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The FDA’s Advisory Committee on Vaccines and Related Biologics (VRBPAC) voted unanimously to recommend the vaccine EUA for people 18 years of age and older.
Acting FDA Commissioner Dr Janet Woodcock and Dr Peter Marks, responsible for the FDA’s vaccination decision, said EUA will come quickly.
“The United States Food and Drug Administration has informed the sponsor that they will work expeditiously to finalize and issue an emergency use authorization.” The agency has also informed our federal partners involved in the allocation and distribution of vaccines so that they can execute their vaccine distribution plans in a timely manner, ”they said in a joint statement after the vote.
The vaccine will become the third vaccine authorized in the United States. This will be the first one-shot vaccine, and one that can be stored in regular refrigerators, making it easier to distribute than the Pfizer / BioNTech and Moderna vaccines, which are more delicate and require two doses.
The vaccine, manufactured by Janssen, the vaccine arm of Johnson & Johnson, has been tested in advanced clinical trials on more than 44,000 people in the United States, South Africa and Latin America. Overall, it has shown an overall efficacy of 66% in preventing moderate to severe disease. In the United States, this effectiveness was 72% and it was 85% effective in preventing serious illness. No one who received the vaccine died from Covid-19 during the trial.
Senior U.S. health officials have said vaccination is the best way to bring the coronavirus pandemic under control. The virus has infected more than 28 million Americans and killed more than half a million.
“We urgently need more vaccines under the EUA to protect the millions of Americans who remain at risk,” said Dr Greg Poland, head of the Mayo Clinic’s vaccine research group.
“We need a vaccine that can be mass produced quickly,” Poland said at Friday’s meeting. “We would like to see a reasonable period of effectiveness and protection,” he added. “The Janssen vaccine candidate checks almost all of the boxes.”
How the vaccine works
Committee members said they had little doubt about their decision.
“I think it’s a relatively easy call. It clearly exceeds the bar and it’s good to have a single-dose vaccine,” Dr Eric Rubin, editor of the New England Journal of Medicine and professor at Harvard TH Chan School of Public Health, said after the vote.
Several members stressed the urgency of tackling a pandemic that has killed more than half a million Americans.
“We are still in the midst of a deadly pandemic. There is a shortage of vaccines that are currently licensed and I think the authorization of this vaccine will help meet the need at this time,” said Dr Archana Chatterjee, vice president of medical affairs at Rosalind Franklin University in Chicago.
“There is an urgent need to do this. We are in a race between mutating the virus, releasing new variants that can cause a new disease and stopping it,” added Dr Jay Portnoy, professor of pediatrics at the University of Missouri in Kansas City School.
“We need to release this vaccine. I think the evidence supports its safety and effectiveness.”
Janssen’s vaccine is different from Pfizer and Moderna vaccines, which are made using new technology that uses genetic material called messenger RNA or mRNA. Janssen’s vaccine uses a common cold virus called adenovirus 26. It has been genetically modified so that it cannot replicate in the body. Instead, it infects a few cells in the arm when injected, carrying the genetic code for a small part of the coronavirus. These cells then produce material that resembles pieces of virus for the immune system, stimulating an immune response.
It is older vaccine technology. “The military has used adenovirus vaccines a lot,” Dr. Arnold Monto, an epidemiologist at the University of Michigan’s School of Public Health who chairs VRBPAC, said at the meeting.
Although the Johnson & Johnson vaccine does not appear to have the astonishing 94% to 95% effectiveness of the Pfizer and Moderna vaccines, researchers told the VRBPAC committee that it was tested at a different time – when more virus was circulating. and afterwards new variants have appeared which have the ability to escape part of the immune response. While they were unable to show that these variants were responsible for the apparent lower efficacy of Johnson & Johnson’s vaccine, they told the committee that this could have been a factor.
What happens next
If the FDA issues an EUA, it could arrive as early as Friday night. It’s up to the US Centers for Disease Control and Prevention to decide whether the vaccine should actually be given to Americans. The CDC’s Advisory Committee on Immunization Practices (ACIP) has scheduled a meeting for Sunday to address the issue. ACIP will vote on Sunday afternoon on whether the CDC should approve vaccine distribution and may also designate priority groups.
The US federal government says it is ready to immediately distribute about 4 million doses of the vaccine.
Dr Anthony Fauci, chief medical adviser to the White House and director of the National Institute of Allergy and Infectious Diseases, said Americans should not try to choose vaccines, but rather get hold of the available vaccine.
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