Single-Shot Vaccine by Johnson & Johnson Found Safe, Effective by FDA - Rolling Stone
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FDA Approves Johnson & Johnson’s Single-Shot Vaccine

The emergency-use authorization comes days after the FDA released a review finding the single-dose vaccine to be safe and effective

UKRAINE - 2021/02/05: In this photo illustration a Johnson & Johnson logo is seen in front of a medical syringe and a vial with coronavirus vaccine.Johnson & Johnson (J&J) has asked regulators to authorize their COVID-19 vaccine for emergency use in the U.S. and also will apply to authorize to EU, reportedly by media. (Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty Images)

Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket/Getty Images

UPDATE: The Food and Drug Administration on Saturday granted emergency use authorization to a single-shot vaccine developed by Johnson & Johnson. “We are ready to roll it out!” White House Covid adviser Andy Slavitt tweeted after the authorization was official.

The authorization comes days after the FDA released a report finding the vaccine to be safe and effective. Vaccines by Moderna and Pfizer, both of which require two shots administered weeks apart, have already been approved for use.

Original story below.

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It looks like we’re about to have a new vaccine, and it only requires one dose.

The Food and Drug Administration on Wednesday released a review of Johnson & Johnson’s single-shot Covid-19 vaccine, finding that it’s both safe and effective. “There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the analysis said of the vaccine. A briefing document added that the FDA found the vaccine to be “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”

The review all but ensures the vaccine will be granted emergency use authorization. 

According to the FDA, Johnson & Johnson’s vaccine showed 86-percent efficacy against severe forms of Covid-19 in the U.S, and that is was 66 percent effective at preventing both severe and moderate cases of the virus. But this data in a way undersells just how effective the vaccine actually is. As was the case with already-approved vaccines from Moderna and Pfizer, Johnson & Johnson’s was shown to be 100-percent effective in preventing hospitalizations and death among those who participated in trials. That means no one, zero people, who were administered the vaccine during trials were hospitalized or died 28 days after receiving it.

In addition to only requiring one shot, Johnson & Johnson’s vaccine can be stored using standard refrigeration, as opposed to the freezing temperatures required to store the vaccines from Moderna and Pfizer, which could help streamline distribution. Johnson & Johnson’s vaccine also differs from Moderna and Pfizer’s in that is uses an inactive form of the virus to train the immune system to combat SARS-Cov-2. Moderna and Pfizer’s both use mRNA, a synthetic genetic material that instructs the immune system to produce antibodies.

The FDA could authorize Johnson & Johnson’s vaccine for emergency use as early as Saturday. On Friday, a group of outside advisers, the Vaccines and Related Biological Products Advisory Committee, will meet to vote on whether to recommend the vaccine’s authorization. They’re expected to do so.

The authorization can’t come soon enough. Infection rates have been dropping, but experts have stressed that inoculating as many people as quickly as possible is crucial to addressing the pandemic. This week, the count of people killed by Covid-19 death in the United States passed 500,000.

This post has been updated.

In This Article: covid-19, fda, Johnson & Johnson, vaccine

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