Tag Archives: Pfizer
Health Minister Hunt failed to take up Pfizer’s June 2020 invitation to meet
Michelle Grattan, University of CanberraDocuments show Pfizer reached out in June 2020 for a meeting with federal Health Minister Greg Hunt, but he did not take up the invitation.
Labor obtained the documents under freedom of information and the opposition health spokesman Mark Butler said they showed the government “took a deliberate ‘wait and see’ approach to vaccine deals”, a claim Hunt rejected in a statement late Wednesday.
Inadequate supplies of Pfizer slowed the rollout, becoming an increasing problem after AstraZeneca was set back by health warnings for some age groups and resultant hesitancy among many people.
The government announced in November last year it had an agreement to obtain ten million Pfizer doses. More were subsequently purchased, but the supply timetable left persistent shortages.
The government scrambled to bring forward some of the Pfizer doses and recently Scott Morrison intervened with some vaccine diplomacy to get extra doses from Poland, Singapore and Britain. Efforts to get doses from the US failed.
The documents include a letter from the managing director of Pfizer Australia to Hunt dated June 30 2020 requesting “a meeting with you to open discussions regarding your planning for potential COVID-19 vaccination programs”.
“I would welcome an opportunity to discuss our candidate vaccine development in more detail, and open discussions on how we might work together to support planning for potential COVID-19 vaccinations in Australia and continue to build a strong partnership for the future.”
The letter said Pfizer would “be in touch to schedule a meeting. I look forward to meeting you and working with you into the future.”
It canvassed progress on developing a mRNA-based vaccine that, if approved, “could be deployed at unprecedented speed for the prevention of COVID-19 infection”.
The letter foreshadowed Pfizer had the potential to supply millions of vaccine doses by the end of 2020, subject to technical success and regulatory approvals and hundred of millions in 2021.
A covering email from a Pfizer representative noted a request for a formal engagement opportunity with members of the Vaccines Taskforce.
Senior members of Pfizer’s global leadership team would be available for this “particularly if the Minister and/or Departmental leadership can be involved,” it said.
“As the vaccine development landscape is moving swiftly, including through engagements with other nations, I am requesting this meeting occur at the earliest opportunity,” the email said.
On July 3 Lisa Schofield, first assistant secretary, health economics and research division, in the health department, wrote to say she was managing the whole of government work on COVID vaccine and would appreciate an opportunity to talk about Pfizer’s plans.
Pfizer wanted a confidentiality agreement for any detailed talks, which would include several senior global representatives. The alternative it put up was a more general exploratory session, with local Pfizer representatives, including the MD of Pfizer Australia.
Schofield said the confidentiality agreement was being considered, although it was not the government’s usual practice to sign such documents. She proposed the more general session adding “we can always line up subsequent ones as needed”.
On July 23 Pfizer drew Schofield’s attention to “recent news of Pfizer’s agreements with the UK and US on vaccine supply”.
Hunt said in a statement that “both Pfizer and the Health Department have consistently confirmed, including on the public record at Senate Estimates, that the Australian government entered into formal discussions on the purchase of vaccines, as soon as the company was in a position to do so, and were in discussions prior to this”.
“When formal discussions began, no country had a contract with Pfizer.”
Hunt said there had been regular discussions with the minister’s office and Pfizer, including a meeting on 26 June 2020, initiated by his office. This was referenced in an email in the documents, and was followed by the June 30 letter, he said.
“The Australian government moved immediately to formal negotiations with the first step being to agree and negotiate a Confidentiality Disclosure Agreement.”
Hunt said the reference to millions of doses was about global capacity, not to what was on offer to Australia.
Michelle Grattan, Professorial Fellow, University of Canberra
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Coronavirus Update: Australia
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Coronavirus Update: Global
Pfizer vaccinations for 16 to 39-year-olds is welcome news. But AstraZeneca remains a good option
Josh Bachman/AP/AAP
Catherine Bennett, Deakin UniversityPrime Minister Scott Morrison yesterday announced the Pfizer vaccine would become available to all Australians aged 16 to 39 from August 30.
This represents a vote of confidence in our vaccine supply, which has been riddled with issues since the rollout began. It gives us a fighting chance to reach current targets, which suggest 70% of eligible Australians could be fully vaccinated by November, and 80% by December.
Importantly, given what we know about the high rates of COVID infections in younger people, and the significant role they’re playing in transmission, this is good news. Boosting vaccination rates in this group will be a crucial step towards controlling the virus.
