Covid-19 vaccine trial plan for Australian children as young as six months as Moderna jabs…


Australian toddlers could be used in a global trial for the new Moderna Covid vaccine as its manufacturers bid to win approval for use on children worldwide. 

Around 6,000 children aged from six months to 12 years old will be targeted in a clinical test run of the vaccine.

And the company – which starts shipping the first of 10 million doses of the jab to Australia next month – says it wants to include Aussie youngsters in the trial.

Australian toddlers could be guinea pigs in a global trial for the new Moderna Covid vaccine as its manufacturers bid to win approval for use on children worldwide. Seen here is a child about to be vaccinated

Details of the clinical trial plan are included in just one paragraph of the company’s 189-page quarterly financial statement issued to Wall Street last Thursday.

In an escalation of US trials on teenagers, the company reveals its roadmap to extend testing to younger age groups in a ‘randomised, observer-blind, placebo controlled study’.

USA-based Moderna says it wants to test the vaccine on ‘approximately 6,000 healthy children, 6 months to [under] 12 years of age’.

The company plans to test different levels of doses on three different age groups, 6 to under 12 years old, 2 to 6 years old and 6 month to 12 years old. 

It adds: ‘The study will enrol in the US and up to two ex-US countries (e.g. Canada and/or Australia).’ 

Moderna starts shipping the first of 10 million doses of the vaccine (pictured) to Australia next month and says it wants to include Aussie youngsters in its experiment on children

Moderna starts shipping the first of 10 million doses of the vaccine (pictured) to Australia next month and says it wants to include Aussie youngsters in its experiment on children

News of the trial comes just 24 hours after Federal Health Minister Greg Hunt said authorisation for use of the Moderna vaccine on adults in Australia was expected in the next two weeks, ahead of its arrival in the country next month. 

Once approved, the first million doses of the Moderna vaccine will arrive in Australia in September and supplies are expected to ramp up to three million per month through October to December.

This comes on top of the effective doubling of the mRNA Pfizer vaccines to two million doses per week, as well as the Australian manufactured AstraZeneca.

Moderna says it wants to test the vaccine on 'approximately 6,000 healthy children, 6 months to [under] 12 years of age'

Moderna says it wants to test the vaccine on ‘approximately 6,000 healthy children, 6 months to [under] 12 years of age’

Increased supply has already seen vaccination rates double from 700,000 per week a month-and-a-half ago to almost 1.3 million over the past seven days.

‘What that does show is we can achieve a two million-a-week outcome in Australia,’ Mr Hunt told the ABC’s Insiders program on Sunday.

Talks are also reportedly underway between the Australian government and Moderna about possibly building a manufacturing plant for the vaccine in Australia. 

The SMH reports the government is talking to several companies about opening a production centre for an mRNA-based vaccine – like the Moderna and Pfizer jabs – in 2023.

The TGA is also assessing a new antibody treatment, Sotrovimab, which is expected to be available for use later this year.

‘This medicine is not for everybody,’ Chief Medical Officer Paul Kelly told reporters in Canberra.

Authorisation for use of the Moderna vaccine on adults in Australia is expected in the next two weeks, ahead of its arrival in the country next month. Pictured here are health workers at the new drive through vaccination clinic in Melton, Victoria

Authorisation for use of the Moderna vaccine on adults in Australia is expected in the next two weeks, ahead of its arrival in the country next month. Pictured here are health workers at the new drive through vaccination clinic in Melton, Victoria

‘It will be mostly aimed at people who are not vaccinated. It will be mostly for people who are at highest risk of severe disease, and it needs to be given early in the treatment course.’

The federal government is also providing $17.7 million to rapidly establish 10 pop-up mental health support sites in and around Greater Sydney and to extend the operation of at least 12 clinics in Victoria until June.

NSW Premier Gladys Berejiklian announced a further 262 virus infections on Sunday as well as a further death, that of an unvaccinated woman in her 80s.

It takes the death toll in the current outbreak to 28.

Increased supply has already seen vaccination rates double from 700,000 per week a month-and-a-half ago to almost 1.3 million over the past seven days. Seen here is a woman being vaccinated in Sydney on Sunday

Increased supply has already seen vaccination rates double from 700,000 per week a month-and-a-half ago to almost 1.3 million over the past seven days. Seen here is a woman being vaccinated in Sydney on Sunday

In Queensland, Cairns was put into a snap lockdown on Sunday after a taxi driver tested positive among nine new cases reported in the state. 

The driver had been infectious in the community for 10 days before his test. The rest of Queensland however saw restrictions lifted on Sunday evening.

Victoria recorded 11 new cases halfway through its one-week lockdown, all of them linked to previously reported cases although they were not in quarantine while infectious.

Federal minister Stuart Robert was asked on Sky New’s Sunday Agenda program to confirm reports the government had appealed to the US Biden administration for additional vaccine does.

‘There are continued conversations all around the world,’ Mr Robert said.

The Moderna supply will boost supply by two million doses a month while Pfizer vaccines increase to two million doses per week, as well as the Australian manufactured AstraZeneca. Seen here is the queue of people waiting to be vaccinated at a pop-up clinic in Lakemba in Sydney on Sunday

The Moderna supply will boost supply by two million doses a month while Pfizer vaccines increase to two million doses per week, as well as the Australian manufactured AstraZeneca. Seen here is the queue of people waiting to be vaccinated at a pop-up clinic in Lakemba in Sydney on Sunday

‘You can be rest assured the government will leave no stone unturned when it comes to maximising the amount of vaccinations for our population, our Pacific Island family and of course our wider region.’

However there remains hesitancy in getting vaccinated.

Labor frontbencher Michelle Rowland said one problem in her NSW electorate that covers Blacktown is the ability to get information.

‘When you go to the information checker, you can get information in Icelandic but you can’t get information in Tamil and I have one of the highest proportions of Tamil speakers in all of Australia in my electorate,’ she told Sky News.



Source link