Hopes unvaccinated will get Novavax as new COVID-19 vaccine, drugs approved for use

The Novavax COVID-19 vaccine is set to be rolled out across Australia, as two oral antiviral drugs for the disease have been provisionally approved.

A vial of the Phase 3 Novavax vaccine is seen ready for use in a trial at St. George's University hospital in London October 7, 2020.

Novavax was first approved by Indonesia in early December. It has since been approved by the European Medicines Agency. Source: AP

The nation's medicines watchdog has given the green light for the Novavax COVID-19 vaccine to be used in Australia.

Health Minister Greg Hunt confirmed the news from the Therapeutic Goods Administration (TGA) on Thursday.

Australia has ordered 51 million doses.

"We know that some people have waited for this vaccine, and ... hopefully this will encourage those people in the last five per cent to come forward," Mr Hunt said.

Mr Hunt said the Australian Technical Advisory Group on Immunisation would now review the decision and, subject to their approval, Novavax would be made available "over the coming weeks".

Minister for Health Greg Hunt
Federal Health Minister Greg Hunt. Source: AAP

Australia's COVID-19 Taskforce Commander Lieutenant General John Frewen said Novavax had been approved for a "primary course", meaning the first and second vaccine doses.

Doses will be delivered 21 days apart.

Quizzed over who might be waiting for the Novavax vaccine, General Frewen said some individuals were "worried about new technology", referring to the Pfizer and Moderna mRNA vaccines.

"The technology on which it is made is an older technology, it uses a protein," General Frewen said.

TGA boss Professor John Skerritt said his agency was only the second major regulator in the world to approve the protein vaccine known as NUVAXOVID.

"Our dream is to turn 95 per cent (vaccination rate) into 97 or 98 per cent," he told reporters.

He said the company had yet to submit data relating to its use as a booster or for people aged under 18, but when a submission was made the regulator would work through it as quickly as possible.

Trials had shown the vaccine had over 90 per cent efficacy with "no strong signals of adverse events", Professor Skerritt said.

Protein vaccines use a non-infectious component found on the surface of the coronavirus and are manufactured in cells in a laboratory.

After vaccination, immune cells recognise the vaccine protein as foreign and launch an immune response against it.

The TGA has also provisionally approved the first oral treatments for COVID-19. 

The antiviral treatments, Lagevrio and Paxlovid, "have been found to be effective in treating people with mild to moderate COVID-19, who have a high risk of progressing to severe disease", Mr Hunt said in a statement on Thursday morning.

The drugs will be free, and if deemed necessary for treatment, general practitioners will be able to provide a prescription for people to obtain them through a pharmacy.

The medical regulator said the treatment, however, is not a substitute for the COVID-19 vaccine.

"The Government has secured access to 300,000 treatment courses of Merck Sharp & Dohme’s (MSD) Lagevrio and 500,000 courses of Pfizer’s Paxlovid for supply throughout the course of 2022, with the first deliveries of both medicines anticipated over the coming weeks," Mr Hunt said. 

The prescription-only medicines are designed to be taken every 12 hours for five days and reduce the virus's ability to rapidly multiply.

Both oral treatments have already been approved for use by the US and UK health authorities.

Mr Hunt said the new treatments won't be used for everyone who contracts COVID-19.

"These treatments will be of most benefit for people most at risk of severe disease and through the oversight from a healthcare professional," he said.

"We are working to target access to those most vulnerable, including the elderly and those in aged care."

Merck Sharp and Dohme medical director Gary Jankelowitz said the provisional approval of Lagevrio was a major achievement in the fight against COVID-19.

"Lagevrio has the potential to help address a medical need in the community," he said.

"The provisional approval of this oral anti-viral treatment for COVID-19 in eligible at-risk adults is a regulatory milestone."

With additional reporting by AAP.

4 min read
Published 20 January 2022 at 8:36am
By David Aidone, Akash Arora
Source: SBS