NASSAU, BAHAMAS — The Food and Drug Administration (FDA) has approved Johnson & Johnson’s coronavirus vaccine for emergency use, which will be administered as a single dose.
The EUA (emergency use authorization) was issued on Saturday and allows the Janssen COVID-19 vaccine to be distributed in the United States for use in individuals 18 years or older.
It is the third vaccine to receive EUA in the United States amidst the ongoing global pandemic, joining the Pfizer-BioNTec and Moderna vaccine.
The FDA has determined the totality of the available data provides clear evidence that the Janssen vaccine may be effective in preventing COVID-19 and shows that the vaccine’s known and potential benefits outweigh its known and potential risks.
“In making this determination, the FDA can assure the public and the medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information,” the organization said.
The effectiveness data includes an analysis of 39,321 participants in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico and the US who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine.
The vaccine was approximately 67 percent effective in preventing moderate to severe or critical COVID-19 symptoms occurring at least 14 days after vaccination and 66 percent effective in preventing moderate to severe or critical COVID-19 symptoms occurring at least 28 days after vaccination.
Currently, there is no data available to determine how long the vaccine will provide protection, nor whether the vaccine prevents transmission of SARS-CoV-2 from person to person.
The vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26) to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus.
While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness.
After someone receives this vaccine, their body can temporarily make the spike protein, which does not cause diseases but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
The Bahamas was expected to receive the first tranche of 100,000 doses of AstraZeneca last week, as part of the World Health Organization/Pan American Health Organization COVAX facility.
However, Minister of Health Renward Wells told the media yesterday that that vaccine has not yet arrived in country.
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