AstraZeneca writes to Irish health committee over European supply

Drugmaker AstraZeneca has told the Oireachtas health committee that it is committed to supply the EU with the agreed quantities of its Covid-19 vaccine despite significant shortfalls during the first quarter.

Use of the company’s vaccine, developed in concert with Oxford University, has also been restricted by many medicines regulators after concerns emerged that it could be linked with rare but serious blood-clotting conditions

In a letter to the committee, the company's country president for Ireland, Daniel Wygal, said it expects to deliver 100 million doses to the EU in the first half of the year.

However, it said that while the Minister for Health Stephen Donnelly has recently published monthly supply estimates "as an indicative rollout", detailed delivery schedules are shorter term "as it is difficult to predict production and supply volumes days and weeks out due to our biological process".

Government to consider extending interval between Covid vaccine doses

---

EU secures additional 100m Pfizer/BioNTech vaccine doses

---

Damage claims against employers unlikely as result of pandemic – barrister

---

Number of Covid-19 cases from outdoor transmission is ‘extremely low’ - HPSC

---

Under the projected delivery schedule published this month by Mr Donnelly, 813,000 doses of the vaccine are expected in the second quarter of the year - 224,000 in April, 262,000 in May and 327,000 in June.

Mr Wygal said the company was “disappointed” to announce a shortfall in its planned shipments to the EU on March 12th.

“We had previously communicated that we were facing shortfalls from our European supply chain due to lower-than-expected output from the production process. We had sought to compensate for part of this shortfall by sourcing vaccines from its international supply network but have been met with export restrictions in this regard.”

Mr Wygal, who was responding to a letter from the health committee sent last month, wrote that the company’s manufacture of the vaccine involves more than a dozen regional supply chains, collaborations with 20 partners from 15 countries, and securing global capacity supply for billions of doses.

“We are extremely cognizant of the urgent need for vaccine rollout as a core tool to defeat the virus and are working relentlessly to overcome these issues and accelerate supply globally. We remain confident that productivity in our EU supply chain will continue to improve to help protect millions of Europeans against the virus.”

He reiterated the company’s “full commitment to supply the agreed quantities to the EU as supply chains increase output”.

In an addendum to the letter outlining the challenges encountered in producing its vaccine, the company outlined how the living organisms that produce the vaccine “are extremely sensitive” and react to “over 1,000 parameters which need to be carefully calibrated and controlled”.

“This makes it very challenging to replicate the same production process at a new manufacturing site.” The company wrote that timelines are normally designed to allow for such variances in productivity and to creation of stocks of supply before the launch of a vaccine, but these were not possible during the pandemic.

It explained that in some instances, it has to hold back deliveries if quality control results are not favourable, even if they were “otherwise already planned into the delivery schedule”.

A second reason for lower predictability of output relates to how the vaccines are produced in bioreactors, which remain closed while the production cycle is ongoing over six-eight weeks.

Only at the end of this process can the company assess how many vaccines can be gained from a production run. The letter states that production forecasts “must necessarily remain estimates, for as long as manufacturing sites are still learning and optimising their process.”

“The reliability of supple schedules will increase over time, however, as more and more production sites manage to stabilise their processes in line with target yields.”

AstraZeneca is sharing knowledge with new partners to improve the process, making new investment, and “mobilising manufacturing partners beyond the EU” in an effort to increase supplies, it said.