(CN) — Soon to be another weapon in the arsenal against the Covid-19 pandemic, pharmaceutical giant Johnson & Johnson announced Friday that a single shot of its Janssen vaccine is effective enough to go to market.
The findings were based on a clinical trial who third phase involved roughly 44,000 volunteers across the globe. While the data showed that globally the drug was 66% effective at preventing moderate and severe cases of the virus, that number creeped up to 72% protection in the United States. In Latin America and South Africa, where a new variant has spread, it proved 66% and 57% effective, respectively.
In preventing severe cases, such as those that could require hospitalization, the vaccine was 85% effective globally.
The company is expected to apply for emergency use authorization from the Food and Drug Administration next week wherein a team of experts will review the study’s findings and overlook safety data to ensure the immunization does not have any intolerable side effects. The company said in a Friday press release that it “intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization.”
If all goes smoothly, by late February or early March the Janssen jab could join the two vaccines by Moderna and Pfizer-BioNTech already being administered to the U.S. public after securing emergency use authorization in December. The FDA has said a vaccine must be at least 50% effective to be authorized. With two doses each, the Pfizer vaccine is 95% effective against the novel coronavirus and Moderna’s vaccine is 94.1% effective.
The addition of Johnson and Johnson’s vaccine to the queue could mean an additional 100 million vaccines available to Americans by the end of June, a number agreed upon in a $1.5 billion contract with the federal government.
“[Johnson & Johnson] expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized,” the company’s release states. “The company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.”
J&J’s would be the only Covid vaccine currently that requires a single dose — expected to go a long way toward President Joe Biden’s goal of vaccinating 100 million Americans during his first 100 days in office.
Hoping to vaccinate 300 million Americans by the end of the summer, Biden pledged Tuesday to purchase 200 million more doses from Pfizer and Moderna. Approximately 330 million people live in the U.S.
Johnson & Johnson CEO Alex Gorsky said Friday that his company had hoped all along to create a single-shot vaccine that would streamline the process of vaccination.
“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,” said Gorsky. “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”
Johnson & Johnson’s vaccine works differently than the two existing approved vaccines. Where the Pfizer and Moderna vaccines use messenger RNA to deliver instructions to cells that create immunity, the Janssen vaccine utilizes a common cold virus. Both instruct the body’s cells to create a spiky protein found on Covid-19, which the immune system learns to recognize and destroy.
The Johnson & Johnson vaccine is currently completing a separate clinical trial wherein volunteers receive two doses of the vaccine which will determine if a second dose further boosts the immune response.
According to data collected by John Hopkins University, there have been more than 25 million cases of Covid-19 in the U.S. and more than 430,000 Covid-19 deaths. The number of Covid-19 cases has trended 33% downward in the last two weeks as vaccinations have risen.
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