FDA approves Johnson & Johnson’s COVID-19 vaccine for emergency use
pharmafile | March 1, 2021 | News story | Sales and Marketing | COVID-19, Janssen, Johnson & Johnson, vaccines
The FDA has issued emergency use authorisation for Johnson & Johnson’s one-shot COVID-19 vaccine, approving the jab for use in individuals aged 18 and older in the US.
The agency’s decision was based on the totality of scientific evidence, including data from the Phase III ENSEMBLE study that demonstrated the vaccine was 85% effective in preventing severe disease, and showed protection against COVID-19 related hospitalisation and death from 28 days after vaccination.
The data also showed that the single-shot vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the its use in people 18 years of age and older.
Under the terms of the emergency use authorisation, distribution of the vaccine is permitted while more data are gathered.
Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, commented: “We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants.
“A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalisation and death, will help ease the burden on people and the strain on health systems worldwide. We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”
Johnson & Johnson has said in a statement that it is committed to making its coronavirus vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its jab, and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the US.
Acting FDA Commissioner Dr Janet Woodcock also said: “The authorisation of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.
“The FDA, through our open and transparent scientific review process, has now authorised three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorisation.”
Darcy Jimenez
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