In announcing the first set of results from the trial, Pfizer’s chairman and CEO. Albert Bourla, said it “provides the initial evidence of our vaccine’s ability to prevent contracting the virus.” The companies, he said, “have reached this critical milestone at a time when the world needs it most with infection rates setting new records.”

Pfizer’s stock initially surged forward nearly 15% on the news and BioNTech’s shares rose 25%.

The preliminary findings from the trial begun in July and still in progress are based on data from 94 US patients. The results have not yet been peer reviewed, but the developers said they are targeting a full data analysis in a peer-reviewed journal in the near future.

Detailed safety data information from the small patient sample has not yet been revealed. Pfizer and BioNTech said in early October that mild side effects such as fever and muscle aches had been observed but were not serious.

To date, nearly 44,000 patients have been enrolled in the duo’s ongoing clinical trial. Commentators said the 90% figure was encouraging, as 50% to 70% effectiveness is considered good. However, before applying to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA), as planned, Pfizer and BioNTech will need to provide data from 164 patients and build up at least two months’ worth of safety data.

Pharma analysts expect the first FDA approvals of a US Covid-19 vaccine to come in the form of EUAs, and from the current viewpoint the first application could be requested by Pfizer by the third week of November. The companies have said they expect to have around 50 million doses ready by the end of 2020 and could produce 1.3 billion more during 2021.

In Europe, the partnership in October began a rolling submission to the European Medicines Agency’s CHMP unit, which reviews trial data as it becomes available. When CHMP decides that the data is sufficient, drug and vaccine makers can submit a complete application to the EMA. If the opinion is positive, the European Commission can grant a marketing authorization.

Cold Storage Issues Complicate Distribution

Although the Pfizer-BioNTech candidate appears to be the closest to reaching commercialization, ahead of many of the development partnership’s peers, it still faces critical issues, in particular as mRNA vaccines needs to be stored at very cold temperatures, thus requiring complex logistics and storage considerations.

In the US, Pfizer will not use the government’s vaccine distribution partner, McKesson, but is setting up its own system to deliver the vaccine directly to healthcare providers, Tanya Alcorn, the drugmaker’s vice president for biopharma global supply chain, said recently.

To keep the vaccine stored at minus 94°F (minus 70°C) degrees, the plan reportedly involves shipping containers that can keep doses at that temperature for 10 days. Pfizer has established storage locations in the US state of Wisconsin as well as in Germany.

Author: Dede Williams, Freelance Journalist