The FDA Vaccines and Related Biologics Advisory Committee (VRBPAC) voted unanimously to recommend the vaccine for EUA in people 18 years of age and older.
Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, FDA’s head of vaccine decision, said the USA would come quickly.
“The US Food and Drug Administration has informed the sponsor that it will work expeditiously toward the finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in the allocation and distribution of vaccines for that they can execute their plans for the timely distribution of vaccines. ”They said in a joint statement after the vote.
The vaccine will become the third licensed for use in the United States. It will be the first single-injection vaccine and one that can be stored in regular refrigerators, making it easier to distribute than the more delicate Pfizer / BioNTech and Moderna vaccines, which require two doses.
The vaccine, manufactured by Johnson & Johnson’s vaccine arm, Janssen, has been tested in advanced clinical trials in more than 44,000 people in the US, South Africa and Latin America. Globally, it showed an overall efficacy of 66% in preventing moderate to severe disease. In the US, this efficacy was 72% and it was 85% in preventing serious illness. No one who received the vaccine died of Covid-19 during the trial.
Top US health officials have said that vaccination is the best way to control the coronavirus pandemic. The virus has infected more than 28 million Americans and killed more than half a million.
“We urgently need more vaccines under the US to protect the millions of Americans who remain at risk,” Dr. Greg Poland, head of the Mayo Clinic Vaccine Research Group, told the meeting.
“We need a vaccine that can be mass produced quickly,” Poland said at Friday’s meeting. “We would like to see a reasonable duration of efficacy and protection,” he added. “Janssen’s vaccine candidate meets almost all the requirements.”
How the vaccine works
Committee members said they had little doubt about their decision.
“I think it’s a relatively easy decision. Clearly the bar is raised and it’s nice to have a single-dose vaccine,” said Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and professor at Harvard TH Chan School of Health Public said after the vote.
Several members highlighted the urgency of fighting a pandemic that has killed more than half a million Americans.
“We are still in the middle of a deadly pandemic. There is a shortage of vaccines that are currently licensed and I believe that licensing 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 urgency to do this. We are in a race between the mutation of the virus, the emergence of new variants that can cause more disease and stop it,” added Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri Kansas. City school.
“We need to get this vaccine out. I think the evidence supports its safety and efficacy.”
The Janssen vaccine is different from the Pfizer and Moderna vaccines, which are made using a new technology that uses genetic material called messenger RNA, or mRNA. The Janssen vaccine uses a common cold virus called adenovirus 26. It has been genetically engineered so that it cannot replicate in the body. Instead, it infects some cells in the arm when injected, carrying the genetic code for a small part of the coronavirus. Those cells then produce material that looks like parts of the virus to the immune system, stimulating an immune response.
It is an older vaccine technology. “The military has used adenovirus vaccines a lot,” Dr. Arnold Monto, an epidemiologist at the University of Michigan School of Public Health who chairs the VRBPAC, said during the meeting.
Although the Johnson & Johnson vaccine does not appear to have the staggering 94-95% efficacy of the Pfizer and Moderna vaccines, the researchers told the VRBPAC committee that it was tested at a different time, when more viruses were circulating and after new variants. have emerged that they have the ability to evade part of the immune response. Although they could not prove that these variants were responsible for the apparent lower efficacy of the Johnson & Johnson vaccine, they told the committee that it could have been a factor.
What happens next
If the FDA issues an EUA, it could come as early as Friday night. It is up to the US Centers for Disease Control and Prevention to decide whether the vaccine should actually be given to Americans. CDC’s Advisory Committee on Immunization Practices (ACIP) has scheduled a meeting for Sunday to address the issue. The ACIP will vote Sunday afternoon on whether the CDC should approve the vaccine distribution and can also designate priority groups.
The United States federal government says it is ready to distribute about 4 million doses of the vaccine immediately.
Dr. Anthony Fauci, chief medical adviser to the White House and director of the National Institute of Allergy and Infectious Diseases, has said that Americans should not try to choose vaccines, but only what is available.