‘It is imperative that this age group is protected.’


Doctor making insulin or flu vaccination shot by syringe to a young woman

Pharmacies are set to begin giving the Moderna vaccine, as the TGA provisionally approves it for 12-year-olds and up

Over the weekend the Therapeutic Goods Administration announced that it had provisionally approved the use of the Moderna Australia Pty Ltd COVID-19 vaccine SPIKEVAX (elasomeran) in individuals 12 years and older.

This decision followed the provisional approval granted by the TGA to Spikevax last month for use in individuals aged 18 years and older.

“The National COVID Vaccine Taskforce is currently finalising arrangements to facilitate the administration of the Moderna COVID 19 vaccine across the country,” a spokesperson for the TGA told the AJP.

“Community pharmacies will be offered the opportunity to participate in the Moderna vaccine rollout program.

“All pharmacies will be permitted to order and vaccinate with both AstraZeneca (Vaxzevria) and the Spikevax (elasomeran) mRNA vaccine.

“As with all vaccines, States and Territories will need to approve pharmacies to administer the Moderna vaccine and stipulate the age group for which they can vaccinate.

“So far some, but not all, states and territories have amended their regulations to allow the Moderna vaccine to be administered for all ages in community pharmacies.”

Current vaccine regulations mean that pharmacists in Queensland, NSW and Tasmania can not administer Spikevax to those aged between 12 and 17 years, said the Pharmaceutical Society of Australia, calling for state decision-makers to allow pharmacists to provide this service.

“Pharmacists have played a key role in the COVID-19 vaccine rollout to date,” said PSA National President, A/Prof Chris Freeman

“With community pharmacists exclusively set to receive the first doses of Moderna around the country, it is crucial that they can administer the vaccine to individuals aged between 12 and 17 years from Day One.

“This is a race, and pharmacists, as one of our most accessible healthcare workforces, must continue to play a key role in vaccinating younger Australians.

“Pharmacists should be allowed to vaccinate with all TGA-approved vaccines in all practice settings,” A/Prof Freeman said.

“Australia has an advance purchase agreement with Moderna to secure 25 million doses of the vaccine – 10 million this year and 15 million of booster vaccines in 2022, with the first doses arriving later this month,” said Federal Health Minister Greg Hunt.

“The Government will now await the advice of the independent Australian Technical Advisory Group on Immunisation (ATAGI) on how the approval of the Moderna vaccine for 12 to 17-year-olds should be incorporated into Australia’s vaccine rollout program.

“This advice is expected in the coming week.”

Mr Hunt noted that the provisional approval of Moderna’s vaccine follows ATAGI’s recent advice that the Pfizer vaccine be approved for 12 to 15-year-olds.

“Significant preparatory work has been undertaken by Operation COVID Shield on how the rollout will be expanded by including the Moderna vaccine and the first doses of the Moderna vaccine will be available through community pharmacies and workplace vaccination clinics,” he said.

“Through increased supply and additional vaccination sites coming on board, we are setting vaccination records on an almost daily basis.

“Almost two million vaccines were administered last week and more than 20 million have now been administered across the country.

“The Government is absolutely committed to vaccinating children as part of the rollout program – and it is expected everyone aged 12 to 18 years of age will have access to a vaccine during 2021.”

The Pharmacy Guild of Australia welcomed the decision.

National President Trent Twomey said the move, which extends availability to people aged 12 and above, would help increase community coverage against the virus.

“Increasingly we are seeing evidence of younger people being affected by the Delta strain of COVID-19, so it is imperative that this age group is protected along with the rest of the community throughout Australia,” Mr Twomey said.

“Community pharmacies will be administering the Moderna vaccine as soon as supplies are available and extending the age-group eligibility is a common-sense move to ensure more people are protected.

“Importantly the availability of the Moderna vaccine means there are now two mRNA vaccines available in Australia – Moderna and Pfizer.  

“The rate that patients are flocking to community pharmacies to have their vaccinations has highlighted the pivotal role community pharmacists are playing in the campaign to maximise vaccination uptake.

“The accessibility of these pharmacies and the trust that people have in their pharmacists and their staff are key to the success of including pharmacies in the rollout. I have no doubt that this will continue to be reflected in the uptake of Moderna vaccines through pharmacies.” 

Mr Twomey highlighted that pharmacies were the most accessible healthcare professionals.

“They are open when other vaccination points such as GP surgeries may not be open and so there are plenty of opportunities for everyone to get their Modera vaccine at a time and place that suits them when supplies are available.

“Pharmacies have helped get the vaccine rollout back on track and will now be able to further consolidate that roll by being able to protect younger people with the Moderna vaccine.”

He told the general public that they can book online, or “just walk in” for their vaccination; or visit the findapharmacy.com.au website.

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3 Comments

  1. Peter Allen
    06/09/2021

    1). Children are not at any significant risk of Covid. Only three have been hospitalized.

    2). We always wait for safety studies on every cohort. None has been done on children.

    3). Wait.

    Yes I know it’s a beast and we have to implement heroic measures.
    No it is not. Actual deaths tragic as they are, almost always are at old overweight with other comorbidities. We’re freaking out, over reacting.
    Q) what is your estimate of death rate in cases?
    A) 38 percent (!!) in a public survey.
    Actually maybe a quarter percent.

    • Sean G
      07/09/2021

      Regarding your 2nd point, the Moderna mRNA vaccine actually has a published Phase III RCT that enrolled children 12-17yrs old (doi: 10.1056/NEJMoa2109522). It found that the safety profile was similar to adults, but of course with only 3732 participants it lacks the statistical power to find rarer safety signals such as CVT and myocarditis. The Pfizer vaccine has also has a Phase III RCT (doi: 10.1056/NEJMoa2107456) with similar findings, hence why Pfizer and Moderna are the only two vaccines approved in this age group.

      While I think your 2nd point is incorrect as the sponsors have done safety studies that are consistent with the historical precedent (e.g. the Gardasil 9 vaccine was approved based on safety studies with 3361 participants in the same age group), I do agree with you that a lot of the public discussion surrounding COVID19 vaccinations for adolescents is alarmist. The actual question of whether it’s prudent or ethical to vaccinate adolescents considering their extremely low risk of bad outcomes from infection is very nuanced, but you wouldn’t know that when so much of the public debate is reduced to “authoritarians vs antivaxxers”.

      I’m not an epidemiologist or a statistician though, so I’ll have to place my trust in ATAGI that they’ve weighed this up.

      • Peter Allen
        07/09/2021

        An elegant response thank you Sean. In an environment where anything but 110 percent barracking is seen as bad faith.
        I do now accept that some pet-release studies have been performed.

        There are people holding back from current vaccines with fears that might be allayed with NovaVax, due in the new year. It’s difference is based on split virus, same as the flu shots we use with confidence.

        The Atlantic “ the mRNA vaccines are extraordinary but NovaVax is even better”
        June2021
        Hilda Bastian’s credentials?
        At Cochran’s founding.
        Editor of PubMed Health.
        !!

        https://amp.theatlantic.com/amp/article/619276/

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