On Wednesday, Johnson & Johnson and the Food and Drug Administration released their detailed analysis on the former’s single-dose COVID-19 vaccine. The FDA has announced that the company’s data has met the requirements needed so that the vaccine can be reviewed for emergency use authorization.
According to FDA scientists, the said vaccine proved to be 85% effective at preventing severe COVID-19 illness in clinical trials. Meanwhile, it is 66% effective at preventing asymptomatic COVID-19 cases.
Additionally, the data shown in the analysis revealed that the single-dose vaccine also works against all other variants. The vaccine was less effective at preventing cases with symptoms in South Africa. There, a known variant of COVID-19 is dominant. However, it still managed to prevent severe illness there at a high rate.
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Additionally, the vaccine manufacturer released preliminary data which shows that the vaccine can help stop asymptomatic infections. It also showed that the variant dominant in Brazil did not have as big of an impact regarding the vaccine’s efficacy rate as the South American one did.
The FDA also did not find serious safety concerns regarding the mild side effects of the vaccine. Such side effects include pain at the injection site, headache, fatigue, and fever. According to the data, 9% of respondents who received the vaccine had a fever.
J&J’s Single-Dose Vaccine Ready to Ship If Granted Authorization
If it receives authorization, Johnson & Johnson claimed it can ship 4 million doses immediately. It also said they would have 20 million doses ready for shipping by March and 100 million by the end of June. Additionally, the said vaccine would likely be authorized for the immunization of adults over 18 years old.
This, along with the supply Pfizer and Moderna have, both of which require two doses instead of one, might be enough to immunize 130 million people in the U.S. by the end of March.
Authorization of the Johnson & Johnson vaccine isn’t expected until Friday at the earliest. The process entails a public hearing on Friday, during which, the FDA’s independent advisory committee will deliberate whether it will give a recommendation for or against the use of the single-dose vaccine.