And with some young adults in different states already eligible for the Pfizer vaccine (depending on where they live, their job, and so on), this move will hopefully serve to reduce confusion.
Why vaccinating younger adults is important
Throughout New South Wales’ current COVID outbreak, we’ve heard young people are being disproportionately infected. We’re hearing this in Victoria too.
In part, this is because this group is generally more mobile, both in the nature of their work and social lives. Of course, the latter shouldn’t be relevant under lockdown conditions, but younger adults are also more likely to live in shared households with essential workers from different workplaces.
While 20 to 39-year-olds have made up the highest proportion of cases throughout the pandemic, the growing numbers of older adults now vaccinated could go some way to explaining why younger adults and children are making up an even greater proportion of infections of late.
Worryingly, data from the NSW outbreak also suggests young people are making up a higher proportion of patients admitted to hospital with COVID-19 compared to earlier in the pandemic.
Given young adults make up a high number of cases, it follows they are big drivers of transmission. The Doherty Institute’s recent modelling described young and working age adults as “peak transmitters” of COVID-19, and advocated vaccinating people in their 20s and 30s would reduce overall spread.
It made sense to prioritise people at highest risk of severe outcomes from COVID-19, as well as those in high-risk jobs, for vaccination earlier on. But there’s a fair bit of catch up to do now to get these younger age groups vaccinated.
For example, 33.5% of 35 to 39-year-olds have received one dose of a COVID vaccine, compared to 86.1% of 75 to 79-year-olds. Some 25% of 25 to 29-year olds have had a first dose, compared to 76.1% of 65 to 69-year-olds.
Opening up Pfizer for everyone aged 16 to 39 will allow us to boost numbers in those younger age groups and in turn, reduce infections and transmission.
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Don’t dismiss AstraZeneca
This news should be impetus for anyone currently eligible for Pfizer who hasn’t got it yet (predominantly adults in their 40s and 50s) to make an appointment as soon as possible. Because it’s only going to get harder once millions more people become eligible.
For people aged 16 to 39 who are champing at the bit for a Pfizer vaccine, it’s important to be aware you probably won’t be able to get one the day bookings open. It may well be that you have to wait weeks for an appointment.
So if you were already considering getting the AstraZeneca vaccine, or if you’ve already booked an appointment, stick with that.
It’s a highly effective vaccine, the risk of any complication is incredibly small, and the benefits are significant — particularly in areas like Sydney, where we’re seeing high community transmission and young people fighting the virus in ICU.
tga.gov.au
What about a ‘mix and match’ approach?
While supply of Pfizer is increasing, and we expect to start receiving Moderna next month, daily demand for these mRNA vaccines is still outpacing supply.
One possible way to address this would be to give some people a first dose of AstraZeneca, and then a second dose of Pfizer. This would allow us to start vaccinating more people sooner and stretch the Pfizer supply further.
This “mix and match” approach is already being explored in a number of countries. Data are showing not only is it effective, but it could provide better protection than two doses of the same vaccine.
Ensuring everyone has the rights that come with vaccination
Vaccination is becoming increasingly important, not only in the face of current Delta outbreaks, but for personal movements and freedoms as rules are introduced that recognise the lower risk of infection among the vaccinated.
For example, people travelling from NSW into Western Australia need to prove they’ve had at least one dose of a COVID vaccine.
Meanwhile, some countries around the world are requiring proof of vaccination to visit the likes of museums, cinemas and to dine indoors — activities that might not be open at all in the absence of vaccination.
Broadening the vaccine rollout to younger people now ensures they will have time to access vaccination and won’t be disadvantaged by any such rules down the track.
Catherine Bennett, Chair in Epidemiology, Deakin University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
If you’re over 60, there’s no sense in ‘waiting for Pfizer’. Here’s why you should get AstraZeneca today
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Nancy Baxter, The University of Melbourne and Benjamin Veness, CQUniversity AustraliaAt least 60 people have now died in the current New South Wales COVID outbreak.
We’ve been keeping track of how old these people were, and have observed 85% of the COVID deaths up to August 18 (51 out of 60) were among people aged over 60.
We’ve also been taking note of reports on their vaccination status. It appears 96% of those over 60 who have died (49 of 51) were not vaccinated, or had only received one dose.
These deaths are tragic and, in all likelihood, were preventable. So if you’re over 60 and are yet to be vaccinated, now is not the time to hesitate.
Older age increases your risk from COVID-19
Age is a major risk factor for serious illness and death from COVID-19.
A person aged 65-74 is at six times greater risk of hospitalisation and 95 times greater risk of dying compared to an adult under 30.
