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 injection.
The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 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 say on approval.
“Authorizing this vaccine expands the availability of vaccines, the best method of medical prevention for COVID-19, to help us fight this pandemic, which has already claimed more than half a million lives in the United States,” said Acting Commissioner of FDA Dr. Janet Woodcock on Saturday.
“The FDA, through our open and transparent scientific review process, authorized three COVID-19 vaccines with the urgency required during this pandemic, using the agency’s stringent standards for safety, efficacy and manufacturing quality necessary to support the authorization of emergency use. “
Johnson & Johnson vaccine has been shown to provide 85% protection against severe COVID-19 28 days after vaccination. Among people who received the vaccine in clinical trials, there were no COVID-related deaths. Phase 3 clinical trials have also shown 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 United States
The vaccine can be stored at a standard refrigerator temperature for up to three months.
“There is no doubt that this vaccine will change the game,” said Dr. Mathai Mammen, Johnson & Johnson’s global head of pharmaceutical research and development, to Dr. Tara Narula of CBS News in January. “The effectiveness of this vaccine in the real world tends to be very high.”
The Centers for Disease Control and Prevention updated state and local partners on vaccine distribution plans on Friday, before FDA authorization and VRBPAC approval. According to a pre-decision outline and discussion points from the CDC obtained by CBS News, the vaccine should be made available for order on Sunday.
The new vaccine will not immediately add a significant boost to vaccine availability in America. Johnson & Johnson announced earlier this week that it expected less than 4 million doses to be ready for shipment after emergency use authorization – 6 million less than the original end of February commitment.
“There will be a limited supply of the Janssen vaccine in the short term,” says the preliminary document from the CDC. “Weekly allocations may vary based on availability in the first few weeks.”
Nearly 70 million doses of vaccine have been administered across the country as of Thursday. The doses are divided almost equally between the two already approved for use in the United States: the Pfizer vaccine, with 36 million, and the Moderna vaccine, with 34 million, according to data from the CDC.
As of February 25, about 1.5 million doses were being distributed daily in the United States, according to the seven-day average of data reported by the CDC. The rate marked a 7.1% drop from the previous week, probably due to the extreme winter, the agency said.
The CDC said on Friday that it expects 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 health centers qualified by the federal government.
Janssen’s product is a single injection vaccine and can solve an obstacle in distribution: obtaining second doses of weapons in time. Pfizer and Moderna vaccines require one person to have two vaccines weeks apart.
Millions of Americans are not receiving their second dose within the recommended time frame to ensure optimal protection against the virus, according to a CBS MoneyWatch review of CDC data.
On Wednesday, more than 2.8 million Americans who received their first injection – nearly 12% of those vaccinated – did not receive their second dose within the 28-day interval prescribed for Moderna’s vaccine.
Alexander Tin and Stephen Gandel contributed to this report.