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 to require only one shot.
The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend authorization of the vaccine by Janssen, a division of Johnson & Johnson, on Friday. The committee provides expert advice to the FDA, but has no final word on approval.
“The authorization of this vaccine expands the availability of vaccines, the best method of medical prevention for COVID-19, to help us fight this pandemic, which has caused more than half a million lives in the United States.” , said the FDA acting commissioner. Saturday, Dr. Janet Woodcock.
“The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency required during this pandemic, using the stringent safety, efficacy and manufacturing quality standards needed to support to the emergency use authorization “.
Johnson & Johnson vaccine it has been shown to provide 85% protection against severe COVID-19 at 28 days after vaccination. Among people who received the vaccine in clinical trials, there were no COVID-related deaths. Phase 3 clinical trials also showed protection against multiple variants of emerging viruses, 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 the standard refrigerator temperature for up to three months.
“There is no doubt that this vaccine will change the game,” Dr. Mathai Mammen, world head of pharmaceutical research and development at Johnson & Johnson, to Dr. Tara Narula of CBS News. “The real-world efficacy of this vaccine is likely to be very high.”
The Centers for Disease Control and Prevention updated state and local partners on Friday about vaccine distribution plans, ahead of FDA approval and VRBPAC approval. According to a draft prior to the decision and the CDC discussion points obtained by CBS News, the vaccine is expected to be available to place the order on Sunday.
The new vaccine will not immediately add a significant boost to vaccine availability in the United States. Johnson & Johnson announced earlier this week that it expected less than 4 million doses to be ready to be shipped after the emergency use permit, 6 million less than originally promised to dispose of. in late February.
“There will be a limited supply of Janssen vaccine in the short term,” says the draft CDC document. “Weekly assignments may vary depending on the availability of the first few weeks.”
As of Thursday, nearly 70 million doses of vaccine had been administered nationwide. Doses are distributed almost evenly between the two already approved for use in the U.S.: the Pfizer vaccine at 36 million and the Modern at 34 million, according to CDC data.
As of Feb. 25, about 1.5 million daily doses were distributed in the United States, according to average seven-day data reported by the CDC. The rate marked a 7.1% decrease from the previous week, probably due to the extreme winter weather, the agency said.
The CDC said Friday that it expects the 3.9 million doses of Janssen to 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 one-shot vaccine and could address an obstacle in distribution: getting second-hand doses on time. Both Pfizer and Moderna vaccines require a person to have two shots a week apart.
Millions of Americans do not receive their second dose in the recommended period to ensure optimal protection against the virus, according to a CBS MoneyWatch review of CDC data.
As of Wednesday, more than 2.8 million Americans who received their first vaccine (nearly 12% of those vaccinated) had not received their second dose within the 28-day interval prescribed for the Moderna vaccine. .
Alexander Tin and Stephen Gandel contributed to this report.