Post by Nadica (She/Her) on Sept 20, 2024 23:40:35 GMT
Why Australia could miss out on Moderna's new COVID-19 vaccine - Published Sept 20, 2024
By Emma Brancatisano
While Australia's therapeutic goods regulator is evaluating two new vaccines targeting the JN.1 strain of COVID-19, the government seemingly only intends to make one available to the public.
Australians could soon have access to a new vaccine targeting a commonly detected COVID-19 variant.
However, the government has suggested that a similar vaccine made by a different company won't be publicly available, leaving some experts concerned about reliance on a single manufacturer.
Last month, applications for two vaccines targeting the JN.1 variant were accepted for evaluation by the Therapeutic Goods Administration (TGA), which approves medical products in Australia.
The two vaccines are Spikevax from Moderna and Comirnaty from Pfizer.
When SBS News asked the Department of Health whether both vaccines would be available in 2024-25, its response suggested only the Pfizer vaccine would be available.
"The department intends to make updated Pfizer JN.1 COVID-19 vaccines available to eligible individuals as soon as possible following regulatory approval," a department spokesperson said.
A department spokesperson said Moderna had satisfied all its delivery requirements and its last batch of Australian vaccine stock was depleted on 12 July.
"The Commonwealth has sufficient supplies of alternative COVID-19 vaccine brands for 2024," the spokesperson said.
Why target JN.1?
While initial vaccines targeted the original strain of SARS-CoV-2 — the virus that causes COVID-19 — subsequent updates have been adjusted to protect people against Omicron variants BA.1, BA.4/5 and XBB.1.5.
Earlier this year, another Omicron variant, JN.1, spread rapidly across Australia, with NSW and Victoria recording a spike in cases and hospitalisations.
As of 25 August, it was the nation's most frequently detected variant, according to the health department.
Subsequent mutations of JN.1, known as FLiRT and FLuQE, have also emerged, with experts now also tracking the emergence of a recombinant variant called XEC overseas.
The adapted Pfizer and Moderna JN.1 vaccines were approved by the United Kingdom's regulator in July and this month, respectively.
Meanwhile, the United States Food and Drug Administration (FDA) gave in August its tick of approval to updated vaccines made by Pfizer and Moderna targeting the KP.2 variant (FLiRT), which closely resembles JN.1.
The FDA has also authorised the emergency use of an updated version of a vaccine made by a third company, Novavax, which targets the JN.1 strain.
What do we know about vaccines from Pfizer and Moderna?
Before any COVID-19 vaccine is approved for use in Australia, it must go through the TGA's independent review process, where it's tested against high safety, efficacy and quality standards.
Moderna and Pfizer produce mRNA COVID-19 vaccines which can be developed more quickly than protein-based versions made by companies including Novavax.
Infectious disease expert Paul Griffin said that, while there are no "head-to-head" studies for the updated vaccines, they are based on similar technology.
"There are some subtle differences, but none that would be substantial enough to make any claims that one is sort of better or worse than the other," said Griffin, a physician and clinical microbiologist at the University of Queensland.
Professor Adrian Esterman, chair of biostatistics and epidemiology at the University of South Australia, said there are several benefits to having a variety of vaccines available.
These benefits include the range of individual responses to different vaccines and public perceptions of choice.
"Even though the two vaccines are very similar, they might have subtle differences depending on individuals concerned," he said.
"Individuals may also prefer to choose, and being told you've only got one might put some people off."
However, his main concern is supply. He said choosing a "limited range of vaccines" was a mistake made earlier in the pandemic.
"My big concern at the moment is they (the government) are going to run into exactly the same sort of problems if they rely on a single manufacturer," he said.
While Griffin acknowledged the government and TGA would have several factors to consider, he also has reservations about returning to a single supplier.
"I would personally think having a number of options to make sure that we both have adequate supply and that we do everything we can to ensure people have a vaccine they're comfortable with would be ideal to try and make sure we have as many people vaccinated as possible," he said.
When might the new vaccines be approved?
The department said TGA approval typically takes 45 working days, with both Pfizer and Modern's applications accepted in early August.
But that doesn't mean they'll immediately be available to the public. Australia's Technical Advisory Group on Immunisation (ATAGI) has to determine dosage guidelines before any new vaccines are rolled out.
The department anticipates Pfizer JN.1 vaccines will be available in 2024-25, subject to approvals. It said all available COVID-19 vaccines continue to provide strong protection.
"Pfizer’s monovalent XBB.1.5 vaccine is available for use in eligible people six months and older," the spokesperson said.
Many earlier COVID-19 vaccines were 'bivalent', meaning they were designed to target multiple variants of the virus, but many experts now see 'monovalent' vaccines as providing improved protection because earlier COVID-19 variants are less commonly encountered.
Both the World Health Organization and the European Medicines Agency recommended in April that vaccines targeting JN.1 should be monovalent.
What about Novavax?
Another updated COVID-19 vaccine could also be coming to Australia, but it may not happen for a while.
Novovax plans to submit its JN.1 vaccine application for TGA approval "in anticipation of the 2025 season", a company spokesperson said.
It comes after the company decided to withdraw its application regarding its XBB.1.5 vaccine.
The government has an agreement with Novavax for the supply of its COVID-19 vaccine.
