It could be accepted as early as Saturday,
An independent committee of vaccine experts unanimously recommended that the Johnson & Johnson one-shot COVID-19 vaccine be approved by the Food and Drug Administration for people 18 and older, putting it one step closer to use in the United States. Within days, the FDA is expected to approve the vaccine.
“I think it’s a relatively easy call,” said committee member Eric Rubin, an immunologist at the Harvard T.H. Chan School of Public Health. “It’s nice to have a single-dose vaccine.”
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) met today to discuss the outcomes of this vaccine’s clinical trials, which the FDA has been monitoring for the past three weeks.
The study by the FDA, published earlier this week, showed that the vaccine was safe and 85 percent effective globally against serious COVID-19 cases. No one who got the vaccine has been diagnosed with COVID-19 or has died from it.
When more mild cases are included, the efficacy declines to 72% in the United States and 64% in South Africa, where a coronavirus type that may partially evade immune defence is spreading. But the trial had some rather good outcomes, including for individuals who obtained mild cases. According to a Johnson & Johnson study, people who got sick with COVID-19 after being vaccinated showed less symptoms than people who got sick after not being vaccinated.
Early vaccine results indicated that it tended to be less successful in older adults or people with health conditions such as HIV, but FDA officials acknowledged that less data was available in certain subsets of participants in the study. The gaps between those at-risk groups and the rest of the people in the trial began to shrink as more cases were added to the study, said Rachel Zhang, a medical officer with the FDA, today during a presentation on the data.
The vaccine from Johnson & Johnson only takes one dose to protect people against COVID-19, which makes it easier to administer than the vaccines from Moderna and Pfizer / BioNTech, which require two doses each. “The mechanism is streamlined. For their full vaccine, individuals just have to make one appointment. During the company’s presentation, Greg Poland, director of the Mayo Clinic’s Vaccine Research Department, said that a one-dose vaccination eliminates the pressure on the health-care system and providers.
In order to see whether two doses of their vaccine will be any better than one, the organisation even conducts clinical trials. VRBPAC member Paul Offit, a vaccine researcher at the Children’s Hospital of Philadelphia, noted that switching the vaccine to two doses if it proved to be more successful would be difficult. During the conference, he said, “You can see how it will be confusing to people.” Rubin brought up the same point. “That seems like a major logistical problem.”
Additional trials will also be performed by Johnson & Johnson to test the vaccine in teens, infants, and pregnant women.
The company says it has 4 million ready-to-ship doses of the vaccine upon authorisation.