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New Covid medications given green light in Australia

TGA gives provisional approval for Novavax and oral treatments

New Covid medications given green light in Australia
Federal Health Minister Greg Hunt
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Pharmaceutical giant Pfizer insists that its new antiviral Covid pill shows ‘effectiveness’ against the variant.

The company's Chairman and CEO Albert Bourla tweeted: “Encouraged to see initial lab findings that suggest Pfizer’s #COVID19 oral therapy has the potential to maintain plasma concentrations many-fold times higher than the amount required to prevent #Omicron from replicating in cells.

Even with three shots, current Covid vaccines have limited impact on transmission – an observation admitted by Pfizer’s CEO during a controversial TV interview.

The pill dubbed ‘Paxlovid’ showed promising results in three separate lab tests conducted in New York City. Its active ingredient Nirmatrelvir has been able to overcome the Covid virus during the trials, with Paxlovid approved by the American Food and Drug Administration (and also approved in Canada).

Paxlovid and Lagevrio, an oral Covid treatment manufactured by American pharmaceutical giant Merck & Co were granted provisional approval today by Australia’s drug regulator, the Therapeutic Goods Administration (TGA).

The drugs are the first oral treatments for Covid approved for use in Australia.

The TGA also granted provisional approval to the Novavax vaccine with Federal Health Minister Greg Hunt acknowledging that some had 'some people have waited for this vaccine'.

The next step is for a domestic advisory group on immunisation to give its rubber stamp after which Novavax will be distributed through state and territory vaccination hubs, general practices and pharmacies.

Paxlovid claims to cut the risk of hospitalisation and death by up to 90% across all coronaviruses. The pill is a daily treatment (up to five days) that was previously approved for emergency use in high-risk patients.

“We specifically designed Paxlovid to retain its activity across coronaviruses, as well as current variants of concern with predominately spike protein mutations.

"These [sic] data suggest that our oral Covid therapy can be an important and effective tool in our continued battle against this devastating virus and current variants of concern, including the highly transmissible Omicron,” said Dr Michael Dolsten, Pfizer’s chief science officer. Of course, laboratory tests are a very different animal to real-world performance."

Bourla with ‘science will win’ on his header, tweeted, “Excited to share that updated analysis from our Phase 3 study with BioNTech also showed that our COVID-19 vaccine was 100% effective in preventing #COVID19 cases in South Africa. 100%!” The claim was linked to this study which, at the time, promoted two doses as 100% protection.

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  • By Avi Yemini

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