San Francisco Chronicle - (Sunday)
Johnson & Johnson vaccine receives FDA authorization
The Food and Drug Administration issued an emergency authorization Saturday for the Johnson & Johnson vaccine, the first singledose vaccine to be available for use in the U.S.
The announcement came a day after an expert panel tapped by the FDA unanimously endorsed the vaccine, green0lighting it to be administered to people 18 and older.
The vaccine is the third approved for use in the United States, with the signoff coming nearly a year after the pandemic began sweeping across the country. To date, the coronavirus has infected nearly 30 million people and killed more than 500,000 in the U.S., and across the globe stricken 113 million and killed 2.5 million. Gov. Gavin Newsom said California expects to receive “around 380,000 doses” of the Johnson & Johnson vaccine “as early as this week.” Newsom called the authorization “excellent news.”
Studies showed the vaccine had a 72% efficacy rate for preventing the virus in the United States, 64% in South Africa and 61% in Latin America, according to FDA materials. Those figures are lower than the Pfizer and Moderna vaccine efficacy rates, which clocked in at 95% and 94%, respectively.
But Johnson & Johnson’s vaccine, made by Janssen Pharmaceuticals, is regarded as a more accessible alternative to vaccines offered by Moderna and the PfizerBioNTech partnership, which both require two shots. Unlike the other vaccines, the J&J vaccine does not need to be shipped and stored frozen and needs only to be refrigerated.
In a press call shortly after the announcement, Acting FDA Commissioner Dr. Janet Woodcock said the vaccine’s authorization adds a crucial tool to the fight against COVID19.
“The process that FDA uses to review medical products is respected worldwide, and commonly referred to as the gold standard,” she said.
San Francisco’s Department of Public Health called the announcement “a positive development in the fight against COVID” and said it looks forward to further guidance from the federal and state governments.
“All populations may benefit from application of a single dose, and we are working on operational plans to manage that supply,” the statement said.
The United States purchased 100 million doses of Johnson & Johnson’s vaccine in August, an investment that would allow its use after an approval or emergency use authorization by the FDA, the company announced at the time. The agreement secured Johnson & Johnson a contract worth more than $1 billion with the federal government’s Biomedical Advanced Research and Development Authority, and left open the option for the United States to buy an additional 200 million doses.
After the advisory committee’s vote Friday, the FDA issued a statement pledging to “rapidly work toward finalization and issuance of an emergency use authorization.”
“The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution,” the statement said.
The first shipments of the vaccine are expected within days.
Separately, the House voted to approve the $1.9 trillion coronavirus aid package early Saturday, sending the first major bill of President Biden’s administration to the Senate. The president urged the Senate to act swiftly.
“If we act now — decisively, quickly and boldly — we can finally get ahead of this virus. We can finally get our economy moving again. The people of this country have suffered far too much for too long. We need to relieve that suffering,” Biden said in remarks from the White House.