 4,000 participants aged 6 to 11 years across the US and Canada, demonstrating that the immune response to the vaccine in children was similar to that seen in older age groups.
In addition to this, clinical data showed that the safety profile in children is similar to that seen in adults. The most frequent side effects in this age cohort were short term and non-severe. These included injection site pain, redness and/or swelling, axillary (groin) swelling or tenderness, fatigue, headache, fever and muscle pain.
Further advice on the rollout of SPIKEVAX to this age group will be provided to the Government by the Australian Technical Advisory Group on Immunisation (ATAGI).
To read the statement in full, please click on the link below:
CDC: Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19–Associated Hospitalization in Infants Aged <6 Months — 17 States, July 2021–January 2022
A recent CDC report revealed that maternal completion of a 2-dose primary mRNA COVID-19 vaccine course during pregnancy reduced the risk of COVID-19 hospitalisation amongst infants <6 months. Data revealed that of 176 COVID-19 related paediatric hospitalisations, 148 (84%) of infants were born to mothers who were not vaccinated during pregnancy.
Transplacental transfer of SARS-CoV2-specific antibodies that may provide protection to infants is evident in women vaccinated during the later stages of pregnancy. Detectable COVID-19 antibodies were also present in breast milk, indicating a transfer of maternal antibodies to the baby.
This study demonstrates that mRNA COVID-19 vaccination in pregnant and breast-feeding women is safe and effective and provides increased protection to the baby.
To read the report in full, follow the link below:
CDC: Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19–Associated Hospitalization in Infants Aged <6 Months — 17 States, July 2021–January 2022
Contemporary Pediatrics: Novavax pediatric COVID-19 vaccine trial yields positive results
Novavax’s protein-based recombinant nanoparticle COVID-19 vaccine NVC-CoV2373 has demonstrated an 80% overall efficacy in paediatric trials against the Delta variant.
The paediatric trial included 2247 adolescent participants between the ages of 12 to 17 years, of diverse racial and ethnic backgrounds, across 73 sites in the United States.
“We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options for COVID-19,” said Filip Dubovsky, MD, Chief Medical Officer, Novavax, in the statement.
To read the full press release, follow the link below:
Novavax pediatric COVID-19 vaccine trial yields positive results
The Washington Post: Coronavirus vaccine for young children further delayed as FDA reverses course, says it will wait for data on three doses
The Food and Drug Administration (FDA) have announced it won’t make a decision on whether to authorise a COVID-19 vaccine for children younger than 5 until data on a third dose becomes available.
The vaccine trial that commenced on 20th January, was designed to test the safety and efficacy of a lower dose of vaccine and was reported to include 3,900 children between the ages of 6 months and 4 years.
To understand if two doses would provide sufficient protection in children younger than 5, Pfizer and BioNTech have been testing two 3-microgram doses, a small fraction of the adult dose. Smaller doses are expected to trigger an equivalent immune response in children, indicating strong protection.
With the study advancing at a rapid pace, Pfizer and BioNTech will opt to wait for the three-dose data suggesting it may provide a higher level of protection in this age group.
Click on the link below to read the article in full:
The Washington Post: Coronavirus vaccine for young children further delayed as FDA reverses course, says it will wait for data on three doses
CEPI opens Call to develop heat-stable vaccine tech for use against epidemic and pandemic threats
The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a $17.5 million initiative to improve the thermostability of current and future vaccines.
Currently, cold chain requirements are one of the leading causes of global vaccine wastage. Improving the thermostability of vaccines will work to improve global access, especially in low-income countries.
CEPI’s Acting Director of Vaccine Manufacturing and Supply Chain, Ingrid Kromann said: “We’re really looking to see a step change in the way that some of these vaccines can be stored and delivered.”
To read the full article, follow the link below:
CEPI opens Call to develop heat-stable vaccine tech for use against epidemic and pandemic threats
WHO: Commonwealth and WHO to strengthen cooperation on health, including access to vaccines
The Commonwealth Secretariat and the World Health Organization (WHO) signed a Memorandum of Understanding (MoU) which works to strengthen their ongoing collaboration and commitment towards improving vaccine equity as well as a wide range of public health issues.
The Rt. Hon. Patricia Scotland QC said: “Equitable access to vaccines is the world’s most pressing political, economic, social and moral priority. Without effective and prompt action on vaccines, we face a never-ending global health crisis that will reduce all of our wealth and security”
The ongoing COVID-19 pandemic has exposed the need for a stronger more accessible global health system, especially in lower-income countries.
To read the full statement, follow the link below.
Commonwealth and WHO to strengthen cooperation on health, including access to vaccines
ATAGI recommendations for use of Pfizer COVID-19 vaccine as a booster dose in adolescents aged 16-17 years
The Australian Technical Advisory Group on Immunisation (ATAGI) has made recommendations for use of Pfizer COVID-19 vaccine as a booster dose in adolescents aged 16-17 years.
Evidence demonstrates that waning of protection against the Omicron variant occurs after a two-dose primary vaccination schedule and a booster dose is required to increase protection against infection and severe disease.
This statement addresses the safety, efficacy and epidemiological considerations.
Follow the link below to read the recommendations in full:
ATAGI recommendations for use of Pfizer COVID-19 vaccine as a booster dose in adolescents aged 16-17 years.