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Pfizer Clinical Trial

12.11.2020

Polar Thermal Packaging go back a long way: collaboration on Clinical Trials has been made a valuable contribution to the Research & Development Department at Polar.

Pfizer Global Research & Development contracted Polar Thermal as the lead in cold chain package development and manufacturing. The trial was expanded to cover UK, Netherlands and the US over a 65 week period – Polar had responsibility for cold chain packaging solutions supporting clinical supply and day to day distribution activities from drug product stage through delivery to clinical site or to a subject’s residence.

Through our efforts it was possible to supply clinical sites and dispense to 84,500 subjects at over 122 locations throughout Netherlands. A small part of Capita (2,000 subjects) was the Subset study that dispensed vaccines to subjects at their residence.

Ray Goff Jr., Director Vaccines R&D at Pfizer, said: “as a key member of the Capita Partner and Logistics Team, the Polar team implemented remarkable solutions in cold chain packaging and clinical supply carriers in the face of major risks. Your collaboration with the Capita teams to identify potential risks, encountered numerous significant obstacles and you overcame these obstacles through creative problem-solving and risk mitigation.”

One example of a major risk encountered and solved was in the beginning of Capita enrolment when the Partner team determined that the ferry system from UK to France was safer than the channel tunnel during the 9/11 timeframe. While Capita vaccine supplies travelled in a van on a ferry crossing from UK to Calais an explosion occurred in the freight tunnel of the channel tunnel complex.

Normally the freight tunnel is the preferred route to cross the channel. The damage, expected to be cleared in 2-3 weeks, became a 6 month closure. The Partner’s team had already implemented the alternate plans to address this high risk area savings hundreds of thousands of Euros and avoided precious delays to the study. This is one of many actions of risk management performed by Capita Partner Team which delivered outstanding results.

At a time when clinical trials are very much in the news it is good to know that Polar Thermal have both the tools and the management to see critical projects through. You can read Pfizer’s Report of this mega-trial here – CLICK FOR MORE

Made in Britain

09.09.2020

Following a visit to a factory in Shenzhen, Polar Thermal Managing Director Paul Harrison has committed to maintaining manufacturing and production in the UK. Paul said: “I was very curious when I was shown example costings but the reality was dreadful working conditions coupled with very poor and variable quality.”

Polar have been investing in new systems in their Warminster factory and taken on additional staff, but are more committed than ever to maintain and improve standards, rather than cut corners:

Office Manager Jemma Griffiths is responsible for maintaining the company’s ISO9001 Certification and is also handling the ISO14001 Environmental Registration – “operating in an ethical way has been core to how we do business and it has become even more relevant given the pandemic. Personally, I am really proud of the way we run our business, treat our staff, customers and suppliers.”

Commercial Manager Alex Porter commented: “We can’t compete on price with the sweatshops in the Far East – we have made a choice to maintain quality and improve service – we trust in our resellers and customers that this is enough – if we start compromising on this then we are just in a race to the bottom.

It is disappointing that some of our products are being copied and imported – we have had customers call us with issues only to discover that they have unknowingly bought cheap lookalikes. Given that we manufacture bags to keep vaccines and pharmaceuticals safe we would never look to outsource our manufacturing.”

Paul added: “it is always a difficult conversation when someone calls us and says they can ‘get it cheaper from China’ – they are correct – they can, and they can get it from the UK, Made in China, but if they are going to trust the lives of their end-customers to this then it is not going to end well.”

Polar has now committed to sourcing 90% of its materials in the UK, 95% within Europe and to maintain all manufacturing in the UK.

Marking and Cutting 20 litre Vaccine Bags for the NHS

NHS Framework Agreement

25.06.2020

Eugene Cooke, National Head of Procurement NHSBT, today signed a two year extension to the framework agreement NHSBT0485 with Polar Thermal Packaging’s Managing Director, Paul Harrison.

Paul said “we have always valued the NHS as a customer, but in recent months the importance of our relationship has really sunk in so we are absolutely delighted to be doing our bit. To see our Blood, Plasma and Vaccine Thermal Transport solutions being used daily by the NHS, the life science businesses and research universities is fantastic. The team in our Warminster factory has been working extra shifts, weekends and bank holidays to support the various vaccine research programmes and we are beginning to see some positive results.”

