BRIEF-FDA Takes Steps To Increase Availability Of Covid-19 Vaccine

June 11 (Reuters) - U.S. FDA:

* FDA TAKES STEPS TO INCREASE AVAILABILITY OF COVID-19 VACCINE

* FDA SAYS AUTHORIZING FOR USE, UNDER EUA FOR JANSSEN COVID-19 VACCINE 2 BATCHES OF VACCINE DRUG SUBSTANCE MANUFACTURED AT EMERGENT BIOSOLUTIONS FACILITY IN BALTIMORE

* FDA SAYS IS TAKING STEPS THAT WILL ALLOW SUPPLY OF THE JANSSEN COVID-19 VACCINE TO BE MADE AVAILABLE

* FDA SAYS IT HAS REVISED THE LETTER OF AUTHORIZATION FOR THE JANSSEN VACCINE TO HELP FACILITATE POTENTIAL EXPORT TO OTHER COUNTRIES

* FDA SAYS FDA IS NOT YET READY TO INCLUDE EMERGENT BIOSOLUTIONS PLANT IN THE JANSSEN EUA AS AN AUTHORIZED MANUFACTURING FACILITY

* FDA SAYS FDA CONTINUES TO WORK THROUGH ISSUES AT EMERGENT BIOSOLUTIONS PLANT WITH JANSSEN AND EMERGENT BIOSOLUTIONS MANAGEMENT

* FDA SAYS UNDER REVISED LETTER OF AUTHORIZATION, DISTRIBUTION & ADMINISTRATION OF EXPORTED VACCINES MUST COMPLY WITH LAWS OF THE RECIPIENT COUNTRIES

* FDA SAYS FDA HAS DETERMINED SEVERAL OTHER BATCHES ARE NOT SUITABLE FOR USE, BUT ADDITIONAL BATCHES ARE STILL UNDER REVIEW

06/11/2021 15:10

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