Why Johnson & Johnson's Covid-19 vaccine is generating a lot of interest

Initial reports indicate the vaccine elicits a very good response. The single-dose vaccine can prove to be a gamechanger, especially in a country with a large population, such as India, where two doses will consume tremendous resources

Viswanath Pilla
January 18, 2021 / 05:11 PM IST

With Johnson & Johnson (J&J)'s COVID-19 vaccine Phase-3 clinical trial data expected to be announced before the end of January, followed by an application for Emergency Use Authorization in the US and other countries, another vaccine may soon  become available in the market. But why is the J&J vaccine generating interest not just in US, but also in India?

Single-dose vaccine

Unlike other COVID-19 vaccines, which require two doses, the J&J vaccine is a single-shot vaccine, adding a lot of convenience for people taking the shot and government bodies struggling to scale-up the mass rollout.  It also greatly simplifies logistics and scalability.  The vaccine's storage temperature requirement is 2-8 degrees Celsius.

What does the interim data from Phase 1/2 say about the vaccine?

The Phase 1/2a interim analysis has been encouraging. J&J showed that its COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants. Data demonstrated that, after a single vaccination, neutralising antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100 percent of participants aged 18-55 years at Day 57. These neutralising antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years.

The study also evaluated a two-dose regimen, in which the data showed that a second dose of the vaccine candidate, administered 56 days apart, was less reactogenic while it triggered more than a two-fold increase in antibodies against COVID-19. Reactogenicity refers to reactions that occur soon after vaccination.

On which platform is the vaccine based?

J&J's COVID-19 vaccine is based on the viral vector platform. The vaccine uses a re-engineered human adenovirus (Ad26) vector fused with genetic material of the SARS-CoV-2 spike protein to elicit an immune response. Ad26 is a benign virus, that causes a mild cold but is effective at invading human cells. J&J scientists have been working on the platform to develop vaccines against Ebola, Zika, the human immunodeficiency virus (HIV) that causes AIDS, and other viruses.

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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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How big is the Phase-3 trial?

J&J is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy in Phase-3. The company is studying a single dose of its vaccine candidate in the Phase 3 trial, which completed enrolment of approximately 45,000 participants on December17, 2020.

The two-dose regimen involving 30,000 participants in Phase 3 is ongoing. The Phase-3 trial is one of the largest multi-country trials.

Why is India interested in the J&J vaccine?

The J&J vaccine is expected to be available in India much sooner, as Indian vaccine maker Biological E has entered into an agreement with J&J to manufacture the drug substance and finished product of the vaccine. J&J had earlier said that the partnership with Biological E, allows for production of 400-500 million doses per year.

The government, in its recent presentation, said the J&J vaccine is expected to be around $10 per dose. Currently, the AstraZeneca-Oxford University vaccine, available in India as Serum Institute of India (SII)'s Covishield, is sold at Rs 200 per dose to the government (excluding taxes), while  Bharat Biotech's Covaxin is sold at Rs 295 per dose (excluding taxes).
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
TAGS: #$2 trillion coronavirus bill #Business #Companies
first published: Jan 18, 2021 05:11 pm