US – The U.S Food and Drug Administration (FDA) has under the emergency authorization use (EUA), authorized the production of the Janssen (Johnson & Johnson) COVID-19 Vaccine for use in the United States.
According to a statement from the FDA, the approval will allow the manufacture of two batches of the Vaccine by the Emergent BioSolutions, a facility in Baltimore.
The move comes at a time when US president Joseph Biden and his Vice Kamala Harris are stepping up the fight against corona virus with clarion calls for more citizens to turn out for the vaccination jab.
As at 14th June, about 174 million Americans or 53.1% of the population had taken at least one dose of the Vaccine.
The inclusion of production of the Janssen vaccine will add to the fire power to the fight against Covid-19 and help the country reach the remaining 46.9% who are yet to be vaccinated.
Before any approval was done, FDA reportedly did a thorough review of the facility’s previous records and results of quality tests performed by Emergent BioSolutions.
After a thoughtful consideration of the COVID-19 public health emergency and the findings from the reviews done, FDA came to a conclusive agreement that the batches are safe for use.
With FDA approval, the Janssen COVID19 vaccine will now be used within the U.S or exported to other countries.
An additional condition to this agreement is that any batch exported will authorize FDA to share vital information to the regulatory authorities of involved countries about the batches under an appropriate confidentiality agreement.
FDA also did a revision of the letter of authorization from Janssen Vaccine to help make the exportation process easier.
Under the revised letter of authorization, the distribution and administration of exported vaccines must comply with the laws of the recipient countries.
Based on information submitted by Janssen, FDA has extended the shelf life of the Janssen COVID-19 vaccine from 3 months to 4.5 months and this is possible if the storage temperature is between 2-8 degrees Celsius.
Though it has deemed other batches not suitable for use, FDA is still reviewing other batches and promises to ensure the public will be well informed about the reviews.