The US Food and Drug Administration (FDA) is presently working to clear yet another COVID-19 vaccine for emergency use in the country that has seen the highest number of cases and casualties. Once approved, the single-dose Johnson & Johnson vaccine will be administered alongside the Pfizer and Moderna vaccines.
According to an analysis released by US regulators, the J&J vaccine is safe and offers strong protection against COVID-19. FDA officials have said that the vaccine is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness.
Called Ad26.COV2.S, it is a non-replicating viral vector vaccine that uses genetic material from the SARS-CoV-2 virus.
Who is it for?
The vaccine is likely to be approved for people aged 18 and older in the US. It must be mentioned that third-phase trials are ongoing.
Does it cause side effects?
Similar to the other COVID-19 vaccines in the US, the main side effects of this shot are pain at the injection site and flu-like fever, fatigue, and headache. The single-dose vaccine has been tested on about 44,000 adults in the US, Latin America, and South Africa with a two-month median follow-up.
"The analysis supported a favourable safety profile with no specific safety concerns identified that would preclude issuance of an EUA," the US FDA said.
The FDA noted that there were no COVID-19-related deaths and no COVID-19 cases requiring medical intervention 28 days or more post-vaccination among participants aged 60 or older with comorbidities in the vaccine group.
How does it have to be stored or used?
According to a press note released by the company, the vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36 - 46°F (2 to 8°C). The company says the vaccine should not be re-frozen if distributed at temperatures of 36°F – 46°F (2°-8°C).
Will this vaccine come to India?
While the temperatures are conducive for the vaccine to be used in India, there are no confirmed reports of this vaccine coming to India in the near future. This, however, might change over the next few months. As per reports from February, Johnson & Johnson is interested in manufacturing its vaccine in India.
(With inputs from agencies)