The Food and Drug Administration (FDA) concluded that Johnson & Johnson (J&J) Covid-19 Vaccines Remain Safe and Effective for Up to 4 1/2 Months, announced the AP agency.
“We are delighted to confirm that the FDA has cleared the shelf life extension of the single-dose vaccine against Covid-19,” J&J commented after the announcement.
Vaccine expiration dates are defined based on the data that laboratories send to regulators, demonstrating how long injections can remain suitable for use under certain storage conditions.
Originally the FDA had authorized Johnson & Johnson’s vaccine against Covid-19, a validity to be used up to 3 months after manufacture, which is when it is stored at normal levels of refrigeration at a temperature between 36 and 46 degrees Fahrenheit .
But J&J said the FDA extended the period to four and a half months, after the stability evaluation studies of the vaccine that show that it remains effective for that period of time.
The announcement comes after state authorities warned that many of the unused stored doses would expire before the end of the month.
The New York Journal recently published that millions of doses were at risk of being discarded. due to the proximity of expiration and that the authorities did not know what destination to assign them so as not to waste them, but with the breadth of validity there will be more time to channel them to where they are most needed.
Johnson & Johnson’s vaccine was highly anticipated at the time due to its unique formulation and easy-to-ship refrigeration requirements.
But the vaccine has had to face some situations such as contamination problems that arose in a Baltimore factory which helps make the injections. Following an FDA inspection, the laboratory was closed and none of the vaccines manufactured there have been distributed.
In April, J&J also had to pause for the FDA to study some cases of thrombosis that were associated with the application of brand-name inoculations. And as if that were not enough, in the American population has registered a significant decrease at the call of the vaccination program National Biden Administration.
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