Johnson & Johnson company announced that U.S. Food and drug Administration (FDA) has issued Emergency Use Authorization for its single-dose COVID-19 vaccine, developed by Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from Phase 3 ENSEMBLE study that demonstrated the vaccine was has 66.3% effectiveness overall and 74.4% effectiveness in the United States.
Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis emergency pandemic use. The company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. during the first half of 2021.
With the FDA’s emergency use authorization of the Johnson & Johnson vaccine on Feb. 27, the U.S. now has three highly effective vaccines against COVID-19.
Britain on Friday approved the use of the single shot Johnson & Johnson coronavirus vaccine, the Medicines and Healthcare products Regulatory Agency (MHRA) announced.
“This is a further boost to the UK’s hugely successful vaccination programme , which has already saved over 13,000 lives, and means that we now have four safe and effective vaccines approved to help protect people from this awful virus,” said Health Secretary Matt Hancock.
The government hopes the single-dose jab “will play an important role in the months to come”, he added, as young people come forward for their vaccinations amid concern over the rise of the so-called Indian variant.
Britain has ordered 20 million doses of the vaccine.
Important Safety Information
What are the side effects?
Side effects have been reported-
1) Injection site reaction- pain, redness of the skin and rashes
2) General side effects- headache, feeling very tired, muscle aches, nausea, fever.
There is a remote chance that Janssen CVOID-19 vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occurs within a few minutes to one hour after getting a dose of Janssen COVID-19 vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring.
Signs of a severe allergic reaction can include-
- Difficulty in breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
These may not be all the possible effects. Serious and unexpected effects may occur.
What should I do about side effects?
If you experience a severe allergic reaction, go to the nearest hospital.
Call the vaccination center or your healthcare provider if you have any side effects that bother you or do not go away.