On Thursday, Johnson & Johnson, a pharmaceutical company that also had a COVID-19 vaccine under development, said in a statement that it had officially submitted an application to US authorities seeking emergency approval for its variant of the COVID-19 vaccine.
After the approval of vaccines produced by Moderna and Pfizer-BioNTech, the J&J vaccine could be the third variant to be granted authorisation in the US.
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A statement released by Janssen Biotech, a subsidiary arm of J&J said, “Johnson and Johnson has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.”
The new vaccine variant has been anticipated by the US as it solves two substantial problems. The vaccine can be stored in refrigerators thus eliminating the need for specialised logistical equipment and does not require a booster dose.
The vaccine advisory committee of the FDA is expected to reconvene and announce the results after analysing clinical trials of the vaccine.
It will be responsible for determining whether the benefits of the vaccine outweigh the risks.
That approval took about three weeks for the Moderna and Pfizer-BioNTech and vaccine variants but could be faster this time around. The final approval for emergency use will then be given, probably the following day.
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The pharmaceutical giant disclosed the results of their clinical trials last week, which involved approximately 44,000 people and was carried out in a total of eight countries.
The vaccine was overall 66% effective, the company said. And it is 85% effective in preventing severe forms of the disease.
However, the results varied geographically as the vaccine showed substantially higher efficacy rates in the US than in South Africa, where a new variant of COVID-19 has emerged.
