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European regulator says Pfizer can be stored in fridges for 31 days


Matt Woodley


18/05/2021 6:12:17 PM

Should the TGA follow suit, it could pave the way for greater general practice involvement in the COVID vaccine rollout.

Frozen Pfizer COVID-19 vaccine vials.
The Pfizer COVID-19 vaccine initially had to be stored at -70°C prior to use. (Image: AAP)

RACGP Vice-President Dr Bruce Willett told newsGP the announcement is ‘brilliant news’ and will improve Australia’s chances of reaching ‘something close to herd immunity’.
 
‘It’s a really important development that [should] allow general practice to become involved in that under-50 vaccination group, which is fabulous,’ he said.
 
‘They’re going to be a difficult group to reach at the best of times, because they have less fear of COVID. So having the convenience of being vaccinated at their local GP will be very important.
 
‘It’s such a large group of people, we’re going to need all hands on deck to get them vaccinated. So it’s a fabulous development for the Australian community, and gives us the opportunity to get back to some sort semblance of normality and protect the community.’
 
The Human Medicines Committee at the European Medicines Agency (EMA) recommended the change after assessing additional stability study data submitted by Pfizer.
 
It extended the approved storage period of unopened, thawed vials of Pfizer’s COMIRNATY vaccine at 2–8°C from five days to one month (31 days), in the process reducing logistical barriers that have so far prevented general practices from offering the mRNA vaccine.
 
The Therapeutic Goods Administration (TGA) has not yet publicly responded to the EMA’s determination, but last month joined the European regulator in relaxing storage requirements for COMIRNATY, less than two weeks after it had announced the vaccine could be stored in normal freezers.
 
GP Dr Nathan Pinskier, who owns multiple practices and has recently noticed greatly reduced demand for COVID vaccines, told newsGP he has received ‘multiple ongoing requests’ from eligible patients of all ages and backgrounds regarding the availability of the Pfizer COVID-19 vaccine.
 
‘At the present time these patients have to be either referred to a tertiary hub, or if they’re under 50 years old, they simply have to wait,’ he said.
 
‘Many general practices would be keen to provide the Pfizer vaccine to their patient population and now that the storage standards have been revised [overseas], we look forward to [hopefully] being given the opportunity to do so.’
 
According to Dr Mukesh Haikerwel, who has been involved in the COVID vaccine rollout from the beginning, the rise in vaccine hesitancy – fuelled by reports of rare blood clots related to AstraZeneca vaccinations – has also led to patients trying to engage in ‘vaccine shopping’ at his clinic.
 
However, he is not convinced that the ability to offer Pfizer will solve the issue until there is ‘ample’ supply, which will likely not occur until at least the final quarter of 2021.
 
‘People are getting aggressive about not being able to get access to their [preferred vaccine],’ he told newsGP.
 
‘There’s a false narrative that says “AstraZeneca, bad. Pfizer, good. If I get AstraZeneca, I’m being short-changed and I deserve Pfizer”. And that’s just wrong.
 
‘They’re all good vaccines. They should all be used. And they can all be used safely, in the right age groups.
 
‘When we have ample amounts of all vaccines, then we’ll have less of those irritating problems.’
 
And while the potentially reduced logistical demands could allow general practices to eventually access Pfizer vaccines – which at this stage are still restricted to state vaccination hubs and Commonwealth vaccine centres – Dr Haikerwal says there will be other complications to overcome.
 
‘One is to actually have doses in the country,’ he said. ‘The second is to actually have it in the fridges, and [have plans in place that] allow that to happen, which is all driven by the Commonwealth.’
 
Another issue is that Pfizer vaccines, like AstraZeneca, are also delivered in multiple-dose vials.
 
‘So when you crack the ampoule, you’ve got to use it because you don’t want to waste it,’ Dr Haikerwal said.
 
‘And that means you’ve got to have floor space, you’ve got to have personnel, you’ve got to have access to parking, and you’ve also got to have patients wanting the vaccine.
 
‘The underlying problems still exist.’
 
Meanwhile, should general practices eventually receive access to Pfizer vaccines, Dr Willett says GPs will need to carefully plan how they structure their clinics alongside the administration of Astrazeneca doses.
 
‘Every practice will do this somewhat differently. But, I know in my practice, my initial reaction would be to do them in separate clinics, in the same way as we do flu clinics separately to COVID clinics,’ he said.
 
‘You do develop a system of double-checking everything and consenting, and you get into a groove where you can cover everything you need to cover off, not miss anything, and do it safely.
 
‘Swapping backwards and forwards would actually reduce the efficiency of that, and it needs to be done quite efficiently to get the job done. So I think it’s going to be a safety and efficiency measure.
 
‘It just reduces the chances of error ... you don’t want to accidentally give the wrong one.’
 
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Dr Jitendra Natverlal Parikh   19/05/2021 2:12:44 PM

Great news Our high profile cooleagues like nathan and mukesh are talking big and probably irrelevant in the sense that any GPs can handle this burden with or withoou practice nurse. I usually check with pateint the ampoule and drawing up with my secretary standing by and it is safe. we need to offer both with common sense evidence based approach.We need here as a GP to show firm kind leadership


Dr Wasan Haider Maghazaji   20/05/2021 9:34:14 AM

Having access to Pfizer vaccine will certainly help improve numbers of immunized patients & improve herd immunity.