People over 85 are 15 times more likely to be hospitalised and 600 times more likely to die than 18 to 29-year-olds.
This is why Australia’s vaccination program has prioritised older adults.
So why do people in this age group remain unvaccinated?
Most older Australians are vaccinated
It’s important to acknowledge that of the 5,632,555 Australians aged 60+, more than 4.4 million (79%) have had a first dose of a COVID-19 vaccine.
This ranges from 71% for 60 to 64-year-olds, to 86% for 75 to 79-year-olds.
So despite the criticism of Australia’s vaccination program, more than three-quarters of Australians aged 60+ have at least partial protection from COVID-19.
Still, that leaves 1.2 million Australians aged 60+ yet to receive a first dose of any COVID vaccine, despite having been eligible for vaccination for several months.
Read more:
A history of blood clots is not usually any reason to avoid the AstraZeneca vaccine
What are they waiting for?
For a variety of reasons, no vaccine ever achieves 100% take-up. But most Australians over 60 want to be vaccinated. Surveys have shown over 65s are the least hesitant age group. As of August 7, only 6.75% of adults over 65 were unwilling to be vaccinated.
Some people have experienced difficulty accessing the vaccine. In particular, we need to improve access in areas which are more vulnerable to COVID outbreaks.
But according to data from the Australian Bureau of Statistics published last month, around 25% of unvaccinated people over 70 are waiting for a different vaccine option.
We can read this to mean they’re waiting for what they perceive to be a “better” vaccine — an mRNA vaccine from Pfizer or Moderna.
Sadly, with the NSW outbreak escalating, and the increasing frequency and likelihood of COVID outbreaks across Australia, some of these folks may die waiting.
AstraZeneca is a highly effective vaccine
The vaccine for which all people aged 60+ in Australia are currently eligible is AstraZeneca.
While adequate supply of the Pfizer vaccine has been an ongoing issue and shipments of the Moderna vaccine are yet to commence, AstraZeneca is being produced in Australia and is widely available.
But not everyone is keen on it.
Read more:
Australians under 60 will no longer receive the AstraZeneca vaccine. So what’s changed?
Some of the lack of enthusiasm surrounding the AstraZeneca vaccine relates to the perception it is less effective than Pfizer.
The most important outcome, however, is prevention of serious illness from COVID-19, and both vaccines perform similarly well on this metric after two doses. Recent modelling from the Doherty Institute assumed an 86% reduction in hospitalisation with the Delta variant after two doses of AstraZeneca, compared to 87% after two doses of Pfizer.
For deaths from Delta, the difference is also very small. The AstraZeneca vaccine is believed to achieve a 90% reduction after two doses, compared to 92% with Pfizer.
Although milder COVID-19 infections occur more commonly in people who have been fully-vaccinated with AstraZeneca, “breakthrough” infections also occur with Pfizer.
So, the benefits of AstraZeneca are clear and the differences between AstraZeneca and Pfizer in terms of effectiveness against the most worrisome outcomes of COVID-19 are very small.
But what about the risks?
Both vaccines have common side effects including pain at the injection site, fatigue and headache. While these side effects are more common with AstraZeneca, they don’t last long with either vaccine.
So that brings us to blood clots. In March, just weeks into the launch of Australia’s vaccination program, reports emerged of a rare clotting syndrome following use of the AstraZeneca vaccine.
Named thrombosis with thrombocytopenia syndrome (TTS) to describe the unusual combination of serious blood clots with a low platelet count, the discovery of this significant complication saw changes to COVID-19 vaccination guidelines in many countries, including Australia.
Deaths from TTS have received extensive coverage in the media, and concern about this condition is undoubtedly a key reason for reluctance towards AstraZeneca.
But importantly, the risk of TTS is small, and becomes lower as you get older (the opposite of the risk from COVID-19). The Australian Technical Advisory Group on Immunisation has estimated below age 60, the incidence of TTS is 2.7 per 100,000 doses. Over age 60 the incidence is thought to be 1.8 in every 100,000 doses.
Of 112 cases of confirmed or probable TTS that have occurred in Australia to date, a total of six people have died. One was over 60 (a 72-year-old woman).
Based on these statistics, if the 1.2 million Australians over 60 not yet vaccinated all received AstraZeneca, we would expect about 22 to develop TTS and one or two of them to die.
While these are serious albeit rare complications, remember that in NSW, in an outbreak with close to 10,000 cases of COVID-19 diagnosed to date, more than 50 people over 60 have already died and more will unfortunately follow.
