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J&J Submits COVID Vaccine for FDA Approval; All Your FAQs Answered

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J&J Submits COVID Vaccine for FDA Approval; All Your FAQs Answered

With COVID cases soaring in the US, the frantic race for respite in the form of a dependable vaccine, too, is at an all time high.

On Thursday, Johnson & Johnson submitted an application for emergency authorization for its much anticipated one-dose coronavirus vaccine, to the Food and Drug Administration potentially speeding up the vaccination process, reported the New York Times.

If greenlighted by the FDA, Johnson & Johnson hope to start shipping the vaccine as early as March.

It would also become the third FDA approved vaccine to come out of the US along with the ones made by Pfizer-BioNTech and Moderna which were authorized back in December.

FIT breaks down everything you need to know about the Johnson & Johnson vaccine, why you should keep an eye out for it, and what it means for India.

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What is the Johnson & Johnson vaccine?

Johnson & Johnson’s, Janssen, is the third COVID-19 vaccine candidate to come out of the US. The single shot vaccine was development at its Janssen Pharmaceutical Companies and has passed the Phase 3 clinical trials having met all primary and key secondary endpoints.

Last week, clinical trials of the vaccine showed promising results. The trials were conducted in the United States, Latin America and South Africa, and after 28 days, none of the vaccinated participants who developed COVID-19 had to be hospitalised.

According to Johnson&Johnson’s statement last week, the Phase 3 ENSAMBLE trial also showed an 85% effectiveness overall in preventing severe disease.

However, it is to be noted that while the trials in the US showed a heartening 72% efficiency, in South Africa it was at 57% . What this means is that the vaccine might not be quite as effective on the much more contagious variant that’s behind most new cases in the region.

What makes Janssen so unique?

The Johnson & Johnson vaccine has two major logistical advantages.

For one, Jansen is a single shot vaccine. This means that if approved, in terms of efficiency, it would be a step up from the other vaccine contenders that require follow up doses. This would not only ease the burden on production but also distribution, and would significantly amp up the COVID immunisation process.

“We were excited to see these preclinical data because they showed our COVID-19 vaccine candidate generated a strong antibody response and provided protection with a single dose.”
Paul Stoffels, Vice Chairman, Executive Committee and Chief Scientific Officer, Johnson & Johnson.

Another significant advantage Janssen has is that it can be stored at refrigerator temperatures (2°-8°C) rather than in special freezers, for up to 3 months, significantly easing distribution.

The vaccine is also said to remain stable for over 2 years in temperatures below -20°C.

What should you know about the FDA application?

  • On Thursday, 4th February, Johnson & Johnson released a statement announcing the submission of application to the U.S. FDA for emergency use authorization of its Investigational Single-Shot Janssen COVID-19.

This comes after the promising results shown in the vaccine’s Phase 3 ENSEMBLE clinical trial, demonstrating that it met all primary and key secondary endpoints.

  • The advisory panel will vote on whether to authorise the vaccine or not on 26th February.

Three weeks may seem like a very short time to go through such a large and complex application that includes clinical and manufacturing data, but incidentally, both its predecessors in the US— Pfizer-BioNTech and Moderna were reviewed within a similar timeline.

“Today’s submission is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”
Paul Stoffels, Vice Chairman, Executive Committee and Chief Scientific Officer, Johnson & Johnson.
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Will it speed up the vaccination process?

Yes, if approved, Johnson & Johnson’s Janssen vaccine would significantly speed up the vaccination process, especially when in tandem with the other COVID vaccines already in use in the market, considering the company is ready to roll out its first batch as early as March.

In a previous statement put out by Johnson & Johnson, they claimed, ‘Janssen Plans to Produce More Than 1 Billion Doses of a Potential Vaccine to Be Distributed Globally Through 2021’.

In its statement, the company also said that it expected to supply the 100 million doses it has promised the US by the end of June.

What does it mean for India?

Back in August, in a statement put our by Johnson & Johnson, Sarthak Ranade, Managing Director, Janssen India, had announced a collaboration with the Hyderabad based biopharmaceutical company Biological E, for the production of their vaccine.

“We are confident that Biological E’s strong vaccine manufacturing experience will assist in the rapid production of a vaccine leveraging Janssen’s proven AdVac® technology beginning in 2021, following approvals from regulators,” he said.

India is home to the world’s largest vaccine makers, contributing to more than 60% of the global vaccine supply.

Although it was reported in August that Biological E has acquired a 39,000-square-foot facility from Akorn India that could add more than 165 million doses to its annual capacity as it works with Johnson & Johnson to scale production of its vaccine, the true extent of Biological E’s assistance in the manufacturing of the vaccine remains to be seen.

As of now their existing batch of vaccines have been manufactured in the US and the Netherlands. While the 30 million doses, made at facilities in the Netherlands and Baltimore could be available by early April, it’s unlikely to be dispatched to India.

Moreover, if green lighted, the Johnson & Johnson vaccine would also be a strong contender to the existing vaccines in the country, Covishield and Covaxin in the race for vaccination.

(Written with inputs from the New York Times)

(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)

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