A similar development is being reported in Canada, where the US-German vaccine was approved by health authorities the same week it received the green light from the EMA.

As if that wasn’t enough, Europe’s hopes that new vaccines set to emerge from the approval pipeline soon could take up some of the slack, are also being dashed. AstraZeneca has announced that it, too, will be unable to deliver all of the contracted volumes on time – and its vaccine has not even been cleared by the EMA.

The European Commission has said it plans to seek clarity on future supply after it was informed by Pfizer last week that vaccine deliveries could fall 20% behind the advised target in January’s final week. This followed a reduction of close to 30% in the prior seven days.

Some EU member states, including Poland and Italy, have suggested they may sue Pfizer for breach of contract, and France threaten to consider imposing sanctions on the US drugs giant if there are further delays. As the EU is responsible for vaccine procurement, some said this may not be possible.

Poland's health minister Adam Niedzielski complained last week that vaccine deliveries from Pfizer were running some 50% below expectation, but said he expected the shortfall to be made up  from mid-February. If not, legal action could follow.  In the Czech Republic, health minister Jan Blatny said last week’s deliveries were 15% less than expected, and the country was looking at a gap of 30% for the next two weeks.

Coincidentally, the constraints on both vaccines have their origin in Belgium.  Pfizer blamed the tightness on an upgrade in progress at its European production hub in Puurs to lift output to 2 billion doses in 2021 from 1.3 billion initially planned. With the expansion in progress, the drugmaker said it had had to shut down part of current production.

AstraZenca has traced its problems in part to a Belgian plant owned by CDMO Novasep, which has been poised to supply the vaccine to European countries as soon as the EMA approves it. The plant, however, is running at only about a third of the drugmaker’s expectations, news agencies said, citing sources.

In the UK – which is being supplied locally –regulatory authorities cleared the vaccine early on, without waiting for clarification of unclear efficacy figures from clinical trials. The EMA has not yet shared its views on the efficacy question, but has hinted that it could make a decision at a meeting this coming week. If the vaccine it was due to receive is being absorbed by the UK, that timetable could be put in jeopardy.

The US Food and Drug Administration (FDA) meanwhile has said it wants to wait for full US trial data before reviewing the candidate for authorization, probably in early February.

As procurement problems persist, Europe is rushing to nail down special syringes that would allow a sixth dose to be extracted from vials of Pfizer and BioNTech's vaccine. The EMA has already authorized six-dose vials, but BioNTech said earlier that an additional dose could be extracted with the needed skills and devices.

Author: Dede Williams, Freelance Journalist