Update 01/03/2021: The Johnson & Johnson single-dose COVID-19 vaccine has been approved by Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, for all adults in the United States, and authorized for use by the Food and Drug Administration (FDA).
Analysis from the US Food & Drug Administration (FDA) has confirmed that the Johnson & Johnson one-shot Janssen vaccine is effective against COVID-19 and it is very effective against the most severe form of the disease that has been spreading across the world over the last 14 months.
The positive analysis suggests that the FDA will soon approve the vaccine. A vote on the data is expected this Friday, February 26, so this new vaccine could be authorized as early as Saturday. This would be the first single-dose COVID vaccine approved in the United States.
The complete analysis reports on a phase 3 trial on 43,783 international participants from the United States, Latin America, and South Africa. This last group was of particular interest as the emergence of the South African variant of SARS-CoV-2 raised the question that vaccines might not be effective on new variants.
The data showed that the vaccine has an overall efficacy of 66 percent across all the geographical areas in preventing moderate and severe COVID-19 after 28 days of the jab.
In the United States, the efficacy was 72 percent. In South Africa, the efficacy was 64 percent, 7 percent higher than the interim results. When looking at severe cases alone, the efficacy was 86 percent and 82 percent respectively in the two nations.
Last week, Johnson & Johnson also submitted the data from the trial to the European Medicine Agency and the World Health Organization. The company has already signed an agreement in principle with the Gavi, the Vaccine Alliance, which would provide at least 100 million doses in 2021 to be distributed to lower-income countries.
Equitable access to vaccines around the world is crucial to curb the spread of the pandemic and to avoid the emergence of variants current vaccines are not effective against.
“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access,” Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, said in a statement. "If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries.”
The company estimate that its single-dose vaccine remains stable for two years at -20°C (-4°F) and can be kept at temperatures of 2-8°C (36°F-46°F) for at least three months, making it easy to be stored and distributed. In the US, distribution is expected to start as soon as the vaccine is authorized.
For more information about COVID-19, check out the IFLScience COVID-19 hub where you can follow the current state of the pandemic, the progress of vaccine development, and further insights into the disease.