The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the USA’s vaccine to people aged 18 and over.
FDA Acting Commissioner Dr. Janet Woodcock and Dr. Peter Marks, head of the FDA’s vaccine decision, said the USA would come quickly.
“The US Food and Drug Administration has informed the sponsor that it will work quickly to finalize and issue an emergency use authorization. The agency has also notified our federal partners involved in the allocation and distribution of vaccines so that they can execute their plans for timely delivery of the vaccine. “they said in a joint statement after the vote.
The vaccine will become the third authorized for use in the United States. It will be the first one-shot vaccine, and can be stored in conventional refrigerators, facilitating distribution than the Pfizer / BioNTech and Moderna vaccines, which are more delicate and require two doses.
The vaccine, manufactured by Johnson & Johnson’s vaccine arm, Janssen, has been tested in advanced clinical trials on more than 44,000 people in the United States, South Africa and Latin America. Overall, it showed an overall effectiveness of 66% in preventing moderate to severe illnesses. In the USA, this effectiveness was 72% and 85% in preventing serious diseases. No one who received the vaccine died of Covid-19 during the test.
US health officials said vaccination is the best way to control the coronavirus pandemic. The virus infected more than 28 million Americans and killed more than half a million.
“We urgently need more vaccines under the U.S. to protect the millions of Americans who remain at risk,” said Dr. Greg Poland, head of the Mayo Clinic’s Vaccine Research Group, at 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 effectiveness and protection,” he added. “The Janssen vaccine candidate checks almost every box.”
How the vaccine works
Committee members said they had little doubt about his decision.
“I think it’s a relatively easy decision. It clearly goes beyond the bar and it’s nice to have a single dose vaccine,” Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and professor at the Harvard TH Chan School of Public Health, said after the vote.
Several members emphasized the urgency of fighting a pandemic that 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 authorized and I think the authorization of this vaccine will help to 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 mutating the virus, new variants that can cause more diseases and prevent them,” added Dr. Jay Portnoy, professor of pediatrics at the University of Missouri, Kansas. City school.
“We need to launch this vaccine. I believe the evidence supports its safety and effectiveness.”
The Janssen vaccine is different from the Pfizer and Moderna vaccines, which are made with 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 modified so that it cannot replicate in the body. Instead, it infects some cells in the arm when injected, carrying the genetic code of a small part of the coronavirus. These cells then produce material that looks like pieces of the virus for the immune system, stimulating an immune response.
It is an older vaccine technology. “The military has used adenovirus vaccines a lot,” said Dr. Arnold Monto, an epidemiologist at the University of Michigan School of Public Health who chairs the VRBPAC, during the meeting.
Although the Johnson & Johnson vaccine does not appear to have the surprising effectiveness of 94% to 95% 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 emerged that have the ability to evade some of the immune responses. Although they were unable to demonstrate that these variants were responsible for the apparent lesser effectiveness of the Johnson & Johnson vaccine, they told the committee that this could have been a factor.
What happens next
If the FDA issues a USA, it could happen Friday night. It is up to the US Centers for Disease Control and Prevention to decide whether the vaccine should really be administered 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 whether the CDC should approve the distribution of the vaccine 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, the White House’s chief medical advisor and director of the National Institute of Allergy and Infectious Diseases, said that Americans should not try to choose vaccines, but rather get any vaccine available.