Johnson & Johnson Plans To Seek FDA Authorization For Its Single-Dose Vaccine

Johnson & Johnson plans to seek FDA authorization in February for what could become the first single-dose COVID-19 vaccine authorized for use by the general public in the U.S.

The company’s COVID-19 vaccine candidate was 66% effective at preventing moderate to severe COVID-19 28 days after recipients received the first and only dose, according to a summary released by the company. Johnson & Johnson also said the vaccine candidate was 85% effective at preventing severe disease, and no one was hospitalized for COVID-19 beginning a month after receiving the shot. The trial data was based on 43,783 participants.

“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” said Dr. Paul Stoffels, chief scientific officer. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”

However, Johnson & Johnson also said the COVID-19 vaccine candidate’s efficacy varied by the country the trial participants were located in. “The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination,” said the company.

The Wall Street Journal reports that Johnson & Johnson will be looking at why the efficacy rates in South Africa were lower and acknowledged it could be because it doesn’t work as well against the variant spreading in that country.

Scientists still consider the vaccine candidate to be promising, reports The New York Times, which notes the annual flu vaccine has an efficacy range between 40% and 60%.

“This is a really great result,” Akiko Iwasaki, a Yale immunologist, told the Times. “I hope this vaccine gets approved as soon as possible to reduce disease burden around the world.”

Dr. Matha Mammen, global head at Janssen R&D, which is owned by Johnson & Johnson, said changing the trajectory of the pandemic would be aided by the development of the company’s single-dose vaccine candidate.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” he said. “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

The New York Times, citing “federal health officials familiar with production,” reports that Johnson & Johnson may only have 7 million vaccines ready by the time it would be authorized for emergency use, should it actually receive FDA emergency authorization.

That said, the officials said Johnson & Johnson could produce 23 million more doses by April. The company has a contract with the federal government to produce 100 million total doses of vaccine by the end of June, enough for 100 million Americans to get one.

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