Covid-19 roundup: AstraZeneca cuts Q1 vaccine supply to EU by a third — report; Sanofi, Translate usher another mRNA shot into clinic
Tensions between AstraZeneca and the EU are far from settling, as the pharma reportedly plans to cut supply of its Oxford-partnered vaccine to the bloc by about a third in the first quarter.
According to documents reviewed by Reuters, AstraZeneca now plans to deliver about 30 million doses to the EU by the end of March, as opposed to the 90 million initially promised in its contract. Another 20 million doses are now set to come in April, Reuters reported.
The news comes as the EU’s vaccine rollout lags behind schedule. In late January, AstraZeneca notified the bloc that it would deliver over 60% fewer doses than promised, blaming production at a Belgian factory. The EU had already been dealing with delays of the Pfizer/BioNTech vaccine, with countries like Italy and Poland threatening to take legal action against the developers.
AstraZeneca CEO Pascal Soriot has maintained that the contract was based on a “best-effort” delivery clause, which was apparently confirmed by unredacted portions of the pharma’s supply contract uncovered by German journalists. The EU later apologized for leaving portions of the contract unredacted.
“I see efforts, but not ‘best efforts,’” EU industry commissioner Thierry Breton posted on Twitter Thursday. “That’s not good enough yet for@AstraZeneca to meet its Q1 obligations.”
AstraZeneca #vaccines delivery : I see efforts, but not “best efforts”.
That’s not good enough yet for @AstraZeneca to meet its Q1 obligations.
It’s time for AstraZeneca’s Board to exercise its fiduciary #responsibility and now do what it takes to fulfil AZ’s commitments.
— Thierry Breton (@ThierryBreton) March 11, 2021
Last week, Italy and the EC blocked the shipment of about 250,000 doses of the AstraZeneca/Oxford vaccine intended for Australia, the first such intervention in vaccine exports since the EU introduced new rules governing such shipments in late January. — Nicole DeFeudis
Sanofi, Translate usher another mRNA shot into clinic
As Pfizer/BioNTech and Moderna rack up more positive data for their mRNA vaccines and set sights on versions 2.0, Sanofi and its partners at Translate Bio are ready to put a new candidate into the clinic.
Investigators will recruit 415 patients for the Phase I/II trial of MRT5500, which is designed to target the original SARS-CoV-2 antigen. The partners say they are running preclinical studies for additional experimental vaccines against emerging variants.
Interim results are expected in Q3.
For Sanofi, launching the trial represents another big move after they finally got a Phase II trial off the ground with a ‘refined’ formulation of a recombinant-protein boosted with a GlaxoSmithKline adjuvant. It followed a lengthy delay due to weak immune responses in an earlier study.
The companies note that they’re also working to improve the temperature stability of their candidate, with a target of -20°C storage temperature for late-stage clinical trials and at launch — and go even further to store it at routine refrigerator temperature (2-8°C). — Amber Tong
Thailand slams brakes on rollout of AstraZeneca/Oxford vaccine
Thailand has joined a growing list of countries suspending the use of AstraZeneca and Oxford University’s vaccine due to reports of blood clots.
The Asian country is the first outside Europe to do so, Reuters reported.
Austria pulled a specific batch of the shot on Sunday after a 49-year-old woman died of “severe coagulation disorders,” and another 35-year-old woman suffered a pulmonary embolism, according to the country’s Federal Office for Safety in Health Care (BASG).
“Based on the known clinical data, a causal relationship cannot be established, as thrombotic events in particular are not among the known or typical side effects of the vaccine in question,” the BASG said in a statement. “The immediately initiated international analysis of side effect reports also shows no accumulation of similar case reports so far.”
Estonia, Latvia, Lithuania and Luxembourg have all suspended use of the same batch as Austria, according to BBC. Italy pulled different batches as Austria. And Denmark, Norway and Iceland have all temporarily paused rollout of the vaccine.
The EMA is currently reviewing the cases, and said in a statement on Wednesday that there’s no evidence the vaccines caused the events.
“The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population,” the EMA’s safety committee PRAC said.
Thailand received more than 117,000 doses of the vaccine last week, the first of which was supposed to go out today, Reuters reported.
“AstraZeneca is still a good vaccine but with what has happened … the health ministry based on this advice would like to postpone the usage of the AstraZeneca vaccine momentarily,” Kiattiphum Wongjit, permanent secretary for the country’s Public Health Ministry, said per Reuters.
Meanwhile, numerous countries including France, Germany, Canada, Australia, the Philippines and South Korea have said they’ll go ahead with the vaccine, according to BBC and Reuters. — Nicole DeFeudis
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