NIBSC statement on batch testing for the COVID-19 Vaccine AstraZeneca

We are continuously looking at ways to speed up the vital independent batch testing of Covid-19 vaccines without compromising safety.

For the COVID-19 Vaccine AstraZeneca, the independent testing performed by the National Institute for Biological Standards and Control usually takes around four days to complete.

This work is just one part of a broader set of quality and safety checks by the manufacturer which – because this is a complex biological product – cannot be sped up further.

To increase speed, our testing is done in parallel with checks by the manufacturer. The data from the manufacturer are sent to us in tranches so we can conduct interim reviews of it and complete our final review quicker.

Once we receive the manufacturer’s complete testing data, it typically takes us less than 24 hours to finalise our review of it and, provided everything meets the product specification, to issue a certificate confirming the batch is suitable in quality for use.

We keep this process under review and will take any further steps necessary to improve the timeline as long as they never compromise quality and safety.

Background

• Biological medicines such as vaccines are very complex in nature. There are two testing processes once a batch of the vaccine is produced – by the manufacturer itself, and by the independent National Institute for Biological Standards and Control (NIBSC), part of the MHRA. It is only when both of these processes are complete that the batch can be released for use. 
• Independent laboratory testing, as done by the NIBSC, takes around 4 days to complete for this vaccine.  These tests are to check the physical appearance of the vaccine in the vial, to check it’s the correct material, and importantly to measure its potency (strength).   
• To ensure the batch can be deployed as quickly as possible, NIBSC testing is done in parallel with the manufacturer’s testing, which involves a range of quality control tests conducted at key points throughout the manufacturing process to ensure the safety and quality of the vaccine. Because this is a biological product, the manufacturer cannot speed this process up further.
• Once we have received the testing data from the manufacturer we review it and, provided everything meets the product specifications, the final NIBSC certification process is typically completed in under 24 hours from receipt of this data.
• We began preparation for independent batch release testing of the COVID-19 Vaccine AstraZeneca in July. Part of this involved increasing our capacity for testing COVID-19 vaccines, including reprioritising work at NIBSC to ensure more staff are able to do this testing. This is an ongoing process to ensure we continually have the best expert staff and resources to enable us to complete our testing as quickly as possible, without compromising on quality. Our planning allows for the greatly increased quantities of batch testing that will be required in the coming weeks and months.