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 

 

 

 

 


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


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 update following weekly COVID-19 meeting – 12 January 2022

Following recent data, ATAGI recommends that severely immunocompromised children between the ages of 5 to 11 years receive a 3rd primary dose of the COVID-19 vaccine to optimise their protection against COVID-19 infection.

Current data has not identified any concerning safety signals in this cohort. ATAGI continues to review and closely monitor reports regarding the safety and efficacy of the COVID-19 vaccine in this age group.

This statement provides a concise summary of the January ATAGI meeting, including the latest recommendations and considerations regarding the safety and efficacy of the COVID-19 vaccine in children ages 5 to 11 years.

To read the full statement, follow the link below:
ATAGI update following weekly COVID-19 meeting - 12 January 2022


CDC: COVID-19 Vaccine Safety in Children Aged 5-11 Years November 3 – December 19 2021

Following the administration of approximately 8 million Pfizer COVID-19 vaccine doses in children between the ages of 5 to 11 years, local and systemic reactions were closely monitored and assessed. The incoming data was reported to VAERS and v-safe, the national passive vaccine safety surveillance system, jointly managed by the CDC and FDA. During the span of 3 November to 19 December, 4,249 reports were submitted, of which 97% were for nonserious adverse events.

For the most recent clinical data regarding the safety and efficacy of the Pfizer COVID-19 vaccine in children aged 5 to 11 years, read the full VAERS report.

COVID-19 Vaccine Safety in Children Aged 5-11 Years November 3 – December 19 2021 

 


European Commission authorises fifth safe and effective vaccine against COVID-19

Nuvaxovid, a COVID-19 vaccine developed by Novavax, has become the fifth COVID-19 vaccine authorised for use in the European Union (EU). Following rigorous safety, efficacy and quality testing by the European Medicines Agency (EMA), the European Commissions has granted a conditional marketing authorization (CMA) of the vaccine for its perceived benefits in providing protection against severe COVID-19 disease. 

 

To read the full statement, follow the link below: 

European Commission authorises fifth safe and effective vaccine against COVID-19

 

 


Pfizer and BioNTech provide update on ongoing studies of COVID-19 vaccine

Following a routine review examining the safety and efficacy of the Pfizer-BioNTech by the external Independent Data Monitoring Committee (DMC), data has demonstrated that whilst there were no safety concerns,  immunogenicity of a two dose primary course consisting of 3µg doses in the 6 to 24 month-old cohort was met with non-inferiority, but not in the 2 - 5 year old group.

The company has also announced that it will resume studies evaluating a third  3µg dose of COVID-19 vaccine in children 6 months to under 5 years of age in order to select the right dose to maximise the risk-benefit profile in this age group. 

For further information on this study and its findings, follow the link below:  

Pfizer and BioNTech provide update on ongoing studies of COVID-19 vaccine


The Sydney Morning Herald: Moderna COVID-19 vaccine booster dose ‘appears protective against Omicron’

Following laboratory testing, data shows that whilst a two-dose primary course of the Spikevax (Moderna) vaccine resulted in a low generation of neutralising antibodies against the Omicron variant, a booster dose provided a 37-fold increase in neutralising antibodies. 

 

For more information on these findings refer to the full article via the link below:

Moderna COVID-19 vaccine booster dose ‘appears protective against Omicron’


Raising Children Network - COVID-19 vaccination and children: 5-11 years

Immunising children against COVID-19 ensures stronger, longer-lasting protection than infection does. To build the best immunity, ATAGI recommends that children aged 5 to 11 years should have a 2 dose primary course of the Pfizer COVID-19 vaccine, 8 weeks apart.  

This Raising Children article developed in collaboration with MVEC explores the safety, efficacy and recommendations for immunising children aged 5 to 11 years against COVID-19. 

To read the full article, follow the link below: 

COVID-19 vaccination and children: 5-11 years