FDA Approves J&J Vaccine for Emergency Use; All You Need to Know

On Sunday, 28 February, The Johnson & Johnson COVID-19 vaccine has been authorized by the US Food and Drug Administration (FDA) for emergency use reports The Washington Post .

This announcement comes a day after an advisory panel of experts endorsed and recommended the vaccine as being safe and effective to the FDA.

The development makes Johnson & Johnson vaccine the third approved vaccine for COVID in the US, after Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines.

An analysis released by the FDA on Wednesday found that the single-shot vaccine is safe and effective, reported CNN.

Now that it's been officially approved, here’s all you need to know about the Johnson & Johnson single shot covid vaccine.

What is the Johnson & Johnson vaccine?

The single shot vaccine was developed at the Janssen Pharmaceutical Companies and has passed the Phase 3 clinical trials having met all primary and key secondary endpoints.

Towards the end of January, 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 the FDA analysis, the efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single-dose vaccination and 66.1% at least 28 days after vaccination, reported CNN.

“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the analysis stated.

Does it work against the coronavirus variants?

Interim data released by the company had shown that the vaccine was found to be 57% effective against the South African variant (found in several countries now) - which was lower than the US results but still above FDA’s minimum requirement of 50%.

But the FDA analysis revealed that the vaccine, in fact, showed an efficacy of 64% in South Africa after J&J did additional sequencing of the cases in the study (almost 95% of the cases in the trial were from the South African variant).

“The fact that the numbers came up a little bit, once they fully analyzed the data from the time of the initial press release, shows that it’s not that different against the South African variant,” said Dr. Philip Grant, the lead investigator on the Stanford University arm of the J&J vaccine trial, reported CNN.

“I think it’s going to have to be looked at more carefully, in terms of which vaccines are most effective in different locations.”

Speaking of other locations, the efficacy in US was found to be 72% and above 68% in Brazil in preventing mild to severe disease in people. It offered almost 86% protection against severe disease in the US, 82% in South Africa and 88% in Brazil.

“We’ll be seeing how much of an impact the variants have and how best these vaccines can address them, whether it will be booster doses, or other vaccines,” Dr. Aditya Gaur said, a co-lead investigator on the J&J trial at St. Jude in Memphis, according to the CNN report. “But I think one could not have asked for better from this first round of vaccine development from a standpoint of how quickly it has happened and how quickly it has started to roll out around the world.”

What are some advantages of this vaccine?

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.

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.

Will its authorisation speed up the vaccination process?

Yes, for now, in the US where it has been approved, Johnson & Johnson’s Janssen vaccine would significantly speed up the inoculation 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.

Not to mention the clear logistical advantages of the single dose vaccine will help amp up the vaccination drive and the supply shortage issue.

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.

The company is looking to contract-manufacture roughly 600 million doses of Johnson and Johnson’s COVID-19 vaccine annually, Ranade recently told Reuters.

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

(With inputs from The Washington Post and CNN)