Johnson & Johnson had requested an EUA for its COVID-19 vaccine in the United States.
Johnson & Johnson on Thursday submitted an application for emergency use authorization (EUA) of its COVID-19 vaccine with US health authorities, the company said in a statement.
The said process could take several weeks, but the said vaccine would be the third COVID-19 vaccine authorized in the United States at the end of it, after those of Pfizer-BioNTech and Moderna.
In a statement, it stated that Johnson & Johnson subsidiary Janssen Biotech had submitted an application to the United States Food and Drug Administration (FDA) requesting emergency use authorization (EUA) for its “investigational single-dose Janssen COVID-19 vaccine candidate”.
The said vaccine was highly anticipated because it has two big logistical advantages: it required just one vaccine dose and it can be stored at refrigerator temperatures.
Following Johnson & Johnson’s request, the Food and Drug Administration in the United States was expected to convene its advisory committee on COVID-19 vaccines, which would deliver its opinion after studying the data from human clinical trials.
It would be responsible for determining whether the benefits of the said vaccine outweigh the risks.
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The said step took about three weeks for the Pfizer-BioNTech and Moderna COVID-19 vaccines, but could be faster this time around as the final approval will then be given, probably the next day.
Johnson & Johnson announced at the end of last week the first results of its human clinical trials, carried out on nearly 44,000 people in eight countries.
The said vaccine was overall 66% effective, the company said, adding that it was 85% effective in preventing severe forms of the coronavirus disease.
However, those results also raised a concern: the said vaccine was more effective in the United States (72% efficacy rate) than in South Africa (57% efficacy rate), wherein a COVID-19 variant that had appeared in the country became dominant.
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