AstraZeneca, Biologika to Increase Output of COVID-19 Vaccine

AstraZeneca and IDT Biologika recently partnered to boost manufacturing and supply capacity for COVID-19 Vaccine AstraZeneca in the second quarter of 2021. 

The companies will also launch a joint investment to build large additional drug substance capacity for the future. The initiatives will help support Europe’s urgent vaccination needs during the pandemic.

“This agreement will greatly help Europe build an independent vaccine manufacturing capability that will allow it to meet the challenges of the current pandemic and create strategic supply capacity for the future,” Pascal Soriot, chief executive officer of AstraZeneca said in the announcement.

“We are delighted to be investing with our partner IDT Biologika in the future health, security and wellbeing of millions of citizens across Europe. I would like to thank the German Federal Government and the European Commission for their support in our efforts,” Soriot continued.

AstraZeneca and IDT Biologika will also invest in capacity expansion at IDT Biologika’s production site in Germany to build five 2,000-litre bioreactors that will make millions of doses of COVID-19 Vaccine AstraZeneca per month.

Additionally, the investment could allow for the manufacture of other vaccines sharing a similar manufacturing process. This would significantly advance Europe’s domestic vaccine production capability, AstraZeneca said.

Details of the agreement are to be finalized and the assets will be fully functional by the end of 2022.

“We are proud that AstraZeneca has chosen us as a strategic partner for the manufacturing of their vaccines. The agreement underscores our expertise in the production of demanding vector-based vaccines and our ability to provide a one-stop solution, from creating drug substance, through to “fill and finish” and secondary packaging,” said Jürgen Betzing, chief executive officer at IDT Biologika.

“I would like to thank the German Ministry of Health for their support in making this cooperation happen, which marks a great day for Germany and Europe,” Betzing continued.

At the beginning of January, the United Kingdom (UK) was the first country to approve COVID-19 Vaccine AstraZeneca for emergency use to prepare for vaccinations throughout 2021.

The two-dose regimen of the vaccine was shown to be safe and effective in preventing symptomatic coronavirus in clinical trials at the end of November.

One dosing regimen showed a 90 percent efficacy when the vaccine was given as a half dose, followed by a full dose at least one month apart, while the second dosing regimen showed 62 percent efficacy when given as two full doses at least one month apart.

There were no severe cases and no hospitalizations reported more than 14 days after the second dose. The company noted that overall, the candidate was well-tolerated across both dosing regimens, generating an average efficacy of 70 percent.

Then at the end of January, COVID-19 Vaccine AstraZeneca was granted conditional marketing authorization (CMA) in the European Union (EU) for active immunization in individuals 18 years of age and older.

The Committee for Medicinal Products for Human Use (CHMP) recommended two doses of the vaccine to be administered at a four to 12-week interval, as this dosing regimen was previously shown to be safe and effective in preventing symptomatic COVID-19.

CHMP based its recommendations on a review of trial data from the primary analysis of the Phase 3 study led by the University of Oxford.

Following the EU approval, millions of doses of COVID-19 Vaccine AstraZeneca began shipping the first week of February as part of the initial 17 million doses that will be delivered over the next weeks. Additional doses are planned to be allocated in March.

India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco, also granted emergency use authorization to COVID-19 Vaccine AstraZeneca at the beginning of January.