Johnson & Johnson sends data on booster vaccines to the FDA. What happens after.

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Johnson & johnson

said on Tuesday that the company had submitted data to the Food and Drug Administration to support the use of a booster dose of its Covid-19 vaccine.

The announcement comes two weeks after the company presented the results of a randomized, controlled Phase 3 study showing that a booster dose given two months after the initial dose of its single vaccine provided 75% protection against Moderate to severe Covid-19. worldwide and 94% in the United States

Johnson & Johnson, however, stressed at the time that its vaccine remains effective without a booster and suggested that giving more first doses was still more important than offering boosters.

In its Tuesday statement, Johnson & Johnson said the data it submitted to the FDA included the results of this Phase 3 trial and that the company would also submit the data to other global regulators.

“We look forward to our discussions with the FDA and other health authorities to inform their decisions regarding boosters,” said Dr Mathai Mammen, global head of research and development at Janssen, the pharmaceutical division of Johnson & Johnson. . “At the same time, we continue to recognize that a single-injection COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component in immunizing the world’s population. “

Johnson & Johnson shares (ticker: JNJ) rose 0.5% in pre-market trading on Tuesday. The company sells its vaccine at a non-profit price, so the news has no impact on its short-term profits.

The FDA has cleared a booster dose of

Pfizer

‘s (PFE) for some Americans in late September.

Modern

(MRNA) said on September 1 that it had provided “initial data” to the FDA on a booster dose of its Covid-19 vaccine, although the company did not announce the completion of its submission. Bloomberg reported last week that the FDA was likely to allow Moderna to be recalled at half the dose used for the initial dose.

Only people who received Pfizer’s vaccine as an initial dose are currently eligible for a booster. The only exception is some immunocompromised people who received their initial doses of Moderna vaccine and are eligible for a Moderna booster. The FDA did not clear the mix-and-match boost, saying there was not enough data available. Public health experts condemned the situation.

“I just don’t understand how… we can tell people 65 and over, you are at risk for serious illness and death, but only half of you can protect yourself right now,” the Dr Sarah Long, a member of the Centers for Disease Control and Prevention’s vaccine advisory committee and a professor of pediatrics at Drexel University College of Medicine, said at an advisory committee meeting in September. “It doesn’t sound like good public health policy. “

It is now up to the FDA to authorize the recalls for the Johnson & Johnson and Moderna vaccines, or to allow people who initially received these vaccines to take the Pfizer booster. According to CDC data, 102.1 million people in the United States received the first doses of the Pfizer vaccine, while 68.7 million received the first doses of Moderna and 14.9 million received the single-injection vaccine. Johnson & Johnson.

The agency said 4.3 million people have received a Pfizer recall, while 1.4 million have received a Moderna recall.

Write to Josh Nathan-Kazis at [email protected]