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:

TGA statement: Moderna's COVID-19 vaccine (SPIKEVAX) provisionally approved for use in individuals 6 years and older 


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 


MCRI: Dose-finding trial paves way for novel rotavirus vaccine to prevent a deadly diarrheal disease from birth

A reduced dose of a rotavirus vaccine developed from a unique neonatal rotavirus strain in Melbourne has produced a robust immune response in children at risk from the fatal rotavirus disease.  

Researchers from the Murdoch Children’s Research Institute (MCRI), the Malawi Liverpool Wellcome Clinical Research Programme and University of Liverpool have confirmed through a phase 2 clinical trial that three doses of the mid-level amount of vaccine produced an equivalent immune response as the highest dose schedule.  

This triumph in research and development is exceptionally gratifying to see as the first rotavirus vaccine was developed by Professors Ruth Bishop and Grame Barned at Murdoch Children’s Research Institute. To continue to provide support to the communities most impacted, MCRI has made RV3-BB readily available to manufacturers for the license to produce on a large scale for an accessible price. 

To read the full statement, follow the link below: 
Dose-finding trial paves way for novel rotavirus vaccine to prevent a deadly diarrheal disease from birth


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


ATAGI statement on defining 'up-to-date' status for COVID-19 vaccination

The Australian Technical Advisory Group on Immunisation (ATAGI) has released a statement on defining 'up-to-date' status for COVID-19 vaccination.

The guidance summarises ‘up-to-date' vaccination status as the number and timing of appropriate COVID-19 vaccine doses recommended for and received by an individual, according to their age and other factors.

The recommendations aim to provide the optimal individual and/or population protective vaccination benefits (over risks) and take into account other factors, such as vaccine access. COVID-19 vaccine up-to-date status will likely need to be modified over time, with the ATAGI recommendations based on future changes in disease epidemiology and as new evidence becomes available regarding booster doses, including those that may be specifically targeting variants of concern (VOC).

To read the statement in full, click on the link below:
ATAGI statement on defining 'up-to-date' status for COVID-19 vaccination


ABC: Australians urged to get flu shot, with children more at risk from influenza than COVID-19

As Australia reopens its’ international borders to visa holders and fully vaccinated travellers on February 21, health authorities are preparing for the first significant influenza season in three years.  

Experts warn that it's particularly important that pregnant women and children receive the influenza vaccine as they are at increased risk of experiencing severe symptoms and more likely to require medical intervention and/or hospitalisation.  

University of Sydney infectious disease expert Dr Booy said “I would say the flu in young children is worse than COVID is in young children”. 

To read the full article, follow the link below:
Australians urged to get flu shot, with children more at risk from influenza than COVID-19 


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 


Bloomberg: More Than 10.2 Billion Shots Given: Covid-19 Tracker

With more than 10.2 billion vaccine doses administered across 184 countries, the COVID-19 inoculation initiative is the biggest in history. Despite the astonishing numbers, the distribution efforts have been copiously imbalanced with high-income regions getting vaccinated more than 10 times faster than those in the lowest economic bracket.  

Vaccines have been integral to the COVID-19 pandemic, but equal access and delivering billions of vaccines is one of the greatest logistical challenges ever undertaken. 

This article explores the stats and logistical considerations of the COVID-19 vaccine rollout initiative. 

To read the full article follow the link below:
More Than 10.2 Billion Shots Given: Covid-19 Tracker