There is great urgency. There is also growing hope.
UPS Healthcare is teaming up with global vaccines company, Novavax, to distribute the company's newly authorized COVID-19 vaccine to customers around the globe, with shipments beginning this week to countries across the European Union (EU).
It is the first protein-based vaccine granted Conditional Marketing Authorisation by the European Commission against the SARS-CoV-2 virus that has plagued the world for the last two years. The COVID-19 pandemic has sickened more than 400 million people and left nearly six million dead.
The Novavax vaccine brings a ray of new hope. In two large clinical trials, the vaccine was approximately 90 per cent effective immunising people age 18 and older against COVID-19. In both trials, the Novavax vaccine demonstrated 90% efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and malaise.
Created using an innovative ap and well-understood recombinant protein platform used for decades to manufacture vaccines such as influenza, shingles and HPV, the Novavax vaccine is stable at 2°C-8°C, about the same as a comfortable outside temperature on a crisp autumn day.
The combination of these characteristics makes the Novavax vaccine a potential transformative player for regions where vaccination rates have not yet been maximised and for remote places that use standard refrigeration supply chain.
"UPS Healthcare is prepared to distribute this vaccine flawlessly in the EU and worldwide. We have demonstrated throughout the pandemic that we have the capabilities, experience and infrastructure necessary to handle complex biologics like this one," said Wes Wheeler, president of UPS Healthcare.
One-stop healthcare solutions and logistics
UPS Healthcare has offered healthcare logistics services for over 20 years and has been at the forefront of COVID-19 vaccine delivery since day one.
On 14 December 2020, UPS Healthcare delivered to Long Island Jewish Medical Center in New York the very first doses of the first COVID-19 vaccine authorised in the United States. In the 14 months since, the global healthcare logistics leader has delivered a staggering 1.5 billion more COVID-19 vaccine doses … with 99.9% on-time performance.
UPS Healthcare has also played a critical pandemic role in planning and coordinating global logistics movements of vaccine clinical trials, personal protective equipment, test kits, ventilators, and other resources that have allowed patients and healthcare professionals to combat COVID-19 and its variants.
For Novavax, UPS Healthcare will store vaccine for distribution at a state-of-the-art facility in Roermond, Netherlands that has expertise and experience in handling a multitude of biopharma products. Roermond has cooler pallet positions to preserve biologics like the Novavax vaccine.
The Netherlands facility is a crucial link in a strong, reliable UPS Healthcare supply chain for biopharma products. Few logistics companies in the EU offer cold chains anchored by advanced quality healthcare distribution centres like Roermond.
Infrastructure, expertise, experience
The rapidly evolving biologics market projects to hit 370.14 billion euros worldwide by 20251. Time-sensitive and temperature-controlled logistics – a cold chain able to ensure the quality of sensitive drugs at every point from manufacturing floor to clinic door – is increasingly crucial.
"As the healthcare sector grows, there is a clear trend towards specialty pharmaceuticals and biologic therapeutic medicines and vaccines like the one developed by Novavax," said Wheeler. "The extensive infrastructure UPS Healthcare has built in the EU to handle temperature-sensitive products will make this life-saving vaccine and other needed healthcare products quickly available to hundreds of millions of people."
In 2021, UPS Healthcare invested in more than 36,000 square metres of cold chain Good Manufacturing Practice (GMP) coolers and UPS freezers in newly dedicated and upgraded healthcare facilities across Europe.
This network buildout took place in Poland, the Czech Republic, Germany, Benelux and the Netherlands. These facilities add to UPS Healthcare's existing one million square metres of global dedicated healthcare warehouse space at 134 facilities in 30 countries.
The new UPS Healthcare infrastructure is the catalyst of industry innovation.
Pioneering healthcare logistics products include UPS® Premier, a priority lane for small parcels carrying advanced sensor technology that allows highly specialised handling, enhanced location status and special control for sensitive goods. UPS reusable packaging centres in several upgraded facilities reduce waste and minimise climate risk.
The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid in a vial containing 10 doses that is stable at 2-8 degrees C. The broad network of UPS Healthcare facilities able to receive and store vaccine doses at required temperatures can make widespread distribution a reality within days.
The Novavax vaccine promises to be a major public health benefit.
"Since the Novavax vaccine can be shipped using existing vaccine supply chain and standard refrigeration temperatures, it can potentially be a game-changer in developing nations and far-flung regions. We believe that our vaccine can be a breakthrough for equitable distribution efforts worldwide," says John Trizzino, Chief Commercial Officer and Chief Business Officer at Novavax.
Anticipating its effectiveness and ease of storage, the European Union and several countries – Canada, Australia and others – have already entered into advance purchase agreements for large quantities of the Novavax vaccine to help protect their citizens.
"There is a pent-up demand for our vaccine that we are ready to answer," confirmed Trizzino.
Wheeler at UPS Healthcare agrees. He said, "UPS Healthcare is proud to be part of this important moment in the continuing fight against COVID-19."
Important Safety Information
- Nuvaxovid™ is contraindicated in persons who have a hypersensitivity to the active substance or to any of the excipients
- Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction
- Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a response to the needle injection. It is important that precautions are in place to avoid injury from fainting
- Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection
- Give Nuvaxovid with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals
- The efficacy of Nuvaxovid may be lower in immunosuppressed individuals
- The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients
- The most common adverse reactions observed during clinical studies (frequency category of very common ≥ 1/10), were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and malaise
Please visit https://www.novavaxcovidvaccine.com for the full leaflet and adverse reaction reporting instructions.
Detailed information on this medicine is also available on the European Medicines Agency web site: http://www.ema.europa.eu
About UPS Healthcare
UPS Healthcare delivers unparalleled healthcare logistics expertise to its customers around the world. UPS Healthcare has 11+ million square feet of cGMP and GDP-compliant healthcare distribution space globally. Its services include inventory management, cold chain packaging and shipping, storage and fulfilment of medical devices, and lab and clinical trial logistics. UPS Healthcare's global infrastructure, its UPS® Premier visibility service, its track and trace technology, and its global quality system are well-suited to meeting today's complex logistics demands for the pharmaceutical, medical device, and laboratory diagnostic industries.
