Drug maker begins applying for vaccine approval

Johnson & Johnson, one of the largest drugmakers developing a vaccine against COVID-19, on Tuesday began the process of applying for emergency approval of its vaccine from the European Medicines Agency and Health Canada.

In what’s called a rolling submission, J&J’s Janssen Pharmaceutical business sent regulators in the EU and Canada early testing data from its experimental one-dose vaccine for preventing COVID-19. Rolling submissions are used to speed up evaluation of crucial drugs by giving regulators data as it becomes available, and while human testing is still ongoing, rather than submitting reams of data at once after testing ends.

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Johnson & Johnson said in a statement that the European Medicines Agency allowed the rolling submission mainly due to positive results from laboratory testing, which showed the vaccine triggered a robust immune response, creating antibodies that could fight the virus.

The New Brunswick, New Jersey-based company also talking with regulators in other countries around the world about starting rolling reviews with them.

J&J is now in the final phase of testing its one-dose vaccine on human volunteers. Meanwhile, it recently began a second study looking at whether two vaccine doses work better than just one.

The company has said it will provide its vaccine on a not-for-profit basis throughout the pandemic emergency.