FDA Panel Signs Off Johnson & Johnson One-Shot Vaccine For Covid-19

Luis Smith, Tech Times 26 February 2021, 11:02 pm

After a day-long meeting on Friday, an advisory panel for the US Food and Drug Administration voted unanimously to recommend and issue an Emergency Use Authorization for Johnson & Johnson's single-shot, refrigeration-stable Covid-19 vaccine.

J&J One-Shot Covid-19 Vaccine

According to the Washington Post, the Johnson & Johnson scientist argued that the One-Shot vaccine was 66 percent effective in protecting against moderate to severe illness cases in a large, global trial and 85 percent effective against severe cases.

The panel's recommendation comes the same week the US reached yet another grim milestone of 500,000 Covid-19 related deaths, raising experts' hopes of a faster and more effective inoculation process as virus mutation spread.

MIT Technology Review reports that the J&J One-Shot vaccine has an additional advantage of being easy to store because it requires nothing colder than ordinary refrigerator temperatures. It stopped 66 percent of mild and serious Covid-19 cases in a trial carried out on three continents.

The J&J One-Shot vaccine will join a US Covid arsenal that already includes authorized vaccines from Moderna and Pfizer. Those vaccines, which use messenger RNA, were significantly more effective, but they require two shots, and doses need to be stored at ultra-cold temperatures.

While the new J&J One-Shot vaccine is not effective as those made using messenger RNA technology, health officials said that should not dissuade people from getting it since it still sharply reduces the chance of illness and death.

Also Read: COVID-19 Vaccine Availability Near Me: How to Sign-Up for Alerts with Visualping!

With that said, US Chief Virologist Anthony Fauci stated that having two vaccines is fine, but having three is better. People have more choices and increases the supply, and will undoubtedly contribute to flattening the curve.

J&J One-Shot Vaccine Efficiency

Arstechnica reports that the J&J One-Shot vaccine's efficiency was 66 percent effective at preventing moderate to severe Covid-19 at 28 days after vaccination. Johnson & Johnson defined mild cases to include cases with two symptoms, such as cough and fever, which would have classified as merely "symptomatic" infections in other trials. This was all in a detailed FDA review of Phase III clinical trial data submitted by the company.

The international trial that involved over 44,000 participants in various trial sites has different efficiency in different locations. In the US, the overall efficacy was slightly higher at 72 percent. However, in places where variants of concern are widely circulating, the effectiveness fell by 64 percent in areas such as South Africa and Latin America.

Simultaneously, the J&J One-Shot vaccine's efficiency against severe and critical diseases was high across the board in all the trial locations and across all age groups. The efficiency against severe conditions was 85 percent overall in 28 days after vaccination. By location, the vaccine was efficient against severe diseases in the US by 86 percent, 82 percent in South Africa, and 88 percent in Brazil.

J&J One-Shot vaccine Side Effects

Meanwhile, the J&J One-Shot vaccine's side effects have a "favorable safety profile," according to the FDA. The most common side effect seen among 44,000 participants were injection site pain (49 percent), headache (39 percent), fatigue (38 percent), and myalgia (33 percent). There were 15 cases of blood-clotting-related conditions among vaccinated participants than the 10 participants in the placebo group.