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COVID-19 Vaccine | Johnson & Johnson has enough data to analyse jab, seek approval, says Fauci

J&J’s vaccine is a single shot one, one big reason why it has led to hawk eyes on its development.

January 22, 2021 / 04:02 PM IST
Dr Anthony Fauci (Image Source: Reuters)

Dr Anthony Fauci (Image Source: Reuters)

Johnson & Johnson (J&J) would soon be able to seek emergency use authorisation (EUA) from drug regulators.

The United States government’s top infectious disease expert Dr Anthony Fauci at a press briefing on January 21 said the company had “sufficient data” from its last stage COVID-19 vaccine trials to begin analysis “in a week or two”, Bloomberg reported.

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J&J’s vaccine is a single shot one—a fact that has led to hawk eyes on its development. If approved, it would make vaccination drives less complicated, as all other approved vaccines follow a two-dose regimen.

Fauci’s declaration is in line with Johnson & Johnson’s earlier statement that it would review data of the 45,000 candidates from its late-stage trial by January-end or February first week.

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COVID-19 Vaccine

Frequently Asked Questions

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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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Data analysis is likely to take one or two weeks, followed by preparation of documents for regulators in the US and globally, to consider for EUA, Chief Scientific Officer Paul Stoffels told Bloomberg.

Check here for the latest updates on all COVID-19 vaccines

Stoffels added that the US Food and Drug Administration (FDA) would not authorise the vaccine candidate before March 2021, as the regulator is expected to assemble an external expert panel to review the data and make recommendations—a process that can take weeks, it added.

Pfizer and BioNTech’s vaccine was cleared on December 11–three weeks after the company’s submission for approval on November 20.

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Moneycontrol News
first published: Jan 20, 2021 01:54 am

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