US pharmaceutical giant Johnson & Johnson has applied for authorisation for its coronavirus vaccine in the EU with a decision possible by the middle of March, Europe's drugs regulator said Tuesday.

The single-shot vaccine would be the fourth jab to be approved for use across the 27-nation European Union if it gets the green light from the Amsterdam-based European Medicines Agency.

"EMA has received an application for conditional marketing authorisation for a Covid-19 vaccine developed by Janssen-Cilag International", J&J's European subsidiary, the watchdog said.

The regulator "could issue an opinion by the middle of March 2021, provided the company's data on the vaccine's efficacy, safety and quality are sufficiently comprehensive and robust."

With delays to deliveries of three already-authorised vaccines by AstraZeneca, Pfizer/BioNTech and Moderna, the EMA is under pressure from European capitals to speed more into service.

COVID-19 Vaccine

Frequently Asked Questions

How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Johnson & Johnson files for EU COVID vaccine approval

The single-shot vaccine would be the fourth jab to be approved for use across the 27-nation European Union if it gets the green light from the Amsterdam-based European Medicines Agency.

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