Pfizer&BioNTech Covid-19 Vaccine: What Next?

Author: Celeste Bravi. Publication date: November 18th, 2020.

“Today is a great day for science and humanity”, said Pfizer Chairman and CEO Albert Bourla only 9 days ago, when the American giant of big pharma and the German BioNTech announced that, based on preliminary data, their candidate vaccine against SARS-CoV-2 was found to be 90% effective. Today, on November 18th, the Phase 3 study has come to an end, and the mRNA-based vaccine has reported an efficacy rate of 95%. In the last week, in fact, Pfizer and BioNTech conducted the final tests on the effectiveness and safety of the second vaccine dose, required as part of the treatment. The 95% result exceeds by far the stakeholders’ previous expectations: the American FDA in fact had established a 50% threshold to give its authorization, whereas the European EMA and the WHO could have been satisfied even by a lower efficacy level. To have a comparator, anti-influenza vaccines currently stand at a 40% — 60% efficacy; on the other hand, the 95% result is in line with the most performing vaccines for children.

What will happen next? In the next few days, Pfizer and BioNTech will apply for the FDA emergency authorization, required prior to the vaccine’s distribution. In case the FDA rules in its favour, the health-tech couple will be leading the race in the health, reputation and business fight to the current pandemic. Interestingly, however, other pharma companies are close to the race end: on November 16th, Moderna has announced his vaccine candidate to have been proven effective in 94.5% of cases (again, based on preliminary data). Who will eventually win, should it be the Pfize-BioNTech duo, Moderna or other companies now conducting clinical studies — will depend on the timing availability of the final tests’ results, on whether they confirm the previous numbers and, eventually, on the grant by regulatory agencies of approval for distribution. Even if all of these remain unanswered questions for now, we can on the other hand try to figure out what to expect in the next months, and have a closer look — thanks to the amount of information released — at what Pfizer plans for the eventual vaccine distribution. Which are the parties involved? Following the FDA approval, millions of Americans could access Pfizer’s vaccine by the end of the year. However, quickly making the vaccine available in hospitals, clinics and pharmacies does not entirely depend on the manufacturer. Federal and state agencies must provide information on where to send how many doses. Medical suppliers must provide to each distribution channel syringes and other necessary supplies. Finally, healthcare employees will need to be trained in the correct administering procedures, making sure that people return three weeks after the first dose to repeat the injection.

Pfizer’s distribution plan Pfizer’s candidate vaccine has a few issues concerning distribution and storing, mainly due to its unique temperature requirements: maintaining the vaccine at a stable temperature around minus 70 degrees Celsius until just before the injection. Even though no one at the moment has experience working with vaccines at such low temperatures, the good news is this should not be an insurmountable problem. As far as Pfizer’s distribution plan is concerned, vaccines will first be put into vials, each of which contains five doses, and then go into trays. In turn, trays will be placed into cooler boxes, each of which is an isolated container equipped with dry ice and a GPS sensor. This will enable Pfizer to track the boxes’ locations and temperatures during the whole transportation, to reassure the end-user that the vaccine is still good. UPS and FedEx are planning to have a central role in the nationwide transportation of the boxes. Once the destination is reached, a few options are available to hospitals and pharmacies: big pharmacy chains as Walgreens or CVS might easily decide to invest in the required ultracold freezers (currently not that widespread), while small and mid-size independent local pharmacies may choose to store vaccines in normal freezers — possible up to five days — or to keep the vaccine in the trials — for as long as 15 days.

Who will get the vaccine first? One of the greatest challenges governments will face when it comes to national distribution is deciding who will receive the vaccines first. This is largely dependent on the expected production capacity: Pfizer and BioNTech’ current projections account for 50 million doses to be produced globally in 2020, and up to 1.3 billion in 2021. Half of these will be assigned to the US; given that each person will receive two doses, around 12.5 million Americans would get Pfizer’s vaccination by the end of the year. Even though other 9 pharma companies are in the final testing stage — meaning that in case of FDA approval the production capacity may increase –, it is sure that supply will not be sufficient to meet the high demand. Therefore, it is crucial to identify various risk groups to ensure that the most vulnerable population segments will have immediate access to the vaccine, potentially followed by healthcare workers. Most of the limited doses should reach elderly care facilities, large hospitals and pharmacies. Additional challenges regard rural areas, where there might be the risk of vaccine doses going bad because of delays in their administration. However, no government indication has been made clear yet.

References

Ordonez, V. (2020, November 13). The reality behind Pfizer’s COVID-19 vaccine distribution plan.

Pfizer. (2020, November 09). Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.

Pfizer. (2020, November 18). Pfizer and BioNTech Conclude Phase 3 Study of Covid-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints.

Robbins, R., & Gelles, D. (2020, November 12). How Pfizer Plans to Distribute Its Vaccine (It’s Complicated).

Valsania, M. (2020, November 10). Pfizer-BioNTech: Dalla sperimentazione alla distribuzione, tutto quello che sappiamo del nuovo vaccino.

Weintraub, A. (2020, November 04). Pfizer goes solo on U.S. shot distribution, opting out of government channels.