Johnson & Johnson announced Tuesday that a second dose of its COVID-19 vaccine given at two months provides 94% protection against the coronavirus in the United States.
The company released data Tuesday from a late-stage clinical trial which showed 100% protection against severe or critical COVID-19 and 75% protection against symptomatic COVID-19 globally. The results of the study have not yet been peer reviewed.
"Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations," Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, said in a statement. "Additionally, our Phase 3 trial data further confirm protection against COVID-19-related death."
"Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases," Mammen added.
The company said that antibody levels rose 4-6 times higher after a booster shot of its COVID vaccine was given after two months, while a booster shot given six months after the first shot provided a 12-fold increase in antibodies.
“It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19. A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population,” Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, said. “At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”
Johnson & Johnson said it has provided the data to the FDA and will submit to other regulators to assess use of booster doses of its vaccine.
More than 14 million Americans have been fully vaccinated with the single-dose J&J vaccine as of Monday, according to data from the Centers for Disease Control and Prevention (CDC).
But with the Food and Drug Administration’s (FDA) independent advisory panel recommending a third dose of the Pfizer-BioNTech COVID-19 vaccine for Americans 65 and older and those at high risk of severe disease last week, many have questioned when such guidance will be available for those who received the J&J and Moderna vaccines.
Dr. Anthony Fauci, the White House's chief medical adviser, discussed the potential for a third dose of the Moderna vaccine and a second dose of the Johnson & Johnson vaccine on talk shows Sunday, saying the data needed for the FDA to examine the possibility of those boosters will be available in “a couple to a few weeks.”
“We're working on that right now, to get the data to the FDA, so they can examine it and make a determination about the boosters for those people,” Dr. Fauci said on NBC’s “Meet the Press” on Sunday of individuals who received either the Moderna or Johnson & Johnson vaccine. “They're not being left behind by any means.”