J&J Decided to Get FDA Approval for Booster Shot

Johnson & Johnson asked the Food and Drug Administration FDA to grant emergency use approval for a booster shot

Johnson & Johnson Planned to Get FDA Approval for Booster Shot Source: Web

According to officials familiar with the plans of the company, Johnson & Johnson is planning to take approval from the federal regulators for the booster dose of the coronavirus vaccine. J&J is the last of the major three federally approved vaccine providers to call for additional shots, amid growing evidence that at least the elderly and other Americans are at high-risk groups who need more protection.

Federal officials have serious concerns that the over fifteen million Americans who received the J&J vaccine face too much risk of severe infection. On Friday, the U.S. Food and Drug Administration (FDA) scheduled a meeting on 15th October of its expert advisory committee to review whether to allow emergency use authorization of a Johnson & Johnson booster vaccine dose.

It is part of a comprehensive effort by the government to bolster the protection provided by all three major vaccines. Last month, health regulators authorized a Pfizer-BioNTech vaccine booster dose for several Americans and considered doing the same this month for recipients of Moderna vaccines.

Biden Government effort to Provide Increased Protection to Americans

Though the federal officials emphasized for the last some months that all three vaccines are highly effective, the latest research by the Centers for Disease Control and Prevention (CDC) found that the single-shot vaccine of J&J was only seventy-one percent effective against hospitalizations and deaths from COVID-19, compared with eighty-eight percent for Pfizer-BioNTech’s vaccine and ninety-three percent for Moderna vaccine.

The virus claimed over seven hundred thousand lives in the country while the filing came as a senior FDA official said that the latest statistics might make a strong case that every American eighteen and older should be eligible for booster shots – but he added that the health agency would have to wait whether its outside advisory committee approves.

Moreover, the FDA plans to meet with its vaccine advisory committee on 14th and 15th October to discuss booster shots for the Johnson & Johnson and Moderna vaccines. The director of the Center for Biologists Evaluation and Research, Peter Marks, said on a webinar that the FDA hopefully has a consistent approach to booster shots for all three COVID0-19 vaccines currently permissible in the U.S. – and to make the eligibility criteria simple for Americans to understand.

A global head of research and development for the Janssen Pharmaceuticals division of J&J, Mathai Mammen, said that in its submission to the FDA, J&J is requesting to look at the company’s statistics and agree with it to support a booster for Americans eighteen and older. In an interview, Mammen said that the company believes the most effective response occurs after administering a booster shot of vaccine at least six months after the regular vaccination.

Will two months gap between actual and booster dose, will increase effectiveness?

Last month, Johnson & Jonson announced that a second shot, administered two months after the first, increased the effectiveness of the vaccine against symptomatic coronavirus by around twenty-two percent to ninety-four percent. The company also said that two doses were hundred percent effective against severe illness, even though estimation was less conclusive.

J&J Decided to Get FDA Approval for Booster Shot — Johnson & Johnson Planned to Get FDA Approval for Booster Shot

A virologist at Beth Israel Deaconess Medical Center in Boston, Dr. Dan H. Barouch, said that the statistics reveal that there is a dramatic surge in efficacy when the boost shot administered after two months of the actual shot. At a September meeting of the CDC advisory committee, some independent authorities asked whether J&J recipients were being forgotten while the federal officials moved to approve a booster dose for Pfizer recipients.

If the FDA administration approves a second dose six months after the initial shot, it will allow the company to market its COVID-19 vaccine as one dose regimen and also a booster. Some statistics indicate that a second dose at six months produced a stronger and more effective immune response than a second dose at two months.