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


Australian Technical Advisory Group on Immunisation (ATAGI) recommendations on the use of Spikevax (Moderna) as a COVID-19 booster vaccine

Following recent approval from the TGA, the Australian Technical Advisory Group on Immunisation (ATAGI) have recommended the use of Spikevax (Moderna) as a COVID-19 booster vaccine for people aged 18 years and older (including pregnant women), who have completed their primary course of COVID-19 vaccine 5 or more months ago. The booster dose is half the recommended dose of the Spikevax vaccine used for the primary course. 

ATAGI notes that Moderna and Pfizer COVID-19 vaccines are equally acceptable for use as booster vaccines in Australia in the eligible population.  

To read ATAGI's full statement on the use of the Moderna COVID-19 vaccine as a booster follow the link below:

Australian Technical Advisory Group on Immunisation (ATAGI) recommendations on the use of Spikevax (Moderna) as a COVID-19 booster vaccine


Updated ATAGI advice on the administration of seasonal influenza vaccines in 2021 (December 2021)

The Australian Technical Advisory Group on Immunisation (ATAGI) has released updated advice for influenza vaccination in 2021.

Due to international borders reopening from November 2021, and greater population movement, seasonal influenza virus is expected to emerge and circulate in Australia outside of the usual influenza season.

Influenza vaccination is recommended for anyone aged 6 months and over who has not had an influenza vaccine this year. In particular, it is strongly recommended for those in higher risk groups.

To read the advice in full, please click on the link below:
Updated ATAGI advice on the administration of seasonal influenza vaccines in 2021 (December 2021)

 


ATAGI recommendations on Pfizer COVID-19 vaccine use in children aged 5 to 11 years

A new formulation of the Pfizer COVID-19 vaccine (Comirnaty) has been provisionally approved for use in children aged 5-11 years by the Therapeutic Goods Administration. This approval is based on the results of a recent clinical trial demonstrating that the vaccine is highly effective and that most side effects are mild and transient. ATAGI notes that real-world evidence on the safety of this vaccine in children aged 5-11 years is rapidly accumulating overseas, including data on the low rate of rare adverse events following immunisation, notably myocarditis, which the clinical trial was insufficiently powered to assess.

The recommended dose for this age group is 10µg (0.2mL), a third of the recommended 30µg dose for people aged ≥12 years.

ATAGI’s recommendations take into account:

  • The direct benefits of vaccination for the child in preventing illness;
  • The indirect benefits of vaccination for the child, their family and for the broader community. To realise some of these benefits, a large proportion of the 5-11 year age group would need to be vaccinated;
  • Adequate supply of the paediatric Pfizer COVID-19 vaccine is expected to be available to vaccinate all 5-11-year-old children.

To read the recommendations in full, please click on the link below:
ATAGI recommendations on Pfizer COVID-19 vaccine use in children aged 5 to 11 years


Safety, side effects, allergies and doses. The COVID-19 Pfizer vaccine for 5-11 year olds explained

Australian children aged 5-11 will start to receive the Pfizer COVID-19 vaccine from January 10 as recommended by the Australian Technical Advisory Group on Immunisation (ATAGI). As part of the recommendation, children in this group will receive two 10 microgram doses (one-third of the over-12s dose), given eight weeks apart.

While this is an important step in helping to protect the community against COVID-19, safety of the vaccines will continue to be paramount and closely monitored.

This article highlights what the current trial data says about safety and efficacy, including what data we already know from real-world experience of the Pfizer vaccine in the US. Currently, more than 5 million US children aged 5-11 have received one dose and more than 2 million have had a second dose.

One safety concern of particular interest is myocarditis, a rare side effect seen after the second dose in young males aged 12-17. Reassuringly, to date, no cases of myocarditis or pericarditis have been reported in the clinical trials of 5-11-year olds.

To read the article in full, please click on the link below:
The Conversation: Safety, side effects, allergies and doses. The COVID-19 Pfizer vaccine for 5-11 year olds explained

 


ATAGI statement on SARS-CoV-2 Omicron variant and COVID-19 booster doses

The Australian Technical Advisory Group on Immunisation (ATAGI) has released a statement regarding the emergence of a new SARS-CoV-2 variant of concern, which has been named the Omicron variant.

ATAGI have advised that there is currently no evidence to suggest that earlier booster doses of current COVID-19 vaccines will augment protection against the Omicron variant. Further to this, it will continue to closely monitor the epidemiology and emerging data on the likely impact of vaccination on this variant and update recommendations in the near future.

To read the statement in full, please click on the link below:
ATAGI statement on SARS-CoV-2 Omicron variant and COVID-19 booster doses


The Conversation: Is your child frightened of needles? Here’s how to prepare them for their COVID vaccine

Most children are fearful of needles and approximately one in five kids (19%) aged 4-6 years old experience needle phobia.

A child’s initial interaction with needles in their primary years may be formative for their relationship with immunisations throughout their lives. As such, it’s important to cultivate a safe and positive vaccination experience.

This article discusses techniques and strategies to help prepare children for vaccination, including accessing professional help from play and child life therapists for those with needle phobia.

To read the full article, please follow the link below:

Is your child frightened of needles? Here’s how to prepare them for their COVID vaccine


The Conversation: How can scientists update coronavirus vaccines for omicron? A microbiologist answers 5 questions about how Moderna and Pfizer could rapidly adjust mRNA vaccines

The new Omicron variant has raised the question of whether current COVID-19 vaccines will provide sufficient protection against infection. If the virus has changed significantly, antibodies created by the original vaccine will no longer be able to recognise and defend against the new mutated variant. Consequentially, vaccines will need to be modified by swapping out the genetic code of the original spike protein for the one found on the new variant.

This article explores the scientific process behind updating mRNA vaccines including timelines and authorization procedures.

Follow the link below to read the full article:

How can scientists update coronavirus vaccines for omicron? A microbiologist answers 5 questions about how Moderna and Pfizer could rapidly adjust mRNA vaccines


About MVEC

The Melbourne Vaccine Education Centre (MVEC) is an educational website, developed with the aim of providing up-to-date immunisation information for both healthcare professionals and members of the public. We are based at Murdoch Children’s Research Institute (MCRI), a research organisation, and are affiliated with SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community), the Victorian Vaccine Safety Service.