FDA advisory panel recommends Johnson & Johnson COVID-19 vaccine for emergency use and cleared for use. The panel including medical experts on Friday, unanimously recommended that the drug from Johnson & Johnson for emergency use. This is the first vaccine that would require just one shot and setting the stage for the likely authorization of the third such vaccine in the United States. The approval from FDA experts clears the way for a third vaccine to soon begin shipping in the world’s hardest-hit country. The panel included 22 members and were convened by the Food and Drug Administration. The committee consists of medical experts, leading scientists, consumers, and industry representatives. They voted in favor of the vaccine, which requires only one shot of protection.
FDA Experts Recommend Johnson & Johnson Vaccine For Emergency Use
The vaccine was tested in an international study of about 40,000 people, half of whom got the vaccine and half of whom got a placebo. The study shows that the vaccine is 66% effective overall in preventing moderate to severe COVID-19 disease. The formualtion of vaccine worked well in clinical trials particularly against severe disease and hospitalizations. Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, and a memeber of the board said, “We are dealing with a pandemic right now. It is great that we have this vaccine”.
The scale and size of the Johnson & Johnson trial was vast
The scale and size of the Johnson & Johnson trial was vast, spanning eight countries, three continents and nearly 45,000 participants. The company has met all the criteria the FDA established last year for a vaccine to be authorized. The large scale trial itself is a proof for safety and effectiveness that the company can manufacture the vaccine consistently and safely. Most of the committee members said that all the three vaccines are safe and effective. Dr. Cody Meissner, chief of the division of pediatric infectious disease at Tufts University School of Medicine in Boston said after voting, “It is important that people do not think that one vaccine is better that another. In this environment, whatever you can get, get”.
The company said that once FDA authorization is granted, Johnson & Johnson would start shipping 4 million doses within days, 20 million by the end of March, and 100 million by the end of June. the vaccine is found to provide robust protection against severe disease caused by resistant virus variants that are widespread in the United Kinfdom, South Africa, and Brazil. The vaccine was developed by Johnson & Johnson along with Beth Israel Deaconess Medical Center, whose center for Virology and Vaccine Research licensed technology to the New Brunswick, N.J., company. The only side effects found in participants of the study were pain at the site of the injection, headache, fatigue, and muscle pain. The committee also noted that these side effects were mostly mild or moderate.