Read more:
Over 18 and considering AstraZeneca? This may help you decide
Balancing the risks and the benefits
Balancing risks and benefits is key to informed decision-making before taking any medication; none are risk-free.
For those 1.2 million Australians over 60 yet to be vaccinated, the benefits of taking the vaccine available now — AstraZeneca — are high, and for most people will outweigh the small risks.
The threat of COVID-19 is no longer theoretical, especially for those living in Sydney and other major metropolitan cities.
And this year’s jabs will not be the last over 60s receive. While it’s very likely mRNA boosters (Pfizer and Moderna) will be offered in 2022, you’ll need to be alive to get one.
Nancy Baxter, Professor and Head of Melbourne School of Population & Global Health, The University of Melbourne and Benjamin Veness, Adjunct Professorial Fellow, CQUniversity Australia
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Pfizer from Poland directed to young super spreaders
Michelle Grattan, University of CanberraPeople aged 20-39, who were identified by the Doherty Institute modelling as super spreaders of COVID, will be targeted for the one million Pfizer doses the Morrison government has purchased from Poland.
Of these, 530,000 doses will be sent urgently to a dozen Sydney local government areas, where the outbreak remains out of control. They will start being administered in state clinics this week, Scott Morrison said.
He said the allocation to NSW “will give everyone aged 20 to 39 years in the 12 LGAs the opportunity to be vaccinated”.
The Doherty modelling said: “As supply allows, extending vaccinations for adults under 40 years offers the greatest potential to reduce transmission now that a high proportion of vulnerable Australians are vaccinated”.
When the modelling was recently released Professor Jodie McVernon, Director of Epidemiology at the Doherty Institute, said the 20 to 39 year olds were “the peak spreaders” of the virus.
“They will bring COVID home to their children, they will take it home to their own parents, and this is the group now where we’re proposing the reorientation of the strategy,” she said.
In the heartland of the Sydney outbreak many of this age group are necessarily mobile because they are in essential jobs and unable to work from home.
Sunday saw 415 new locally acquired NSW cases announced and four deaths. Late Saturday the state government locked down the whole of regional NSW. Victoria recorded 25 new cases and the ACT two, in Sunday’s announcements.
NSW Premier Gladys Berejiklian said:“The experience of Delta is that no other jurisdiction has been able to eliminate it. It’s not possible to eliminate it completely. We have to learn to live with it. But the best chance we have to live with it freely and safely is to get the case numbers down as low as possible.”
A particular concern is the spread of the disease into regional areas of NSW where there are vulnerable Indigenous populations.
The Pfizer doses from Poland were set to begin landing in Australia on Sunday night.
The rest of the vaccines will be distributed on a per capita basis to other parts of the country, to accelerate the vaccination of the under 40s and high risk groups.
“Within days of landing in Australia, these extra Pfizer doses will be available to go into the arms of young Australians in our hardest hit COVID hot-spots,” Morrison said.
“These young Australians are often the backbone of our essential workforce and these doses will not only protect them, but their loved ones, their state and our nation.”
He thanked Polish Prime Minister Mateusz Morawiecki and the Polish government “for their generous support of Australia’s COVID-19 response, during this challenging time”.
The vaccines were produced at Pfizer’s Belgium facility.
The federal government has been pulling out all stops internationally to try to get more Pfizer.
Michelle Grattan, Professorial Fellow, University of Canberra
This article is republished from The Conversation under a Creative Commons license. Read the original article.
What do I need to know about the Moderna vaccine? And how does it compare with Pfizer?
Archa Fox, The University of Western Australia and Thomas Preiss, Australian National UniversityAustralia’s medical regulator has provisionally approved another COVID-19 vaccine, Moderna, for use in Australia.
One million doses of Moderna are due in the second half of September and three million doses a month will begin to arrive from October.
Read more:
Australia’s vaccines boosted with provisional approval for Moderna
Like Pfizer, Moderna is an mRNA vaccine. So how does it work, and what are the similarities and differences with Pfizer?
Remind me, how do mRNA vaccines work?
mRNA is a temporary genetic instruction that tells our cells to make a particular protein. It consists of a central portion with the genetic code for the protein and shorter portions either side that are important for the “readability” of the code.
The mRNA is wrapped in an oily coat that helps it enter our cells. The mRNA gets broken down quite quickly after it is delivered and used.
The Pfizer and Moderna vaccines were designed with the same goals and principles: to make an mRNA (genetic instruction) for the spike protein found on the surface of the SARS-CoV-2 virus (which causes COVID-19).
