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March 05, 2021

Health Law Weekly

Biden Expects Wide Availability of COVID-19 Vaccines by End of May; Merck to Aid Production of Newly Authorized J&J Shot

  • March 05, 2021

President Biden said this week that his administration is expecting enough vaccine supply to be available for all Americans by the end of May.

The projection came after the Food and Drug Administration (FDA) issued February 27 an emergency use authorization (EUA) for Johnson & Johnson’s (J&J’s) COVID-19 vaccine.

In March 2 remarks, Biden announced that Merck & Co. would work with J&J to boost production of the COVID-19 vaccine. J&J previously had signaled it was behind on production of its one-dose shot.

The Department of Health and Human Services said the “historic manufacturing collaboration” will help J&J move up by a month to the end of May its delivery of 100 million vaccine doses. “In the long term, these actions will ultimately double J&J’s U.S. capacity to produce drug substance and increase the U.S. capacity for fill-finish,” HHS said in a press release.

J&J’s COVID-19 vaccine candidate passed a critical milestone last week after the FDA confirmed that data on its safety and efficacy met the requirements for an EUA. An independent advisory panel unanimously voted on February 26 to recommend authorizing emergency use of the vaccine in adults 18 years and older. FDA issued the EUA the next day, with the Centers for Disease Control & Prevention signing off the shot on February 28.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.

In December 2020, the FDA issued EUAs to Pfizer Inc. and Moderna Inc. for their vaccines. Unlike the single-dose J&J vaccines, both the Pfizer and Moderna vaccines require two doses spaced about three to four weeks apart.