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The Food and Drug Administration on Saturday cleared Johnson & Johnson’s COVID-19 vaccine for emergency use. The vaccine is the third to be approved in the United States and the first to require only one vaccine.
The FDA’s Vaccines and Related Biologics Advisory Committee (VRBPAC) on Friday voted unanimously to recommend the vaccine’s approval 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 expands the availability of vaccines, the best method of medical prevention of COVID-19, to help us in the fight against this pandemic, which has claimed more than half a million lives in the United States “said the acting commissioner of the FDA. Dr Janet Woodcock Saturday.
“The FDA, through our open and transparent scientific review process, has now cleared three COVID-19 vaccines with the urgency required during this pandemic, using the agency’s rigorous standards for safety, efficacy and build quality necessary to support emergency use authorization. “
Johnson & Johnson vaccine Protection against severe COVID-19 has been shown to be 85% 28 days after vaccination. Among people who have received the vaccine in clinical trials, there have been no deaths related to COVID. Phase 3 clinical trials have also shown protection against several emerging viral 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 standard refrigerator temperature for up to three months.
“There is no doubt that this vaccine will be a game changer,” Dr Mathai Mammen, global head of pharmaceutical research and development at Johnson & Johnson, told CBS News’ Dr Tara Narula in January. “The actual effectiveness of this vaccine is likely to be very high.”
On Friday, the Centers for Disease Control and Prevention updated local and state partners on vaccine distribution plans, ahead of FDA clearance and VRBPAC approval. According to a draft pre-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 increase vaccine availability in the United States. Johnson & Johnson announced earlier this week that it expects less than 4 million doses to be ready to ship after emergency use clearance – 6 million less than it originally pledged to have ready by the end of February.
“The supply of Janssen vaccine will be limited in the short term,” the CDC’s draft document said. “Weekly allowances may vary depending on availability during the first few weeks.”
Nearly 70 million doses of the vaccine had been administered across the country as of Thursday. The doses are split almost evenly between the two already approved for use in the United States: Pfizer’s vaccine at 36 million and Moderna’s at 34 million, according to CDC data.
As of February 25, approximately 1.5 million doses were being distributed across the United States daily, according to seven-day average data reported by the CDC. The rate marked a decline of 7.1% from the previous week, likely due to extreme winter conditions, the agency said.
The CDC said on Friday it expects Janssen’s 3.9 million doses to be divided as follows: 2.8 million doses for states and 800,000 doses for retail pharmacies, 70,000 doses for community vaccination centers and 90,000 doses for federally qualified health centers.
Janssen’s product is a single injection vaccine and could solve a delivery hurdle: getting the second doses in the arms on time. The Pfizer and Moderna vaccines require that a person be given two weeks apart.
Millions of Americans do not receive their second dose within the recommended timeframe for 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 in the 28-day prescribed interval for Moderna’s vaccine.
Alexander Tin and Stephen Gandel contributed to this report.
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