EU to Begin COVID-19 Inoculations With Pfizer/BioNTech Vaccine on Dec. 27

With COVID-19 cases surging across Europe, EC President Ursula von der Leyen announced yesterday that EU countries will start vaccinations with the two-dose Pfizer/BioNTech vaccine on Dec. 27.

After heavy lobbying from EU leaders, especially from Germany where BioNTech is based, the European Medicines Agency rescheduled a review of the vaccine by its human medicines committee from Dec. 29 to Dec. 21. The committee is expected to recommend a conditional marketing authorization that will allow vaccinations to begin (DID, Dec. 16).

Gearing up for the immunization programs, the EC this week exercised its option with Pfizer/BioNTech for an extra 100 million vaccine doses, for a total of 300 million — enough to vaccinate one third of the EU’s population.

Also this week, the EU exercised its option for an additional 80 million doses of Moderna’s vaccine, mRNA-1273, for a total of 160 million doses. In addition, the EC has negotiated advance purchase agreements with AstraZeneca for 400 million doses, with Sanofi/GlaxoSmithKline for 300 million, with Johnson & Johnson for enough doses to immunize 400 million people and with CureVac for 405 million doses. And this week, the EC announced that it has finalized talks with Novavax for 200 million doses of its vaccine.

As is now being seen in the U.S., distribution of the Pfizer/BioNTech vaccine is likely to face some distribution snags. The FDA advised pharmacists this week that vials labeled as containing enough of the vaccine for five doses could in fact deliver six doses — after some pharmacists had already discarded excess vials out of caution.

“After dilution, the multidose vial contains enough vaccine for at least five doses,” a Pfizer spokesperson told FDAnews. “The amount of vaccine remaining in the multidose vial after removal of five doses can vary, depending on the type of needles and syringes used.”

“At this time, we cannot provide a recommendation on the use of the remaining amount of vaccine from each vial. Vaccinators need to consult their institution’s policies for the use of multidose vials,” the spokesperson said, adding that the company is continuing to “closely coordinate with the FDA on this matter.”

Another potential problem is the need to maintain the Pfizer/BioNTech vaccine at an ultra-cold temperature during shipping and storage. The temperature monitors that accompanying the shipments reportedly have been switching off too soon, risking the possible loss of usable vaccines. Pfizer declined to comment on the issue. ― Jason Scott