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Body cells near the vaccine injection site will make the spike protein, display it on their surface and trigger the immune system to learn how to fight the actual virus if it encounters it.
Do Pfizer and Moderna work any differently?
The vaccines are remarkably similar overall, with just a few technical differences. The two mRNAs are based on the same chemistry and produce the same spike protein variant.
But the mRNA sequences differ in two ways: the exact “wording” of the genetic code for the spike protein; and the shorter portions outside the actual genetic code that determine its “readability”.
The two companies also use different oily coatings in their formulations.
How many doses for Moderna? And how far apart?
Despite their similarities, the Moderna doses have more than three times the amount of mRNA material (100 micrograms), compared to Pfizer (30 micrograms).
The dose spacing is also different: three weeks apart for Pfizer and four weeks for Moderna.
These differences may be due to those small technical differences highlighted above.
Alternatively, given the great urgency of developing and trialling the vaccines, it’s also plausible both manufacturers ran out of time to fully test different formulations and timelines, and simply went with the amounts and spacing that produced the desired results.
How effective is Moderna at preventing COVID-19?
Large phase 3 clinical trials showed the Moderna vaccine was 94% effective at preventing severe disease, and Pfizer was 95% effective.
Read more:
What is the Moderna COVID vaccine? Does it work, and is it safe?
Newer studies based on real-world data of millions of vaccinated people in many countries have shown Moderna and Pfizer vaccines are:
- 80-90% effective at preventing asymptomatic infection
- 90% effective at preventing symptomatic infection
- 95% effective at preventing hospitalisation.
The Moderna vaccine has been approved for emergency use in many countries including the United States, many European Union countries, Canada, the United Kingdom, Israel and India, among others.
Several studies, only some of which have been peer-reviewed, indicate both Pfizer and Moderna vaccines are highly effective against the Delta variant, although there is a slight reduction compared to the original viral strain.
Are there any side effects?
Both vaccines have some side effects common to most vaccines, including some soreness at the injection site, fatigue and headaches.
There is an association, but not a causal link between a slight increase in incidence of myocarditis (inflammation of heart muscle) and pericarditis (inflammation of the lining of the heart) with both Pfizer and Moderna vaccines.
These conditions are more common in young men and are generally treatable and not fatal; most patients make a swift recovery.
Read more:
The benefits of a COVID vaccine far outweigh the small risk of treatable heart inflammation
For both Moderna and Pfizer vaccines the rates of anaphylaxis (extreme allergic reaction) are similar, and extremely low (two to four cases per million).
How long does the immunity last?
Moderna recently announced no change in efficacy six months after participants received their COVID-19 vaccines, with a 93% protection against severe disease after six months, compared to 94% reported in the clinical trial.
Pfizer has reported similar data, with protection sitting at 84% after six months.
No longer term effectiveness studies have been possible, as the wide-scale vaccine rollout only commenced at the end of 2020.
What about storage and transport?
Moderna requires a -50°C to -15°C range during transport and long-term storage (until the expiration date is reached) and this can be achieved with standard freezers.
In contrast, the Pfizer vaccine needs to be transported and stored at temperatures below -60°C, needing dry ice and ultra-cold freezers. Then, undiluted Pfizer vaccine can be stored in a regular freezer (between -25°C and -15°C) for up to two weeks, or in a fridge (between 2°C and 8°C) for up to four weeks.
How much Moderna is coming to Australia?
Moderna is approved for use in adults aged 18 and over. Australia’s medicines regulator, the Therapeutic Goods Administration (TGA) is currently reviewing an application from Moderna to approve the vaccine’s use in children aged 12 and over.
Prime Minister Scott Morrison says planning is underway for Moderna vaccines to be rolled out through approved pharmacies and other providers from September, after the government receives advice from its immunisation advisory group ATAGI.
Ten million Moderna doses will arrive during 2021: one million in the second half of September and nine million doses due by December.
That compares with plans to roll out four million Pfizer doses in September, ten million in November and six million in December.
Next year, 15 million Moderna doses are due to arrive; these will be reserved as booster shots. A further 60 million Pfizer doses will also be available in 2022.
It’s likely Australians in eligible groups will be offered either Moderna or Pfizer and given their similarities, it really doesn’t matter which one you have – they’re both very effective.
Read more:
Can the Pfizer or Moderna mRNA vaccines affect my genetic code?
Archa Fox, Associate Professor and ARC Future Fellow, The University of Western Australia and Thomas Preiss, Molecular biologist, Australian National University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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