Johnson & Johnson Requests Emergency Approval for Single-Shot Covid-19 Vaccine

Pharmaceutical giant Johnson & Johnson said on Thursday it’s ready to join the arms race against the pandemic with its request for emergency use authorization from the FDA for its single-shot Covid-19 vaccine.

This Sept. 2020 photo provided by Johnson & Johnson shows a clinician preparing to administer investigational Janssen COVID-19 vaccine. (Johnson & Johnson via AP)

(CN) — As new Covid-19 variants leap across oceans and continents, pharmaceutical giant Johnson & Johnson announced on Thursday that their one-dose Covid-19 vaccine is ready for emergency authorization and would be ready to immediately ship after approval by U.S. regulators.

News of the vaccine comes as new variants are reported more frequently across the globe. The Centers for Disease Control and Prevention estimate that these variants will become the dominant versions of the virus within the U.S. in the coming months.

The company announced it submitted its application based on data from its clinical trials and in the coming weeks federal regulators will meet with outside medical advisers to consider the application.

A tinge of optimism follows the news of a possible new defense against the virus from Johnson & Johnson, even as thousands continue to die each day across the globe.

If approved by the Food and Drug Administration, J&J’s vaccine will join Pfizer and Moderna, which released their two-shot vaccines in late 2020. While the J&J vaccine has proven safe in clinical trials, it was shown to be less effective than the other vaccines on the market. 

The Pfizer and Moderna vaccines are roughly 95% effective against the Covid-19 virus, while the J&J vaccine is 72% effective in the U.S. and 66% effective overall according to safety data from clinical trials.

The vaccine is more effective (85%) in preventing severe disease that could lead to hospitalizations according to clinical trial data that involved roughly 44,000 volunteers across the globe, according to the company. But the efficacy waned when the vaccine confronted variants in other parts of the world, dropping to 66% in Latin America and 57% in South Africa. 

All study volunteers showed some level of protection within 28 days after vaccination. Within 49 days, the vaccine’s efficacy increased and there were no severe diseases reported in the trial study.

“These topline results with a single-shot Covid-19 vaccine candidate represent a promising moment,” said J&J Chief Scientific Officer Paul Stoffels in a statement. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance.”

The one-shot vaccine makes J&J an appealing candidate for health officials across the globe. The logistics behind coordinating a large-scale vaccination program becomes especially daunting when a vaccine requires two doses. Global shortages have heightened an already frustrating situation against the virus and even in the U.S. it’s unclear how many vaccines are on the way.

“Johnson & Johnson embarked on the global effort to combat the Covid-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine,” said J&J CEO Alex Gorsky in a statement. 

“Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic. We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

The urgency mounts over a year after the virus was first reported in the U.S. and across the globe. Roughly 2.2 million people have died due to the virus and over 104 million confirmed cases have been reported since the onset of the pandemic.

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