The Food and Drug Administration's staff has endorsed Johnson & Johnson’s COVID-19 vaccine for emergency use, paving the way for the one-dose shot to receive its final approval for emergency use in America by a final committee.
This week, the FDA announced it supported the approval of the vaccine, which is easier to store and would represent a third vaccination option for those looking to get inoculated as the country combats the virus.
The FDA’s Vaccines and Related Biological Products Advisory Committee is expected to meet on Friday, Feb. 26 to determine whether the new vaccine is viable for emergency use authorization, similar to the process before the Pfizer and Moderna vaccinations were approved for general distribution.
According to the FDA, the Johnson & Johnson vaccine works safely and has been more than 66 percent effective in preventing moderate to severe disease. It also reportedly showed signs of slowing the asymptomatic spread of COVID-19.
Officials said the vaccine “met the pre-specified success criteria” after reviewing a 44,000-person study, which found it was successful in protecting moderate and severe COVID-19 cases.
During the study, the FDA reported two COVID-19 hospitalizations starting 14 days after receiving the shot, versus 29 in the placebo group. There were no new hospitalizations after 28 days among those who were vaccinated, while there were 29 in the placebo group.
There were seven virus-related deaths among study subjects who received a placebo compared to none among those who received the vaccine.
The advisory is expected to recommend that the FDA authorize the Johnson & Johnson vaccine, with the rollout of doses expected as soon as next month. Approximately 20 million doses are ready to be distributed in America by the end of March, which could boost the country’s vaccination capacity by approximately 20 percent.
Johnson & Johnson said that it expects to ship approximately 100 million doses throughout the country by the summer, and more than one billion worldwide by the end of the year.
The vaccine appeared mostly safe with some side effects, Johnson & Johnson said, including headache, fatigue, muscle ache, and injection-site pain. There were no severe allergic reactions in studies of its vaccine.
Dr. Richard Nettles, Johnson & Johnson subsidiary Janssen's vice president of medical affairs, told a House Energy & Commerce Committee hearing this week that: "we will have 20 million doses of the vaccine to be made available by the end of March and we're prepared to ship, immediately upon emergency use authorization, nearly four million doses of our vaccine."
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