The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend EUA for this vaccine in people over 18 years of age.
Acting FDA Commissioner Dr. Janet Woodcock and FDA vaccine decision leader Dr. Peter Marks said that the EUA will be coming soon.
“The U.S. Food and Drug Administration has notified the sponsor that it will work quickly to finalize and issue the emergency use authorization. The agency has also notified federal partners involved in vaccine distribution and distribution so that they can execute their plans in a timely manner Distribute vaccines,” they said in a joint statement after the vote.
This vaccine will become the third vaccine approved for use in the United States. This will be the first one-time injection vaccine and can be stored in a regular refrigerator, making it easier to dispense than Pfizer/BioNTech and Moderna vaccines, which are more refined and require two doses.
The vaccine is produced by Janssen, the vaccine division of Johnson & Johnson, and has undergone advanced clinical trials in more than 44,000 people in the United States, South Africa and Latin America. Globally, it has shown an overall efficacy of 66% in the prevention of moderate to severe diseases. In the United States, the efficacy is 72%, and the effective rate in preventing serious diseases is 85%. During the trial, no one had received the Covid-1
Senior US health officials say that vaccination is the best way to control the coronavirus pandemic. The virus has infected more than 28 million Americans and killed more than 1 million.
Dr. Greg Poland, head of the Mayo Clinic’s vaccine research team, said at the meeting: “According to the EUA, we urgently need more vaccines to protect the millions of Americans who are still at risk.”
Poland said at the Friday meeting: “We need a vaccine that can be produced quickly in batches.” He added: “We want to see a reasonable efficacy and protection period.” “Jensen vaccine candidates checked almost all boxes. .”
How the vaccine works
Committee members said they had no doubts about their decision.
“I think this is a relatively easy call. It clearly exceeds the standard and can use a single dose of vaccine.” Editor-in-chief of the New England Journal of Medicine, Harvard University Professor Eric Rubin, Ph.D., after a vote from the Chen Public Health School Said.
Several members emphasized the urgency of fighting the pandemic, which has killed more than half a million Americans.
Dr. Archana Chatterjee, Vice President of Medical Affairs, said: “We are still in the midst of a fatal pandemic. There is a shortage of approved vaccines, and I think the current approved vaccines will help meet the demand.” Rosalind Franklin University in Chicago Study.
Dr. Jay Portnoy, a professor of pediatrics at the University of Kansas in Missouri, said: “This task is urgently needed. Urban schools.
“We need to take out this vaccine. I do believe there is evidence to support its safety and effectiveness.”
Janssen’s vaccine is different from the Pfizer and Moderna vaccines, which are manufactured using a new technology that uses genetic material called messenger RNA or mRNA. Janssen’s vaccine uses a common cold virus called adenovirus 26. It is genetically engineered, so it cannot be replicated in the body. Instead, it infects some cells in the arm when injected and carries a small portion of the genetic code of the coronavirus. These cells then produce substances similar to viral fragments in the immune system, thereby stimulating the immune response.
This is an older vaccine technology. Dr. Arnold Monto, an epidemiologist at the University of Michigan School of Public Health, said at the meeting: “The military has already used a lot of adenovirus vaccine.
Although the Johnson & Johnson vaccine does not seem to have the amazing 94% to 95% efficacy of the Pfizer and Moderna vaccines, the researchers told the VRBPAC committee that it was tested at different times-as more viruses spread and new variants appear. The ability to evade certain immune responses has emerged. Although they could not prove that these variants were the reason for the significantly reduced efficacy of Johnson & Johnson’s vaccine, they told the committee that this might be a factor.
What happened next
If the FDA issues an EUA, it may appear as early as Friday night. The U.S. Centers for Disease Control and Prevention decides whether the vaccine should actually be given to Americans. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practice (ACIP) has scheduled a meeting on Sunday to discuss the issue. ACIP will vote on whether the CDC should approve the distribution of the vaccine on Sunday afternoon, and can also designate a priority group.
The U.S. federal government said it is ready to distribute about 4 million doses of vaccine immediately.
Dr. Anthony Fauci, chief medical adviser to the White House and director of the National Institute of Allergy and Infectious Diseases, said that Americans should not try to choose a vaccine, but should choose any available vaccine.