Johnson & Johnson's COVID-19 Vaccine Gets OK From FDA Panel
An advisory panel to the U.S. Food and Drug Administration (FDA) voted unanimously on Friday to recommend that the agency approve the use of Johnson & Johnson's COVID-19 vaccine in adults.
"I think authorization of this vaccine will help meet the needs at the moment," Dr. Archana Chatterjee, a committee member and dean of the Chicago Medical School, said after casting her vote as USA Today reported.
Once the FDA's acting commissioner agrees, the Johnson & Johnson COVID-19 vaccine could begin rolling out in the U.S. as early as next week. This would make Johnson & Johnson the third vaccine to reach Americans, joining Moderna and Pfizer-BioNTech.
Since Johnson & Johnson has met all the requirements that the FDA set last year, the approval of the FDA advisory group, known as the Vaccines and Related Biological Products Advisory Committee, was expected.
These FDA's criteria or standards include a large-scale trial proving safety and effectiveness and evidence that the firm can manufacture the COVID-19 vaccine consistently and safely.
Related article: Johnson & Johnson COVID-19 Vaccine Applies for Emergency Use Authorization
FDA Panel Member Says the 3 COVID-19 Vaccines Are Safe
All three COVID-19 vaccines are deemed safe and effective, according to several committee members after the vote. Dr. Cody Meissner, chief of the division of pediatric infectious disease at Tufts University School of Medicine in Boston, said it is important that people do not think that one COVID-19 vaccine is better than the other.
The panel, consisting of infectious disease experts, doctors, and medical researchers, has considered whether the benefits of the Johnson & Johnson single-dose vaccine outweigh its risk for use in people aged 18 and older.
In a 44,000-person trial, Johnson & Johnson's vaccine candidate showed an overall 66 percent effectiveness in preventing moderate to severe cases of COVID-19. The effectiveness of the single-dose vaccine varied over time and location.
In the U.S., the vaccine's reported effectiveness was 74 percent at 14 days and 72 percent two weeks later. On the other hand, the shot was 64 percent effective after 28 days in South Africa, according to a Reuters report.
The vaccine was also reported to have 100 percent effectiveness at preventing hospitalizations 28 days after vaccination. There were also no COVID-19 deaths among those who received the shot.
Aside from that, the Johnson & Johnson vaccine can be stored at normal refrigerator temperature, making distribution easier than Pfizer-BioNTech and Moderna vaccines.
Dr. Jay Portnoy of Children's Mercy Hospital in Kansas City, Missouri, said that there is an urgency to roll out the Johnson & Johnson vaccine as the country is in a race between the virus mutating and stopping it as new variants are coming out that can cause further disease.
Johnson & Johnson COVID-19 Vaccine
Johnson & Johnson vaccine was tested in the U.S., Latin America, and South Africa at a time when more contagious mutated versions of the virus were spreading.
The vaccinemaker's representatives said they chose to start with the single-shot as the World Health Organization (WHO) and other experts agreed that it would be a faster and more effective tool in an emergency.
Centers for Disease Control and Prevention (CDC) director Dr. Rochelle Walensky noted that new COVID-19 cases in the U.S. have increased over the past few days.
Walensky said the third vaccine would help protect more people faster despite being early to tell if the trend will last. A CDC panel is expected to meet soon to discuss how to best utilize the Johnson & Johnson vaccine.
Read more: Pfizer to Seek FDA Approval for COVID-19 Vaccine After Election