The US Food and Drug Administration approved Johnson & Johnson’s COVID-19 vaccine for emergency use on Saturday. This vaccine is the third vaccine approved for use in the United States and the first vaccine that only requires one injection.
The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend that Janssen, a subsidiary of Johnson & Johnson, authorize the vaccine. The committee provides expert advice to the FDA, but has no final decision.
The FDA Acting Commissioner said: “The authorization of this vaccine expands the availability of the vaccine. This is the best medical prevention method for COVID-1
“The FDA, through our open and transparent scientific review process, has approved three COVID-19 vaccines, and has adopted strict standards for emergency use of the vaccine during the pandemic to support the safety, effectiveness, and safety required for emergency use authorization. Production quality.”
28 days after vaccination, it has been shown to provide 85% protection against severe COVID-19. Among those vaccinated in clinical trials, there were no COVID-related deaths. Phase 3 clinical trials also showed protection against multiple emerging virus variants, including more infectious strains, which were first discovered in South Africa and later in the United States.
The vaccine can be stored at standard refrigerator temperature for three months.
“There is no doubt that this vaccine will change the rules of the game,” Dr. Mathai Mammen, director of global drug development at Johnson & Johnson, told Dr. Tara Narula of CBS News in January. “This vaccine is often very effective in the real world.”
Prior to the US Food and Drug Administration (FDA) approval and VRBPAC approval, the Centers for Disease Control and Prevention updated the vaccine distribution plan to state and local partners on Friday. According to the pre-decision draft 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 greatly increase the supply of vaccines in the US. Johnson & Johnson announced earlier this week that it expects to be able to ship less than 4 million doses of drugs after obtaining emergency use authorization, which is 6 million fewer doses than initially promised at the end of February.
The CDC draft document says: “The supply of Janssen vaccine will be limited in the short term.” “The weekly distribution may vary based on availability in the previous weeks.”
As of Thursday, nearly 70 million doses of vaccine have been vaccinated nationwide. According to CDC data, the doses of the two vaccines approved for use in the United States are almost even: Pfizer’s vaccine is 36 million, and Moderna’s is 34 million.
According to the 7-day average data reported by the Centers for Disease Control and Prevention (CDC), as of February 25, approximately 1.5 million doses were distributed every day across the United States. The agency said that this data was down 7.1% from the previous week, which may be due to the harsh winter weather.
The CDC said on Friday that Janssen’s 3.9 million doses of vaccine are expected to be distributed as follows: 2.8 million doses in each state, 800,000 doses in retail pharmacies, 70,000 doses in community vaccine centers, and 90,000 doses in federally qualified health centers.
Janssen’s product is a one-time vaccination that can solve one of the obstacles in distribution: getting the second dose on time. Both Pfizer and Moderna’s vaccines require a person to get two shots two weeks apart.
According to CBS MoneyWatch’s review of CDC data, millions of Americans did not receive a second dose within the recommended time period to ensure the best protection against the virus.
As of Wednesday, more than 2.8 million Americans who had received the first shot-12% of the total vaccinations-had not received a second dose within the 28-day interval designated for the Moderna vaccine.
Alexander Tin and Stephen Gandel contributed to this report.