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One-shot COVID vaccine approved for emergency use by Johnson & Johnson

The Food and Drug Administration on Saturday approved the emergency use of Johnson & Johnson’s COVID-19 vaccine. This vaccine is the third vaccine approved for use in the United States and the first vaccine to require a single dose.

The FDA’s Vaccine and Related Biologics Advisory Board (VRBPAC) unanimously voted for vaccine approval by Janssen, a division of Johnson & Johnson, on Friday. The Commission, which provides expert advice to the FDA but does not have the final say on approval, said that “based on the overall scientific evidence available”, the benefits of the vaccine were “18 years of personal use. It is based on a vote on whether to “exceed the risk”. Over age. “

“Janssen Biotech Inc. Following the results of today’s positive advisory board meeting on the COVID-19 vaccine, the U.S. Food and Drug Administration has informed sponsors that it will work swiftly towards the final decision and issuance of an emergency use authorization.” Said Dr. FDA Deputy Commissioner. .. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“Authorities have also notified federal partners involved in vaccine allocation and distribution so that they can implement timely vaccine distribution plans,” they said Friday.

The White House senior adviser Andy Slavit called the panel’s decision “very welcome news.”

The Centers for Disease Control and Prevention updated its state and local partners on Friday for vaccine distribution plans prior to FDA approval and VRBPAC approval. According to the pre-determined draft and CDC issues obtained by CBS News, the vaccine will be available for order on Sunday.

The new vaccine does not immediately significantly increase the availability of American vaccines. Johnson & Johnson announced earlier this week that it expects to ship in less than 4 million doses after an emergency use authorization — 6 million less than that Initial commit It was ready by the end of February.

“In the short term, the supply of Janssen vaccine will be limited,” said the draft CDC document. “Weekly allocations may vary based on availability in the first few weeks.”

As of Thursday, there have been about 70 million vaccinations nationwide. The dosage is almost evenly divided into two that have already been approved for use in the United States. Pfizer’s vaccine is 36 million and Modana’s vaccine is 34 million. CDC data..

As of February 25, approximately 1.5 million doses were distributed daily throughout the United States, according to 7-day average data reported by the CDC. The rate recorded a 7.1% decrease from the previous week, probably due to extreme winter weather, officials said.

The CDC said Friday that Janssen’s 3.9 million doses are projected to be split as follows: 2.8 million in the state, 800,000 in retail pharmacies, 70,000 in regional vaccine centers, and federally qualified. 90,000 times at the health center.

Janssen’s product is a one-shot vaccine that can address one obstacle in distribution. That is to give a second vaccination on time. Both Pfizer and Modana vaccines require people to be two weeks apart.

According to the report, millions of Americans have not received a second dose within the recommended period to ensure optimal protection from the virus. CBS MoneyWatch Review Of CDC data.

As of Wednesday, more than 2.8 million Americans who received the first injection (almost 12% of those who received the vaccine) received a second dose within 28 days of being prescribed for the Moderna vaccine. did not.

Johnson & Johnson’s vaccine has been shown to provide 85% protection against severe COVID-19 28 days after vaccination. This requires a single dose and may accelerate widespread vaccination as production increases. Phase 3 clinical trials have also shown protection against multiple emerging viral variants, including more contagious strains since they were first discovered in South Africa. Detected in the United States

Vaccines can be stored at standard refrigerator temperatures for up to 3 months.

“There is no doubt that this vaccine will be a breakthrough,” said Dr. Mathai Mammen, Global Head of Pharmaceutical Research and Development at Johnson & Johnson. Talked to Dr. Taranarula on CBS News In January. “The actual effectiveness of this vaccine tends to be very high.”

Alexander Tin and Stephen Gandel contributed to this report.



One-shot COVID vaccine approved for emergency use by Johnson & Johnson

Source link One-shot COVID vaccine approved for emergency use by Johnson & Johnson

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