UPDATE: UK government puts in order for Moderna COVID vaccine – how does it stack up against Pfizer’s vaccine and costs?
- Moderna has 94.5% efficacy, longer shelf life, and effective in older and BAME individuals
- According to Dr Zoltán Kis, Research Associate at the Future Vaccine Manufacturing Hub, Imperial College London, BioNTech/Pfizer vaccine can be produced at a substantially higher number of doses compared to the Moderna vaccine when using the same scale/size of mRNA production process. In addition, due to the lower amount per dose, the production cost per dose of the BioNTech/Pfizer vaccine will also be lower compared to the Moderna vaccine.
- Kis said that Moderna’s Covid-19 vaccine candidate is stable at -20 degrees C, compared to the -70 degrees C of the BioNTech/Pfizer vaccine candidate. Therefore, once approved by the regulatory authorities, Moderna’s Covid-19 vaccine can be distributed substantially easier and at lower costs compared to the BioNTech/Pfizer vaccine
The UK government has completed negotiations with biotech company Moderna to secure access to 5 million doses of its promising vaccine, enough for around 2.5 million people, the Business Secretary announced on Monday (16 November).
Monday’s deal means “the government has put in place agreements with 7 different developers and has secured 355 million vaccine doses, giving the UK the best possible chance of protecting the public from coronavirus as soon as possible,” the government stated.
Business Secretary Alok Sharma said:
Today’s announcement is on top of the 350 million doses the UK has already secured from a range of other vaccine developers, putting us towards the front of the international pack on a per capita basis.
The Freelance Informer reported on Monday ghat Moderna, Inc. (Nasdaq: MRNA), a US-based biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines had reported its vaccine candidate against COVID-19 had met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
This Moderna study, known as the COVE study, enrolled more than 30,000 participants in the US.
Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months.
What makes the mRNA-1273, its COVID-19 vaccine candidate, stick out is its ability to remain stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.
As previously reported by The Freelance Informer, the Pfizer vaccine, in its current state, had issues with its ability to be delivered on a mass scale due its current state and temperature and storage needs.
The Moderna option is more compatible with the existing healthcare infrastructure of most doctor offices, hospitals and care homes across the world.
- Vaccine candidate now expected to remain stable at standard refrigerator temperatures of 2° to 8°C (36° to 46°F) for 30 days, up from previous estimate of 7 days
- Shipping and long-term storage conditions at standard freezer temperatures of -20°C (-4°F) for 6 months
- mRNA-1273 to be distributed using widely available vaccine delivery and storage infrastructure
- No dilution required prior to vaccination
“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna.
Dr Zoltán Kis, Research Associate at the Future Vaccine Manufacturing Hub, Imperial College London, compares the cost benefits of both the Moderna and BioNTech/Pfizer vaccines. “Moderna’s Covid-19 vaccine candidate has a higher mRNA amount per dose, 100 micrograms per dose, compared to the BioNTech/Pfizer vaccine candidate which has 30 micrograms of RNA per dose. This means that the BioNTech/Pfizer vaccine can be produced at a substantially higher number of doses compared to the Moderna vaccine when using the same scale/size of mRNA production process. In addition, due to the lower amount per dose, the production cost per dose of the BioNTech/Pfizer vaccine will also be lower compared to the Moderna vaccine.”
“On the other hand,” said Kis, “Moderna’s Covid-19 vaccine candidate is stable at -20 degrees C, compared to the -70 degrees C of the BioNTech/Pfizer vaccine candidate. Therefore, once approved by the regulatory authorities, Moderna’s Covid-19 vaccine can be distributed substantially easier and at lower costs compared to the BioNTech/Pfizer vaccine.”
“This vaccine is very similar in design to the Pfizer/BioNtech vaccine that reported interim results last week,” said Prof Eleanor Riley, Professor of Immunology and Infectious Disease at the University of Edinburgh.
“Although the numbers are small, this trial [Moderna] also gives an indication that vaccination is effective in older and BAME individuals and prevents severe disease, all of which are key to allowing the world to start opening up again. The absolute prerequisite for a COVID-19 vaccine is that is stops people becoming ill enough to require hospital treatment and stops people dying,” said Riley.
Shipping & Long-term Storage: For shipping and longer-term storage, Moderna expects that mRNA-1273 will be maintained at -20°C (-4°F), equal to most home or medical freezer temperatures, for up to 6 months. Using standard freezer temperatures of -20°C (range of -25° to -15°C or -13° to 5°F) is an easier and more established method of distribution and storage than deep freezing and most pharmaceutical distribution companies have the capability to store and ship products at -20°C (-4°F) worldwide.
Refrigeration Storage: After thawing, to facilitate storage at points of administration, Moderna expects that mRNA-1273 will remain stable at standard refrigerated conditions of 2° to 8°C (36° to 46°F) for up to 30 days within the 6-month shelf life. The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices.
Room Temperature for Vaccination: Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature conditions for up to 12 hours.
No Dilution Required at Vaccination Site: The vaccine will not require onsite dilution or special handling, which facilitates vaccination across a range of settings including pharmacies and physicians’ offices.
Moderna anticipates that it will continue to gather additional stability information over the coming months to assess whether mRNA-1273 can be shipped and stored under increasingly flexible conditions, which will be described in detail following regulatory approval.
Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an Emergency Use Authorization and/or similar global authorizations. The Company is also working closely with the U.S. Food and Drug Administration (FDA) to submit data from its ongoing stability testing for approval.
BARDA is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 per cent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract No. W911QY-20-C-0100.