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COVID-19 Vaccine | FDA inspection found problems at factory making J&J vaccine

The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the now-idle Emergent Biosciences factory.

April 21, 2021 / 09:52 PM IST
Johnson & Johnson's COVID-19 vaccine

Johnson & Johnson's COVID-19 vaccine

The Baltimore factory contracted to make Johnson & Johnson's COVID-19 vaccine was dirty, didnt follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material that was going to be put in the shots, U.S. regulators said Wednesday.

The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the now-idle Emergent Biosciences factory.

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Agency inspectors said a batch of the bulk drug substance for J&J's single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. That batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.

Other problems cited in the inspection report were peeling paint, black and brown residue on floors and walls in the factory, inadequate cleaning and employees not following procedures to prevent contamination.

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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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Both Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible. Nothing made at the factory for J&J has been distributed yet.

At the moment, use of the J&J vaccine is on hold in the U.S. as government health officials investigate its connection to very rare blood clots. The nearly 8 million doses of J&J vaccine that had been used in the U.S. came from European sources.

The Baltimore factory halted production late last week at the request of the FDA. The agency hasn't given emergency approval to the factory, which is needed before any vaccine material made at the factory can be distributed.

All the bulk vaccine substance Emergent has made is being stored and will undergo additional testing by the FDA, the agency said.
Associated Press
first published: Apr 21, 2021 09:52 pm

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