The framework agreement is signed by the NHS Blood and Transplant Service, but also covers all European Blood Alliance members making it possible for any of the 27 countries in Europe as well as the Australian National Blood Authority, Lifeblood Australia, Canadian Blood Services and the New Zealand Blood Service to avail of the special terms. All of the test data is also available to those member countries.

Polar delivers again in Covid 19 Convalescent Plasma Trial

12.05.2020

Today another 100 Blood Plasma Systems were finished by the team in the Warminster factory. Extra shifts were put on over the Bank Holiday to keep ahead of schedule.

Whilst Oxford Univesity is leading the way the US Food & Drug Administration (FDA) has issued guidance for trials of the process.

Already accepted in China the use of antibody-rich plasma has reportedly been very beneficial for many patients.

In the UK, thousands of recovered Covid-19 patients have volunteered to give plasma for the trials, and the collection and transport using Polar Thermal Blood Plasma Systems is being scaled up.

It is important to understand that this is not being put forward as a vaccine or cure, but there is significant hope that it may reduce the symptoms and slow down the effect of the virus.

Vaccine Transport Systems

23.11.2020

Polar Thermal is ready to take whatever vaccines are made available and assist in their safe movement by air, sea, road, rail, bike or by hand – from manufacture to final delivery.

We may not know exactly what will be required but we do know that Polar Thermal will have the solution. Why? Because Polar Thermal has developed a complete range of Vaccine Transport Systems – from Bulk Vaccine Shipments to individual doses.

Trusted by major pharmaceutical and life science companies like Pfizer, Astra Zeneca and Roche not to mention our longstanding relationship with the NHS and NHS BT.

Vaccine Delivery

23.11.2020

Paul Harrison, Managing Director, appears on BBC Morning Live with Shane Brennan to discuss the difficulties of delivering Covid-19 vaccines at very low temperatures, and also the prospect of large-scale distribution of other vaccines at more manageable temperatures.

covid-19-<b>vaccines</b>-–-the-blues-and-ease-of-cold-storage

COVID-19 Vaccines – The Blues And Ease Of Cold Storage

16.11.2020

Published

(RTTNews) – The tally of COVID-19 cases has crossed the 54 million mark globally, with fatalities of over 1.31 million, according to the Johns Hopkins University. With over 11 million cases and more than 246,000 fatalities, the U.S. remains the worst-hit country by the pandemic.

An effective coronavirus vaccine is one good way to put an end to the pandemic. According to the World Health Organization, 48 vaccines targeting the SARS-CoV-2 virus are in clinical evaluation and 168 are in preclinical stage.

Vaccines must be stored properly from the time they are manufactured until they are administered. Proper storage and handling of the vaccines by maintaining the cold chain will go a long way in assuring the potency and efficacy of a vaccine. A proper cold chain is a temperature-controlled supply chain that includes all equipment and procedures used in the transport and storage and handling of vaccines from the time of manufacture to administration of the vaccine. (Source: CDC).

In this article, you will find a few stocks listed on the U.S. stock exchanges that merit attention as the companies continue to make progress with their COVID-19 shots.

1. BNT162b2 by Pfizer/BioNTech

BioNTech SE (BNTX) is developing a COVID-19 vaccine BNT162b2, in collaboration with Pfizer Inc (PFE). This vaccine candidate is under a phase III study – the pivotal, last stage on which the approval is based.

BNT162b2 is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. This vaccine is being tested at a 30 micrograms (mcg) dose level in a two-dose regimen, given 21 days apart.

In the first interim efficacy analysis of the phase III trial, conducted on November 8, 2020 by an external, independent Data Monitoring Committee, BNT162b2 has been found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.

The safety data of the vaccine is expected to be available by the third week of November after which the companies plan to seek Emergency Use Authorization from the FDA.

The European Medicines Agency and Health Canada have already begun rolling review of BNT162b2.

Pfizer and BioNTech have agreed to supply 200 million doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to European Union (EU) Member States, with an option for the European Commission to request an additional 100 million doses. If approved, the companies expect to start delivery of the vaccine to the European Union by the end of this year.

The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

BNT162b2 is said to be stable only when it is stored at minus 70 degrees Celsius or below. So, the ultra-low temperature storage may pose a significant challenge for the transport and distribution of Pfizer/BioNTech’s COVID-19 shot.

