J&J Issues Statement on U.S. COVID-19 Vaccine Manufacturing

Since January of 2020, Johnson & Johnson has been working directly with governments, health authorities, and other companies to help end the global pandemic. We continue to expect to deliver our COVID-19 vaccine at a rate of more than one billion doses by the end of 2021, stated a press release issued on March 31, 2021.

'We are pleased we have met our commitment to deliver enough single-shot vaccines (Janssen COVID-19) by the end of March to enable the full vaccination of more than 20 million people in the United States. This is part of our plan to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, aiming to deliver those doses by the end of May.'

'As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.'

'This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine.'

'This batch was never advanced to the filling and finishing stages of our manufacturing process.'

The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).

Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility,

Johnson & Johnson is providing additional experts in manufacturing, technical operations, and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine. In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April 2021.'

The Johnson and Johnson Janssen COVID-19 single-shot experimental vaccine leverages Janssen's AdVac and PER.C6® technologies. Janssen’s AdVac® vectors are based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease. Adenoviruses are a group of viruses that can cause the common cold.