2. #Pfizer COVID-19 vaccine PI (Product Information leaflet) has been updated with the warning about myocarditis and pericarditis has been updated to emphasise that rare cases can also occur in females.
3. The following sentence about severity has also been added:
“Cases of myocarditis and pericarditis following vaccination have rarely been associated with severe outcomes including death.”
4. The existing warning about the signs and symptoms of myocarditis and pericarditis following vaccination has been updated to include atypical presentations and non-specific symptoms of fatigue, nausea and vomiting, abdominal pain, dizziness or syncope, oedema and cough.
5. Non-sexually acquired genital ulceration has been added as an adverse reaction that can potentially occur after vaccination. A causal association between non-sexually acquired genital ulceration and COVID-19 vaccination has not been definitively established.
🧵 on paediatric dose of Pfizer’s COVID-19 vaccine.
On 29th Sept 2022, TGA (#Australia ) provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged 6 months to less than 5 years.
A THHREE dose (3 μg) regime for children under the 5 years of age was informed by clinical study and real-world data showing a third dose was likely necessary to provide a high level of protection against Omicron variants.
1) "Australian Bureau of Statistics" has released their recent numbers for Provisional mortality till June 2022.
Key statistics:
In 2022, there were 92,699 deaths that occurred by 30 June and were registered by 31 August, which is 13,524 (17.1%) more than the historical average.
2) In June there were 16,749 deaths, 2,410 (16.8%) above the historical average.
Deaths due to COVID-19 increased in July when compared with May and June.
In Australia, 98.2% of people aged 16+ with at least 1 dose, 96.5% of people aged 16+ with 2 doses, 71.8% of people aged 16+ with 3 doses AND deaths due to COVID-19 increased in JULY?
A study published (6th June, 2021) last year in JAMA Pediatrics mentioned that Vaccine-associated mRNA was not detected in 13 milk samples collected 4 to 48 hours after vaccination from 7 breastfeeding individuals.
Recent study published (26th Sept, 2022) in JAMA Pediatrics mentions that of 11 lactating individuals enrolled, trace amounts of BNT162b2 and mRNA-1273 COVID-19 mRNA vaccines were detected in 7 samples from 5 different participants at various times up to 45 hours postvaccination.
WHAT CHANGED?
I’d like to highlight that in the study from 2021 in the conflict-of-interest section, among others, we can see National Institutes of Health (NIH), Bill & Melinda Gates Foundation, CDC Foundation mentioned.