The regulatory approval of the Johnson & Johnson
On Saturday, the U.S. Food and Drug Administration (F.D.A.) approved the drugmaker's request for an emergency use authorization (E.U.A.) for the vaccine, following the unanimous recommendation from the health regulator's independant vaccine review board--known as the Vaccines and Related Biological Products Advisory Committee--which plays a key role in approving vaccines for use in the U.S.
The addition of a third vaccine, following the approvals of both two-shot mRNA vaccines developed by Pfizer
Johnson & Johnson said that the vaccine's level of protection varies by the region its late-stage clinical trials were conducted, with the shot demonstrating 66% overall effectiveness, 72% in the United States, 66% in Latin America, and 57% in South Africa, where the concerning B.1.351 variant strain is rapidly spreading. However, the F.D.A. noted that the vaccine was found to be 64% effective in South Africa about a month after initial inoculation. The drugmaker also found that the vaccine prevented 100% of hospitalizations and deaths associated with severe infection.
The one-dose vaccine will help the United States' effort to control the virus before multiple variant strains can spread further. Johnson & Johnson has begun shipping 3.9 million doses of its vaccine to states this week, but additional supply will be halt initially as the company works to increase its manufacturing capacity. The company hopes to increase production of the one-dose vaccine by the end of the month, with 20 million total doses available to the public and 100 million delivered by June.
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