"The department intends to make an updated Novavax COVID-19 vaccine, from Biocelect Pty Ltd, available to eligible individuals as soon as possible following regulatory approval," the spokesperson said.
By Emma Brancatisano
While Australia's therapeutic goods regulator is evaluating two new vaccines targeting the JN.1 strain of COVID-19, the government seemingly only intends to make one available to the public.
Australians could soon have access to a new vaccine targeting a commonly detected COVID-19 variant.
However, the government has suggested that a similar vaccine made by a different company won't be publicly available, leaving some experts concerned about reliance on a single manufacturer.
Last month, applications for two vaccines targeting the JN.1 variant were accepted for evaluation by the Therapeutic Goods Administration (TGA), which approves medical products in Australia.
The two vaccines are Spikevax from Moderna and Comirnaty from Pfizer.
When SBS News asked the Department of Health whether both vaccines would be available in 2024-25, its response suggested only the Pfizer vaccine would be available.
"The department intends to make updated Pfizer JN.1 COVID-19 vaccines available to eligible individuals as soon as possible following regulatory approval," a department spokesperson said.
A department spokesperson said Moderna had satisfied all its delivery requirements and its last batch of Australian vaccine stock was depleted on 12 July.
"The Commonwealth has sufficient supplies of alternative COVID-19 vaccine brands for 2024," the spokesperson said.
Why target JN.1?
While initial vaccines targeted the original strain of SARS-CoV-2 — the virus that causes COVID-19 — subsequent updates have been adjusted to protect people against Omicron variants BA.1, BA.4/5 and XBB.1.5.
Earlier this year, another Omicron variant, JN.1, spread rapidly across Australia, with NSW and Victoria recording a spike in cases and hospitalisations.
As of 25 August, it was the nation's most frequently detected variant, according to the health department.
Subsequent mutations of JN.1, known as FLiRT and FLuQE, have also emerged, with experts now also tracking the emergence of a recombinant variant called XEC overseas.
The adapted Pfizer and Moderna JN.1 vaccines were approved by the United Kingdom's regulator in July and this month, respectively.
Meanwhile, the United States Food and Drug Administration (FDA) gave in August its tick of approval to updated vaccines made by Pfizer and Moderna targeting the KP.2 variant (FLiRT), which closely resembles JN.1.
The FDA has also authorised the emergency use of an updated version of a vaccine made by a third company, Novavax, which targets the JN.1 strain.
What do we know about vaccines from Pfizer and Moderna?
Before any COVID-19 vaccine is approved for use in Australia, it must go through the TGA's independent review process, where it's tested against high safety, efficacy and quality standards.
Moderna and Pfizer produce mRNA COVID-19 vaccines which can be developed more quickly than protein-based versions made by companies including Novavax.
Infectious disease expert Paul Griffin said that, while there are no "head-to-head" studies for the updated vaccines, they are based on similar technology.
"There are some subtle differences, but none that would be substantial enough to make any claims that one is sort of better or worse than the other," said Griffin, a physician and clinical microbiologist at the University of Queensland.
Professor Adrian Esterman, chair of biostatistics and epidemiology at the University of South Australia, said there are several benefits to having a variety of vaccines available.
These benefits include the range of individual responses to different vaccines and public perceptions of choice.
"Even though the two vaccines are very similar, they might have subtle differences depending on individuals concerned," he said.
"Individuals may also prefer to choose, and being told you've only got one might put some people off."
However, his main concern is supply. He said choosing a "limited range of vaccines" was a mistake made earlier in the pandemic.
"My big concern at the moment is they (the government) are going to run into exactly the same sort of problems if they rely on a single manufacturer," he said.
While Griffin acknowledged the government and TGA would have several factors to consider, he also has reservations about returning to a single supplier.
"I would personally think having a number of options to make sure that we both have adequate supply and that we do everything we can to ensure people have a vaccine they're comfortable with would be ideal to try and make sure we have as many people vaccinated as possible," he said.
When might the new vaccines be approved?
The department said TGA approval typically takes 45 working days, with both Pfizer and Modern's applications accepted in early August.
But that doesn't mean they'll immediately be available to the public. Australia's Technical Advisory Group on Immunisation (ATAGI) has to determine dosage guidelines before any new vaccines are rolled out.
The department anticipates Pfizer JN.1 vaccines will be available in 2024-25, subject to approvals. It said all available COVID-19 vaccines continue to provide strong protection.
"Pfizer’s monovalent XBB.1.5 vaccine is available for use in eligible people six months and older," the spokesperson said.
Many earlier COVID-19 vaccines were 'bivalent', meaning they were designed to target multiple variants of the virus, but many experts now see 'monovalent' vaccines as providing improved protection because earlier COVID-19 variants are less commonly encountered.
Both the World Health Organization and the European Medicines Agency recommended in April that vaccines targeting JN.1 should be monovalent.
What about Novavax?
Another updated COVID-19 vaccine could also be coming to Australia, but it may not happen for a while.
Novovax plans to submit its JN.1 vaccine application for TGA approval "in anticipation of the 2025 season", a company spokesperson said.
It comes after the company decided to withdraw its application regarding its XBB.1.5 vaccine.
The government has an agreement with Novavax for the supply of its COVID-19 vaccine.
"The department intends to make an updated Novavax COVID-19 vaccine, from Biocelect Pty Ltd, available to eligible individuals as soon as possible following regulatory approval," the spokesperson said.