Pfizer and BioNTech’s COVID-19 vaccine looks likely to be the first to be given Emergency Use Authorisation in the US and Europe and the company has announced its amazing supply and distribution plans.
Pfizer CEO Albert Bourla wrote an open letter stating it was likely the vaccine would, if it works and is safe, be submitted to the US Food and Drug Administration in the third week of November. The COVID-19 vaccine BNT162b2 is also in a rolling review with the European Medicines Agency.
“It has an excellent profile and I consider this vaccine … near perfect, and which has a near-perfect profile,” BioNTech CEO and Co-Founder Ugur Sahin told CNN.
Pfizer and BioNTech’s BNT162b2 triggers the production of neutralising antibodies and dominant T cells that target COVID-19 (SARS-CoV-2). A combination of an antibody and T cell response is believed to be important in eliciting protection against viral infection and disease.
When the Emergency Use Authorisation is given, Pfizer aims to ship 7.9 million doses of the COVID-19 vaccine daily. Hundreds of thousands of doses are already in Pfizer’s warehouses in the US and Europe.
The plan centres around distribution sites in Kalamazoo, Michigan, and Puurs, Belgium, where the company will load reusable, temperature-controlled containers on a total of 24 trucks per day. Kalamazoo is where Pfizer’s largest manufacturing site is located. BioNTech has been adding to its production capacity at two of its facilities in Germany.
Pfizer’s mRNA-based doses of COVID-19 vaccine must be stored at almost -100°F (-73.33°C). To make that happen, Pfizer designed suitcase-sized shipping containers that will keep the doses of the vaccine at ultra-cold temperatures for up to 10 days. Each temperature-controlled container holds between 1,000 and 5,000 doses, Wall Street Journal reported.
Pfizer aims to buy cargo space on an average of 20 planes per day from FedEx, UPS and DHL International to transport vaccine doses to points as close as possible to vaccination sites, such as major hospitals or medical centres.
The carriers will then be responsible for trucking the doses from airports to those sites. In all, Pfizer expects deliveries to take three days.
Pfizer had already said it had chosen sites in Kalamazoo, Andover, Massachusetts and St Louis for its US COVID-19 production. Pfizer hopes to deliver 100 million vaccine doses in 2020 and 1.3 billion next year. Along with distribution centres in Kalamazoo and Puurs, Pfizer has sites in Wisconsin and Germany for additional storage to prepare for shipping.
Pfizer has agreed supply deals with the US for 100 million doses, with an option for 500 million more. It has an agreement with Europe for up to 300 million doses, Japan (120 million) and the UK (30 million). Countries in South America and in the Asia-Pacific region also have placed significant orders.
In other COVID-19 vaccine developments, a volunteer, a 28-year-old man, taking a placebo in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, Brazil’s National Health Surveillance Agency said on Wednesday. The trial continues.
The US Phase 3 trials of the COVID-19 vaccine developed by AstraZeneca and Oxford University and the vaccine developed by Johnson & Johnson will resume this week following a review by the US Food and Drug Administration after a volunteer fell ill in each trial.
The coronavirus pandemic seems not to be abating with 20 countries in Europe recording a record number of confirmed cases of COVID-19 on Wednesday. UK had the highest, a new record of 26,668 new cases. New records were set in Italy (15,199), Czech Republic (11,984), Poland (10,040), the Netherlands (8,500), Ukraine (6,719), Switzerland (5,596), Romania (4,848), Slovakia (2,202), Armenia (1,836), Slovenia (1,503), Croatia (1,424), Bulgaria (1,336), Greece (865), Bosnia & Herzegovina (728), Belarus (733), North Macedonia (640), Luxembourg (430) Lithuania (311) and Latvia (188).