Johnson & Johnson will seek FDA authorization for booster shot

WASHINGTON – Johnson & Johnson plans to press federal regulators earlier this week to allow a coronavirus vaccine booster, according to officials familiar with the company’s plans. Against the backdrop of growing evidence that at least the elderly and other high-risk groups need more protection, the company is the last of three federally approved vaccine providers to request additional injections.

Federal officials are increasingly concerned that the more than 15 million Americans who have received the Johnson & Johnson vaccine are at very high risk for serious COVID-19. The Food and Drug Administration has scheduled a meeting of its panel of experts for October 15 on Friday to discuss whether to approve emergency clearance for Johnson & Johnson’s vaccination.

This is part of a broader government effort to increase protection against the three vaccines. Regulators last month approved booster vaccinations for some Pfizer BioNtech vaccine recipients and are considering doing the same for Moderna recipients this month.

The fact that a Johnson & Johnson Advisory Committee meeting is scheduled before the company submits an application to the Food and Drug Administration for better protection for these vaccine recipients creates a certain sense of urgency within the Biden administration. Mirror.

Although the federal government insisted all three vaccines were highly effective for months, a recent study by the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine for COVID-19 was only 71% more effective than hospitalization. 88% for Pfizer BioNtech vaccines and 93% for Moderna.

“Real-world data suggest that Moderna and Pfizer-BioNtech two-dose mRNA vaccination regimens provide greater protection than Johnson & Johnson single-dose regimens,” the researchers said. Other research has shown that recipients of Johnson & Johnson are more likely to experience breakthrough infection or COVID-19 symptoms than recipients of the other two vaccines.

Johnson & Johnson cites several studies with better results: A company-sponsored study of nearly two million people estimated that the vaccine was 81% effective against hospitalizations. Other studies have shown that protection against Johnson & Johnson’s vaccine does not decrease over time as protection with Pfizer BioNtech’s vaccine.

Even so, Johnson & Johnson now agrees with federal agencies that one shot of its vaccine is not enough.

Last month, the company announced that a second dose was given two months after the first, increasing the effectiveness of the symptomatic COVID-19 vaccine by nearly 22 percentage points to 94 percent. The company also says both injections are 100% effective against serious illness, though that assessment is less than convincing.

“The data show a dramatic increase in efficiency when increased for more than two months. And we believe it might be even better if it is given later,” said dr. Dan H. Baruch, the US virologist who helped develop the vaccine.

“I’m not a public health department, but I would say that for people who want a high level of effectiveness, it makes scientific sense to get a booster shot two to six months after the first vaccination.” , said.

At a CDC advisory committee meeting in September, several independent experts questioned whether Johnson & Johnson receivers were forgotten when the federal government tried to give Pfizer receivers a third chance.

“For me, Johnson & Johnson is the biggest political issue,” said Dr. Helen Kip Talbot, specialist in internal medicine and infectious disease at Vanderbilt University, at a meeting last month. For some Pfizer receivers. “I’m afraid the Pfizer Booster issue will distract us when we have bigger and more important things to do in the midst of a pandemic.”

dr. Nirav D. Shah, Maine senior health official and president of the Association of State and Territorial Health Officers, said that after the Johnson & Johnson vaccine became available this spring, many states were directing it to rural areas because only one was available to him. Requires injection and is easy to carry.

“Rural areas are currently heavily affected by delta options,” said Dr. Shah. “So I think there’s good reason to offer boosters to J&J receivers if the data supports it.”