ABC News: Pfizer to apply for approval for COVID-19 vaccine to be used for five to 11 year-old children

Initial results from the highly anticipated trial involving more than 2,000 children studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 have shown the vaccine is safe and establishes a strong antibody response against the virus.

Despite the initial promising results, it will be some time before an official rollout of vaccines for children ages 5 to 11 both in the US and here in Australia. Once the analysis of the trial is completed, in order to be granted approval, the company is required to provide the FDA with a formal immune “bridging” study which provides data-based evidence that children developed the same antibody levels already proven to be protective in older children and teenagers. The results will be submitted to the Food and Drug Administration (FDA) for review and emergency use authorisation.

To read the article in full, please click on the link below:
https://www.abc.net.au/news/2021-09-21/pfizer-covid-19-vaccine-5-to-11-year-old/100478362


The Age: ‘Jabba the Bus’ to take regional vaccination drive onto the road

Jabba the bus brings about exciting news for COVID-19 vaccination in regional Victoria. The mobile vaccine hub will deliver essential AstraZeneca and Pfizer vaccines to isolated residents of regional Victoria. The focus will be on the City of Greater Shepparton as well as Moira, Benalla, Strathbogie, Mitchell, Mansfield Murrindindi and Campaspe.

A high sense of urgency perpetuated the need for the mobile vaccination hub following a large COVID-19 outbreak in Shepparton which forced more than 20 000 people into isolation, including more than 500 staff from Goulburn Valley Health. Goulburn Valley Health Chief executive Matt Sharp indicated that currently, only 45 per cent of people had received even their first dose of a COVID-19 vaccine, while an increasingly more alarming rate of just 26 per cent received their second dose.

The mobile vaccination station, which is the first service of its’ kind in the state represents a promising opportunity to increase vaccine uptake amongst groups of people who otherwise may not have access to the vaccine and includes easy accessibility for people with disabilities.

Full article:
The Age: The Age: ‘Jabba the Bus’ to take regional vaccination drive onto the road

 


FDA news release: FDA Approves First COVID-19 Vaccine

The US Food and Drug Administration (FDA) has granted full approval of Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and above. The mRNA vaccine was first approved under emergency use authorisation back in December 2020, and is currently the first and only COVID-19 vaccine to receive full authorisation for use.

Pfizer CEO Albert Bourla said in a statement the FDA's approval "affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed."

All FDA-approved vaccines undergo a rigorous standard process for reviewing the quality, safety, and effectiveness. For Comirnaty, new clinical data is used in conjunction with existing information submitted during the initial EUA stage. The FDA’s approval process concluded that the vaccine was 91% effective in preventing COVID-19 disease based on the evaluation of approximately 20,000 vaccine recipients as well as 20,000 placebo recipients aged 16 years and above. Furthermore, to better assess the long term safety outcomes, approximately 12,000 recipients were monitored for an additional 6 months following their second dose of the vaccine. Conclusively, results suggest that the vaccines show an increased risk of myocarditis and pericarditis, particularly among males under the age of 40, following their second jab. The FDA and Centers for Disease Control and Prevention along with the company will continue to monitor the safety and effectiveness of the Comirnaty vaccines, to ensure any concerns continue to be identified and evaluated in a timely manner.

To read the full article, click on the link below:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine