Australians react to Moderna Covid-19 vaccine approval news

Australia has welcomed the news of the approval of the Moderna vaccine in the fight against covid but not all are happy with how long it took.

Australia has welcomed the news of the approval of the Moderna vaccine in the fight against coronavirus but not all are happy with how long it took.

On Monday, Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), announced it had granted provisional approval to the Covid-19 vaccine for Australians aged 18 and over.

The US-made Moderna should soon be deployed alongside Pfizer and AstraZeneca jabs and could ultimately be approved for babies as young as six months.

It is recommended that the vaccine is given in two doses that are administered 28 days apart.

Australia has ordered a total of 25 million doses of the jab with at least 10 million expected by Christmas.

Based in Cambridge, in the US state of Massachusetts, Moderna was founded in 2010.

A key component of TGA chief John Skerritt’s announcement was how results of the vaccine overseas proved “really exciting”.

Moderna is already proving effective around the world, with the TGA citing the United Kingdom, Canada, the European Union, Switzerland and Singapore, but Mr Skerritt pointed to results out of the United States, showing the jab is proving to be 93 per cent effective against Covid-19 infection, 98 per cent against severe disease and 100 per cent against death.

“We are pleased that our COVID-19 vaccine is showing durable efficacy of 93 per cent through six months, but recognise that the Delta variant is a significant new threat so we must remain vigilant,” said CEO Stephane Bancel in a statement.

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Half of the US population is now fully vaccinated against Covid-19, the White House confirmed, as vaccination rates rise again in response to the surging Delta variant.

That means more than 165 million people have received either the two-dose Moderna or Pfizer vaccine, or the one-and-done Johnson & Johnson shot.

A health worker receives a dose of the Moderna Covid-19 coronavirus vaccine donated by the US, during a booster vaccination drive at the Zainoel Abidin hospital in Banda Aceh on Monday. Picture: Chaideer Mahyuddin

In Australia, Moderna should soon be deployed alongside Pfizer and AstraZeneca jabs, as well as the Johnson & Johnson vaccine when that receives the final tick of approval.

It aims to produce between 800 million and a billion doses of its jab this year, and with its overseas success, one federal government MP has asked why it took so long to arrive in Australia.

“This has been a concern for me for a long time about the TGA, why it needs to go through its own process around determining whether a medicine can be approved for use in Australia when its been approved by the EU regulatory body, when its been approved by the FDA (Food and Drug Administration) in the United States, by Canada, by a whole bunch of other people,” Northern Beaches MP Jason Falinski told the ABC’s Patricia Karvelas.

“I do think we need to have reciprocal recognition as part of our regimen and part of what the TGA does”.

Karvelas replied that the “TGA goes through its own processes” and “those processes are quite slow” and asked what reform could possible be made to speed things up.

Mr Falinksi said he raised concerns over the issue of timing with Health Minister Greg Hunt in 2020 but not since.

The TGA says it “is responsible for assessing all Covid-19 vaccines before they can be used in Australia and “will only register a vaccine if its benefits are much greater than its risks”.

There is a six step process to approving Covid-19 vaccines: Pre-application, Application, Evaluation, Decision, Registration and Monitoring.

“The TGA will continue to play an active role in the ongoing monitoring of any vaccines available in Australia, and has robust procedures in place to investigate any potential new safety issues,” it says.

A man is inoculated with the Moderna vaccine at a park in Medellin, Colombia, last week. Picture: Joaquin Sarmiento

Meanwhile, Crikey’s Kishor Napier-Raman on Monday revealed the government “didn’t cut a deal with Moderna till May”, in a piece asking Why is it taking so long for Australia to get the Moderna vaccine?

Napier-Raman also revealed the TGA “takes on average 120 days longer than the US FDA to approve drugs”.

But that could be the least of Australia’s problems, with the federal government saying it is confident supplies will arrive as scheduled despite South Korea’s health minister being forced to apologise for Moderna vaccine shortages.

Health Minister Kwon Deok-cheol said Moderna would deliver less than half of its planned shipment due to shortages and shipment delays.

The Moderna COVID-19 vaccine has received approval for use in Australians aged over 18 years by the Therapeutic Goods Administration.

The Australian Government has secured 25 million doses of Moderna’s vaccine, with the first million doses scheduled to arrive next month. pic.twitter.com/TArVGa3ZAF

— Greg Hunt (@GregHuntMP) August 9, 2021

Health Minister Greg Hunt assured Australians he had been in direct contact with Moderna and jabs will be in arms as soon as next month.

“As late as the weekend, the advice from Moderna to me directly was that we’re expecting one million in the second half of September,” he said.

“And as exactly as the Prime Minister set out, three million in each of October, November and December.

“But as we do, we are constantly, with all of our suppliers, checking and pushing to bring forward. But that advice was provided over the weekend.”

Originally published as Australians react to Moderna Covid-19 vaccine approval news