Could Delivery of Vaccine Be Sped Up in Exchange for Phase IV Trial?
Could the delivery of Pfizer/BioNTech’s COVID-19 vaccine for Iceland be sped up in exchange for a phase IV trial of the vaccine in Iceland? Chief Epidemiologist Þórólfur Guðnason and deCode Genetics CEO Kári Stefánsson have been engaged in informal talks with Pfizer since before Christmas regarding this possibility.
Formal talks between the two men and Pfizer will begin this week, mbl.is reports.
The goal is to speed up the delivery of the vaccine to make it possible to vaccinate enough people in a short time to achieve herd immunity.
The first 12,000 doses of the vaccine, sufficient for 6,000 people, arrived in Iceland yesterday, and vaccinations began this morning, Morgunblaðið reports. (First reports indicated the doses were 10,000). What has been guaranteed is the delivery of 3,000-4,000 doses a week through the end of March.
Yesterday afternoon, mbl.is reported that an agreement about the purchase of an additional 80,000 doses will be signed today. No delivery date has been set, though. This additional purchase is Iceland’s share in an additional purchase agreement between the European Commission and Pfizer.
Þorleifur Hauksson, a nursing home resident, was the first Icelander, aside from healthcare workers, to be vaccinated. Minister of Health Svandís Svavarsdóttir, left, was present. mbl.is/Kristinn Magnússon
Icelandic authorities had originally negotiated the purchase of 170,000 doses of the vaccine, sufficient for 85,000 people, but counting the additional 80,000 doses, the country now has secured vaccine from Pfizer sufficient for 125,000 people.
The Pfizer/BioNTech vaccine is in high demand worldwide, so why would Pfizer even consider sending it to Iceland ahead of schedule?
“I think a phase IV trial, conducted after a vaccine is marketed, would answer very many important questions, very valuable to the firm and to many countries engaged in vaccinations,” Þórólfur tells mbl.is .
Among those questions are the following:
What is needed to achieve herd immunity?
Does the vaccine work well against different variants of the virus?
What effect would it have if restrictions at the border were lifted once herd immunity has been achieved?
What potential side effects can be expected when this many people are vaccinated?
Obtaining answers to such questions could benefit, not only the pharmaceutical company, but the whole world, Þórólfur explains.
In his opinion, we have what it takes to do such research: a strong infrastructure, good monitoring of the vaccinations, good registration and, last but not least, sequence analysis.
Morgunblaðið reports that negotiations with Pfizer are at a very delicate stage. The newspaper’s sources report that an attempt is being made to obtain a total of 600,000 doses - enough to vaccinate 82 percent of the nation.