2. mRNA-1273 by Moderna

Moderna Inc.’s (MRNA) COVID-19 vaccine candidate mRNA-1273 is under a phase III study.

mRNA-1273 is a lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine, and in the phase III trial, dubbed COVE, the vaccine is being tested at a 100 mcg dose level in a two-dose regimen, given about 28 days apart.

The first interim analysis of the COVE study is expected this month, and in order for mRNA-1273 to be a success, it needs to demonstrate an efficacy of 74% or greater, according to the company. The safety data is expected to be available in the second half of this month.

The company plans to seek emergency nod from the FDA for mRNA-1273 upon positive efficacy and 2-month median safety data.

Moderna has initiated rolling submissions for mRNA-1273 in the U.K. and Canada. Swissmedic has started a rolling review of the vaccine candidate.

The storage conditions of mRNA-1273 are not as challenging as Pfizer/BioNTech’s BNT162b2 as it can be stored at minus 20 degrees Celsius.

Moderna believes it can produce about 20 million doses of mRNA-1273 in 2020 and from 500 million up to one billion doses worldwide in 2021.

3. AZD1222 by AstraZeneca

AstraZeneca PLC’s (AZN) Covid-19 vaccine, AZD1222, licensed from the Oxford University, is a recombinant adenovirus vaccine and is under phase III testing.

In the phase III trial, the vaccine is being tested at a dose of 5 × 10^10 viral particles in a two-dose regimen, given about 28 days apart.

The pivotal trial was put on hold in early September after 1 case of serious adverse reaction was reported in a participant in the U.K. However, the trials have now resumed across the world. Results from the late-stage trials are anticipated later this year.

AZD1222 can be stored at normal refrigeration temperatures of 2 to 8 degrees Celsius.

4. Ad26.COV2.S by Johnson & Johnson

Johnson & Johnson’s (JNJ) COVID-19 vaccine Ad26.COV2.S is an adenovirus serotype 26 (Ad26) vector-based vaccine that is under a phase III trial, dubbed ENSEMBLE.

The trial, initiated in late September, was temporarily paused after a study participant developed an unexplained illness. However, the trial resumed late October after an independent Data Safety Monitoring Board, which conducted a thorough evaluation, deemed it safe to do so.

In the ENSEMBLE trial, Ad26.COV2.S is being tested at a dose level of 5 × 10^10 viral particles as a single dose vaccine. Initial readout from the trial is expected early next year.

Ad26.COV2.S can be stored at normal refrigeration temperatures of 2 to 8 degrees Celsius for at least three months and it can remain stable for two years when stored at minus 20 degrees Celsius.

5. NVX-CoV2373 by Novavax

Novavax Inc’s (NVAX) COVID-19 vaccine candidate NVX-CoV2373 is under a phase III trial in the U.K.

NVX-CoV2373 is a stable, purified SARS-CoV-2 spike (S) glycoprotein made using the company’s recombinant protein nanoparticle technology that includes proprietary MatrixM adjuvant.

In the phase III trial, NVX-CoV2373 is being tested at 5 mcg dose with 50 mcg Matrix-M adjuvant in a two-dose regimen, administered 21 days apart. Interim data from the phase III UK trial are expected as soon as early first quarter 2021.

Novavax expects to begin its pivotal phase III trial of NVX-CoV2373 in the United States and Mexico by the end of November.

The transport, storage and handling of NVX-CoV2373 could be less challenging as the vaccine is stable at normal refrigeration temperature of 2 to 8 degrees Celsius.

6. CVnCoV by CureVac

CureVac N.V.’s (CVAC) COVID-19 vaccine candidate CVnCoV is an mRNA-based vaccine that is under a phase IIa clinical trial in Peru and Panama.

The company plans to initiate a pivotal phase IIb/III clinical study of CVnCoV by the end of this year. This trial will test 12 mcg of CVnCoV in a two-dose regimen, given 28 days apart.

CVnCoV has the potential to fulfill standard vaccine cold chain requirements, as it is said to remain stable for at least 3 months when stored at 5 degrees Celsius and up to 24 hours as ready-to-use vaccine when stored at room temperature.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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BBC Radio Wiltshire

12.11.2020

Paul Harrison, Managing Director, is interviewed by James Thomas about the requirements for delivering Pfizer’s Covid-19 Vaccine. Polar Thermal has paid a major part in the past with Pfizer’s Cold Chain Dristribution.

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