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Coronavirus vaccine update: Johnson & Johnson starts human safety trials

Coronavirus vaccine update: When exposed to the virus, six out of six animals who got the vaccine candidate were completely protected from lung disease and five out of six were protected from infection as measured by the presence of virus in nasal swabs, according to the study published in the journal Nature.

July 30, 2020 / 05:05 PM IST

Johnson & Johnson on Thursday kicked off US human safety trials for its COVID-19 vaccine after releasing details of a study in monkeys that showed its best-performing vaccine candidate offered strong protection in a single dose.

When exposed to the virus, six out of six animals who got the vaccine candidate were completely protected from lung disease and five out of six were protected from infection as measured by the presence of virus in nasal swabs, according to the study published in the journal Nature.

"This gives us confidence that we can test a single-shot vaccine in this epidemic and learn whether it has a protective effect in humans," Dr. Paul Stoffels, J&J's chief scientific officer, told Reuters in a telephone interview.

The drugmaker said it had started early-stage human trials in the United States and Belgium and would test its vaccine candidate in over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.

The US government is backing J&J's vaccine effort with $456 million in funding as part of a spending spree aimed at speeding production of a vaccine to end the pandemic, which has infected millions and killed more than 660,000 people.

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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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Stoffels said prior tests of this type of vaccine in other diseases found that a second shot significantly increases protection. But in a pandemic a single-shot vaccine has a significant advantage, sidestepping a lot of the logistical issues involved in getting people to come back for their second dose.

The company plans to take up the question of one or two doses in its phase 1 trial.

Depending on those results, J&J plans to start large-scale, phase 3 testing with a single-shot regimen in the second half of September. Around the same time, the company will start a parallel phase 3 study testing a two-shot regimen of the vaccine, Stoffels said.

J&J's vaccine uses a common cold virus known as adenovirus type 26 or Ad26 to ferry coronavirus proteins into cells in the body, causing the body to mount an immune defense against the virus.

In the monkey study, scientists from J&J and Harvard's Beth Israel Deaconess Medical Center studied seven different potential vaccines in 32 animals and compared the results to 20 control animals who got placebo shots.

Six weeks later, all of the animals were exposed to the SARS-CoV-2 virus. All 20 animals that received the placebo developed high levels of virus in their lungs and nasal swabs.

In the best-performing candidate, which J&J selected for human testing, none of the animals had virus in their lungs and only one showed low levels of virus in nasal swabs. Lab tests showed they all had developed antibodies capable of neutralizing the virus after a single shot.

"This study shows that even just a single immunization with the Ad26 vaccine leads to neutralizing antibody responses and robust protection of monkeys against COVID-19," said Dr. Dan Barouch, a vaccine researcher at Beth Israel Deaconness who led the research in collaboration with J&J.

J&J shares were up nearly 2 percent at $149.72 before the bell on Thursday.

Follow our full coverage of the coronavirus pandemic here.
Reuters
first published: Jul 30, 2020 04:40 pm

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