Germany advises against Oxford/AstraZeneca for over 65s | Alds

The Morrison Government has reassured Australians they have bought “three times” the number of vaccines needed to vaccinate the entire population.

Mr Hunt said even in the event there were issues with import slowdowns from Europe that Australia was well-placed to secure enough vaccine particularly as a result of onshore manufacturing capability at CSL.

“We are already prepared for all of the possible options,’’ Mr Hunt said.

“We have a total vaccine supply of approximately 140 million doses for a population of 25.5 million, requiring two doses per person, so we have strong levels of vaccine, but we also have a range of options for roll out, which have already been prepared for all circumstances.”

There are also reassuring signs today that a third vaccine in Australia’s sights, Novavax, has a 95.6 per cent efficacy against the original COVID virus strain and 85 per cent against the UK strain.

It may turn out that after Australia has been vaccinated with AstraZeneca – which has an efficacy rate of between 70 per cent and 90 per cent depending on the dosage – that we switch to Novavax to provide boosters.

It’s not yet clear whether those boosters would be annually or every few years.

“Professor (Brendan) Murphy this week and all of our medical advisors have been absolutely clear throughout that we do not yet know, not Australia, but the whole world does not yet know the longevity of immunity, that will be determined in what will be the greatest global vaccination program the world has yet seen,’’ Mr Hunt said.

“There will be ample evidence for the world but that evidence is not yet known. The strategy has been carefully constructed.”

Australia remains on track for a late February commencement of the vaccine rollout.

“With regards to the 50 million doses of onshore production of the AstraZeneca vaccine by CSL, firstly, we are not just on track but we announced this week that we are ahead of schedule for the delivery of the CSL doses,’’ Mr Hunt said.

“The first doses have been brought forward to an expected late March supply of approximately 1 million per week and under current guidance is that we will receive approximately 2 million doses during the close of late March from CSL, of the AstraZeneca vaccine, as it is produced in Australia.

“Always, we are subject to production, distribution and shipping challenges.”

Foreign Minister Marise Payne has confirmed that DFAT will be making representations through the World Health Organization and through various European agencies and relevant countries about ensuring that our supply is guaranteed on a continuous basis.

“Then in relation to AstraZeneca, I understand that yesterday, Professor John Skerritt, the head of the TGA, spoke to the Senate committee in particular, he noted that there was no evidence relation to any risk with regards to effectiveness or other elements, with regards to over 65 is being negative,’’ Mr Hunt said.

TGA ‘CAREFULLY CONSIDERING’ VACCINE USE FOR ELDERLY

Australia’s vaccine safety regulator says it is “carefully considering” the use of the AstraZeneca vaccine in seniors after Germany advised against it.

The Therapeutic Goods Administration is expected to make a final decision next week.

“The AstraZeneca COVID-19 vaccine candidate remains under evaluation by the TGA,” the TGA said today.

“All matters are being carefully considered as part of that process, including the evidence supporting immunisation in various age groups. TGA’s decision will also be informed by the Advisory Committee on Vaccines (ACV), an independent group of clinical and technical experts.”

But the Health Department said the current evidence confirmed the vaccine was generally well tolerated and effective.

“On November 23, 2020, AstraZeneca announced that its COVID-19 vaccine was up to 90 per cent effective in participants who received a half dose followed by a full dose,” it said.

“Further analysis of clinical trial data across multiple different dosing regiments showed that the vaccine efficacy is 70.4 per cent effective at preventing symptomatic COVID-19 more than 14 days after the second dose.

“The AstraZeneca/Oxford vaccine clinical trials demonstrated the vaccine is generally well tolerated and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.”

GERMANY ADVISES AGAINST VACCINE FOR OVER 65S

It comes after Germany’s decision to advise against the use of the Oxford/AstraZeneca jab in over 65s overnight raised fresh concerns over Australia’s vaccination strategy.

As Australia’s Therapeutic Goods Administration prepares to approve the AstraZeneca vaccine for use as early as next Friday, Germany has sparked worldwide headlines for recommending against its use on seniors.

Germany’s caution in rolling out the AZ vaccine for over 65s basically comes down to a lack of data, not safety or side effects.

