Pfizer says it is prepped to overcome the logistical challenges of distributing its mRNA vaccine against COVID-19 as it submits an Emergency Use Authorization (EUA) to the US FDA.
Today, Pfizer submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of BNT162b2, an mRNA vaccine candidate codeveloped with Germany’s BioNTech, against SARS-CoV-2.
The news follows Phase III trial data showing the vaccine has an efficacy rate of 95% and marks a major milestone in the industry’s – and indeed the world’s – fight against the COVID-19 that has killed over 1.35 million people worldwide.
If the EUA is approved, the vaccine could be administered to high-risk populations in the US by the end of the year and could pave the way for global distribution of potentially billions of doses.
“We are now pivoting from the excitement around the possibility of vaccine to now how do we actually get it out to the public and into the arms of people,” Angela Hwang, group president of Biopharmaceuticals Group at Pfizer, said at the Wolfe Research Healthcare Conference two days ago.
However, distribution of the vaccine could be hampered due to the low storage temperature the lipid nanoparticle used in the vaccine requires to remain stable. Minus 80 degrees Celsius (-112 degrees Fahrenheit) requires equipment beyond standard freezers and refrigerators and may cause storage and logistical issues going forward.
Hwang acknowledged the onus of the low temperature concern falls on Pfizer, but it is confident it will not be an issue once global rollout begins.
“We have to date 152 sites around the world who are receiving this vaccine as part of our clinical trial. So we know that the distribution and the logistics systems that we have created to date for our clinical trials work. And so we have proof of concept that the logistics and the distribution are not insurmountable. In fact, they’re doable. We’re doing it every day now.”
Pfizer is aiming to make up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.
Storage and distribution
Before transporting batches, the vaccines need to be stored securely and as such Pfizer has created ‘freezer farms’ across its manufacturing network.
“But for the administrator of the vaccine or to the sites that will receive the vaccine, a minus 80 storage is not necessary, and that’s because we have created the thermal shippers,” Hwang said.
“The thermal shippers that we have designed specifically are storage units unto themselves, and they leave our facilities with dry ice and they arrive at other facilities or at the points of vaccination, where, if one chooses, one can replenish those shippers with dry ice and continue to store the vaccine at minus 80.”
While there are concerns that a shortage of carbon dioxide, used to make the dry ice, could hinder distribution efforts, Hwang said vaccination sites were more likely to be administering vaccines than storing them and that the shipper would in the majority of cases suffice.
“In addition to that, you may not even need the shipper for all that long if you are again vaccinating at high volumes where you can store the vaccine in the fridge for five days…it’s probably unlikely that anyone would need other than us to be storing it for six months, right. What you want is a very agile distribution and logistics network that allows you to get the product when you need it. And that’s what we’re really focused on.”
While Pfizer is confident the temperature issue won’t be a setback for the rollout of its vaccine, it may make some of its competitor’s products more appealing to payors and administrators. Moderna’s candidate is also approaching approval, is also an mRNA vaccine, and also has shown a similar level of efficacy in Phase III trials. However, mRNA-1273 is stable at -20 degrees Celsius, making it far easier to store and transport.