The Food and Drug Administration on Saturday authorized Johnson & Johnson’s COVID-19 vaccine for emergency use. The vaccine is the third to be approved for use in the United States, and the first that requires only one shot.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to approve the vaccine by Janssen, a division of Johnson & Johnson, on Friday. The committee, which provides expert advice to the FDA but does not have final say on approval, based their vote on whether, “based on the totality of scientific evidence available,” the vaccine’s benefits “outweigh its risks for use in individuals 18 years of age and older.”
“Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” said FDA Acting Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
“The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution,” they said on Friday.
White House senior adviser Andy Slavitt called the panel’s decision “very welcome news.”
The Centers for Disease Control and Prevention updated state and local partners on distribution plans for the vaccine on Friday, ahead of the FDA’s authorization and VRBPAC’s approval. According to a pre-decision draft and CDC talking points obtained by CBS News, the vaccine is expected to be made available for ordering on Sunday.
The new vaccine will not immediately add a significant boost to America’s vaccine availability. Johnson & Johnson announced earlier this week it expected under 4 million doses would be ready to ship after the emergency use authorization — six million less than it originally committed to having ready by the end of February.
“There will be limited supply of Janssen vaccine in the short term,” the draft CDC document says. “Weekly allocations may vary based on availability for the first few weeks.”
Nearly 70 million vaccine doses had been administered across the country as of Thursday. Doses are split almost evenly between the two already approved for use in the U.S.: Pfizer’s vaccine at 36 million, and Moderna’s at 34 million, according to CDC data.
As of February 25, about 1.5 million doses were being distributed daily across the U.S., according to seven-day average data reported by the CDC. The rate marked a 7.1% decrease from the previous week, likely due to extreme winter weather, the agency said.
The CDC said Friday it expects Janssen’s 3.9 million doses will be divided as follows: 2.8 million doses for states, and 800,000 doses for retail pharmacies, 70,000 doses for community vaccine centers, and 90,000 doses for federally qualified health centers.
Janssen’s product is a single-shot vaccine, and could address one obstacle in distribution: Getting second doses in arms on time. Both Pfizer’s and Moderna’s vaccines require a person to get two shots weeks apart.
Millions of Americans are not getting their second dose within the recommended time period for ensuring optimal protection from the virus, according to a CBS MoneyWatch review of CDC data.
As of Wednesday, more than 2.8 million Americans who received their first shot — nearly 12% of those vaccinated — had not gotten their second dose within the 28-day interval prescribed for Moderna’s vaccine.
Johnson & Johnson’s vaccine has been shown to provide 85% protection against severe COVID-19 28 days after vaccination — necessitating only one dose, and potentially accelerating widespread vaccination once production is scaled up. Phase 3 clinical trials also showed protection against multiple emerging virus variants, including a more contagious strain that was first discovered in South Africa and has since been detected in the U.S.
The vaccine can be stored at standard refrigerator temperatures for up to three months.
“There’s no question that this vaccine is going to be a game-changer,” Dr. Mathai Mammen, global head of pharmaceutical research and development for Johnson & Johnson, told CBS News’ Dr. Tara Narula in January. “The real-world effectiveness of this vaccine is apt to be very high.”
Alexander Tin and Stephen Gandel contributed to this report.
