An FDA committee will meet Friday to discuss granting authorization.
Currently, the United States has two primary COVID-19 vaccines on deck, one from Pfizer, and one from Moderna. Vaccine distribution has been gradually improving in the last month, barring sudden shake-ups such as the recent winter storm in the southern United States. If, however, a third viable vaccine were to receive emergency authorization, it could accelerate the mass-vaccination process even more and aid in a more expedient return to normalcy. American pharmaceutical company Johnson & Johnson is aiming to be that third candidate, and they seem to be on the right track.
Johnson & Johnson recently finalized their COVID-19 vaccine candidate and submitted it to the US Food and Drug Administration for analysis. In order to secure emergency authorization for a vaccine’s deployment, a vaccine candidate must be run through a bevy of tests to determine any potential side effects in a wide swath of test case patients, as well as how effective it is in surprising its target virus. The results of this analysis were released today, and they seem promising.
“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the FDA’s analysis reported. According to their results, the Johnson & Johnson vaccine showed a 66.9% efficacy against moderate to severe or critical COVID-19 reactions two weeks after a single dose, taking all known COVID-19 variations into account.
With these results, the FDA has determined that the vaccine candidate is “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
However, the vaccine has not been approved for emergency authorization just yet. The Vaccines and related Biological Products Advisory Committee, an independent committee of FDA advisers, will be meeting on Friday to decide whether or not to give Johnson & Johnson the green light.