Johnson & Johnson’s COVID-19 vaccine will now become the third available vaccine approved by the Federal Drug Administration (FDA) for Emergency Use Authorization (EUA) in the United States in adults over the age of 18. In a hearing held on Friday February, 26, the FDA ruled that the vaccine met all criteria for issuance of an EUA, and has met all safety requirements set forth by the FDA.
Johnson & Johnson will begin the shipment of the nearly 4 million doses of their single-dose vaccine, with hopes of another 100 million to follow in early June. In a press conference held directly after the hearing, the FDA’s director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., reassured the public that “After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use.”
The Johnson & Johnson vaccine is now the only approved vaccine to be administered in one dose, which could prove to be a major victory in the ongoing battle against COVID-19.
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- What is the New One-Dose Vaccine?
The vaccine was produced by Johnson & Johnson (J&J), by one of their pharmaceutical holdings in Beerse, Belgium, Janssen Pharmaceuticals. The vaccine, Ad.26.COV2.S requires only one single dose to be administered to achieve high levels of efficacy; it can also be stored for months in normal refrigeration temperatures (Pfizer’s vaccine requires ultra-low temperatures of around -100 Fahrenheit).
This comes as potentially groundbreaking news, as current vaccinations take up to four weeks to reach maximum effectiveness. Currently, the vaccine has achieved effectiveness of approximately 66% (some doses were reportedly 85% effective, however, after adding in moderate cases of COVID-19, those numbers were calculated to produce the now accepted 66%), compared to the 95% average between Pfizer and Moderna’s two-dose vaccine. However, scientists urge patients to get the J&J vaccine if it is approved for use. While the overall effectiveness of preventing COVID-19 may seem low compared to that of Moderna and Pfizer’s, its ability to prevent hospitalizations and deaths in regards to COVID-19 has proven to be on par with current, approved vaccinations.
- When is the Meeting?
The meeting is scheduled for Friday, February 26, from 9:00 AM (EST) to 5:00 PM (EST), with results of the vote likely to be heard as early as Saturday. The panel consists of the same 22 medical specialists that voted on the Pfizer and Moderna vaccines back in December 2020. The committee will vote on the Emergency Use Authorization (EUA) of the vaccine in persons 18 years of age and older. While it is still too early to speculate on the results of the hearing, results lean towards approval, as the Biden administration hopes to deliver 3 million to 4 million doses of J&J’s prospective vaccine in just one week barring approval by the Food and Drug Administration (F.D.A).
- What has Testing Looked Like?
On January 29, 2021, J&J announced that their single-dose vaccine had “announced topline efficacy and safety data” from phase three of its clinical trials. The testing was conducted on a group of 43,783 participants, of which 468 displayed symptomatic COVID-19. A spokesperson for J&J said in a press release days after phase three had concluded, “The Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination.”
- What Does This Mean?
The vaccine has not been tested in children or any persons under the age of 18, meaning it will not be authorized for use for those age groups. This being said, it is important to note that an approval by the F.D.A would be a major step in the fight against COVID-19. The J&J vaccine could prove effective where others may not; in areas like storage and transportation, as well as in areas where follow-up vaccination appointments may not be possible. For now, results of the hearing are yet to be released, however, with such a breakthrough on the horizon, Americans may not have to wait long for a third vaccine.
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