Provisional determination granted to Pfizer's COVID-19 vaccine (COMIRNATY) - for use in children 5-11 years of age
The Therapeutic Goods Administration (TGA) has granted provisional determination to Pfizer’s COVID-19 vaccine, Comirnaty™ as part of an application process to lower the approved age limit of vaccine administration from 12 years and above, to children 5 to 11 years.
Provisional determination is the first step in the provisional registration pathway. The provisional pathway for registration provides a formal and transparent mechanism for speeding up the registration of promising new medicines based on preliminary clinical data. Having provisional determination does not mean that provisional registration will be granted.
To read more follow the link below:
Provisional determination granted to Pfizer's COVID-19 vaccine (COMIRNATY) - for use in children 5-11 years of age
A recording is now available from The Alfred’s community information session on COVID-19 vaccinations and fertility
A webinar recording is now available from The Alfred’s community information session on COVID-19 vaccinations and fertility which was held on Thursday 7 October.
In this session, Alfred Health Infectious diseases physician and immunisation expert Prof Michelle Giles is joined by A/Prof Kate Stern, Head of Reproductive Services at The Royal Women's Hospital to discuss vaccination and fertility. They explain in detail how the vaccines work and answer questions from the community around fertility issues.
The full recording is available via the link below:
The Alfred community discussion 7 October
ATAGI statement on the use of a 3rd primary dose of COVID-19 vaccine in individuals who are severely immunocompromised
Recommendations from the Australian Technical Advisory Group on Immunisation (ATAGI) on the use of a third primary dose of COVID-19 vaccine in individuals who are severely immunocompromised have been announced.
The recommendations have been outlined below:
- ATAGI recommends a 3rd dose of COVID-19 vaccine as part of the primary course in individuals who are severely immunocompromised.
- This is to address the risk of suboptimal or non-response to the standard 2 dose schedule.
- The 3rd dose is intended to maximise the level of immune response to as close as possible to the general population.
- This recommendation applies to all individuals aged ≥12 years with certain conditions or on therapies leading to severe immunocompromise, as defined in Box 1 (refer to full statement).
- An individual with an unlisted condition should only be considered for a 3rd dose where the treating physician has assessed the patient as having a similar level of severe immunocompromise to the listed conditions in Box 1, and where the benefits of a 3rd dose of COVID-19 vaccine outweigh the risks.
- Individuals who currently are not severely immunocompromised but who will commence significant immunosuppressive therapy ≥ 2 weeks after their 2nd dose do not require a 3rd dose, as it can be expected that an adequate response to 2 primary doses will be achieved.
- ATAGI does not recommend subsequent doses beyond the 3rd dose at this time. Many patients who fail to respond to 3rd doses may not respond to further doses.
- Protection from 3 primary doses in severely immunocompromised individuals may still be lower than the general population. People should continue risk mitigation strategies such as mask wearing and social distancing even after receipt of a 3rd dose.
- ATAGI will continue to monitor the evidence around duration of protection and advise on the need for subsequent (booster) doses in immunocompromised populations to address waning of protection or risk from variants of concern.
- ATAGI will provide further advice on booster doses (including for healthcare workers, older adults and the general population) separately. See about the need for additional doses of COVID-19 vaccines.
To view the statement in full, please click on the link below.
ATAGI statement on the use of a 3rd primary dose of COVID-19 vaccine in individuals who are severely immunocompromised
WHO recommends groundbreaking malaria vaccine for children at risk
The World Health Organization (WHO) is recommending widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot programme in Ghana, Kenya and Malawi that has reached more than 800 000 children since 2019.
According to the WHO, malaria remains a primary cause of childhood illness and death in sub-Saharan Africa where more than 260 000 African children under the age of five die from malaria annually.
WHO Director-General Dr Tedros Adhanom Ghebreyesus commented “This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”
WHO recommends that the RTS,S/AS01 malaria vaccine be used for the prevention of P. falciparum malaria in children living in regions with moderate to high transmission as defined by WHO. In addition to this, RTS,S/AS01 malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden.
To read the extract in full, please click on the link below:
WHO recommends groundbreaking malaria vaccine for children at risk
SMH: Separating reproductive health fact from COVID-19 vaccine fiction
Dr Daryl Cheng spoke to ABC journalist Sarah Berry regarding the increasing amount of misinformation circulating about COVID-19 vaccines and women’s health. Many of the rumours target women who are pregnant or planning a pregnancy and who are already experiencing anxiety about making the best choices for the health of their babies.
In this article, Dr Daryl Cheng provides scientific data-based insights on the vaccine’s effect on reproductive health. The data focuses on providing advice and information to help refute some persistent rumours regarding fertility, menstruation, and IVF treatments in women.
Follow this link to read the full article:
SMH: Separating reproductive health fact from COVID-19 vaccine fiction
The Conversation: Who can’t have a COVID vaccine and how do I get a medical exemption?
State and territory governments and businesses are currently in the process of establishing COVID-19 vaccine mandates across a range of sectors, including the Victorian government which mandated COVID vaccination for all authorised workers last week. Despite this necessary step, there is still a very small amount of people who are unable to receive a COVID-19 vaccine for medical reasons. ATAGI has released guidelines on which instances an individual may be granted a medical exception.
The only criteria for a permanent exception are due to anaphylaxis following a previous COVID-19 vaccine dose or to any component of a vaccine.
Temporary exceptions may be approved for some “acute major medical illnesses” where the COVID vaccine can be deferred for a certain amount of time.
COVID vaccine exceptions can be administered by general practitioners, paediatricians, clinical immunologists, infectious disease, general or public health physicians, gynaecologists, or obstetricians. As vaccine mandates continue to be implemented, it’s crucial for employers, individuals, and medical providers to stay up to date with new ATAGI clinical guidance regarding the medical exemption criteria.
Click the link to read the full article:
The Conversation: Who can’t have a COVID vaccine and how do I get a medical exemption?