Pfizer-BioNTech Pledge 300 Million Vaccine Doses to EU

13.11.2020 - US drugmaker Pfizer and its German development partner BioNTech have reached a final agreement with the European Commission to supply 200 million doses of their mRNA-based Covid19 vaccine candidate to the EU’s member states at an undisclosed price.

The deal, which carries an option to request an additional 100 million doses of the candidate labeled BNT162b2, follows a preliminary agreement sealed in September this year. The companies hope to be able to start supply by the end of this year, contingent on the success of ongoing clinical trials and regulatory approval.

While sources speaking to Reuters estimated the EU deal could be worth $5.85 billion, based on the value of Pfizer's agreement with the US to acquire 100 million doses for $1.95 billion, an EU official told the news agency the price would be somewhat lower, due to Europe’s funding of the vaccine’s development.

Pfizer and BioNTech have also inked supply deals with the UK and Japan. In addition to engagements with governments, the companies have said they are willing to provide doses to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO).

The US-German vaccine duo could apply for an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) as early as next week. The companies have also initiated a rolling submission to the European Medicines Agency (EMA), in which they pledge to continue regular and open dialogue with the EMA providing results from their ongoing Phase 3 study.

Doses for Europe will be produced at BioNTech’s German manufacturing sites, as well as at a Pfizer site in Belgium. If the vaccine candidate receives approval from the EMA, the doses will be ordered individually by the countries that have requested to be supplied under the bloc’s agreement.

At the beginning of the week, the companies reported a vaccine efficacy rate above 90%, at seven days after the second dose, meaning that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

In a note to clients, SVB Leerink analyst Geoffrey Porges said this result should boost confidence of the general public in Covid vaccines and potentially drive up the early adoption rate. The analyst said he saw the Pfizer-BioNTech vaccine as nailing down all of the early share of the market and generating $258 million in this year’s fourth quarter.

Bourla share sale raises eyebrows

On the back of the encouraging results from the Phase 3 trial, shares of both Pfizer and BioNTech soared, with Pfizer CEO Albert Bourla looking likely to profit the most from the surge. On the day of the announcement, the chief executive filed to sell millions of dollars of the drugs giant’s shares, netting around $5.6 million.  Another executive reportedly unloaded stock worth $1.8 million

Pfizer told skeptical US media that the Bourla transaction was part of a regularly scheduled plan the CEO set up last year to periodically sell some of his shares, adding that the sale took place on that particular day because the shares hit a predetermined price.

The stock sale parallels a similar transaction at Pfizer’s US-based mRNA vaccine rival Moderna following the release of promising clinical trial results last May. According to stock market reports, Moderna's chief financial officer and chief medical officer executed options and sold nearly $30 million of shares combined.

Author: Dede Williams, Freelance Journalist