“There is currently insufficient data available to assess the vaccine efficacy from 65 years of age,” the standing committee on vaccination of the Robert Koch Institute, Germany’s disease control said overnight.

“The AstraZeneca vaccine, unlike the mRNA vaccines, should only be offered to people aged 18-64 years at each stage.”

But that could pose a big problem if Australian experts recommend a similar approach, because it’s the main vaccine we are using to cover the majority of Australians.

Australia has purchased 50 million doses of the Oxford/AstraZeneca jab which is enough to vaccinate the entire population.

Because the vaccine is a two-shot jab 50 million doses will vaccinate 25 million people.

That compares with just 10 million doses of the first vaccine approved by the TGA for use in Australia, the Pfizer vaccine which is enough to vaccinate five million people.

The issues raised by Germany are not new and were in fact first flagged in the Lancet on December 8.

There’s no suggestion the vaccine is unsafe or won’t work in older people. Just a concern that not enough older people have been involved in the original trial.

Here in Australia, AstraZeneca’s local representatives told news.com.au that more reassuring information on its efficacy in older people will be published within days.

“The latest analyses of clinical trial data for the AstraZeneca/Oxford COVID-19 vaccine support efficacy in the over 65 years age group,’’ a spokesperson said.

“We await a regulatory decision on the vaccine by the European Medicines Agency (EMA) in the coming days.”

Australia’s chief medical officer Paul Kelly has previously backed the vaccine as “a good vaccine” noting most of the issues were first raised months ago and are being carefully considered by the Therapeutic Goods Administration.

“The AstraZeneca vaccine is effective, it is safe, and it’s a high quality vaccine. But those are the things that the TGA will be looking at with their full approval coming very soon,’’ he said.

“I would say that the one thing that we do have in the public domain is The Lancet paper, the published paper on the interim results of their Phase 3 trials, which was published a month ago, more than a month ago, on December 8 – I read it on that same day.

“I’m not sure why some people – I would dispute that they are the medical experts – are now disputing that particular set of data. But that’s a small component of what the TGA will be looking at, and we’ll be guided by their assessment of the vaccine.”

Researchers found very similar immune responses in younger and older adults.

But they noted there were not enough older people in the original trials to reach any final conclusions.

While some seniors in nursing homes will get the Pfizer jab as part of the early program of vaccination, most Australians will get the AstraZeneca vaccine.

Germany’s decision to advise against use in over 65s is not the approach being taken in the United Kingdom, which suggests Australia may not follow the German example.

But it does follow other concerns raised about the AstraZeneca vaccine, which relate to the fact it has a lower efficacy rate compared to the Pfizer vaccine.

Earlier this week, a German newspaper claimed the vaccine had as low as 8 per cent efficacy in older adults – claims that were rejected as completely untrue by AstraZeneca and other experts.

“Reports that the AstraZeneca/Oxford vaccine efficacy is low in adults over 65 years is not an accurate reflection of the totality of the data. The latest analyses support efficacy in this age group, which we expect to be published by the EMA (European Medicines Agency) in the coming days,” AstraZeneca said.

The bigger controversy in Australia has been around AstraZeneca reporting an efficacy rate below the 90 per cent reported by Pfizer.

But it remains central to Australia’s strategy because it can be manufactured here in Australia at CSL.

That means we are less vulnerable to being stuck in the queue with other countries or affected by recent threats to exports in the European Union.

Australian health officers have argued vaccinating the entire population with AstraZeneca is more effective than vaccinating 20 per cent of the population with a “better” vaccine.

“Well, the advantage of the AstraZeneca vaccine is that we do have it here in Australia, it’s being made in Australia,’’ Prof Kelly said earlier this month.

“There will be plenty to vaccinate the entire population of Australia twice. The choice of the vaccines was based on the best medical advice that we had last year.

“We had to take a chance in a sense about several vaccines. We picked a diversified portfolio and the AstraZeneca vaccine has now published their interim results from their phase 3 clinical trial. That was in early December, I read it the same day, and we’ve been, continue to be guided by that information.

“But most importantly, we are waiting for the TGA, the Therapeutic Goods Administration here in Australia, the independent regulator to make their full assessment of the data, not just one paper in The Lancet on December 8.”