Posted on 04/11/2021 3:03:35 PM PDT by SeekAndFind
Australia’s regulator is assessing early data about the Novavax vaccine, which has a high chance of becoming the country’s third vaccine against COVID-19.
The Therapeutics Goods Administration in January granted a provisional determination to Biocelect Pty Ltd, on behalf of Novavax Inc.
This meant Novavax was eligible to apply for provisional registration, the first step in the complex and technical assessment process.
While Novavax’s phase three trials – conducted mainly in the UK and US – are not complete, interim data is being made available as it emerges.
Interim results suggest it has 95.6 per cent efficacy against COVID-19, dropping to 86 per cent against the UK variant and 49 per cent against the South African variant.
Should the US vaccine prove safe and effective, Australia has a deal for 51 million doses. While supply cannot be predicted, the Department of Health website says some could arrive in the first half of this year and the complete number within the year.
As a traditional protein vaccine, Novavax is in a different class to the AstraZeneca and Pfizer jabs now in use in Australia.
It is in the same class as the University of Queensland vaccine that was withdrawn last year but has since resumed development. Being traditional, there is confidence in the methodology. Both are expected to require two doses.
Novavax’s phase one human trials were conducted exclusively in Australia last year. Paul Griffin, an associate professor at the University of Queensland, was the principal investigator in his capacity as medical director of the Nucleus Network, a company specialising in early trials.
He said the trial was conducted in Melbourne and Brisbane and involved about 120 people. The phase two trials were conducted by other parties in a few sites in Australia and other countries.
“While we obviously have to wait for the full phase three data, the vaccine is looking to be safe and effective,” Professor Griffin said.
“It looks very well tolerated and I think there is a strong chance it will be approved and be in use in Australia later this year.”
The vaccine is also being evaluated by the New Zealand government.
A TGA spokesperson said that to expedite COVID-19 vaccines, including Novavax, it was working with rolling submissions, collaborating with international regulators and proactively working with sponsors to evaluate the candidates without compromising the authority’s strict standards.
“However, the time frame for each vaccine will ultimately depend on when the complete data package is provided by sponsors to enable the required regulatory processes.”
The TGA is part of a network of international regulators that meet regularly to discuss the development of COVID-19 vaccines and systems to monitor them. This, together with the ability to access early data, helps it expedite the evaluation of new vaccines.
the novavax covid vaccine is probably the worst one yet because its effect is so weak that it has to include a proprietary adjuvant called Matrix-M to hyperstimulate the immune system ...
artificial hyperstimulation of the immune system is a very dangerous thing to do as it can promote autoimmune diseases, especially for those genetically predisposed to them ...
an epidemic of hyperthroidism and injection-site sarcomas in cats was traced back to annual vaccinations with cheap, weak feline vaccines that were loaded with adjuvants to rev up the cats’ immune systems ...
Oh FFS, a vaccine isn’t AGAINST anything. It doesn’t FIGHT for you. A vaccine helps your body’s NATURAL defenses to fight against a foreign invader.
We’ve gone to bizzaro-land. Our education system has completely failed a majority of the people in this country and around the world. There’s not a biology textbook anywhere that would say a vaccine “fights” anything.
“Interim results suggest it has 95.6 per cent efficacy against COVID-19, dropping to 86 per cent against the UK variant and 49 per cent against the South African variant.”
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These results align largely with the efficacy of the Moderna and Pfizer Phase 3 trial results and post-trial efficacy studies for those two vaccines.
“the novavax covid vaccine ... has to include a proprietary adjuvant called Matrix-M to hyperstimulate the immune system ...”
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Yes, it does include an adjuvant.
Mothra!
Isn’t the Astra-Z killing people with blood clots?
RE: Isn’t the Astra-Z killing people with blood clots?
Well AstraZeneca had been suspended in several European countries but some have resumed. The blood clot cases are so minimal that they account for 4 in a million vaccinations.
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