The Food and Drug Administration approved Johnson & Johnson’s COVID-19 vaccine for emergency use on Saturday. The vaccine is the third to be approved for use in the United States and the first to require only one injection.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously on Friday to approve the vaccine by Janssen, a division of Johnson & Johnson. The committee provides expert advice to the FDA, but does not have the final say on approval.
“The authorization of this vaccine increases the availability of vaccines, the best medical prevention method for COVID-19, to help us fight this pandemic, which has claimed more than half a million lives in the United States,” said acting FDA Commissioner Dr. Janet Woodcock on Saturday.
“The FDA has now approved three COVID-19 vaccines with the urgency required during this pandemic through our open and transparent scientific review process, leveraging the agency’s rigorous standards of safety, effectiveness and manufacturing quality needed are in support of an emergency use permit. “
Johnson & Johnson’s vaccine has been shown to provide 85% protection against severe COVID-19 28 days after vaccination. There were no COVID-related deaths among the people who received the vaccine in clinical trials. Phase 3 clinical trials also demonstrated protection against multiple emerging virus variants, including a more contagious strain first discovered in South Africa and since then detected in the US.
The vaccine can be stored at standard refrigerator temperatures for up to three months.
“There is no doubt that this vaccine is going to be a game-changer,” said Dr. Mathai Mammen, global head of pharmaceutical research and development for Johnson & Johnson, in January to Dr. Tara Narula from CBS News. “The actual effectiveness of this vaccine is probably very high.”
The Centers for Disease Control and Prevention notified state and local partners of the vaccine distribution plans on Friday, ahead of FDA approval and VRBPAC approval. According to a preliminary draft decision and CDC talking points obtained by CBS News, the vaccine is expected to be available for order on Sunday.
The new vaccine will not immediately give a significant boost to the availability of vaccines in America. Johnson & Johnson announced earlier this week that it expected fewer than 4 million doses to be ready for shipment after approval for emergency use – 6 million fewer than it originally promised to be ready by the end of February.
“In the short term, the supply of Janssen vaccine will be limited,” the draft CDC document said. “Weekly assignments may vary based on availability for the first few weeks.”
Nearly 70 million vaccine doses had been administered nationwide on Thursday. According to data from the CDC, the doses are split almost evenly between the two already approved for use in the US: Pfizer’s vaccine for 36 million and Moderna’s vaccine for 34 million.
On Feb. 25, approximately 1.5 million doses were distributed across the U.S. daily, according to data over an average of seven days reported by the CDC. The rate was down 7.1% 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 to be distributed as follows: 2.8 million doses to states and 800,000 doses to retail pharmacies, 70,000 doses to local vaccine centers and 90,000 doses to federally qualified health centers.
Janssen’s product is a single vaccine and could address one obstacle in distribution: getting a second dose in time. Both Pfizer and Moderna vaccines require a person to inject two weeks apart.
According to a CBS MoneyWatch review of CDC data, millions of Americans do not receive their second dose within the recommended time period to ensure optimal protection against the virus.
As of Wednesday, more than 2.8 million Americans who received their first injection – nearly 12% of those vaccinated – did not have their second dose within the 28-day interval prescribed for Moderna’s vaccine.
Alexander Tin and Stephen Gandel contributed to this report.